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The Parliament of the Commonwealth of Australia

SENATE STANDING COMMITTEE ON SOCIAL WELFARE

Another Side to the Drug Debate . . . a medicated society?

Brought up and ordered to be printed 14 May 1981

Parliamentary Paper No. 98/1981

ANOTHER SIDE TO THE DRUG DEBATE ... a medicated society?

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

ANOTHER SIDE TO THE DRUG DEBATE . . . a medicated society?

Report from the Senate Standing Committee on Social Welfare

A ustralian G overnm ent Publishing Service C anberra 1981

Reference:

Continuing oversight of relevant aspects of the Report of the Senate Select Committee on Drug Trafficking and Drug Abuse

A report on the use and abuse of medication available over the counter or on prescription

( Commonwealth of Australia 1981 ISBN 0 642 05865 2

Printed by Watson Ferguson & Co.. Brisbane

MEMBERS OF THE COMMITTEE

Senator Shirley Walters (Tasmania). Chairman Senator Neville Bonner (Queensland) Senator Ron Elstob (South Australia) Senator Don Grimes (Tasmania) (1) Senator Bernie Kilgariff (Northern Territory) (2) Senator Jean Melzer (Victoria)

Former Members of the Committee Senator Peter Baume (New South Wales) (to 24 November 1980)

Senator George Georges (Queensland) (from 16 October 1979 to 22 April 1980)

Secretary Peter Keele The Senate Parliament House

Canberra

(1) Discharged from Committee on 16 October 1979. reappointed 22 April 1980 (2) Appointed 24 November 1980

Contents

Page

Reappraisal of a declared strategy . . . . . ix

Recommendations . . . . . . . xi

CHAPTER 1 Introduction. . . . . . . . . i

SECTION ONE THE USE OF MEDICATION IN OUR SOCIETY.................................. 5

CHAPTER 2 Consumption levels and patterns of prescription and over-the-counter drugs Introduction . . . . . . . . 7

Recent survey information on the use of medication in the community . . . . . . . . 8

Australian Health Survey 1977-1978 . . . . 8

Gosford-Wyong and lllawarra Survey . . . . 1 1

Survey conducted by the South Australian Royal Commission 14 The Traralgon Survey . . . . . . 1 5

Summary of surveys . . . . . . . 1 6

Consumption patterns and levels . . . . . 1 6

Patterns of drug usage . . . . . . 1 6

Data collection . . . . . . . 1 8

Pensioner Pharmaceutical Benefits Scheme prescribing . 21 Repatriation Pharmaceutical Benefits Scheme prescribing . 22 Prescribing in hospitals . . . . . 25

Trends in total ethical drug consumption sold through pharmacy outlets . . . . . 2 6

Trends in overall drug consumption . . . . 2 7

Conclusions and recommendations . . . . . 28

CHAPTER 3 Consumption of drugs which cause concern Introduction . . . . . . . . 30

Prescription psychotropic drugs . . . . 30

Surveys . . . . . . . . . 30

Consumption . . . . . . . . 33

Over-the-counter analgesics . . . . . 35

Vitamins . . . . . . . . . 37

Cough and cold preparations . . . . . . 39

International comparisons . . . . . 40

Conclusions and recommendations . . . . 41

SEC TION TWO AN EXAMINATION OF THE EVALUATION, DISTRIBUTION AND CONTROL OF DRUGS Introduction . . . . . . . 45

CHAPTER 4 Evaluation, quality, standards Commonwealth legislation and controls . . . 47

Importation of therapeutic substances . . . 47

v

Import licences . . . . . . . 48

Approval to import a new drug for marketing . . 48

Standards . . . . . . . . 48

The Therapeutic Goods Act . . . . . 4 8

The National Biological Standards Laboratory . . 49

Code of Good Manufacturing Practice . . . 4 9

Unique Australian standards . . . . . 5 0

Evaluation . . . . . . . . 51

The Australian Drug Evaluation Committee . - 5 1

Lack of international uniformity . . . . 5 1

The time taken to evaluate a drug . . . - 5 2

Erosion of patents . . . . . . 54

State legislation and controls . . . . . . 55

Control of drugs through scheduling . . . - 5 5

Registration . . . . . . . . 57

The Victorian registration system . . . - 5 7

National registration scheme . . . . - 5 9

Imported products for personal usage and borderline therapeutic substances. . . . . . . 6 1

Imported products for personal usage . . . . 6 1

Borderline therapeutic substances . . . . . 6 1

Herbal remedies . . . . . . . 6 1

Therapeutic foods and dietary foods . . . . 6 2

Conclusions and recommendations . . . . . 6 3

CHAPTER 5 Distribution system—its structure and controls Introduction . . . . . . . . 67

Structure . . . . . . . . . 67

Manufacture and importation of therapeutic substances . 67 Wholesaling . . . . . . . . 7 1

Retail pharmacies . . . . . . . 72

The future of manufacturing, wholesaling and retailing . 75 The hospital pharmacy . . . . . . 7 6

The doctor . . . . . . . . 77

Controls . . . . . . . . . 77

Introduction . . . . . . . . 77

Manufacturing controls . . . . . . 77

The Pharmaceutical Benefits Scheme . . . . 7 8

Pharmacy boards . . . . . . . 79

Medical boards . . . . . . . 80

Summary- professional boards . · . . . . 8 0

Industry and professional associations . . . . 8 1

Conclusions and recommendations . . . . . 8 1

CHAPTER 6 Monitoring drugs of dependence—the need for accountability Introduction . . . . . . . . 84

Importation of drugs of dependence . . . . . 8 4

Drugs of Dependence Monitoring Scheme . . . . 8 6

Four-weekly reports . . . . . . . 86

Responsibility of doctors and pharmacists . . . . 8 8

Law enforcement . . . . . . . . 88

Conclusions and recommendations . . . . . 8 9

Page

vi

Page

CHAPTER 7 Drug promotion Types of promotion . . . . . . . 9 1

Expenditure on promotion . . . . . . 9 1

Advertising in journals . . . . . . . 92

C o s t ....................................................................................... 92

Content of advertisements in journals . . . . 9 4

Medical representatives . . . . . . . 95

Direct mail and other types of promotion . . . . 9 6

Controls on promotion . . . . . . 97

Prescription drugs . . . . . . . 97

Over-the-counter drugs . . . . . . 99

The effect of promotion on consumption . . . . 100

Conclusions and recommendations . . . . . 1 0 2

SECTION THREE UNTOWARD EFFECTS OF DRUGS

CHAPTER 8 Adverse drug reactions Surveys of incidence . . . . . . . 1 0 7

Undergraduate and continuing medical education . . . 1 0 8 Adverse drug reaction surveillance . . . . . 1 0 9

Hospital drug monitoring . . . . . . 1 1 2

Conclusions and recommendations . . . . . 1 1 3

SECTION FOUR MEDICATION—THE SOLUTION TO SOCIETY'S ILLS?

CHAPTER 9 Why medication? Methods of coping with illness . . . . . . 1 1 7

Mystique of medication . . . . . · 117

Placebo effect . . . . . . . 1 1 8

Symbolic aspects of medication . . . . 118

Ritual (doctor-patient roles) . . . . ■ 118

Tacit government support . . . . ■ . 1 1 9

Economic aspects of medication . . . . . 1 1 9

Benefits of medication . . . . ■ · 119

Summary benefits . . · · ■ ■ 120

Conclusions . . . . · ■ ■ . 1 2 0

CHAPTER 10 Some aspects of inappropriate use Introduction . . . . · ■ · 122

Non-compliance . . . ■ ■ · · 123

What can be done? . . · ■ · · - 1 2 7

Medication the solution to society's ills'1 . . . . 1 2 8

Women . . . . ■ ■ ■ · 129

The elderly . . . ■ ■ ■ · . 1 3 0

Children . . . · · ■ ■ 131

Responsibility the doctor . . . . . 133

Responsibility industry . . . . . . 134

Responsibility the individual . . . . . 1 3 5

Barbiturates a model . . · . · ■ - 1 3 5

Conclusions and recommendations . . . . . 1 3 9

vii

Page

CHA PTER 11

SECTION FIVE

CHAPTER 12

CHAPTER 13

APPENDIXES Appendix 1

Appendix 2

Appendix 3

Appendix 4 Appendix 5

Medication and the maintenance of health Introduction . . . . .

Medicine equals health? . . .

Medicalisation of society . . .

Future of medicine . . . .

Determinants of health . . . .

What can be done? . . . .

Conclusions and recommendations . .

BACKGROUND

History of medication The development of therapeutic drugs . The development of the drug industry . Pharmacies . . . . .

The medical profession . . .

The pharmaceutical manufacturing industry The history of the Pharmaceutical Benefits Scheme Conclusions . . . . .

Background and conduct of the inquiry Collection of evidence . . . .

Expert adviser . . . . .

Commissioned data . . . .

Acknowledgments . . . .

142

142

143

144

145

146

148

151

152

152

153

154

155

155

158

159

159

159

Surveys of sales of therapeutic drugs from manufacturers to hospitals 1974-1979 . . . . . . . 160

Use of medically prescribed psychotropic drugs (sedatives, anti­ depressants and tranquillisers)- a compilation of survey informa­ tion 1971-1977 . . . . . . . . 162

Code of conduct for the Pharmaceutical Industry Code Relating to Ethical Advertising . . . . . . . 166

List of witnesses . . . . . . . . 1 7 0

List of submissions . . . . . . . 1 7 3

Reappraisal of a declared strategy

In 1977 this Committee outlined a seven-point strategy to deal with the inappropriate use of drugs. That strategy is still relevant today and in particular we would like to re­ emphasise the following three points:

1. Total elimination of drug abuse is unlikely, but government action can contain the problems and limit their adverse effects. Control of drug abuse requires a long-term commitment within a publicly declared program with clearly identified goals, and with a time frame, monitoring procedures, financing arrangements and standards all specifically

stated.

2. All drugs are not equally dangerous and all drug use is not equally destructive. Control efforts should therefore concentrate on drugs having the most adverse public health effects, particularly where use puts others at risk. Programs should give priority to individuals abusing high-risk drugs and to compulsive users of any drugs.

7. The F ederal Government has p articular responsibility fo r giving national leadership in coping with drug abuse. The States have an equally important role, especially in the direct provision of services. No national control program will be effective unless all governments co­ ordinate their activities. The Commonwealth Minister for Health should have primary

responsibility for Commonwealth action relating to all forms of drug use and abuse.1 In addition, the Committee urges the Commonwealth Government to recognise that:

8. Because of the complexities and ramifications of drug therapy, Australia must retain its own expertise and personnel involved in all facets of drug development, manufacture and use. With an annual expenditure on drugs of around $800 million, such a strategy will have significant economic benefits. It w'ould also enable the continued training of the key personnel required to evaluate, research

and monitor our future drug requirements. Without the maintenance of a nucleus of an industry which is involved in the manufacture of active ingredients as well as formulation and packaging, we could become totally dependent on overseas expertise and advice. 9. Most modern medications are powerful, specific and effective in many of their

applications, and, perhaps largely because of this, have become an integral part of our society. There were around 90 000 000 pharmaceutical benefit pre­ scriptions in Australia in 1979 80, and in over 98 per cent of these doctors have prescribed the maximum amounts as set out in the benefits formulary .2 10. As Australia enters the 1980s it is faced with an oversupply of professionally

qualified and trained doctors and pharmacists .3 It is important, therefore, that with such an oversupply, the current high level of per capita drug consumption ($55 per head) does not escalate further. Continuing education programs are needed for doctors, pharmacists and for the community. Such programs should

stress the appropriate use of and expectations from drug treatment. In addition, broader community programs need to be implemented which w ill encourage and promote a more positive approach to health, with greater emphasis being placed on the individual's control over his own well-being.

11. Appropriate use of therapeutic substances cannot always be isolated from

inappropriate use. There is a need for a balanced and rational debate on what constitutes inappropriate use. it should be recognised that all forms of drug use cannot be seen simply in terms of right or wrong, desirable or undesirable, beneficial or harmful. Most problems associated with therapeutic drugs are in what can be termed the 'grey' area, that is, an area where there are costs and benefits associated with their use. As stated in the previous report, inappropriate use is primarily a social- medical rather than a legal problem, though such use may have important legal consequences and aspects, it is not simply inherent in

the drug but depends upon the consumer as well as the provider, inappropriate users are not a clearly defined subgroup within our society but are spread through all age levels and social groupings.

References

1. Senate Standing Committee on Social Welfare, Drug problems in Australia an intoxicated society'.', AGPS, Canberra, 1977, pp. 1, 2. 2. Supplementary evidence supplied by the Commonwealth Department of Health. 3. Supplementary evidence supplied by the Pharmacy Guild of Australia and Australian Medical

Association.

Recommendations

The recommendations made in this report are brought together and listed here for convenient reference.

CHAPTER 2 Consumption levels and patterns of prescription and over-the-counter drugs 1. That the Commonwealth Department of Health develop a data base which is able to give an adequate assessment of the consumption of therapeutic drugs. CHAPTER 3 Consumption of drugs which cause concern

2. That the Australian Drug Evaluation Committee, the Food Standards (Standing) Committee and the National Therapeutic Goods Com­ mittee jointly study the question of vitamins and produce a public- report which should be widely disseminated. CHAPTER 4 Evaluation, quality, standards

3. That merchant importers be subject to the same conditions of import as manufacturers. 4. That the States incorporate the Code of Good Manufacturing Practice into their legislation as soon as practicable.

5. That both the Commonwealth and the State governments ensure that officers are made available to staff the Inspection Unit of the National Biological Standards Laboratory with the numbers necessary to allow that Unit to meet the requirements of the Code of Good Manufactur­ ing Practice. 6. That the continued role of the Commonwealth Department of Health

to control drug approvals should be dependent upon its capacity to undertake this task with efficiency and despatch. The Department should be required to demonstrate at intervals that it is doing so. 7. That the patent life of drugs be extended from 16 to 20 years. 8. That the States incorporate the General Labelling Order into their

legislation as soon as legal drafting is completed. 9. That the Commonwealth Department of Health in co-operation with the States undertake an investigation into the feasibility of establish­ ing a system of information transfer among the relevant regulatory

authorities throughout Australia. 10. That the national registration scheme proposed by the National Therapeutic Goods Committee be instituted as soon as practicable. 11. That the Commonwealth Department of Health be enabled to recruit

the necessary qualihed staff to allow the Department to effectively manage the borderline therapeutic substances area. CHAPTER 5 Distribution system— its structure and controls 12. That all State medical and pharmacy boards meet with their respective

counterparts to establish a uniform code of practice regarding inquiry and disciplinary procedures to ensure that similar matters in each State are dealt with uniformly and expeditiously. CHAPTER 6 Monitoring drugs of dependence— the need for accountability

13. That any drug of dependence that is subject to inappropriate use. in particular recreational use. should be monitored.

CHA PTER 7

CHAPTER 8

CHAPTER "10

14. That the Drugs of Dependence Monitoring Scheme be extended to the patient-doctor level. Drug promotion 15. That representatives from the Commonwealth Department of Health,

the Australian Pharmaceutical Manufacturers Association, the Aus­ tralian Medical Association and other interested parties come together to frame appropriate values and standards of advertising. 16. That the abovementioned group look into the need to promote and

inform doctors about the vast number of less profitable (and in many cases non-profitabale) drugs. 17. That a certain percentage of advertising revenue be specifically earmarked by the drug manufacturers for educational advertising. 18. That the journal Australian Prescribe!· continue to receive government

funding.

19. That the Australian Pharmaceutical Manufacturers Association, the National Medical Media Council, the Australian Medical Association and other relevant organisations draw up a new code relating to ‘reminder advertisements'. If a more satisfactory voluntary code cannot be formulated by the abovementioned bodies within six months of this report appearing, the Committee recommends that the National Therapeutic Goods Committee draw up proposals (which do not require full disclosure of the drug but do set out adequate standards of advertising) to be enforced by legislation for controlling the promotion of prescription

medication. 20. That the Therapeutic Advertising Council as a matter of urgency invite representation from one or more of the medical associations. 21. That a clause forbidding the advertising of therapeutic substances at

discount prices be inserted into the Voluntary Code for the Advertising of Goods for Therapeutic Use. Adverse drug reactions 22. That the Government provide the Commonwealth Department of Health with any financial assistance it requires to help implement the establishment of adequate and effective schemes designed to monitor and detect the occurrence of adverse drug reactions. 23. That the establishment within hospitals of adequate monitoring and reporting of adverse drug reactions be a necessary requirement for accreditation. Some aspects of inappropriate use 24. That representatives from manufacturers, medical associations, the pharmacy guilds and the Commonwealth Department of Health meet together to draw up standard instruction sheets for various courses of medication. 25. That barbiturates be scheduled as Schedule 8, which incorporates narcotic drugs and drugs of dependence. That doctors prescribing barbiturates for a regular patient who uses that drug appropriately, and whom the doctor would prefer to remain on that drug, be enabled to seek and receive permission from the Commonwealth Department of Health to continue to prescribe that drug without interruption. No new patient should be eligible for the prescribing of barbiturates unless special circumstances such as epilepsy warrant it.

CHAPTER 11

26. That necessary staff be made available immediately to the Drugs of Dependence Monitoring Scheme to enable it to monitor the specified barbiturates. Medication and the maintenance of health 27. That all governments in Australia reaffirm their support, both to the

concept and implementation, of the declared strategy outlined in our previous report. Drug problems in Australia—an intoxicated society?. as well as the reappraisal of that strategy outlined in this report. 28. That the Commonwealth Department of Health undertakes a study to

obtain more information about the relative importance of all determinants of health. 29. That the Commonwealth Department of Health undertake a pilot study to examine the feasibility of using the mass media to get across to

the public effective messages concerning determinants of health other than drugs. 30. That all education departments or their equivalent reassess the place of sport and physical education within school curricula.

CHAPTER 1

I n t r o d u c t i o n

This report supplements an earlier report of the Committee. Drug problems in Australia - an intoxicated society?.' As well as considering issues relating to appropriate and inappropriate use of drugs, it has examined the context in which therapeutic drugs are used and the need to encourage preventive medicine and positive attitudes to health in the community.

The dividing line between the legitimate use of drugs for either medical or social purposes and their inappropriate use is indistinct. For example, some people are able to use alcohol without harm but many others become dependent upon it both emotionally and physically. Where drugs have been used for medical purposes, the general population has in the past had a suspicion of the adverse effects of medical care. Much of this suspicion has disappeared in the modern community largely because of the dramatic advances made in medical treatment over the last 50 years.

The introduction of anaesthesia, antiseptics, antibiotics, insulin, modern surgical techniques for the treatment of trauma, reconstructive surgery, blood transfusion, immunisation for diseases such as diphtheria, poliomyelitis and rubella, and the virtual abolition of the detrimental effects of Rh negativity in the newborn, have been dramatic

breakthroughs in medical practice. Diseases such as polio which produced great hardship in the community are now largely unknown, and tuberculosis is no longer the ‘white plague’. These positive outcomes of medical intervention have led to increased expectations of medication by both physicians and the community. Many patients are now attended by medical practitioners for minor medical matters or even for untoward personal effects of social problems. In 1978 79, the total cost of health care expenditure w as approximately $8 billion2, a substantial amount of which was spent on 'curative' medicine. An integral part of ‘curative’ medicine is the use of medication and it was estimated that the retail value of the pharmaceutical market (for human use) in 1978-79 was around $800 million .3

It must be pointed out, however, that the rapid rise in health care costs over the last 8 years, as shown in Table 1.1, is due mainly to the provision of other services such as hospitals, pathology etc. and not medication. Nonetheless, an expenditure of $800 million in 1978-79 on medication for a population of around 14.5 million ($55.00 per head) is still cause for concern.

Table 1.1: Health care expenditure $m

Year ending 30 June 1972 1973 1974 1975 1976 1977 1976 1979

Total health care c o s t ...................... . 2253 2505 3007 4109 5224 6254 7275 7950

Total cost of PBS prescriptions . . . 178 194 234 279 352 338 361 391

Total cost of repatriation PBS p re s c rip tio n s ................................ . 19 20 21 23 30 31 33 36

Note: No time series data was available for private prescriptions, over-the-counter medicines and hospital usage. Source: Commonwealth Department of Health, Department of Veterans' Affairs.

The nature of illnesses has changed over the last 50 years. In 1930 the main causes of death for all age groups were infectious and parasitic diseases. However, in part because

of improved environmental conditions and in part because of medical advances, the death rate from these causes has declined. They now account for only 5 to 6 per cent of deaths. New diseases have come to the forefront, including some which cause death and others which cause considerable illness or disability.

The first group includes heart disease (36 per cent of all deaths), cancer (20 per cent), cerebrovascular disease (13 per cent) and accidents and suicides (8 per cent .)4 The second group includes minor psychological disturbances and debilitating illnesses. While degenerative illnesses (which include heart disease, cerebrovascular disease and some cancers) are normally associated with advancing age, many people feel that social stress, the environment and one’s lifestyle also contribute to the high incidence of this type of illness in the community. In addition, these factors are said to contribute to the incidence of other diseases such as hypertension, chronic bronchitis, emphysema, liver cirrhosis and diabetes melitus.

It has been argued that it is not sufficient to adopt the traditional curative approach of medical practice to modern diseases, but that as a society we should look to trying to remove some of the stresses of life, to improving environmental and social factors which contribute to these diseases and to instituting positive programs to encourage people to be more health conscious .5 If successful, such programs could reduce the need for curative medical care. For example, in Victoria a number of steps have been taken to reduce the road toll. Since 1970 the Victorian Government has introduced various pieces of legislation covering seat belts, speed limits, lower blood alcohol levels (.05) and preliminary (or random) breath testing. The combination of these measures plus numerous media campaigns directed at driver and pedestrian responsibility has reduced the road toll from an annual rate of 1085 in 1970 to 663 in 1980. The success of these non­ medical programs in coming to grips with one of our major modern 'diseases’ has now- encouraged other States to follow similar strategies in an effort to contain or reduce their

respective road tolls. The second group of illnesses which now concerns the community does not usually cause death but results in considerable disability within the population at large. This group includes many patients with minor degrees of anxiety and depression. It also includes people with chronically painful and debilitating illnesses, such as rheumatoid arthritis, which require repeated appointments with the medical profession and for which large quantities of drugs are dispensed. The extent of the use of drug treatment, in regard to disturbances of mood, raises questions about the future direction of health care in our society. Currently there is considerable research being done in an attempt to understand these disease processes more fully and hence facilitate the development of preventive and curative treatments. However, if the pathways controlling mood come to be fully understood, and drugs which alter mood are developed, should we accept as a norm a society in which widespread drug taking is used to treat the outcomes of social distress? We have to ask ourselves whether this is the sort of society we want and indeed whether the need for widespread drug taking reflects serious problems in our society. To what extent should we be concentrating our resources to solving society’s social ills with non­ chemical means?

In our society, the giving of medication is a symbol of caring .6 The symbolic gesture is an important aspect of the use of medication quite apart from any specific pharmacological effect that it may have. It is common for people to give friends headache remedies or cough lozenges for their symptoms. The desire ‘to give you something to make you better' is strong and in many cases, although the medicinal benefit is probably minimal, the psychological benefit may be considerable.

Patient expectations of drug treatment are such that in some areas it has become a form of faith healing. Thus some patients will improve when given placebo treatment and this makes evaluation of the effectiveness of many treatment regimes difficult.

2

This is not to say that drug treatment is not an important part of the total health care in the modern community. It is through various forms of drug therapy that many of the important medical advances have been made and in some cases, such as contraception, drug treatment has had important social as well as medical consequences. Rather, it is

suggested that the expectations of drug therapy are becoming too great and that perhaps society is becoming too dependent on drug treatment as a cure for social as opposed to medical problems. Moreover, the medical profession has been forced to involve itself not only in the treatment of disease but also in trying to cope with all sorts of social and

community problems which society regards as an ‘illness’ but which the profession has not been trained to deal with. The Committee has interpreted the terms of reference of this inquiry to require an examination of the value of drug treatment, identification of areas where there is concern about the inappropriate use of drugs and an examination of legislative and administrative

procedures which regulate drug usage and obviate inappropriate use. The question of what constitutes inappropriate use is a difficult one and is determined by the normative standards held in a particular society. Thus in Australia the temperate use of tobacco and alcohol is generally acceptable, smoking cannabis is acceptable to a minority of the

population and the use of ‘hard’ drugs is a matter of considerable concern. The community should also be concerned with its high usage of prescription and over- the-counter drugs. Despite the shortcomings of the pharmaceutical benefits prescribing statistics, the extent of the widespread use of drugs such as anti-depressants, tranquillisers, analgesics and sedatives is highlighted. Out of a populatioaof 14.6 million,

for the year ending June 1980 there were over 3.3 million prescriptions for anti­ depressants, 3.7 million prescriptions for tranquillisers. 2.7 million prescriptions for sedatives and 11.8 million for analgesics dispensed through the Pharmaceutical Benefits Scheme .7 Data from Intercontinental Medical Statistics (Australasia) Ply Ltd showed that

in 1979, 413 million daily dosages of psychotropic drugs were taken, that is 29 daily dosages per head of population. The Committee has examined a number of factors which contribute to this large and at times unquestioned use of drugs. These include historical,

social and environmental influences and continued government support for drug therapy through the operation of the heavily subsidised Pharmaceutical Benefits Scheme. The Committee also considered the inappropriate use of drugs. The term 'inappropriate use’ has been used throughout this report in place of terms such as "abuse’ and ‘misuse’. The Committee found the latter terms unacceptable for a number of reasons, which arc detailed in the introduction to Section Four. In this report the term ‘appropriate use" describes any use which complies with instructions from the doctor, pharmacist or manufacturer; ‘inappropriate use’ is any other form of use.

The Committee considered three aspects of the inappropriate use of drugs, but acknowledges that there are many other forms. These three aspects include non­ compliance, the use of medication for social problems such as stress and tension, and deliberate inappropriate use. As a community we have to look to the reasons behind all

forms of inappropriate drug use, and seek long-term strategies, where possible, to rectify the current inadequacies in our society. This in turn w ill lead to a generally improved state of physical and mental health in the community. A number of more specific matters were also considered by the Committee. I he community is entitled to be assured that the manufacturing standards of drugs are high,

and that, if used correctly, drugs are safe and non-toxic and do not interfere with the health and safety of other members of the community. The Committee has rev iewed the present drug evaluation and regulatory procedures set dow n by the ( ommonwealth and has discussed particular areas of concern within the States' jurisdiction of therapeutic

goods. It has looked at standards for the safety, efficacy and toxicity both for prescription and over-the-counter preparations. As well, the Committee has examined the drug

manufacturing, distribution and promotion systems, and the controls that are currently in force over these systems. The Committee has also discussed the need for collecting information on drug consumption and other data relating to inappropriate use and adverse side-effects of drugs. It has presented a model of consumption of a comprehensiveness not previously published in this country.

In total, the Committee has made recommendations in a number of areas, which it believes will lead to a better appreciation and awareness of drug usage, improved evaluation, manufacture and distribution and a broader societal approach to the maintenance of health.

References

1. Senate Standing Committee on Social Welfare, Drug problems in Australia an intoxicated society'.’. Canberra, 1977, pp. 1. 2. 2. Senate Committee Secretariat estimate. 3. See Chapter 5, Table 5.3. 4. Commonwealth Department of Health, Annual Report o f the Director-General of Health.

1978-79. p. 181. 5. See Chapter 12. 6. See Chapter 11. 7. Commonwealth Department of Health, Annual Report o f the Director-General of Health.

1979 80. p. 214.

4

SECTION ONE

The use of m e d i c a t i o n in our so ciety

■

CHAPTER 2

C o n s u m p t i o n l e v e l s a n d p a t t e r n s of

p r e s c r i p t i o n a n d o v e r - t h e - c o u n t e r d r u g s

Introduction Many people have suggested that Australia has become a nation of "pill-poppers". This chapter presents a detailed body of data covering all aspects of therapeutic drug

consumption in Australia. In the next chapter special attention is paid to psychotropic drugs, over-the-counter analgesics, vitamins and cough and cold remedies, because the Committee was repeatedly informed that the extent of consumption of these groups of therapeutic substances is a matter of concern.

There are three major sources of information on drug consumption in Australia. Accordingly, this chapter is divided into three broad sections, each of which encompasses specific survey information. These sections are:

1. specific surveys designed to establish the extent of the use of medication in the Australian community; 2. data obtained from the Departments of Health and Veterans' Affairs which include prescribing patterns under the Pharmaceutical Benefits and Repatriation

Schemes; and 3. information obtained from commercial sources, in particular the Australian Pharmaceutical Manufacturers Association and Intercontinental Medical Statis­ tics (Australasia) Pty Ltd.

Consumption in this report refers to drugs purchased, not to drugs actually ingested. The difference between consumption and ingestion may be quite high as some studies indicate a non-compliance rate of between 30 50 per cent (see Chapter 10, p. 000). Therapeutic drugs can be obtained from pharmacies, public hospitals, supermarkets and health food stores. Proprietary analgesics may also be purchased at milk bars, garages etc. Drugs are also dispensed from 14 private hospitals. However, as they also

account for only 0.2 per cent 1 of the total prescribing of therapeutic drugs, they are considered negligible in this report. The Committee has data on drugs obtained from pharmacies and public hospitals and, for some proprietary drugs, from food stores. There are no data on analgesics bought from milk bars and garages or on drugs from health food

stores. For the purposes of this report, therapeutic drugs arc divided into two categories. Each category encompasses all drugs available on the market but has been defined differently by different bodies whose data the Committee has drawn on within the report.

Category One Prescribed drugs are drugs which have been formally prescribed by a doctor. There arc three different types of prescriptions. These include Pharmaceutical Benefits Scheme prescriptions. Repatriation Pharmaceutical Benefits Scheme prescriptions, and private

prescriptions. Prescribed drugs also include drugs that are used in hospitals and mat include preparations which can normally be bought without a prescription form.

Over-the-counter drugs are drugs which have been bought without a prescription. They include drugs which the doctor may have suggested but has not formally ordered on a prescription form, or w hich the patient has taken of his own volition.

7

Category Two Ethical drugs. This is a classification defined by Intercontinental Medical Statistics (Australasia) Pty Ltd. Included in this category are the more potent drugs which drug companies believe are often prescribed by a doctor. All drugs which require a prescription are included as well as some drugs which can normally be purchased without a prescription, for example aspirin.

Proprietary drugs. This also is a classification defined by Intercontinental Medical Statistics (Australasia) Pty Ltd, It consists of the less potent drugs which do not require a prescription for their purchase.

Recent survey information on the use of medication in the community A variety of information was presented to the Committee on the extent of the use of medication in the Australian community. Most of the information contained in this section is derived from four surveys:

1. The Australian Health Survey, 1977 1978 2. The Gosford Wyong and Illawarra Survey, 1975 3. The South Australian Royal Commission into the Non-Medical Use of Drugs, 1978 4. The Traraigon Survey, 1970-71 All four surveys show an alarming incidence of drug use in the population as a whole.

Australian Health Survey, 1977 1978

The most recent survey on the use of medication in the community is the Australian Health Survey by the Australian Bureau of Statistics, which was conducted during 1977 1978.2 A random sample of 15 000 dwellings was used and the results extrapolated

to the total population of Australia. The following table shows that 32.7 per cent of the surveyed population had taken medicine on the advice of the doctor in the 2 days prior to interview and 25.1 per cent had taken self-prescription medication. The total percentage of the population taking medication in the 48 hours prior to interview was 49.8 per cent. These data are supported by the findings obtained from the other surveys.

Table 2.1: Australian Health Survey— Percentage of persons taking medication in the two days before interview

Under 5 5 14 15 24

years

25 44 45-64 65 years

and over

Total ad ages

On doctor's a d v ic e ..................... . 25.7 14.0 25.7 30.7 46.5 66.6 32.7

Self-prescribed medication . . . 28.9 20.0 25.2 28.4 25.8 20.2 25.1

Total all forms of medication . . 48.4 31.6 43.6 49.8 61.4 74.6 49.8

Source: Derived from Tables 2.2. 2.3 and 2.4.

Table 2.2 reveals that 50 percent of the population was taking medication in the 2 days before the interview. More females (58 per cent) were taking medication than males (42 per cent). The most marked differences between the sexes occurred in the 15 24 and the 25 44 age groups. Some of this difference is accounted for by the consumption of oral contraceptives 19.9 percent of women aged between 18 and 50 were taking birth control

pills. However, when individual classes of medicine are examined, it appears that females do take more medication than males, especially pain relievers (20 per cent females, 13 per cent males), vitamins and tonics (14 percent females, 10 percent males) and medicines for heart conditions, blood pressure or fluid tablets (11 per cent females, 6 per cent males).

8

Table 2.2: Percentage of persons taking medication in the two days before interview by type of medication taken, by age and sex(a)

Age group

Under 5 6-14 15-24 25-44 45-64 65 years

Type o f medication(b) years years years years years and over Total

Males

Common pain relievers . . .

Cough medicines and other rem-9.6 6.4 10.8 15.0 19.4 18.9 13.4

edies for c o l d s ..................... 12.6 8.3 4,1 3.6 5.5 7.6 6.0

Allergy tablets and medicines . 1.3 3.2 2.4 2.0 2.2 3.1 2.4

Skin ointments and salves(c) . Laxatives and medicines for the 8.0 3.8 7.9 6.3 6.4 7.7 6.4

s t o m a c h ................................

T ranquillisers, sedatives and 1.3 1.0 1.3 3.4 6.7 10.5 3.6

other medicines for nervous conditions ........................... 1.6 1.1 1.1 2.7 8.2 9.6 3.7

Sleeping pills and medicines . 0.8 0.4 0.8 4,0 9.3 1.9

Vitamins and tonics . . . .

Medicines for heart conditions, 19.0 10.8 7.7 9.8 9.6 8.8 10.3

blood pressure or fluid tablets 1.6 15.8 32.6 6.1

O ther medications . . . . 12.5 7.8 4.6 5.4 13.0 21.9 9.1

T o tal m ales taking m edica-tion(b) ................................ 48.0 32.4 31.3 37.2 53.9 68.8 42.0

Females

Common pain relievers . . .

Cough medicines and other rem-11.0 7.2 18.6 24.0 25.8 27.8 19.8

edies for c o l d s ...................... 12.8 7.0 5.5 4.5 4.3 5.8 5.9

Allergy tablets and medicines . 0.8 2.0 3.0 4.3 3.2 3.1 3.0

Skin ointments and salves(c) . Laxatives and medicines for the 8.7 4.9 9.2 7.1 7.8 8.2 7.4

s t o m a c h ................................

T ranquillisers, sedatives and 2.2 1.3 3.1 5.7 9.7 11.8 5.6

other medicines for nervous conditions ........................... 1.1 0.6 1.9 5.3 13.2 13.8 6.0

Sleeping pills and medicines . 0.5 0.7 1.9 7.5 14.9 3.7

Vitamins and tonics . . . .

Medicines for heart conditions, 20.1 8.4 12.3 17.1 13.5 13.1 13.9

blood pressure or fluid tablets 1.2 5.4 22.6 44.5 10.7

Birth control pills . . . . (e) (e) M (i/) 19.9

O ther medications . . . . 13.7 7.7 6.9 7.8 14.2 22.7 10.9

Total females taking medica-tion(&) ................................ 48.9 30.7 56.2 62.9 69.0 79.0 57.7

Persons

Common pain relievers . . .

Cough medicines and other rem-10.3 6.8

edies for c o l d s ..................... 12.7 7.7

Allergy tablets and medicines . 1.0 2.6

Skin ointments and salves(f) . Laxatives and medicines for the 8.3 4.3

s t o m a c h ................................

T ranquillisers, sedatives and other medicines for nervous

1.8 1.1

conditions ........................... 1.3 0.8

14.7 19.4 22.6 24.0 16.6

4.8 4.0 4.9 6.6 6.0

2.7 3.2 2.7 3.1 2.7

8.5 6.7 7.1 8.0 6.9

2.2 4.5 8.2 11.2 4.6

1.5 4.0 10.7 12.0 4.8

9

Table 2.2: Percentage of persons taking medication in the two days before interview by type of medication taken, by age and se\(a)

Age group

Under 5 6-14 15-24 25-44 45 64 65 years

Type oj medication(b) years years years years years and over Tola!

Persons

Sleeping pills and medicines . 0.7 0.1 0.6 1.3 5.7 12.5 2.8

Vitamins and tonics . . . . 19.5 9.6 10.0 13.4 11.6 11.3 12.1

Medicines for heart conditions, blood pressure or fluid tablets 0.6 3.5 19.2 39.4 8.4

Birth control pills . . . . (?) (?) (?) (4)19.9

Other medications . . . . 13.1 7.8 5.7 6.5 13.6 22.3 10.0

Total persons taking medica-tion(6) ................................ 48.4 31.6 43.6 49.8 61.4 74.6 49.8

{a) Percentage figures relate the numbers of males, females and persons taking medication to the total number of males, fe­ e males and persons respectively. (b) A person who took more than one type of medication is counted in each type of medication taken; however, the total taking medication is an unduplicated total. (c) Excludes cosmetic creams or preparations. (d) Includes only female population aged 18 50 years. (e) Percentage age break-up not available total figure only included.

Source: Australian Bureau of Statistics, ‘Australian Health Survey 1977 1978', Catalogue No. 4311.0, pp. 7 and 19.

The largest incidence of drug taking was in the over 65 age group (74.6 per cent) but over 30 per cent of all age groups, including young children, had taken some form of medication. The data in Table 2.3 indicate that after the age of 15 more women take medication

prescribed or suggested by a doctor than do men. In addition, slightly more women than men take self-prescribed medication (Table 2.4). The greatest users of self-prescription medication were children under 5, of whom 29 per cent took medication in the 2 days before the interview. Most of this medication was vitamins and tonics (14 per cent), analgesics (6 per cent), cold remedies (6 per cent) and skin ointments and salves (3 per cent). It is interesting to observe that the 65 years and over age group is one of the lowest consumers of self-prescribed medication (20 per cent) but is by far the largest consumer ol doctor-advised medication (67 per cent). One of the reasons for this is that drugs for pensioners under the National Health Scheme are free, and doctors therefore prescribe drugs the generic equivalent of which could normally be bought over the counter (for example, Solprin).

Table 2.3: Percentage of persons taking medication prescribed or suggested by a doctor in the two days before interview, bv age and sex

Under 5 years

5 14 15 24 25 44 45 64

years

65 years and over Total

Males ..................... . . . 25.4 14.4 12.7 16.8 39.8 60.5 24.3

F e m a l e s ..................... . . . 25.9 13.5 39.0 45.1 53.4 71.2 41.2

Total . . . . . . 25.7 14.0 25.7 30.7 46.5 66.6 32.7

Source: Australian Bureau of Statistics, ‘Australian Health Survey 1977 1978', Catalogue No. 431 1.0, Tables 1 and 20.

Overall, the differences in the consumption of self-prescribed medication between age groups are small, ranging from 20 per cent to 29 per cent. This is in marked contrast to the differences in the consumption of doctor-advised drugs between age groups, which range from 14 per cent to 67 per cent.

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Table 2.4: Percentage of persons taking self-prescribed medication in the two days before interview, by age and sex

Under 5 years

5-14 years

15-24 years

25-44 years

45-64 years 65 years and over Total

Males ...................... . . . 29.5 20.7 21.7 25.3 22.8 18.0 23.2

F e m a l e s ...................... . . . 28.3 19.4 28.7 31.6 28.8 21.8 27.2

Total . . . . . . 28.9 20.0 25.2 28.4 25.8 20.2 25.1

Source: Australian Bureau of Statistics,'Australian Health Survey 1977-1978', Catalogue No. 4311.0, Tables 1 and 21.

Gosford Wyong and lllawarra Survey

A survey of similar design to the Australian Health Survey quoted above was conducted in the areas of Gosford-Wyong and lllawarra 3 in 1975. The sample sizes were 3898 residents in the Gosford-Wyong area and 5236 in the lllawarra area. The results were extrapolated to the whole population of these areas. The following tables are derived from

the findings of the survey but have been reorganised in a format comparable to the Australian Health Survey:

Tab!e 2.5: Percentage of residents of Gosford-Wyong taking medication in the two days before interview, by age and sex(b)

Under 5 5 14 15-44 45 64 65 years

Type o f medication(a) years years years years and over Total

Males

Common pain r e l i e v e r s ................................................ 6.6(c) 6.3 16.8 23.6 23.3 16.6

Cough medicines and other remedies for colds . . 9.9 6.4 3.8 7.0 12.3 7.0

Allergy tablets and m e d i c i n e s ...................................... ω 2.5(c) 3.5 3.1(c) 4.2(c) 3.3

Skin ointments and salves ........................................... 11.3 7.0 10.9 12.6 14.6 1 1.2

Laxatives and medicines for the stomach . . . . V) ω 3 .8 10.6 20.5 7.4

Tranquillisers, sedatives and other medicines for ner-vous c o n d i t i o n s ........................................................... ω ω 2.3(c) 12.4 14.2 8.1(c)

Sleeping pills and medicines ...................................... ω ω 8.1 15.5 6.3(c)

Vitamins and tonics ...................................................... 25.3 10.2 8.1 15 0 15.6 12.8

Medicines for heart conditions, blood pressure or fluid tablets ...................................................................... 1.4(c) 20.2 37.9 1 1.4

Other medications ...................................................... 11.8 5.0 5.2 13.5 18.5 9.9

Total males taking m edication(a) . . . . 50.9 28.7 40.0 64.4 75.0 50.3

Females

Common pain r e l i e v e r s ................................................ 9.3 9.5 31.0 38.4 29.4 27.6

Cough medicines and other remedies for colds . . 10.0 8.3 5.5 5.7 5.3 6.3

Allergy tablets and m e d i c i n e s ..................................... ω 2.4(c) 6.0 5.1 2.3(c) 4.2

Skin ointments and salves ........................................... 12.0 9.5 11.6 9.9 14.2 1 1 4

Laxatives and medicines for the stomach . . . . 5.0(c) ω 5.8 14.5 22.3 10.1

Tranquillisers, sedatives and other medicines for ner- 17.4 17.1 11 9(Γ vous c o n d it i o n s ........................................................... ω ω 5.2

Sleeping pills and medicines ...................................... 2.8 8.1 21.1 6.7

Vitamins and tonics ...................................................... 21.0 10.8 15.4 16 4 1 2.6 14.9

Medicines for heart conditions, blood pressure or fluid tablets ...................................................................... 6.1 28.2 40.1 16.2

Birth control p i l l s ( t / ) ..................................................... 26.1 3.7 2.5(ί ) 1.3.4

Other medications ...................................................... 15.8 5.4 10.8 15.7 22.1 1 3.6

Total females taking m edication(a) . . . 49.2 34.9 74.1 78.0 82.9 68.8

Table 2.5: Percentage of residents of Gosford Wyong taking medication in the two days before interview, by age and sex(/>j

Type o f medictttion(a)

Under 5 years

5-14 years

15-44 years

45-64 years 65 years and over Total

Persons

Common pain r e l i e v e r s ................................................ 7.9 7.8 24.2 31.9 26.5 22.3

Cough medicines and other remedies for colds . . 10.0 7.3 4.7 6.3 8.7 6.6

Allergy tablets and m e d i c i n e s ..................................... (J) 2.3(c) 4.8 4.2 3.2 3.7

Skin ointments and salves ........................................... 11.6 8.2 11.3 11.1 14.4 11.3

Laxatives and medicines for the stomach . . . .

Tranquillisers, sedatives and other medicines for ner-3.7 if) 4.8 12.8 21.4 8.8

vous c o n d it i o n s .......................................................... if) if) 3.8 15.2 15.7 10.1(f)

Sleeping pills and medicines ..................................... if) — 1.7 8.1 18.4 7.6(f)

Vitamins and tonics ..................................................... 23.2 10.5 11.9 15.8 14.0 13.9

Medicines for heart conditions, blood ..................... — — 3.9 24.7 39.1 13.9

Birth control p i l l s ( r f ) ..................................................... — — 13.7 2.1 1.3(f) 13.4

Other medications ..................................................... 13.8 5.2 8.1 14.8 20.4 11.8

Total persons taking medication(a) . . . 50.1 31.6 57.8 72.1 79.1 60.0

(ύ) A person who took more than one type of medication is counted in each type of medication taken; however, the total taking medication is an unduplicated total. (b) Percentage figures relate the numbers of males, females and persons taking medication to the total number of males, females and persons respectively. (c) Relative Standard Error Rate between 25% and 40%. (i1) Includes only female population aged 15 years or more. (e) Excludes persons under 15 years because figures in these groups have a Relative Standard Error Rate greater than 40%. (J) Figure deleted because Relative Standard Error Rate greater than 40%.

Source: Health Commission of New South Wales, ‘Health Care Survey of Gosford-Wyong and Illawarra 1975', Sydney, 1978. pp. 339 and 341.

Tables 2.5 and 2.6 reveal that 60 per cent of the population in Gosford- Wyong and 47 per cent of the population in Illawarra had taken medication in the 2 days before the interview. Of the adult population, 67 percent (55 percent males and 77 percent females) in Gosford-Wyong and 54 per cent (42 per cent males and 66 per cent females) in Illawarra had taken medication. For children these rates were 38 per cent (36 per cent males and 40 per cent females) in Gosford Wyong and 32 per cent (same for both males and females) in Illawarra.

The consumption rate of medication for children was approximately the same as in the Australian Health Survey, ranging from 32 per cent to 38 per cent. There were no significant differences between consumption rates for male and female children in any of the surveys. All three surveys agree that pain relievers are the most commonly used medications (ranging in percentage from 16 per cent to 22 per cent), followed by vitamins and tonics (10 per cent to 14 per cent). Females took more of both of these medications than did males.

Although not shown on the table, the Gosford-Wyong and Illawarra survey also studied other variables. It was found that medication taking was most common among widowed, divorced or separated people. Single adult persons (who had never been married) showed the lowest rate of medicine use. The proportion of adults in the low

income groups taking medication was greater than those w'ho were classified as "fairly poor to average" or "above average". A reversal of this pattern occurred for children, w ith those in the low income groups taking less medication. The interviewee’s perception of his state of health was associated with the use ol medicines. The proportion of persons taking medication increased as perception of health changed from "good" to "fair" to "poor".

12

Table 2.6: Percentage of residents of illawarra taking medication in the two days before interview, by age and sex (b)

Under 5 5-14 15-44 45-64 65 years

Type o f medication (a) years years years years and over Total

Males

Common pain relievers ..................................................... 7.2 4.9 15.0 19.2 19.3 13.0

Cough medicines and other remedies for colds . . . . 13.6 6.6 2.9 3.3(c) 9.2(c) 5.3

Allergy tablets and medicines ........................................... ω 1.9(c) 2.0 2.3(c) if) 1.9

Skin ointments and salves ................................................ 7.9 4.2 7.4 7.7 12.0(c) 7.1

Laxatives and medicines for the stomach ..................... ω if) 2.7 7.6 9.2(c) 3.4

Tranquillisers, sedatives and other medicines for nervous conditions ...................................................................... if) if) 0.9(c) 7.9 if) 2.3

Sleeping pills and medicines ........................................... V ) — 0.7(c) 5.5 5.8(c) 2.4(c)

Vitamins and tonics ........................................................... 20.3 7.2 5.2 9.4 8.0(c) 8.3

Medicines for heart conditions, blood pressure or fluid t a b l e t s ................................................................................ — — 0.8(c) 16.7 30.5 5.1

Other m e d ic a tio n s ................................................................ 4.9(c) 5.3 5.0 12.4 22.4 7.3

Total males taking medication (a) ..................... 42.1 25.6 33.0 53.8 71.2 38.4

Females

Common pain relievers ...................................................... 5.1(c) 7.7 22.8 24.0 18.8 17.9

Cough medicines and other remedies for colds . . . . 12.2 6.1 4.7 4.0 5.7(c) 5.8

Allergy tablets and medicines ........................................... if) 1.8(c) 4.2 2.9(c) if) 2.9

Skin ointments and salves ................................................ 7.1 5.2 9.2 10.1 10.0(c) 8.4

Laxatives and medicines for the stomach ..................... 3.2(c) ω 6.1 11.6 13.8 6.3

Tranquillisers, sedatives and other medicines for nervous conditions ...................................................................... if) if) 5.3 13.5 14.5 6.1

Sleeping pills and medicines ........................................... if) 1.8 5.8 17.3 4.2(c)

Vitamins and tonics ........................................................... 21.1 6.7 11.2 10.1 12.9 11.4

Medicines for heart conditions, blood pressure or fluid t a b l e t s ................................................................................ 5.1 25.1 40.3 9.3

Birth control pills ( d ) ........................................................... 29.4 9.3 12.3 22.6

Other m e d ic a tio n s ................................................................ 6.2 5.2 9.7 16.3 27.4 10.7

Total females taking medication (a) . . . . 42.6 24.7 64.0 67.9 77.0 55.6

Persons

Common pain relievers ..................................................... 6.1 6.2 19.0 21.6 19.1 15.5

Cough medicines and other remedies for colds . . . . 12.9 6.4 3.8 3.7 7.3 5.5

Allergy tablets and medicines .......................................... 1.2(c) 1.8 3.1 2.6 if) 2.4

Skin ointments and salves ................................................ 7.5 4.7 8.3 8.9 11.0 7.8

Laxatives and medicines for the stomach ..................... 2.6(c) 0.8(c) 4.4 9.6 1 1.6 4.8

Tranquillisers, sedatives and other medicines for nervous conditions ..................................................................... 1.2(c) if) 3.1 10.7 9.8 4.2

Sleeping pills and medicines ........................................... if) 1.2 5.6 11.9 3.3(c)

Vitamins and tonics ........................................................... 20.7 7.0 8.2 9.8 10.6 9.8

Medicines for heart conditions, blood pressure or fluid t a b l e t s ................................................................................ 3.0 20.9 35.7 7.2

Birth control pills (d ) .......................................................... 14.8 4.7 6.5 22.6

Other m e d ic a tio n s ................................................................ 5.5 5.2 7.4 14.4 25.1 9.0

Total persons taking medication (a) . . . . 42.4 25.2 48.6 60.9 74.2 47.0

(a) A person who took more than one type of medication is counted in each type of medication taken; however the total taking medication is an unduplicated total. (b) Percentage figures relate the numbers of males, females and persons taking medication to the total number of males, females and persons respectively.

(c) Relative Standard Error Rate between 25% and 40%. (d ) Includes only female population aged 15 years or more. (e) Excludes persons under 15 years because figures in these groups have a Relative Standard Error Rate greater than 40 r (f ) Figure deleted because Relative Standard Error Rate greater than 40%.

Source: Health Commission of New South Wales, ‘Health Care Survey of Gosford Wyong and Illawarra 1975', Sydney. 1978. pp. 340 and 342.

13

Survey conducted by the South Australian Royal Commission The South Australian Royal Commission into the Non-Medical Use of Drugs4 conducted a survey on over-the-counter drugs and prescription psychotropic drugs. The con­ sumption of over-the-counter drugs is discussed here and the use of prescription psychotropic drugs is outlined in the following section.

The survey was conducted in 1978 using a sample of 2928 persons aged between 13 and 60. The findings are set out in the following table.

Table 2.7: Prevalence and recency of use of over-the-counter drugs among subgroups of respondents

Ever used

Past month use

Past year not past month

Not in past year

Never used

% % % % %

All respondents ..................... (2 928) 96 52 38 6 4

Age: 13 17 y e a r s .......................... (680) 95 45 46 5 5

18 74 y e a r s .......................... (644) 96 52 39 5 4

25 34 y e a r s ........................... (900) 97 55 36 5 3

35 44 y e a r s .......................... (277) 96 59 31 7 4

45 60 v e a r s .......................... (427) 94 50 33 11 6

Sex: M a l e ..................................... (1 370) 95 45 43 8 5

Female ................................ (1 558) 96 58 34 5 4

Marital status: (adults only) S i n g l e ................................ (879) 95 51 38 6 5

De facto/m arried . . . (1 358) 96 55 35 6 4

Divorced/separated . . (148) 97 55 33 10 3

W id o w e d .......................... (36) 97 58 19 19 3

Major activity: In workforce or looking for j o b ................................ (1 708) 96 52 38 6 4

Male (1009) . . . . 95 47 41 8 5

Female (699) . . . . 95 60 33 3 5

Home duties ..................... (578) 97 60 32 6 3

Pens/retd/other . . . . (157) 97 45 41 11 3

Male (90) ..................... 99 38 46 16 1

Female ( 6 7 ) ..................... 95 55 36 5 5

Educational qualifications: Trade ................................ (252) 96 52 37 7 4

Technical .......................... (177) 97 59 31 7 3

T e r t i a r y ................................ (107) 92 53 37 3 8

Degree/higher degree . . (153) 98 46 44 7 2

Occupational status: (a) Status level 1 ..................... (51) 98 49 45 4 • 2

Status level 2 ..................... (309) 96 50 40 6 4

Status level 3 ..................... (673) 96 51 40 6 4

Status level 4 ................. (1882) 95 52 37 6 5

Weekly gross income: No i n c o m e .......................... (644) 95 52 37 5 5

SI $59 ................................ (591) 96 48 42 6 4

$60 $139 .......................... (565) 97 55 36 6 3

$140 $199 .......................... (612) 96 55 36 5 4

$200+ ............................... (468) 96 48 40 8 4

(a) Status was determined h\ a scoring system developed by the Department of Sociology at the Australian National University.

Source: South Australian Royal Commission into the Non-Medical Use of Drugs, ‘Three Studies in Drug Use . Research Papers 3. 4, 5. Adelaide, 1979, p. 8 1

14

This survey shows that the use of over-the-counter drugs is not concentrated in any one age group. It also shows that there is no marked difference in use between the sexes. Women are slightly more likely to have used over-the-counter drugs than men -58 per cent of women report use in the past month compared with 45 per cent of men. However,

men are more likely to have used over-the-counter drugs within the past year but not the past month—43 per cent of men compared with 34 per cent of women. In contrast to the Gosford Wyong and Illawarra survey, this study shows that marital status does not have a significant effect on the use of over-the-counter medication. Apart from the effect of sex difference, there is little difference in rates of use between those in the workforce and those

who are not. Educational qualifications, occupational status or income appear also to have no marked effect on the use of over-the-counter drugs.

The Traralgon Survey

A survey of 346 persons on the use of medication was conducted in Traralgon. Victoria, in 1970 and 1971,5 The following table sets out the use of medication in the two weeks before the interview:

Table 2.8: Use of medication in the community in the two weeks before the interview

Drugs taken IS umber o f drugs

Five or

Age group (years) None Any One Two Three Four more

% % % % %

Children (Oto 1 4 ) ..................... . . 42

(36.2%)

14

(63.8%)

30.2 22.4 8.6 1.7 0

Young males (15 to 24) . . . . . 17

(63.0%)

10

(37.0%)

11.1 14.8 3.7 3.7 3.7

Young females (15 to 24) . . . . 10

(33.3%)

20

(67.3%)

33.3 23.3 3.3 3.3 0

Adult males (25 to 64) . . . . . 33

(41.8%)

46

(58.2%)

33.0 12.6 8.8 2.5 1.3

Adult females (25 to 64) . . . . . 15

(20.3%)

59

(79.7%)

37.8 21.6 9.5 1.4 9.5

Elderly persons (over 65) . . . . 2

(10.0%)

18

(90.0%)

45.0 5.0 15.0 15.0 10.0

Total ........................... . . 119 227 111 64 29 10 1 1

(34.4%) (65.6%) (32.1%) (18.5%) (8.4%) (2.9%) (3.2%)

Source: C. Bridges-Webb,'Drug Medication in the Community', The Medical Journal o f Australia, 1 April 1972, p.676.

The table shows that 66 per cent of the population used medication in the 2 weeks before the interview. Of the adult females (between 15 and 64 years) 76 per cent used medication, and of the adult males 53 percent used medication. The group with the lowest percentage taking medication was young males (15 to 24 years) and the group with the

highest percentage was persons over 65 years. Most people who took medication used only 1 or 2 drugs (50.6 per cent ol the population). About 15 per cent of the population used 3 or more drugs in the 2 weeks before the interview. The most frequent consumers of medication were persons over 65 years (40 per cent of these used 3 or more medicines). The next most Irequent consumers were adult females aged 25 64 years (20 per cent used 3 or more medicines).

The study also revealed that in the 2 weeks before the interview 40 percent of people used medication which was self-prescribed or prescribed by a chemist, and about 26 per cent took medication which was prescribed or suggested by a doctor (this includes long­ term therapy and contraception). This is different from the findings of the Australian

15

Health Survey conducted in 1977 and 1978, which found that 25 per cent of people used medication which was not prescribed or suggested by a doctor and 33 per cent used medication which was doctor advised. This difference could be partly due to the 7-year time gap between the surveys.

Summary of surveys

Overall these surveys reveal that between 47 and 68 per cent of the population used medication in a 2-day period. Between 54 and 67 per cent of adults, and 32 to 38 per cent of children under 15 years used medicine over a 2-day period. All studies revealed that more women than men take medication (in the ratio of about 1.5:1), and that painkillers are the most popular medicines (used by 16 to 22 percent of the population) followed by vitamins and tonics (10 to 14 per cent).

Consumption patterns and levels

Patterns of drug usage

In order to obtain a total picture of the consumption of drugs in the community, the Committee received data from a number of sources including the Pharmacy Guild, Commonwealth Department of Health. Department of Veterans' Affairs, Australian Pharmaceutical Manufacturers Association and Intercontinental Medical Statistics (Australasia) Pty Ltd. The information obtained from these various sources is summarised in the following section. Value only is shown as there arc no adequate data on volume.

Table 2.9: Estimate of retail and ex-manufacturer value(a) of drugs dispensed on prescription^) 1978-1979

Retail value Ex-manufacturer value

Percentage Percentage Percentage

o f Of o f total

value pharmacy value pharmacy drugs

($ millions) prescriptions ($ millions) prescriptions prescribed

Pharmaceutical Benefits Scheme . R e p a tr ia tio n P h a rm a c e u tic a l 382.8 83 175.1 84 66

Benefits Scheme (all prescrip­ tions) (r) ..................................... 35.6 7.5 17.3 8 6.5

Private p re s c r ip tio n s ..................... 42.8 9.5 16.1 8 6

Total pharmacy prescriptions . . 461.2 100 208.5 100

Hospitals ..................................... 56.8(4) 21.5

Total drugs prescribed . . . . 265.2(e) 100

Over-the-counter drugs . . . . 133.2

Total drugs consumed . . . . 398.4

(pharmacies and hospitals)

(a) The ex-manufacturer value for PBS and RPBS prescriptions is calculated on the basis that the average dispensing fee during 1978 79 was $1.32 and the average mark-up was 26.38 per cent. The ex-manufacturer value of private prescriptions is estimated on the basis that the average retail value of a private prescription is $6.00 (estimate by the Pharmacy Guild of Australia), the mark-up is about 50 per cent and the dispensing fee $2.00. It is assumed that the wholesaler's commission is 15 per cent of the wholesale price. (b) Includes extemporaneous preparations. (r) Includes some proprietary products. {d) ΑΡΜΑ data represents 98 per cent of sales to hospitals. The figure here is an estimate of 100 per cent value. (e) Error is due to rounding.

Source: The Pharmacy Guild of Australia, ‘The Pharmacy Guild Digest', June 1979, p. 8; the Commonwealth Department of Health; the De­ partment of Veterans' Affairs; Intercontinental Medical Statistics (Australasia) Pty Ltd.

16

Table 2.10: Estimate of ex-manufacturer value of total ethical drugs from pharmacies, Pharmaceutical Benefits Scheme (PBS) prescriptions and Re­ patriation Pharmaceutical Benefits Scheme (RPBS) prescriptions, 1978-1979

$ Ό00

Total PBS pre- RPBS pre-

ethical scriptions scriptions drugs (a) (a) (b)

A n a lg e s ic s ...........................................

Heart, Drugs acting o n ......................

Bronchial spasm, Drugs acting on . Blood vessels, Drugs acting on . . Penicillins ( < r ) ......................................

Diuretics ...........................................

Antacids ...........................................

Tranquillisers ................................

T e tr a c y c lin e s ......................................

Skin sedatives .................................

Anovulants(c) ................................

Anti-diabetics ................................

Sulphonamides(f) ...........................

Sedatives and hypnotics . . . .

Eye d r o p s ...........................................

A n tid e p r e s s a n ts ................................

Gastro-intestinal sedatives . . .

Antihistamines ................................

Erythromycin ................................

Water and electrolyte replacement (c) Skin fungicides ...........................

A n tic o n v u ls a n ts ................................

Vagina or urethra, Drugs acting on . A n t i - e m e t i c s ......................................

Corticosteroids ................................

Urinary a n t i s e p t i c s ...........................

Antibiotics- o t h e r ...........................

Extemporaneous preparations(d) Other .................................................

Total * ( б )

36 084 17 604 1 570

21 350 18 428 1 426

19 717 12 903 930

16 691 13 908 993

14 043 15 000 190

13 440 12 008 794

9 574 1 874 315

7 643 5 057 380

7 346 6 853 207

6 747 1 713 130

6 706 7 120

6 189 5 528 432

5 731 5 880 105

5 477 1 816 255

5 303 2 541 164

5 280 4 249 217

4 894 2 722 126

4 769 1 844 62

3 650 3 363 (?)

3 453 3 730 279

3 426 1 714 (?)

3 115 2 716 (?)

2 754 1 969 (?)

2 433 1 144 87

1 707 1 311 144

1 272 1 110 (?)

750 (?) (?)

5 868 5 105 503

27 722 15 895 1 643

253 134 175 055 10 952

(а) The ex-manufacture value for PBS and RPBS prescriptions is calculated on the basis that the average dispensing fee during 1978-79 was $1.32 and the average mark-up was 26.38 per cent. It is assumed that the wholesaler’s fee is 1 5 per cent of the wholesaler’s price. (б) The cost of RPBS prescriptions for 1978-79 is estimated by using the computer

data on the number of NHS prescriptions under the RPBS for 1979 80 (this is the first year that the computer has been available and multiplying this by an estimate of the cost of a prescription in each therapeutic category, which is calculated from PBS data. The cost of RPBS prescriptions has been estimated so that broad esti­

mates of RPBS and PBS data can be compared with IMS data. It cannot be assumed that this is an accurate assessment of the actual cost of RPBS prescrip­ tions for each therapeutic class. (c) The reason for PBS being greater than IMS estimate may be due to the 1 2 per cent overall error in IMS data due to sampling. For individual categories this sampling error becomes higher. (if) Extemporaneous preparations include only those on the PBS and RPBS. (e) The value of these figures is very small and is included in the category Other"

Source: Intercontinental Medical Statistics (Australasia) Pty Ltd., Commonwealth Department of Health and Department of Veterans' Affairs.

17

A study of 595 pharmacies conducted by the Pharmacy Guild of Australia6 in 1978 analysed the sales value of each of the three types of prescription. It was found that on average, Pharmaceutical Benefits Scheme prescriptions comprise 83 per cent of the retail value of all prescriptions dispensed, Repatriation prescriptions 7 per cent, and private prescriptions about 10 per cent.

Using the percentage breakdowns obtained from the Pharmacy Guild Survey (1978), and inserting data obtained from selected sources, the following table has been derived.

This table reveals that, in terms of value, of all drugs prescribed Pharmaceutical Benefits Scheme prescriptions represent 66 per cent. Repatriation Pharmaceutical Benefits Scheme prescriptions represent 61 per cent, private prescriptions represent 6 per cent and drugs prescribed in hospitals represent 21.5 per cent.

Table 2.10 gives a broad breakdown of the types of ethical drugs being consumed.

Some of the items in Table 2.9 can be grouped into broader classes as shown in the following table:

Table 2.1 i. Ex-manufacturer value of ethical drugs of the more frequently used drug groups sold from pharmacies 1978-1979

$ ’000

Total ethical drugs (IMS)

PBS

prescriptions

RPBS

prescriptions

Antibiotics (including fungicides) (a) . . . . . 38 972 35 889 502

Cardiovascular drugs (A) ................................ . . 38 041 32 336 2 419

Analgesics .......................................................... . . 36 084 17 604 1 570

Psychotropic drugs (c) ..................................... . . 18 400 11 122 852

Gastrointestinal drugs (d ) ................................ . . 14 468 4 596 441

(a) Includes penicillins, tetracyclines, sulphonamides, erythromycin, skin fungicides, drugs acting on the vagina or urethra, urinary antiseptics and 'antibiotics, other'. (b) Includes drugs acting on the heart and drugs acting on the blood vessels. (c) Includes tranquillisers, sedatives and hypnotics, and antidepressants. (d ) Includes antacids and gastro-intestinal sedatives.

Source: Intercontinental Medical Statistics (Australasia) Pty Ltd, Commonwealth Department of Health and Department of Veterans’ Affairs.

Data collection

Although community surveys give an indication of patterns of drug usage in the community, they arc open to a number of criticisms in terms ol how representative ol the community as a whole is the population studied. The results depend on the nature of the questions asked, the co-operation of the people being interviewed and the circumstances at the time ol' interview. For example, an interview taken during a flu epidemic may give a totally distorted picture of community health problems. Another shortcoming of community surveys is that the surveys only give patterns of consumption:

they do not giv e levels of usage and nor are they able to comment on w hether the usage is appropriate or inappropriate.

Consumption patterns derived from statistics on the Pharmaceutical Benefits Scheme are not satisfactory as an indication of drug usage in the community, either. 1 he> represent only 51 percent of the value of all drugs sold through pharmacies, and only a very low percentage of drugs which cause concern, such as psychotropic drugs and analgesics.

18

The diagram outlined in Figure 2.1 sets out the source and distribution of drugs in the Australian community and shows various points in the distribution system where data can be collected.

Imports— 1. Australian Bureau of Statistics 2. Bureau of Customs

(Imported raw materials and partly processed goods)

(Imported finished products) 12%

M anti fact ure-

(Finished products

1. Australian Bureau of Statistics (ASIC class 2723)

complete local manufacture, 15% part local manufacture. 73%)

100% Ex-manufacture-Price Waterhouse and Co.

on sales to food stores) Statistics (Australasia) Pty

Ltd (data on 100% of pharmacy sales—based on survey data) Pharmaceutical Benefits Scheme (data on 51% of

pharmacy sales) Repatriation Pharmaceutical Benefits Scheme (data on 3% of

pharmacy sales)

(data on 98% sales to public hospitals)

Figure 2.1 Distribution of therapeutic drugs and data collection points

The classifications for the data on imports collected by the Australian Bureau ol Statistics are different from the classifications used for pharmaceuticals manufactured in Australia. Therefore, total consumption cannot be estimated by combining these sources. In any case, both are far removed from the points of final consumption and could not be expected to reflect accurate levels of consumption in any one period.

19

The diagram indicates that the optimum point of data collection would be at the ex­ manufacture level. Price Waterhouse and Company collect data from all major manufacturers at this stage on (1) ethical drugs;

(2) proprietary products; and (3) drugs to hospitals.

However, only the value of therapeutic drug classes is recorded; there are no data on volume. These data, too, are far from the final point of consumption. Even so, their data on sales to public hospitals are comprehensive and provide a good estimate of consumption of drugs to hospital patients.

As shown in Figure 2.1, Intercontinental Medical Statistics (Australasia) Pty Ltd collects statistics on all drugs sold from pharmacies. This is called the Australian Pharmaceutical index. The data include information on volume of sales as well as value, and arc therefore more appropriate as an indicator of consumption than Price

Waterhouse and Company data. However, Intercontinental Medical Statistics (Austra­ lasia) Pty Ltd do not collect statistics on proprietary products to retailers other than pharmacies or on drugs to hospitals. The Committee feels, however, that the Australian Pharmaceutical Index would be a good source of information on consumption for the Commonwealth Department of

Health when decisions on social policy are being made. This matter was discussed with Mr Norman Taylor, the Managing Director of Intercontinental Medical Statistics (Austra­ lasia) Pty Ltd, during a public hearing of the Committee. He indicated that such data could be made available for social policy purposes.7

The following table presents similiar data to that shown in Table 2.9 but uses the categories ‘ethical’ and "proprietary' instead of ‘prescription" and ‘over-the-counter’.

Table 2.12: Estimates of ex-manufacturer value (a) of ethical and proprietary drugs that are sold from pharmacies and drugs sold to hospitals in Australia 1978-1979

Value ($'()00)

Percentage o f ethical drugs fr o m pharm acies

Percentage o f all

drugs to pharm acies and hospitals

Ethical drugs from pharmacies Pharmaceutical Benefits Scheme ..................................... 1 75 055 70 44

Repatriation Pharmaceutical Benefits Scheme (NHS drugs) ............................................................................... 11 000(A) 4 3

Other ethical drugs (includes private prescriptions) . . 64 785 26 . 16

Total .................................................................................... 250 840 100

Drugs sold to hospitals .......................................................... 56 760(c) 14

Proprietary drugs sold from p h a r m a c i e s ................................ 90 750(rf) 23

T o t a l ............................................................................... 398 350 100

(a) Includes extemporaneous preparations which are on the PBS and RPBS. (b) Includes only NHS drugs which account for about 77 per cent of all RPBS prescribing. Many of the remaining 23 per cent are proprietary preparations which are included in the class 'Proprietary drugs sold in pharmacies'. (c) ΑΡΜΑ data represents 98 per cent of sales to hospitals. This figure is an estimate of 100 per cent value. (d) The total wholesale figure for proprietary medicines supplied by IMS was $125 000 000. From this was subtracted the

category 'other non-therapeutic' which includes items such as toothpaste and sugar or salt substitutes. This figure was then reduced by 17.5 per cent to convert it to ex-manufacturer value.

Source: Intercontinental Medical Statistics (Australasia) Pty Ltd.

20

Table 2.12 shows that 70 per cent of ethical drugs sold from pharmacies are dispensed on Pharmaceutical Benefits Scheme prescriptions, 4 per cent are dispensed on Repatriation Pharmaceutical Benefits Scheme prescriptions and 26 per cent are dispensed on private prescriptions or sold without a script. As a percentage of all drugs.

Pharmaceutical Benefits Scheme prescriptions comprise 44 per cent. Repatriation Pharmaceutical Benefits Scheme prescriptions comprise 3 per cent, hospitals comprise 14 per cent and proprietary drugs sold in pharmacies comprise about 23 per cent. In most articles on therapeutic usage in the community. Pharmaceutical Benefits

Scheme figures are used to indicate the levels and trends in consumption. Tables 2.10, 2.11 and 2.12 show that Pharmaceutical Benefits Scheme statistics are wholly inadequate for this purpose. Even with the Repatriation Pharmaceutical Benefits Scheme figures they represent only 74 per cent of all ethical drugs bought from pharmacies and 47 per cent of all drugs used. In some categories which cause concern, for example analgesics, their percentage of the total consumption from pharmacies is less than 60 per cent. With

Repatriation Pharmaceutical Benefits Scheme drugs, they represent only 39 per cent of the value of sedatives and hypnotics (the remainder is on private prescriptions) and only 53 percent of ethical analgesics from pharmacies (see Table 2.10). It is therefore no longer appropriate for the Commonwealth to depend on Pharmaceutical Benefits Scheme

figures for planning and explaining public policies. The Commonwealth requires a more comprehensive data base and. in particular, one that will enable comparisons to be made from one region to another or from one community group to another. If drug taking is only masking more serious problems in our

society then it is essential that the policy makers have at their disposal adequate comparative data to identify specific problems faced by particular groups or regions w ithin our society. The Committee RECOM M ENDS that the Commonwealth Department of Health develop a data base which is able to give an adequate assessment of the consumption of

therapeutic drugs. This could in part be achieved by purchasing data from commercial sources such as Intercontinental Medical Statistics (Australasia) Pty Ltd. but the Department would need to negotiate with manufacturer·; and distributors to gain more comprehensive data on hospital consumption and the sales of proprietary drugs to non­

pharmacy outlets.

Pensioner Pharmaceutical Benefits Scheme prescribing

Although the data obtained from the Pharmaceutical Benefits Scheme are not adequate to estimate the total drug usage in the community , important information is available from this source. All prescriptions dispensed under the Scheme arc sent to the Commonwealth Department of Health by the dispensing pharmacists so detailed information on dosage,

method of administration and combined use w ith other medication is potentially av ail­ able. Data on the number of Pharmaceutical Benefits Scheme prescriptions lor the general and pensioner population for 1978 1979 arc given in the following table. Table 2.13 reveals that the drugs most commonly used by pensioners are analgesics

(3.68 prescriptions per head). An explanation for this could be the physical discomforts that are usually associated with old age. As stated above, the lact that under the

Pharmaceutical Benefits Scheme pensioners can obtain these drugs free probably contributes to their high usage. While the Committee is concerned w ith the high level of analgesic use by the elderly, it is more concerned with their use of psychotropics, which account for 3.59 prescriptions per head. This is about 4 times the rate of prescribing of

psychotropic drugs for the general population. (This estimate assumes that all private prescriptions are for the general population and is therefore an underestimate of the actual ratio.)

Table 2.13: Number of general and pensioner Pharmaceutical Benefits Scheme prescriptions 1978-79

P e n i c i l li n s ...........................................

A n a lg e s ic s ..........................................

Preparations for bronchospasms . Anovulants .....................................

Drugs acting on the heart . . . .

Diuretics ..........................................

Drugs acting on blood vessels . .

T e tr a c y c lin e s .....................................

Sulphonamides ................................

Tranquillisers ) . . . .

Antidepressants I psychotropic Hypnotics and f drugs .

sedatives J

Erythromycin ................................

Anti-diabetics ................................

Water and electrolyte replacement . O ther1 * * * * * * ................................................

Total

General Pensioner

No. ‘000

No.

per head

No. ‘000

No.

per head

6 680 0.54 1 035 0.58

4 930 0.40 6518 3.68

3 423 0.28 1 763 0.99

4910 0.40 — —

2 439 0.20 2 524 1.42

3 825 0.31 3 709 2.09

1 843 0.15 1 886 1.06

2811 0.23 677 0.38

2 904 0.24 578 0.33

2 101 0.17 2 206 1.24

1 909 0.15 1 492 0.84

193 0.02 2 672 1.51

1 569 0.13 235 0.13

308 0.02 504 0.28

982 0.08 1 352 0.76

12 773 1.04 12 249 6.91

53 600 4.36 39 400 22.22

1 Approximate.

Source: Annual Report of the Director-General of Health, 1978 79, pp. 24 5.

In 1973 Dr D. de Souza wrote a paper on the adverse effects of some of the drugs more commonly prescribed for the aged. In relation to sedatives and hypnotics, he recognised that the use of these drugs may be unavoidable for insomnia in some cases but commented that 'much of the prescribing is indiscriminate and little attempt is made to establish the cause of their sleeplessness before prescribing a hypnotic or sedative’.8 Often loneliness and boredom cause old people to sleep during the day and they consequently have difficulties sleeping at night.

At a conference in March 1980 called 'Drug Use Among the Elderly’, several notable people spoke against the excessive use of psychotropic drugs for the aged. Professor G. Andrews, Professor of Community and Geriatric Medicine at the University of Sydney, said that from what he has observed in hospitals, a significant portion of the psychotropic drugs used for the elderly was not necessary. He added that the risk of adverse drug

reactions was greater with the aged. Dr B. Learoyd from the Doctors Reform Society said that 'the usefulness of psychotropic drugs in helping elderly patients is by no means established as unequivocally beneficial’. Mr N. McArthur of the Association of Drug Referral Centres in New South Wales said that drug misuse was not always voluntary and was frequently for the benefit of the person’s family or the staff at an institution'.0 Ms J

McC'lintock, Program Co-ordinator from the Australian Council of Social Service Inc., told the Committee of a nursing home where the patients are given a sleeping pill every night. She felt that this was the nursing home’s response to not having adequate staff.111 The Committee realises that the problems of ill health associated with old age necessitate an increase in the use of drugs by the individual. Aspects of inappropriate drug use by the elderly are discussed in more detail in Chapter 10.

Repatriation Pharmaceutical Benefits Scheme An estimate of the number of prescriptions dispensed under the Repatriation Pharmaceutical Benefits Scheme for National Health Scheme drugs is given in the

22

following table. Non-National Health Scheme drugs, which are drugs not listed in the Pharmaceutical Benefits Scheme booklet, are not included here because many of them are proprietary products.

Table 2.14: Estimate of the number of prescriptions for N.H.S. drugs ( a ) prescribed under the RPBS 1978-79

No.

A n a l g e s i c s ................................

Heart drugs ...........................

Bronchial spasm, Drugs acting on Blood vessels, Drugs acting on P e n i c i l l i n s ................................

Diuretics ................................

Antacids ................................

T r a n q u illis e r s ...........................

T e t r a c y c l i n e s ...........................

Skin s e d a t i v e s ...........................

A n ti- d ia b e tic s ...........................

Sulphonamides .....................

Sedatives and hypnotics . .

A n ti-d e p re s s a n ts .....................

Eye-drops ................................

Gastro-intestinal sedatives . . Antihistamines .....................

W ater and electrolyte replacement Anti-emetics ...........................

Corticosteroids .....................

Expectorants-cough suppressants Anti-mala rials .....................

Vitamins ................................

Laxatives ................................

Other .....................................

Γ000) Per head

1 019 3.48

384 1.31

373 1.27

266 0.91

98 0.33

500 1.71

315 1.08

325 1.11

105 0.36

134 0.46

63 0.22

62 0.21

405 1.38

173 0.59

135 0.46

58 0.20

70 0.24

175 0.60

89 0.30

62 0.21

64 0.22

59 0.20

46 0.16

44 0.15

406 1.39

Total 5 430 18.55

(a) N.H.S. drugs represent about 77 per cent of total drugs prescribed on the RPBS. The number of prescriptions is estimated by using the computer data for 1979- 80 (the first year computer data is available) on the proportion of prescriptions for each therapeutic class and multiplying this by 5 763 000 (in­ cludes extemporaneous drugs) which is the approximate number of NHS pre­ scriptions for 1978 79. (b) Extemporaneous drugs are excluded.

Source: Department of Veterans’ Affairs.

To give a clearer picture of prescribing on the Repatriation Pharmaceutical Benefits Scheme, the following table of the top 40 non-National Health Scheme drugs is also given. Altogether in 1978-79 there were about 1 721 000 prescriptions for non-National Health Scheme drugs. These 40 drugs represent about 42 per cent of all non-National

Health Scheme prescribing. Tables 2.14 and 2.15 together show 82 per cent of prescribing under the Repatriation Pharmaceutical Benefits Scheme. The other 18 per cent is non-National Health Scheme drugs which are not in the top 40. Altogether, in 1978 79 there were 7 484 528

prescriptions dispensed under the Repatriation Pharmaceutical Benefits Scheme, or 25.6 prescriptions per head. Table 2.14 shows that the consumption rate and patterns of prescribing for repatriation pensioners are similar to those for pensioners under the Pharmaceutical

Benefits Scheme shown in Table 2.13. The total number of prescriptions per head (25.6) for Repatriation Pharmaceutical Benefits Scheme beneficiaries is higher than the 22.22 prescriptions per head for pensioners. There is. however, no limit on the types of drugs

23

Table 2.15: Estimate of the number of prescriptions for the top 40 non-NHS drugs prescribed under the RPBS 1978-1979 ( a )

No.

(Ό00) Per head

Analgesics ................................................ 210 0.72

C o r tic o s te r o id s .......................................... 89 0.30

Sedatives and h y p n o t i c s ........................... 74 0.25

Tranquillisers .......................................... 28 0.10

Expectorants and cough suppressants . . 49 0.17

Blood vessels, drugs acting on . . . . 12 0.04

A n ti-h is ta m in e s .......................................... 15 0.05

A n t a c i d s ..................................................... 53 0.18

Other .......................................................... 188 0.64

Total .......................................................... 718 2.45 * 4 6

(a) The number of prescriptions is estimated by using the computer data for 1979 80 (the first year computer data is available) on the proportion of pre­ scriptions for each therapeutic class and multiplying these by 1 721 000 which is the approximate number of non-NHS prescriptions for 1978 79.

Source: Department of Veterans' Affairs.

that can be prescribed under the Repatriation Pharmaceutical Benefits Scheme and therefore they include both proprietary products and prescriptions for scheduled (S4) drugs which are not on the Pharmaceutical Benefits Scheme list. Consequently, we can assume that the actual consumption of drugs for veterans and pensioners is probably

about the same. This is to be expected as both groups are elderly. As with general pensioners, the rate of prescribing psychotropic drugs for repatriation pensioners is high compared with the general population. The Committee once again urges caution in prescribing these types of drugs to old people.

In their submission to the Committee in 1978, the Department of Veterans' A Hairs said ‘the incidence of prescribing of a number of the top 40 non-National Health Scheme drugs could be questioned as not being in the best interests of the patients for example, Mandrax, Carbrital and Ncmbudeine'.11 These are potentially addictive and dangerous drugs.

A survey for 1976 77 showed that these drugs accounted for about 60 000, 24 000 and 46 000 prescriptions respectively.12 To curb the prescribing of Mandrax, the Department issued an order in October 1979 specifying that the prescribing of this drug be subject to prior approval from the Department of Veterans' Affairs.13 As a result, the prescribing of

Mandrax decreased significantly and between 1 October 1979 and 30 June 1980 only 205 prescriptions were approved.14 The prescribing of Carbrital and Ncmbudeine has decreased markedly over the last 3 years but is still high. The number of prescriptions issued for these drugs under the

Repatriation Pharmaceutical Benefits Scheme in 1979 80 was about 11 000 and 27 000 respectively.15 Another concern of the Department is that often non-National Health Scheme drugs are prescribed when similar, cheaper National Health Scheme drugs are available, bor example, Solprin, which is available under the National Health Scheme and has a dispensed price of $2.37 (per 100). and Disprin, which is not available under the National

Health Scheme and has a dispensed price of $3.79 (per 96). are identical drugs. However, in 1979 80, about 13 000 prescriptions16 were written for Disprin for repatriation patients, resulting in unnecessary cost to the Government. The Committee recognises the right of the doctor to prescribe the drugs which he believes are necessary for the health of

24

his repatriation patient, and realises that often old people are disturbed by any brand change, even to a generic equivalent. Nonetheless, we do urge doctors to consider carefully the therapeutic and economic value of some of the non-National Health Scheme drugs and endeavour to prescribe drugs from the National Health Scheme list wherever

possible.

Table 2.16: Estimate of value of drugs sold to hospitals 1974-1979, top ten therapeutic classes

1974 1975 1976 1977 1978 1979

Antibiotics Subtotal ($’000) ...................... 8 968.4 9 321.0(a) 10401.5 10 811.9 11 037.0 12 576.2

Per capita ($) ........................... 0.66 0.68 0.75 0.77 0.77 0.87

Index ........................................... 100 103 114 117 117 132

Cardiovascular drugs Subtotal ($’000) ...................... 1 800.5(a) 2 132.0(a) 2 949.7(a) 3 798.4(a) 4 043.3 4 847.1

Per capita ($) ........................... 0.13 0.15 0.21 0.27 0.28 0.34

index ........................................... 100 115 162 208 215 262

Psychotropic drugs Subtotal ($’000) ...................... 2 854.0 3 044.7 3 204.5 3 510.7 3011.2 3 624.8

Per capita ($) ........................... 0.21 0.22 0.23 0.25 0.21 0.25

Index ........................................... 100 105 110 119 100 119

Anti-asthmatics Subtotal ($’000) ...................... 1 382.7 1 410.8 2 109.8 2 608.6 2913.1 3 117.5

Per capita ($) ........................... 0.10 0.10 0.15 0.19 0.20 0.22

Index ........................................... 100 100 150 190 200 220

Antineoplastics Subtotal ($’000) ...................... 862.2 1 148.0 1 848.4 2 789.0 2 844.1 2 784.7

Per capita ($) ........................... 0.06 0.08 0.13 0.20 0.20 0.19

Index ........................................... 100 133 217 333 333 317

Antispasmodics Subtotal (S'000) ...................... 528.0 524.1 684.8 1 283.4 2 286.3 2 506.7

Per capita ($) ........................... 0.04 0.04 0.05 0.09 0.16 0.17

Index ........................................... 100 100 125 225 400 425

Hormones Subtotal ($’000) ...................... 1 471.0 1 524.1 1 806.5 2 108.8 2 437.6 2 478.6

Per capita ($) ........................... 0.11 0.11 0.13 0.15 0.17 0.17

Index ........................................... 100 100 118 136 155 155

Dermatologicals Subtotal ($’000) ..................... 2 051.5(a) 2 337.6(a) 2 715.5(a) 2 472.0(a) 2 605.2 2 198.8

Per capita ($) ........................... 0.15 0.17 0.20 0.18 0.18 0,15

Index ........................................... 100 113 133 120 120 100

Analgesics Subtotal ($’000) ..................... 1 011.0 1 270.7 1 609.3 1 738.8 1 826.6 1 887.9

Per capita ($) ........................... 0.07 0.09 0.12 0.13 0.13 0.13

Index ........................................... 100 129 171 186 186 186

Anticoagulants Subtotal ($’000) ..................... 574.0 1 296.3 2 063.1 2 461.0 2 205.8 1 747.7

Per capita ($) ........................... 0.04 0.09 0.15 0.17 0.15 0.12

Index ........................................... 100 225 375 425 375 300

Others Subtotal ($’000) ..................... 11 593.4 12916.5 15 591.8 17 432.9 19 114.5 20 970.3

Per capita ($) ........................... 0.85 0.94 1.12 1.24 1.34 1.45

Index ........................................... 100 111 132 146 158 171

Total drugs used in hospitals ($’000) ..................................... 33 096.7(a) 36 925.8(a) 44 984.9(a) 51 015.5(a) 54 324.7 58 740.3

Per capita ($) ........................... 2.42 2.67 3.24 3.64 3.79 4.06

Index ........................................... 100 110 134 150 157 168

(a) Approximate.

Source: Derived from data collected by Price Waterhouse and Co.

25

Prescribing in hospitals

The value of prescribing in hospitals accounts for 14 per cent of the total drug cost (that is, prescribed and over-the-counter medicine see Table 2.12) and 21.5 per cent of all prescribed medicine (see Table 2.9). The ex-manufacturer value of the top 10 therapeutic classes of drugs sold to hospitals

from 1974 to 1979 is given in the following table. The Index refers to value per capita consumption (total population). The complete table is in Appendix 1. The increase in price during this time has been fairly small, at about 1.7 per cent per year.17 The table reveals that in 1979 hospitals spent most on antibiotics, followed by cardiovascular drugs. This is similar to the pattern in the general community (see Table 2.11). Psychotropic drugs (discussed later) are the third most costly drug item in hospitals.

Within (he general population, analgesics are the third most expensive drug whereas in hospitals they are only the ninth most expensive.

Table 2.17: Estimate(a) of trends in value and volume of pharmacy sales of ethical drugs per capita 1975-1979

1975 1976 1977 1978 1979

Ex-manu­ facturer value fo r 1978-1979

$'000

Antibiotics Penicillins Index (value) ..................................... . . . 100 111 125 128 132 14 043

Index ( v o l u m e ) - ................................ . . . 100 100 97 96 94

Tetracyclines Index (value) ..................................... . . . 100 88 87 92 94 7 346

Index (volume) ................................ . . . 100 95 93 95 90

Erythromycin Index (value) ..................................... . . . 100 76 77 81 85 3 650

Index (volume) ................................ . . . 100 75 76 76 76

Sulphonamides Index (value) ..................................... . . . 100 103 122 111 105 5 731

Index (volume) ................................ . . . 100 143 170 176 142

Urinary antiseptics Index (value) ..................................... . . . 100 79 75 74 80 1 272

Index (volume) ................................ . . . 100 83 80 70 65

Antibiotics Other Index (value) ..................................... . . . 100 60 59 55 58 750

Index (volume) ................................ . . . 100 60 64 61 69

Cardiovascular drugs Drugs acting on heart Index (value) ..................................... . . . 100 113 167 209 255 21 350

Index (volume) ................................ . . . 100 127 196 244 265

Drugs acting on blood vessels)/;) Index (value) ..................................... . . . 100 96 120 128 135 16 691

Index (volume) ................................ . . . 100 87 102 99 97

Analgesics Index (value) ..................................... . . . 100 98 113 121 137 36 084

Index (volume) ................................ . . . 100 97 105 106 97

Antihistamines Index (value) ..................................... . . 100 73 76 80 82 4 769

Index (volume) ..................................... . . 100 94 66 63 59

(a) Estimates were made by taking the value and volume of the largest selling items in each category. (b) Includes hypotensive drugs.

Source: Derived from Intercontinental Medical Statistics (Australasia) Pty Ltd.

26

The value per capita of drugs used in hospitals has risen by 68 per cent between 1974 and 1979. The price of drugs sold to hospitals during this time has risen by only about 9 per cent, and it therefore follows that consumption has increased substantially. The most significant increase has been for the antispasmodics (that is, anticholinergics and anti­

parkinsonism agents), the value of which rose by 325 per cent during this time. The value of antineoplastics (that is, drugs for the treatment of cancer) has also risen substantially (217 per cent) since 1974.

Trends in total ethical drug consumption sold through pharmacy outlets

The following table was derived from sales data obtained from Intercontinental Medical Statistics (Australasia) Pty Ltd on the major selling items in each therapeutic class over the period 1975 to 1979. For comparative purposes the data have been expressed in index form and with reference to 1975 as 100. The last column in the table shows the actual dollar value for all drugs sold in that therapeutic category and is included to show the

relative size of each class. Table 2.17 reveals that the total volume and the volume per capita of almost all types of antibiotics has decreased over the last 5 years. The prescribing of sulphonamides has increased, but their value is only 17 per cent of the total value of all antibiotics.

The use of the major cardiovascular drugs (that is, drugs acting on the heart and drugs acting on the blood vessels) has increased by 165 per cent over the last 5 years. This may be one of the reasons why the incidence of mortality from coronary heart disease has decreased by 20 per cent between 1974 and 1978.18 The prescribing of drugs acting on

blood vessels has remained fairly constant with a few fluctuations since 1975. The prescribing of antihistamines has decreased significantly over the last 5 years until now they are at 59 per cent of the 1975 level. One of the reasons for this is that the long- acting antihistamines were removed from the Pharmaceutical Benefits Scheme in April

1976. The volume of ethical analgesics has on the whole remained fairly constant between 1975 and 1979, with only a few fluctuations. The per capita consumption of proprietary analgesics purchased from chemists in the same period has decreased (by 22 per cent see Table 3.5). Analgesics bought from food stores during the last 3 years, 1978-1980. have

also decreased (by 16 per cent).19 It appears therefore that, provided there has not been an increase in sales from other outlets, total analgesic consumption in the community is declining.

Trends in overall drug consumption Table 2.18 shows the ex-manufacture dollar values of drugs from pharmacies and hospitals over the period 1975 to 1979. It reveals that the most significant rise in value (53 per cent) over the last 4 years has been with proprietary drugs. However, the price

increase for these drugs has been about 47 per cent-0 and therctore actual increase in consumption is probably very low. Hospitals show the next most significant increase in value (52 per cent) and in this case the price increase has been small (about 9 per

cent).21 It therefore follows that the increase of drug consumption in hospitals has been substantial. The value of ethical drugs from pharmacies has risen by 30 per cent and the price of these drugs by about 18 percent.22 Consumption has therefore risen moderately.

The overall value of drugs from pharmacies and hospitals has risen by 37 per cent and the overall prices of drugs have increased by about 23 per cent.2' IT APPEARS THEREFORE THAT THE OVERALL CONSUMPTION OF DRUGS HAS INCREASED MODERATELY OVER THE PERIOD 1975 TO 1979.

27

Table 2.18: Trends in the ex-manufacturer value of drugs from pharmacies and hospitals 1975-1979

1975 1976 1977 1978 1979

Ethical drugs from pharmacies Total ($ m i l l i o n s ) ..................... 188.4 195.0 215.6 228.4 255.7

Per capita ( $ s ) .......................... 13.68 14.01 15.32 16.03 17.73

Index .......................................... 100 102 112 117 130

P ro p rie ta ry drugs from p h a r­

m acies^) Total ($ m i l l i o n s ) ..................... 56.6 63.5 73.4 81.0 90.5

Per capita ( S s ) ........................... 4.11 4.56 5.22 5.69 6.27

Index .......................................... 100 111 127 138 153

Drugs from hospitals Total ($ m i l l i o n s ) ..................... 36.9 45.0 51.0 54.3 58.7

Per capital ( $ s ) .......................... 2.67 3.24 3.64 3.79 4.06

Index .......................................... 100 121 136 142 152

Total drug value ($ m i l l i o n s ) ................................ 281.9 303.5 340.0 363.7 404.9

Per capita ( $ s ) .......................... 20.46 21.81 24.16 25.53 28.07

Index .......................................... 100 107 118 125 137

(a) About 12 per cent of proprietary products called ‘other non-therapeutic’ are items such as toothpaste, sugar or salt sub­ stitutes etc. They have not been included here.

Source: Derived from data supplied by Intercontinental Medical Statistics (Australasia) Pty Ltd and Price Waterhouse and Co.

Conclusions and recommendations Surveys which studied drug consumption in a 2-day period found that between 47 and 60 per cent of the population had taken some form of medication during the 2-day period.

All surveys found that more women than men take medication (in the ratio of 1.5:1). 1 he proportion of children (0 14 years) who had consumed medication in the 2-day period was between 32 to 38 per cent, and there were no significant differences in drug intake between the sexes.

Painkillers are the most popular medicines (16 22 per cent of the population consumed these) followed by vitamins and tonics (10 14 per cent). The findings of the surveys differ as to what are the next most important medications. In 1978-79 about $400 million (ex-manufacturer value) was spent on therapeutic drugs in pharmacies and hospitals. In both pharmacies and hospitals the drugs of highest value were antibiotics, followed by cardiovascular drugs.

Over the period 1975 to 1979 the consumption of proprietary drugs from pharmacies rose only slightly. The increase in consumption of ethical drugs from pharmacies was moderate and the increase in drug consumption generally in hospitals was significant. Overall it appears that total drug consumption between 1975 and 1979 increased moderately.

The only way in which drug usage can be monitored effectively is to establish a comprehensive data base. The shortcomings of the present system of data collection have been highlighted throughout this chapter. The Committee has therefore recommended that the Commonwealth Department of Health develop a data base which will enable a full assessment of the levels of consumption and use of all therapeutic drugs (see page 21). The Committee has suggested various sources from which a comprehensive data base could be established.

R eferences 1. C o m m o n w e a lth D e p a rtm e n t o f H e alth , p e rso n al co m m u n ica tio n . 2. A u stra lia n B ureau o f S tatistics, A ustralian H ealth Survey 1977 78, C atalo g u e N o. 431 1.0.

28

3. Health Commission ot' N.S.W., H ealth Care Su rvey o f G osford II lo n g and Illaw arra 1975. Sydney, 1978. 4. South Australian Royal Commission into the Non-Medical Use of Drugs, 'Three Studies in Drug Use’, Research Papers 3, 4, 5. Adelaide, 1979.

5. C. Bridges-Webb, 'Drug Medication in the Community'. The M edical Journal of A ustralia 1 April 1972. p. 675. 6. The Pharmacy Guild of Australia, The P harm acy G uild D igest June 1979. p. 8. 7. Evidence, p. 1723. 8. D. de Souza, 'Some Aspects of Clinical Therapeutics as Applied to Geriatric Medicine" Part II.

The Jo u rn a l o j G eriatrics June 1973. p. 30. 9. The W est A u stra lia n, 14 March 1980, p. 22. 10. Evidence, p. 1339. 11. Evidence, p. 2632. 12. Submission from the Department of Veterans' Affairs, Appendix 12. 13. Correspondence from the Department of Veterans' Affairs, 8 August 1980. 14. Correspondence from the Department of Veterans' Affairs. 8 August 1980. 15. Correspondence from the Department of Veterans' Affairs, 1 September 1980.

16. Correspondence from the Department of Veterans' Alfairs. 1 September 1980. 17. Australian Pharmaceutical Manufacturers Association, personal communication. 18. The National Heart Eoundation, 'Heart Facts 1978'. Information Paper No. 9 80. 19. Data obtained from A. C. Nielsen Pty Ltd. 20. Pharmaceutical Manufacturing Industry Inquiry, R eport. Canberra. 1979. p. 46. 21. Commonwealth Department of Health, Intercontinental Medical Statistics (Australasia) Pty

Ltd, and Australian Pharmaceutical Manufacturers Association. 22. Commonwealth Department of Health, Intercontinental Medical Statistics (Australasia) Pty Ltd, and Australian Pharmaceutical Manufacturers Association. 23. Commonwealth Department of Health, Intercontinental Medical Statistics (Australasia) Pty

Ltd, and Australian Pharmaceutical Manufacturers Association.

29

CHAPTER 3

C o n s u m p t i o n o f d r u g s w h i c h c a u s e c o n c e r n

Introduction During public hearings, the Committee received numerous submissions suggesting that there was excessive consumption of many different types of drugs in the Australian community. Concern was expressed repeatedly that psychotropic drugs, appetite suppressants, hypnotics, analgesics, vitamins and over-the-counter cough and cold remedies were the subject of inappropriate use. For this reason the Committee has presented in this chapter details of trends in the consumption of these products. Overall there appears little evidence of a general increase in consumption. In fact, consumption of psychotropic drugs seems to have fallen somewhat during the last 5 years. However, the general rate of consumption of these products is still extremely high and there is evidence that there are significant sections of the community which are taking these drugs on a chronic basis. Thus in 1979, 413 100 000 days" treatment of psychotropic drugs were consumed by the Australian people, that is, an average of 29 days' treatment per person.

The one real growth area in drug consumption has been some vitamin preparations. In this situation the statistics may not give the w-hole picture because in recent years there has been a tendency to add vitamins to foods. There is little evidence that consumption of high dose vitamins is of any medical benefit, and the Committee views with some concern the uncontrolled proliferation ol high dose vitamin preparations largely because the toxic and long-term effects of high doses of these compounds are unknown.

Prescription psychotropic drugs

Surveys A summary of surveys relating to prescribed psychotropic drugs has been compiled by Patricia Mealy1 and is given in Appendix 2. For the purposes of this summary, psychotropic drugs are defined as hypno-sedatives, antidepressants and tranquillisers. These are largely drugs which alter mood.

The surveys, ranging over a period of years, vary considerably. However, they do give some indication of psychotropic drug usage. They reveal that about one-third of the adult population have used psychotropic drugs at some time, and that 10 14 per cent of adults are current users of one or more of these drugs (8 10 per cent of males. 12 20 per cent

females) and 4 7 per cent of males and 7 18 per cent of females use them daily or on most days. Of the adolescent population at school, 5 14 per cent are currently using one or more psychotropic drugs and about 2 4 per cent are using them daily or several times each week.

The most recent study of the patterns of use of prescribed psychotropic drugs w as conducted in 1978 by the South Australian Royal Commission into the Non-Medical Use of Drugs.2 A stratified sample of 2928 people was used. Because the sample was stratified in favour of younger persons, the figures on the percentage of people taking psychotropic drugs may be underestimated.-’ A summary of the relevant findings is set out in Table 3.1

30

Table 3.1: Patterns of use of prescription psychotropic drugs among subgroups of respondents (percentages)

Used but Frequency o f use

not in Used in in past 4 weeks

past 4 past 4 ----------------------------

N ot used weeks weeks 1-4 times 5 + times

Prescribed sedatives and painkillers Sex: M a l e ........................................... (1370) 80 17 3 2 2

Female ..................................... (1558) 69 25 6 4 2

Age: 13-17 y e a r s ................................ (680) 89 10 2 1 1

18-34 y e a r s ................................ (1544) 73 24 4 3 1

35 60 y e a r s ................................ (704) 64 27 9 5 4

P r e s c r i b e d t r a n q i l l i s e r s a n d

antidepressants Sex: M a l e ........................................... (1370) 81 16 3 1 2

Female ...................................... (1558) 67 28 5 2 3

Age: 13 17 y e a r s ................................ (680) 93 5 1 1 1

18 34 y e a r s ................................ (1544) 70 27 3 1 2

35-60 y e a r s ................................ (704) 62 28 10 3 7

Source: Royal Commission into the Non-medical Use of Drugs, South Australia, ‘Three Studies in Drug Use', Research Papers 3,4, 5, Adelaide, 1979.

Table 3.1 shows that females tend to be greater users of prescribed sedatives, painkillers, tranquillisers and antidepressants than males and that a greater number of people in the 35-60 age group use these types of drugs more frequently than those in the 13-34 age group.

The South Australian Royal Commission into the Non-Medical Use of Drugs, from an analysis of its own study and some other available studies, concluded that 'frequent or regular use for more than a short time is very much the exception rather than the rule'.4 However, several surveys (w'hich are mentioned later in the Commission's report) did not

support the Commission's conclusions. In 1971, using a sample of 639 adults, George found that 5 per cent of adults used sedatives and tranquillisers daily and an additional 2 per cent used them several times per week.5 In late 1971, Hennessy, Bruen and Cullen surveyed 1422 persons and found that 5

per cent of women used sleeping tablets daily and 2 per cent used them several times per week. They also found that 5 per cent of women used tranquillisers daily and 1 per cent several times per week.6 George conducted another random survey in 1973 using a sample of 101 1 adults and found that 5 percent used sedatives and tranquillisers daily and I per

cent used them several times per week." Some non-randomly sampled surveys also found rates higher than the South Australian Royal Commission s study. In 1974. C arrington- Smith, using a sample of 500 women, found that 8 per cent used sedatives daily.' Reynold's survey of 23 032 Mcdicheck* patients found in 1975 that 7 percent of men and

19 per cent of women were daily users of sedatives, tranquillisers or antidepressants and that in 1976, 7 per cent of men and 16 per cent of women were daily users of the drugs." in 1975 76 Gibson surveyed 9829 adult members of the Australian Workers Union and found that 6 per cent of men and 13 per cent of women were 'regular' users of tranquillisers or sedatives.111 In 1976. Magro. using a sample of 206 v.omen, found that 12 per cent were 'daily or more of ten users of tranquillisers and hypno-sedatives.11

* M cdicheck is an au to m ated health testing facility located in Sydnex.

31

Because of the findings of these additional surveys, the Committee is unable to agree with the conclusion of the South Australian Royal Commission into the Non-Medical Use of Drugs that frequent use of psychotropic drugs is exceptional. It appears that frequent use may be widespread, particularly among women. The figures presented in Table 3.2 do confirm an alarming rate of consumption of psychotropic drugs in the Australian community. However, the Committee believes that, in the absence of any practical alternative solution to the cause of anxiety or depression, the frequent short­ term use of psychotropic drugs may be necessary. On the other hand, the Committee also believes that prolonged use of these drugs is an inappropriate solution to any problem.

Table 3.2: Estimated daily dosages (units) of ethical psychotropic drugs purchased in pharmacies 1975-1979 ( a )

1975 1976 1977 1978 1979

Hypnotics and sedatives Total ( m i l l i o n s ) ................................ 173.4 176.2 167.5 156.4 157.3

Per capita (units) ........................... 12.59 12.67 11.90 10.97 10.91

In d ex (b) ........................................... 100 101 95 87 87

Barbiturates Subtotal (millions) . . . . 94.3 81.5 71.2 65.6 59.0

Per capita (units) . . . . 6.85 5.86 5.06 4.60 4.09

Index .....................................

Non-barbiturates

100 86 74 67 60

Subtotal (millions) . . . . 79.1 94.7 96.3 90.8 98.3

Per capita (units) . . . . 5.74 6.81 6.84 6.37 6.82

Index ..................................... 100 1 19 119 111 1 19

Tranquilizers Total ( m i l l i o n s ) ................................ 167.1 181.5 160.0 158.5 1 70.4

Per capita (units) ........................... 12.14 13.04 11.36 11.12 1 1.82

Index ................................................ 100 107 94 92 97

Diazepam Subtotal (millions) . . . . 107.7 102.9 75.2 62.5 63.3

Per capita (units) . . . . 7.82 7.39 5.34 4.39 4.39

Index ..................................... 100 95 68 56 56

Oxazepam Subtotal (millions) . . . . 10.7 26.8 32.0 43.1 53.5

Per capita (units) . . . . 0.78 1.93 2.27 3.02 3.71

Index ..................................... 100 247 291 387 476

Diazepam and Oxazepam Subtotal (millions) . . . . 118.4 129.7 107.2 105.6 1 16.8

Per capita (units) . . . . 8.60 9.32 7.61 7.41 8.10

Index ..................................... 100 108 88 86 94

Other tranquilizers Subtotal (millions) . . . . 48.7 51.8 52.8 52.9 53.6

Per capita (units) . . . . 3.54 3.72 3.75 3.71 3.72

Index ..................................... 100 105 106 105 105

Antidepressants Total ( m i l l i o n s ) ................................ 76.9 86.0 88.8 89.4 85.7

Per capita (units) .......................... 5.58 6.18 6.31 6.27 5.94

Index ................................................ 100 1 1 1 113 112 106

A ll ethical psychotropic drugs Total ( m i l l i o n s ) .......................... . 417.4 443.7 416.3 404.3 413.4

Per capita (units) ..................... . 30.3! 31.89 29.57 28.36 28.67

Index .......................................... . 100 105 98 94 95

(a) The daily dosage was estimated from the Australian Medical Index. (b) Index relates to the base year 1975 per capita consumption.

Source: Intercontinental Medical Statistics (Australasia) Ply l td.

32

Consumption

Tables 3.2 and 3.3, derived from Intercontinental Medical Statistics (Australasia) Pty Ltd data, give a good estimate of the total consumption and trends in consumption of psychotropic drugs purchased from chemists between 1975 and 1979. The original data in Table 3.3 were supplied in wholesale values but these have been converted to ex­ manufacturer value for the purpose of comparison with Table 3.4, assuming that most of the pharmacists stock is bought from wholesalers, whose commission is about 15 per cent ol the wholesalers' price.12 The data on daily dosage (Table 3.2) were derived by taking the average daily dose ot each drug using the Australian Medical Index and dividing this figure into the total consumption of the drug. These per capita units represent the number

Table 3.3: Estimated ex-manufacturer value of ethical psychotropic drugs purchased in pharmacies 1975-1979

1975 1976 1977 1978 1979

Hypnotics and sedatives Total ($ ’000) .................................. 3 175.9 3 888.2 4 103.0 4 127.8 4 503.9

Per capita (cents) ........................... 23.1 27.9 ' 29.2 29.0 31.2

Index ................................................ 100 121 126 126 135

Barbiturates Sub-total ($ ’0 0 0 ) ....................... 1 130.1 1 061.0 986.9 1 009.5 1 035.7

Per capita (cents) . . . . 8.2 7.6 7.0 7.1 7.2

Index ...................................... 100 93 85 87 88

Non-barbiturates Sub-total ($ ’0 0 0 ) ....................... 2 045.8 2 827.2 3 116.1 3 1 18.3 3 468.2

Per capita (cents) . . . . 14.9 20.3 22.2 21.9 24.0

Index ...................................... 100 136 149 147 161

Tranquillisers Total ($ ’0 0 0 ) ............................ 8 050.3 8 589.7 7 492.9 6 951.8 7 626.4

Per capita (cents) . . . . 58.5 61.7 53.2 48.8 52.9

Index ...................................... 100 105 91 83 90

Diazepam Sub-total ($ ’0 0 0 ) ..................... 4 830.7 4 680.0 3 218.1 2 349.7 2 463.1

Per capita (cents) . . . . 35.1 33.6 22.9 16.5 17.1

Index ..................................... 100 96 65 47 49

Oxazepam Sub total ($ ’0 0 0 ) ....................... 533.1 1 016.4 1 179.3 1 426.6 1 779.1

Per capita (cents) . . . . 3.9 7.3 8.4 10.0 12.3

Index ..................................... 100 187 215 256 315

Diazepam and Oxazepam Sub-total ($’0 0 0 ) ...................... 5 363.8 5 696.4 4 397.4 3 776.3 4 242.2

Per capita (cents) . . . . 39.0 40.9 31.3 26 5 29 4

Index ..................................... 100 105 80 6X 75

Other tranquillisers Sub-total ($ ’0 0 0 ) ...................... 2 686.5 2 893.3 3 095.5 3 175.5 3 384 2

Per capita (cents) . . . . 19.5 20.8 22.0 22.3 23.5

Index ..................................... 100 107 1 1 3 1 14 121

Antidepressants Total ($ ’000) .................................. 4 170.7 4 6X7.6 4 804.4 4 949.5 5 015.5

Per capita (cents) .......................... 30.3 33.7 34.1 34.7 34.8

Index ................................................ 100 11 1 1 1.3 115 115

A ll ethical psychotropic drugs Total ($O00) ................................15 396.9 17 165.5 16 4(H).3 16 029.1 17 145.8

Per capita (cents) ........................... 111.9 123.3 116.6 112.5 11X 9

Index ................................................ 100 110 104 101 106

Source: Intercontinental Medical Statistics (Australasia) Pt> l td.

of days' treatment per head of population. The estimates of expenditure are probably extremely reliable as they are almost identical to the figures on the value of sales of psychotropic drugs produced by Price Waterhouse and Company for 1978-79. Table 3.3 reveals that the ex-manufacturer value of ethical psychotropic drugs from pharmacies in 1979 was $17.1 million, or $ 1.19 per head of population.

Table 3.2 shows that, apart from a 5 percent increase in 1976, the overall consumption of psychotropic drugs from pharmacies has declined slightly over the last 5 years, most significantly for hypnotics and sedatives which have fallen by 13 per cent. Apart from a few fluctuations, use of tranquillisers has remained fairly constant. Antidepressants rose by 11 per cent in 1976, remained at about this level for the next 2 years and then fell by 5 per cent in 1979.

The most interesting changes have occurred within these broad groups. Consumption of barbiturates has fallen steadily over the last 5 years and is now 40 per cent below the 1975 level. The use of non-barbiturate hypno-sedatives increased by 19 per cent in 1976 and, apart from a 7 per cent decrease in 1978, has remained at this level.

The consumption of diazepam fell dramatically by 32 per cent in 1977 and again by 12 per cent of the 1975 level in 1978, remaining at this level in 1979. The consumption of oxazepam, however, increased significantly in 1976 and has continued to increase over the last 4 years until in 1979 consumption was almost 5 times the 1975 level. If the consumption of diazepam and oxazepam are added, the overall trend, apart from a few

fluctuations, is fairly level with perhaps a slight inflection downwards. Recent information obtained from Roche Products Pty Ltd on their sales of diazepam and oxazepam show that over the 12 months ending June 1980, the combined volume of these drugs has remained constant and that the sales of oxazepam now exceed those of diazepam. These developments are likely to reflect the adverse publicity in the media given

to the most common form of diazepam Valium. Data on hospital consumption of psychotropic drugs are provided by a survey conducted by Price Waterhouse and Company for the pharmaceutical manufacturers. Forty-seven companies contribute their sales figures quarterly (value only) to this ongoing survey and these figures make up 98 per cent of hospital sales. Table 3.4 sets out the findings of this survey from 1975 to 1979. It should be noted that the price of drugs to hospitals has increased only slightly—less than 1.7 per cent per year.

The table reveals that in 1979 $3.6 million was spent on psychotropic drugs in hospitals, or 25 cents per head of population. The value of psychotropic drugs represents 6 per cent of the total value of drugs sold to hospitals (see Table 2.16). Taking into consideration the slight price rises, the table shows that apart from fluctuations, the overall value of psychotropic drugs in hospitals has remained fairly constant over the last 5 years. The value of hypno-sedatives rose in 1976 and then declined

until in 1979 it was 22 per cent below the 1976 value. The value of barbiturates increased markedly by 32 percent in 1976, declined until 1978 and then rose again. In 1979 the value was 27 per cent higher than in 1975. (The Committee has no data on how much of this is used as pre-medication or how much is used as an hypnotic.)

The overall value of tranquillisers used in hospitals has increased slightly. The most significant change has been in the value of major tranquillisers (for example, Largactil), which has risen steadily over the last 5 years until in 1979 the value of these drugs was 57 per cent higher than in 1975. In contrast, the use of minor tranquillisers has fallen significantly and in 1979 the value was 46 per cent lower than in 1975. The value ot antidepressants fluctuated between 1975 and 1978 but in 1979 it rose significantly by 50 per cent of the 1975 level.

The price of Pharmaceutical Benefits Scheme drugs to hospitals is 21 per cent lower than to wholesalers, and when consumption in the community is being compared with consumption in hospitals, this factor must be considered. However, even if the value ol

34

Table 3.4: Estimates of sales of psychotropic drugs to hospitals 1975-1979

1975 1976 1977 1978 1979

Hypnotics and sedatives Total ($ ’000) .................................. 447.8 548.2 510.3 419.2 427.2

Per capita (cents) ........................... 3.2 3.9 3.6 3.0 3.0

Index ................................................ 100 122 113 94 94

Barbiturates Subtotal ($ ’0 0 0 ) ....................... 29.8 40.8 39.1 35.7 40.2

Per capita (cents) . . . . 0.22 0.29 0.28 0.25 0.28

Index ...................................... 100 132 127 114 127

Non-barbiturates Subtotal ($ ’0 0 0 ) ....................... 418.0 507.4 471.2 383.5 387.0

Per capita (cents) . . . . 3.0 3.6 3.3 2.7 2.7

Index ...................................... 100 120 110 90 90

Tranquillisers Total ($ ’000) .................................. 2262.4 2309.8 2608.3 2235.7 2682.9

Per capita (cents) ........................... 16.4 16.6 18 5 15.7 18.6

Index ................................................ 100 101 113 96 113

N eu ro lep tics (m ajo r tran q u il-Users) Subtotal ($’0 0 0 ) ....................... 1307.5 1507.7 1841.7 1789.9 2152.0

Per capita (cents) . . . . 9.5 10.8 13.1 12.6 14.9

Index ........................................ 100 114 138 133 157

Other tranquillisers Subtotal ($ ’000) ...................... 954.9 802.1 766.6 445.8 530.9

Per capita (cents) . . . . 6.9 5.8 5.4 '3 .1 3.7

Index ........................................ 100 84 78 45 54

A n tid ep ressa n ts Total ($ ’000) .................................. 334.5 346.5 392.1 356.3 514.7

Per capita (cents) ........................... 2.4 2.5 2.8 2.5 3.6

Index ................................................ 100 104 117 104 1 50

ΛΙ1 hospital psychotropic drugs Total ($ ’000) .................................. 3044.7 3204.5 3510.7 3011.2 3624.8

Per capita (cents) ........................... 22.0 23.0 24 9 21.2 25.2

Index ................................................ 100 105 113 96 115

Source: Price Waterhouse and Co.

drugs in hospitals is inflated by 21 per cent, the ratio of hospital drug value to value ol drugs sold through pharmacies is still small (a ratio ol 1:4). Because ol this, and because the trends in hospital consumption have not been significant, it may be assumed that the trends for total psychotropic drug consumption in hospitals are the same as the trends

shown in Table 3.3 for the drugs sold from pharmacies. It can therefore be said with a reasonable amount ol certainty that the overall consumption of psychotropic drugs in Australia ov er the last 5 years has declined slightly.

Over-the-counter analgesics The trend in consumption of over-the-counter analgesics purchased from pharmacies over the last 5 years is given in Table 3.5. A. C. Nielsen Pty Ltd is a company which surveys the sales of 10 700 food stores

throughout Australia and audits the sales from pharmacies. Data obtained from this company on over-the-counter analgesic consumption are shown in Table 3.6. The table reveals that the volume of analgesics purchased from food stores has

declined by 16 per cent over the last 3 years. According to A. ( Nielsen Pty Ltd. ov er-the-

Table 3.5: Pack sales of over-the-counter analgesics for pharmacies 1975-1979

1975 1976 1977 1978 1979

Number ( ’000) ........................... 13 385 12 865 11 710 11 595 10 956

Per capita ( u n i t s ) ........................... 0.97 0.92 0.83 0.81 0.76

I n d e x ................................................ 100 95 86 84 78

Source: Intercontinental Medical Statistics (Australasia) Pty Ltd.

Table 3.6: V olume of analgesic tablets and powders sold from 10 700 food stores 1978-1980

Ό00 units (1 unit = 1 dozen tablets or powders)

1978 1979 1980

Number . . 33 321.6 32 430.0 27 929.4

Index . . . 100 97 84

Source: A. C. Nielsen Pty Ltd.

counter analgesics sold from food stores account for 56 per cent by volume of all over-the- counter analgesics sold. There are no statistics available on other outlets such as clubs, hotels, milk bars, garages etc. Provided there has not been an increase in sales from outlets other than pharmacies

and food stores, and in the number of these outlets, it appears that the consumption of over-the-counter analgesics in the community is decreasing. Recent data obtained from the Proprietary Association of Australia on sales of over-the-counter analgesics from October- November 1978 to April May 1980 show that this decrease continued until

February-March 1980 and then in the next 2 months slightly increased. The overall decrease in sales has been particularly apparent in food stores. However, it must be reiterated that there are no adequate data on sales from other outlets. In the past the main concern with over-the-counter analgesics was the compound analgesics. In the Committee’s earlier report13, a detailed description and analysis of compound analgesic use and 'abuse" was given which will not be repeated here. It was concluded that "there is a relationship between the excessive use of compound analgesics and the occurrence of analgesic nephropathy"14 and it was recommended that compound analgesics be scheduled S4 and single analgesics be sold in packs of specified type and size in accordance with the National Health and Medical Research Council proposals of its Eighty-Third Session in April 1977.15

The National Health and Medical Research Council recommendations have been put into legislation in Queensland. New South Wales. Tasmania, Victoria. Western Australia and South Australia.1,1 The Northern Territory has no restriction on the sale of minor analgesics, but a draft ordinance which follows the National Health and Medical

Research Council recommendations is being put to Cabinet.1' The restrictions on compound analgesics have not been in operation long enough to determine their effect on the incidence of end stage renal failure. However, the C ommittee will monitor the statistics on this disease over the next few years to determine the effect of the restrictions in the various States.

Vitam ins

There are inadequate data on the consumption of vitamins in the community. F igures arc available for pharmacy sales but cannot be obtained for other retail outlets, including

36

health food stores which seem to be flourishing. The following table shows the number of pack sales in pharmacies for vitamins from 1975 to 1979:

Table 3.7: Pack sales of over-the-counter vitamins from pharmacies 1975-1979

1975 1976 1977 1978 1979

Multivitamins Total ( Ό 0 0 ) ................................ 2913 3 048 3 220 3 054 3 051

Per capita ( u n i t s ) ...................... 0.211 0.219 0.229 0.214 0.212

Index ........................................... 100 104 109 101 100

Vitamins A and D Total (’0 0 0 ) ................................ 225 156 135 118 104

Per capita ( u n i t s ) ..................... 0.016 0.011 0.010 0.008 0.007

Index ........................................... 100 69 63 50 44

Vitamins Bl and Combinations Bl. B6. B12 Total ( Ό 0 0 ) ................................ 186 164 150 136 117

Per capita ( u n i t s ) ...................... 0.014 0.012 0.011 0.010 0.008

Index ........................................... 100 86 79 71 57

Vitamin B Complex Total ( Ό 0 0 ) ................................ 178 253 399 505 1 000

Per capita ( u n i t s ) ...................... 0.013 0.018 0.028 0.035 0.069

Index ........................................... 100 138 215 269 531

Vitamin C Total ( Ό 0 0 ) ................................ 2 705 2 470 2 938 3 557 3 945

Per capita ( u n i t s ) ...................... 0.196 0.178 0.209 0.249 0.274

Index ........................................... 100 91 107 127 140

Others Total ( Ό 0 0 ) ................................ 383 392 610 626 636

Per capita ( u n i t s ) ...................... 0.028 0.028 0.043 0.044 0.044

Index ........................................... 100 100 154 157 157

All vitamins Total t ’O t l O l ................................ 6 590 6 483 7 452 7 996 8 853

Per capita ( u n i t s ) ...................... 0.478 0.466 0.530 0.560 0.614

Index ........................................... 100 97 111 117 128

Source: Intercontinental Medical Statistics (Australasia) Pty Ltd.

Table 3.7 reveals that the overall consumption of vitamins from pharmacies has increased by 28 per cent over the last 5 years. Overdoses of Vitamins A or D can cause serious toxic effects (discussed later) but the Committee notes that consumption ol these preparations is low in magnitude and is rapidly decreasing. The consumption ol V itamins

B1, B6 and Bl 2 is also very low and is steadily decreasing. In contrast, the use ol \ itamin B complex is rapidly increasing and between 1978 and 1979 there was a 97 per cent rise. The consumption of Vitamin C is also increasing and in 1979 was 41) per cent higher than the 1975 level.

Conflicting evidence was given to the Committee as to whether or not there is a need for the Australian population to supplement its diet with added vitamins. T he Proprietary Association of Australia commented that the literature on the vitamin requirements ol our population as a whole is scant.18 However, in its submission to the C ommittee. the Association reviewed three available articles1'1, which suggested that there max he nutrient deficiencies in the diets of some Australians, and made the following conclusion:

Based on the available evidence and extrapolating the results ol the specific vitamins and nutrients studied to date to the overall range of necessary vitamins and minerals, it w ould appear that a significant proportion ol the Australian population may require supplementary

vitamin and mineral intake to maintain their normal physiologic and metabolic function. It is now commonly accepted by nutritionists that increasing dependency on take-away foods is likely to increase the tendency towards depressed dietary vitamin intake.20

Mrs E. Richardson, Secretary of the Australian Association of Dietitians, Canberra, expressed a different view. She felt that vitamins and minerals are available in adequate amounts from our foods and if suitable foods are not selected, the addition of vitamin or mineral supplements will not correct the problem. She added:

Our food provides more than fifty known nutrients. The supplements may contain from one to ten of these. These are most unlikely to make good the deficiencies in an inadequate diet.21 In a joint submission to the Committee, Miss B. Wood, Chief Dietitian, and Dr K. Breen, Director of the Gastroenterology Unit, of St Vincent’s Hospital, Victoria, said that "large doses of vitamins of any kind are unnecessary if a varied diet is taken’.22

The American Dietetic Association has said:

. . . that normal healthy individuals do not need vitamin, mineral and dietary supplements if an adequate diet is consumed.

. . . No one food contains all vitamins and minerals needed, but a varied diet selected from the basic food groups (meat, milk, vegetables and fruits, breads and cereals) will provide an adequate diet for optimal health.2 '

They listed a few exceptions and while these do not include vitamins, they seem appropriate to include here:

Women and adolescent girls in the child-bearing years may need an iron supplement (ferrous iron). Pregnant women: Beginning with fourth month of pregnancy. 30 to 60 mg (milligrams) of iron supplement (ferrous iron) and 200 to 400 meg (micrograms) of folacin (folic acid) are needed daily.

Children under four years of age may need an iron supplement (ferrous iron).24

There is also a view that babies who are fed on artificial milk may need vitamin supplements.25 The American Dietetic Association added that ‘supplements should not be used to correct inadequate food intakes or faulty food habits without medical supervision".20

Mrs Richardson and the Proprietary Association both agreed that vitamins could be toxic. Large doses of Vitamin A or Vitamin D cause well-recognised syndromes which may require urgent treatment. It is difficult to know the incidence of vitamin toxicity in the community because of a lack of data.27 However, the consumption figures in Table 3.7 show that the use of Vitamins A and D in multivitamin combinations is decreasing and that consumption of Vitamins A and D as single doses is negligible. It seems therefore that a major problem is unlikely.

Perhaps the major area of concern is the proliferation of high dose proprietary preparations and high dose products such as Tang’ which arc promoted in supermarkets as foods. There seems no fixed upper limit to dosage, and the upper limits of safety of unrestricted high dose vitamin intake does not appear to have been established.

On the evidence available the Committee cannot determine the therapeutic efficacy or adverse effects of vitamins. However, at present, the Commonwealth Department of Health is considering the matter of vitamins through various Committees. The Australian Drug Evaluation Committee is looking at their therapeutic use: the food Standards (Standing) Committee of the National Health and Medical Research Council is examining vitamin supplements in food and is draw ing up a list of recommended daily allowances for vitamins and minerals.2" The National Therapeutic Goods Committee is also studying vitamins.20 We RECOMMEND that these C ommittees jointly study tin- question of vitamins and produce a public report which should be widely disseminated.

Cough and cold preparations The following table shows the level of consumption and trends in the use of cough and cold preparations bought from pharmacies over the last 5 years:

Table 3.8: Pack sales of over-the-counter cough and cold preparations from pharmacies 1975-1979

1975 1976 1977 1978 1979

Cold preparations and nasal decon­ gestants Total (’0 0 0 ) ................................ 2238 2660 2189 2429 2435

Per capita ( u n i t s ) ..................... 0.163 0.191 0.156 0.170 0.169

Index ........................................... 100 117 96 104 104

Expectorants Total ( Ό 0 0 ) ................................ 1013 1135 1247 1167 1411

Per capita ( u n i t s ) ..................... 0.074 0.082 0.089 0.082 0.098

Index ........................................... 100 111 120 111 132

Cough sedatives Total ( Ό 0 0 ) ................................ 3498 3897 4164 3963 3745

Per capita ( u n i t s ) ..................... 0.254 0.280 0.296 0.278 0.260

Index ........................................... 100 110 117 109 102

Other Total ( ’0 0 0 ) ................................ 633 616 748 1108 971

Per capita ( u n i t s ) ...................... 0.046 0.044 0.053 0.078 0.067

Index ........................................... 100 96 115 170 146

All cough and cold preparations Total (’0 0 0 ) ................................ 7382 8308 8348 8667 8562

Per capita ( u n i t s ) ..................... 0.537 0.597 0.594 0.608 0.594

Index ........................................... 100 111 111 113 1 11

Source: Intercontinental Medical Statistics (Australasia) Ply Ltd.

The table reveals that the consumption of cough and cold preparations brought from pharmacies rose by 11 per cent in 1976 and has remained fairly constant since then. Data obtained from A. C. Nielson Pty Ltd show the consumption of liquid cough and cold preparations sold from food stores over the last 3 years:

Table 3.9: Volume of liquid cough and cold preparations sold from food stores 1978-1980

Ό00 units (1 unit = 100 mis)

1978 1979 1980

Liquid cough and cold products Index ..........................................

2521.7 100

2847.7 113

2544.2 101

Source: A. C. Nielson Pty Ltd.

The table reveals that cough and cold products bought from food stores rose in 1979 and then fell again to the previous level in 1980. According to A. C. Nielson Pty Ltd. consumption in 1979 of liquid cough and cold preparations from food stores accounted for only 15 per cent by volume of all liquid

cough and cold products sold. Food stores are therefore not a major retailer ol these products and there seems to be no cause for concern about them. The Committee received some anecdotal evidence on the inappropriate use of these preparations. In a submission to the Committee the Association of Retail Pharmacy

39

Employees said that there is a problem of younger people attempting to purchase compound cough mixtures for the specific purpose of taking large quantities to achieve a drug ‘high’.30 There was, however, no hard evidence to support these assertions they were ‘the experience of members as gleaned in preparing this submission’.31

The Australian Royal Commission of Inquiry into Drugs cited some cases of inappropriate use but had no statistics to indicate the size of the problem.32 In evidence to the Royal Commission, the Health Commission of New South Wales commented that until mid 1978 they had received only intermittent reports of the inappropriate use of cough mixture but that since then the problem had escalated.33

In response to the increasing number of reports of inappropriate use, the Pharmacy Board of New South Wales issued warnings to pharmacists about certain cough mixtures, mainly those containing antihistamines.34 They have also taken action against pharmacists who have been supplying these cough mixtures without proper surveil­ lance.35 During the period 1 January 1977 to 1 June 1980 the Board suspended from practice 7 pharmacists for this offence.36

At present most of the cough and cold preparations which are causing concern are contained in Schedule Three which restricts the product to sale in pharmacies. At its Eighty-Third Session in April 1977. the National Heajth and Medical Research Council recommended that Schedule Three be tightened so that substances under this Schedule:

(i) were to be sold only by a pharmacist; (ii) were to be in a separate part of the store to which customers do not have access; and (in) sales were to be recorded and the bottle labelled with the customer’s name and

address.

Also, adequate instructions for use were to be supplied.37 At a later Session in June 1979 the National Health and Medical Research Council recommended that oral liquid preparations containing antihistamines be transferred to Schedule Four (prescription drugs).38 Except for South Australia, these recom­ mendations have not been implemented and are still under consideration. The Committee

urges all States to implement the recommendations of the National Health and Medical Research Council as soon as possible.

International comparisons it is very difficult to obtain valid data which compare the consumption of therapeutic drugs in Australia with other countries. The Committee commissioned data from Intercontinental Medical Statistics (Australasia) Pty Ltd (Table 3.10) on value per capita for various therapeutic classes of both ethical and proprietary drugs sold through pharmacies in the United States, the United Kingdom and Canada. There are. however, severe limitations on this data. The countries listed have different controls on drugs, and sales through outlets other than pharmacies may be substantial.

Also, there are large price differences between countries. This problem has been partly overcome by deflating the values in accordance with the data available on overall price comparisons, but there are still individual therapeutic category price differences which arc not accounted for. Table 3.11 illustrates the large variation in prices that does exist.

The Pharmaceutical Manufacturing Industry Inquiry surveyed prices of 25 brands of major Pharmaceutical Benefits Scheme products in Australia and other countries and found that in the United Kingdom prices were about 39 per cent higher than those in Australia, in the United States about 68 per cent higher and in Canada about 55 per cent higher.3" These estimates arc used to deflate the figures in Table 3.10 to enable better comparison between countries. The deflated figures are shown in brackets.

40

Table 3.10: Wholesale value per capita for 1979 of selected therapeutic categories in Australia, the United States, Canada and the United Kingdom

United States cents

Australia United Slates Canada United Kingdom

Hypnotics and sedatives T o t a l ........................................................ 45.4

Non-barbiturate S u b t o t a l ........................................... 34.8

Barbiturate S u b t o t a l ................................................... 10,6

Tranquillisers Total ........................................................ 74.4

Major tranquillisers S u b t o t a l ................................................... 25.5

Mild tranquillisers S u b t o t a l ................................................... 48.9

Antidepressants T o t a l ........................................................ 48.2

Total psychotropic drugs ............................ 168.0

Antibiotics(a) ...................................... 194.3

Cardiovascular drugs(h) ............................ 178.6

A n a l g e s i c s ........................................................ 82.3

Systemic antihistamines ............................. 41.1

46.5 (27.7) 40.3 (26.0) 78.7 (56.6)

34.3 (20.4) 32.6 (21.0) 69.9 (50.3)

12.2 (7.3) 7.7 (5.0) 8.8 (6.3)

226.6 (134.9) 92.2 (59.5) 40.9 (29.4)

54.1 (32.2) 28.7 (18.5) 24.0(17.3)

172.5 (102.7) 63.5 (41.0) 16.9 (12.2)

89.4 (53.2) 362.5 (215.8) 123.2 (73.3) 332.0 (197.6) 293.3 (174.5)

31.6 (18.8)

47.6 (30.7) 180.1 (116.2) 89.2 (57.5) 136.8 (88.3) 177.2 (114.3)

18.5 (11.9)

81.0(58.3) 200.6 (144.3) 149.9 (107.8) 198.9 (143.1)

194.8 (140.1) 17.4 (12.5)

Figures in brackets are deflated estimates which take into account broad price differences between countries (a) includes tetracyclines and penicillins. (b) Includes cardiac therapy, hypotensives and peripheral vasodilators.

Source: Intercontinental Medical Statistics (Australasia) Ply Ltd.

Table 3.11: Wholesale prices of the leading brands of tranquillisers in Australia, the United States, United Kingdom and Canada in December 1979

A ustralian dollars

Australia US.

Librium tabs lOmg/100 . 3.84 8.14 2.69 3.88

Index ........................... 100 212 70 101

Valium tabs 5mg/100 . . 2.20 10.87 2.87 3.88

Index ........................... 100 494 130 176

Serepax tabs 30mg/100 . 2.30 13.72 3.79 7.76

Index ........................... 100 597 165 337

(a) In this country prices are not fixed and prices quoted are total market average (i.e. total actual value divided by total units.)

Source Intercontinental Medical Statistics (Australasia) Pty Ltd.

The Committee has included the data made available to it trom Intercontinental Medical Statistics (Australasia) Pty Ltd but because of their severe inadequacies has drawn no conclusions.

Conclusions and recommendations Although consumption of psychotropic drugs has slight!} declined over the period lb 7 to 1979, survey evidence indicates that frequent use may still he widespread, particularly among women. The Committee believes that in the absence ot any practical alternative

solution to the cause of anxiety or depression, the frequent short-term use of psychotropic

41

drugs may be necessary. The Committee also believes, however, that prolonged use of psychotropic drugs is an inappropriate solution to any problem. The consumption of over-the-counter analgesics declined and the consumption of cough and cold preparations increased only slightly over the period 1975 to 1979. An

increase in the consumption of vitamins may be significant. The data available on vitamins from pharmacies show that consumption has increased by 28 per cent over the last 5 years but there are no data available from other retail outlets, including health food stores which seem to be flourishing.

To date, there is insufficient evidence available on which to determine the therapeutic efficacy or adverse effects of vitamins. Various committees within the Commonwealth Department of Health are looking into aspects of vitamin use. The Committee has therefore recommended that these committees, on completion of their studies, jointly produce a report on vitamins which can be widely disseminated throughout the community (see page 38).

References

1. P. Hcaly, 'Patterns of Drug Use in Australia: 1970 77', Drug Education Unit, Health Commission of N.S.W.. 1978. 2. Royal Commission into the Non-Medical Use of Drugs, South Australia, 'Three Studies in Drug Use’, Research Papers 3, 4, 5, p. 84. 3. Royal Commission into the Non-Medical Use of Drugs, South Australia, "Three Studies in

Drug Use", Research Papers 3, 4, 5. 4. Royal Commission into the Non-Medical Use of Drugs, South Australia, Final Report. Adelaide, 1979. p. 83. 5. A. George, 'Survey of Drug Use in a Sydney Suburb', The M edical Journal of A ustralia 29 July

1972. p. 233. 6. B. L. Hennessy, W. J, Bruen and J. Cullen. 'The Canberra Mental Health Survey: Preliminary Results', M edical J o u rn a l o f A ustralia 14 April 1973. p. 721. 7. A. George, 1973 Survey of Drug Use in a Western Suburb of Sydney, unpublished report. 1974.

Division of Health Education. N.S.W. Health Commission. 8. D. Carrington-Smith. 'Do Women Need Drugs to Cope with Life? Women's Health in a Changing Society", Vol. 3, Commonwealth Department of Health, Canberra, 1978. 9. 1. Reynolds, J. Harnas. H. Gallagher and D. Bryden, Drinking and Drug-Taking Patterns ol

23 000 Sydney Adults: A Comparison Between Two Samples, unpublished report. Medicheck Referral Centre, Sydney, 1975 76. 10. .1. Gibson. A. Johansen, G. Rawson and 1. Webster, "Drinking, Smoking and Drug-Taking Patterns in a Predominantly Lower Socio-Economic Status Sample'. M edical Journal of

A ustralia 1 October 1977. p. 459. 11. D. Magro, 'The Problems of Psychoactive Medication Users', Australian Journal of A lcohol and Drug D ependence 5. 1. February 1978. p. 21. 12. Pharmaceutical Manufacturing Industry Inquiry. R eport. Canberra. 1979. p. 78. 13. Senate Standing Committee on Social Welfare, Drug problem s in A ustralia an into xica ted

society'/. AGPS, Canberra, 1977. pp. 107 126. 14. Senate Standing Committee on Social Welfare, p. 124. 15. Senate Standing Committee on Social Welfare, pp. 120 1. 16. Australian Royal Commission of Inquiry into Drugs. R eport. Canberra, 1980. p. C 173. 17. Northern Territory Department of Health, personal communication. 18. Evidence, p. 2219. 19. a) E. N. Owles. Ά Comparative Study of Nutrient Intakes ol Migrant and Australian

Children in Western Australia". M edical Journal of A ustralia 2. 1975, pp. 130 33. b) B. Brown. J. F. Rogers and M. Pang. Intake of Selected Nutrients compared with Socio­ economic Status in Young Women', M ed ica l Journal o f A ustralia 2. 1975. pp. 796 7. c) National Health and Medical Research Council. 'Summary Report on the Thiamine Status

of the Australian People'. Report o j the R3rd Session. Appendix XIV. April 1977. 20. Evidence, p. 2220.

42

21. Evidence, p. 2406. 22. B. Wood and K. J. Breen, "Submission to the Senate Standing Committee on Social Welfare'. p. 2. 23. American Dietetic Association. "Position Paper on food and nutrition misinformation on

selected topics'. J o u rn a l of the A m erican D ietetic A ssociation 66. March 1975. p. 278. 24. American Dietetic Association, p. 278. 25. Dr J. L. Frew, personal communication. 26. Position paper on food and nutrition misinformation on selected topics, p. 278.

27. Commonwealth Department of Health, personal communication. 28. Correspondence from the Commonwealth Department of Health, 18 August 1980. 29. Commonwealth Department of Health, personal communication. 30. Evidence, p. 2316.

31. Evidence, p. 2338. 32. Australian Royal Commission of Inquiry into Drugs, p. A85. 33. Australian Royal Commission of Inquiry into Drugs, p. A85. 34. Pharmacy Board of N.S.W., "Standards of Pharmacy Practice', issued October 1978.

35. Exhibit 73. 36. Exhibit 73. 37. National Health and Medical Research Council. R eport of the E ig h ty -T h ird Session. April 1977, p. 91.

38. National Health and Medical Research Council, R eport of the E ighty-Seventh Session. June 1979, p. 29. 39. Pharmaceutical Manufacturing Industry Inquiry, p. 50.

43

SECTION TWO

An e x a m i n a t i o n o f t h e e v a l u a t i o n ,

d i s t r i b u t i o n a n d c o n t r o l o f d r u g s

Introduction

A full assessment of all matters covered in this section of the report raised a number of problems which the Committee had great difficulty resolving. First, the Committee found there was a great deal of overlap in many areas of responsibility between the Commonwealth and the States. In many instances, regardless of how the Committee approached a particular matter, we repeatedly found that the Commonwealth or State

Health departments were unable to clearly identify who had the final say in this matter and where one group’s responsibilities ended and another's commenced. Secondly, due to the non-uniformity of legislation between Commonwealth and States and between individual States, the Committee had a great deal of difficulty in drawing up an overall picture of national drug regulatory procedures. This was a cause for concern in the Committee.

Thirdly, it was readily apparent to the Committee that there exists a maze of committees, boards, councils, groups and numerous other organisations which have been set up to examine, oversee and control the various aspects of medication discussed in this section. Even though many of them have quite clear functions and rules, the mere existence of so many committees etc. added to the confusion and complexity in following

through a particular line of inquiry. Fourthly, throughout this section of the report, the Committee has made repeated reference to evidence from the Commonwealth Department of Health that it has been unable to fulfil a number of its functions adequately due to a lack of resources. The Committee believes that these functions are important and have been introduced to ensure the proper regulation and control of all facets of drug manulacture and

distribution Therefore, the Committee does not accept as satisfactory the explanation ol financial and manpower shortages. Rules and regulations are of minimal value unless there are adequate resources to ensure that they arc complied with at all times. It is essential that resources arc found by the Department trom either a reallocation of. or addition to, existing resources. This criticism applies equally to all State health departments and commissions.

CHAPTER 4

E v a l u a t i o n , q u a l i t y , s t a n d a r d s

In the area of therapeutic substances, Australian standards are considered by health authorities in Australia and overseas to be amongst the highest in the world. This chapter details the relevant legislation and evaluation procedures, and considers their effectiveness and adequacy.

The responsibility for controls over therapeutic substances is divided under the Australian Constitution between the Commonwealth Government and the States. The Commonwealth has control over imports and exports, therapeutic goods supplied to Commonwealth authorities (such as Territory hospitals and the armed services) and

under the Pharmaceutical Benefits Scheme, and therapeutic goods subject to interstate trade. The State governments are responsible for controls over local manufacturers of therapeutic goods and the sale and distribution of those goods within State boundaries.1

Commonwealth legislation and controls

Importation of therapeutic substances

It must be stated at the outset that most of the drugs marketed in Australia (85 per cent) have been fully imported or manufactured locally from imported materials (either raw or semi-processed). Because of this, the Commonwealth has been able to play a significant

role in the control over the evaluation, quality and type of drugs that are available for use on the Australian market. Since 1970, amendments have been introduced to the Customs (Prohibited Imports) Regulations requiring that all importations of therapeutic substances, and their

subsequent distribution in Australia, be approved by the Director-General of Health.: Under the Regulations, an application to import therapeutic substances may not be approved if an importer is unable or unwilling to provide sufficient information to satisfy the Director-General of Health as to the quality of the substance, the purposes for w hich

it may safely be used and whether it is properly packaged and labelled. ’ This evaluation process, however, docs not cover all drugs available in Australia. Locally produced goods from locally sourced materials arc not evaluated, as they do not require import approval. Further, apart from biological drugs (for example, serums,

vaccines etc.), most imported drugs which have been marketed in Australia prior to 19 /(I have not been evaluated. When the amended regulations came into force it was not practicable to evaluate the thousands of imported items then on the market. Instead, licences were granted to major importers which allow ed them to continue importing those

therapeutic substances.'1 If there iscausc forconcern about a particular drug, or if a period of more than 7 years elapses between importations of a substance by a licenced importer, the Dircctoi ( ieneral may declare any such substance to be a 'designated therapeutic substance. I o date, this

option has been used on only a few occasions. W hen such action is taken the substance is then subject to all controls normally exercised over a 'new' drug.’ There is, however, a minor problem with these import procedures in relation to raw materials. Drug manufacturers are fully subjected to the provisions of these regulations

for all therapeutic substances that they import designated or non-designated. On the other hand, merchant importers, when importing non-designated substances, arc only

4

required to supply information on quality.6 Even though at this time there is no evidence to suggest that this loophole is causing any difficulties, the Committee RECOMMENDS that merchant importers be subject to the same conditions of import as manufacturers.

Import licences The Commonwealth maintains a check over all importers through the issuing of import licences. Since the introduction of import licences in 1970, the Commonwealth Department of Health has endeavoured to maintain a progressive review of all licence holders.7 The Department seeks to determine that no unapproved changes have been made to the product, including labelling and product information material, and that no substances have been imported without approval. The procedure relies very much on the integrity of the licence holder to submit accurate and complete data. While the

Department has the authority to inspect all records at first hand, the Committee was told that financial and manpower shortages within the Department have prevented such checks.8 It is hoped that as a result of the computerisation of this data a more efficient and effective control over the import of therapeutic substances will result.9 Previously, the laboriously slow manual retrieval of data has hindered the early detection of any changes in the nature of imports of a licence holder from one period to the next.

Approval to import a new drug for marketing A person or company wishing to import a new drug for marketing must provide a submission to the Commonwealth Department of Health.10 All known information, both favourable and unfavourable, must be included in that submission in sufficient detail to permit independent evaluation.11 The submission requires a substantial amount of time, effort and cost for the applicant company. Often, several thousands of pages of supporting documentation along guidelines set out by the Department are required1:. covering chemistry and quality control, clinical trials, toxicology, product information and literature.13

The submission is then evaluated by people either within or outside the Department. Within the Department, officers of the National Biological Standards Laboratory collect data such as chemistry, manufacturing procedures, quality control and packaging. Information relating to pre-clinical studies and clinical experience is evaluated within the

Drug Evaluation Section of the Department’s Therapeutic Division.14 Evaluations by specialists outside the Department are conducted along the same lines as those within the Department. Finally, the evaluations arc referred to the Australian Drug Evaluation Committee for its examination. This Committee makes recommendations as to whether or not marketing should be approved, the indications to which marketing should be limited, and on any conditions which should be applied. These recommendations are adopted as de­

partmental policy.15 .

Standards

The Therapeutic Goods Act The purpose of the Act is to provide minimum standards for goods for therapeutic purposes. Standards under this legislation refer specifically to quality*, and are not concerned with efficacy and safety. The Act also allows for the testing for conformity to

official standards of therapeutic goods subject to Commonwealth control.16 The Therapeutic Goods Act applies the standards of the British Pharmacoepaeia. the British

* Including potency, stability, sterility etc.

48

Pharmaceutical Codex and the British Veterinary Codex.1" The Minister for Health has powers under the Act to vary or add to these standards. The Government has proposed a number of amendments to the Act. including additional government controls over quality and safety of biological products manufactured in Australia, and the compilation of a national products register. It is anticipated that these amendments will be incorporated into the Act in the first parliamentary session in 1981. The Act is to be further amended to take account of developments in the British Pharmacoepaeia since British entry into the European Common Market, and will permit reference to additional sources including those published by the Standards Association of Australia and the World Health Organi­ zation.18

The National Biological Standards Laboratory The main function of the National Biological Standards Laboratory is to ensure that therapeutic goods available in Australia are of a satisfactory quality as specified under the Therapeutic Goods Act.19 The Laboratory undertakes its functions through sampling of

products, investigation of complaints and the inspection of manufacturing procedures to ensure that they comply with the Code of Good Manufacturing Practice.20 Where necessary standards of quality do not exist, the Nationial Biological Standards Laboratory carries out the required research and draws up standards for consideration by

a subcommittee of the Therapeutic Goods Standards Committee, and finally by the full Therapeutic Goods Standards Committee. The proposed standards are then subject to further scrutiny by interested parties before legal drafting, and are finally considered by the Therapeutic Goods Advisory Committee before being recommended for ministerial

approval.21

Code o f Good Manu facturing Practice The purpose of the Code is to "provide a uniform criterion for the licensing and inspection systems which exist in all States’.22 Through the Code, the National Biological Standards Laboratory, in conjunction with the States, is able to inspect the whole manufacturing

process.23 While State health departments or commissions arc responsible for the control of activities under the Code, it is regulated by both the Commonwealth and the States.24 The Code covers any part of the manufacture or preparation of a therapeutic substance

and the packaging and labelling of those substances25 and therefore relates to importers, wholesalers and manufacturers.26 Under the Code, a condition of a manufacturer's licence, whether he manufactures prescription or over-the-counter products, is compliance with the Code. No distinction is made between over-the-counter and prescription drug manufacturers in the number ol

inspections made to ensure compliance with the Code, or in the quality programs undertaken to ensure uniform product quality.2 1 he Code establishes provisions regarding, amongst other things, equipment, the manufacturing process, premises, processes, personnel, systems of quality control, and the release o! products. Other countries have similar codes, which are important to the maintenance of the quality of

therapeutic goods in international trade.28 The Committee was told by the Commonwealth Department of Health that it was because the use of sample testing is inadequate as a means of ensuring the satisfactory quality of goods on the Australian market that the Code was introduced to Australia.

Bearing this in mind, the Committee was disturbed to learn that at this stage onl\ New South Wales has enacted suitable legislation to license manufacturers according to then- compliance with the Code. Yet industry throughout Australia has accepted the Code. In some States, manufacturers arc licensed under their Poisons Acts. This means that various therapeutic products which are not classed as poisons, such as vitamins and

aspirin, are not subject to the conditions of the manufacturer’s licence. Consequently a person or company can manufacture therapeutic goods without holding any form of licence. This creates inspection problems as there is no record of every manufacturer

within the State. Indeed, because there is no register of over-the-counter products in Australia at this time, the Laboratory is not aware of all proprietary medicines on the market.29 The Committee was also disturbed to learn that the number of inspections required

under the Code were not taking place. The commitment under the Code is that every manufacturer be inspected once a year, and on the basis of this inspection, licences to manufacturers are either renewed or revoked. However, with only two Commonwealth officers and limited numbers of State inspectors available, the National Biological Standards Laboratory Inspection Unit is understaffed. As a result, at present manufacturers are inspected approximately once in 15 months to 2 years, the number of

inspections in a set period varying between States. Western Australia, for example, has less inspections than the other States because of its distance from Canberra. Should a manufacturer refuse to comply with the Inspection Unit's directions, the Unit is limited, particularly in the area of proprietary products, as to what action it can take. Where proprietary medicines are concerned, the Unit can undertake negotiations with the relevant State authority, but whether or not action will be taken against the offending manufacturer is a matter for the State to decide. If the Code of Good Manufacturing Practice was adopted by all States, the Unit would be much more effective. Where a pharmaceutical benefit item is at issue, it is possible for the Inspection Unit to undertake

measures to have the product delisted.30 The Committee finds the current position of the Code of Good Manufacturing Practice most unsatisfactory. It therefore RECOMMENDS that the States incorporate the Code into their legislation as soon as practicable. The Committee further

RECOM M ENDS that both the Commonwealth and the State governments ensure that officers are made available to staff the Inspection Unit with the numbers necessary to allow that Unit to meet the requirements of the ( ode.

Unique Australian standards The appropriate standards of manufacture and standards of Australian therapeutic goods are a bone of contention between health authorities and the pharmaceutical industry. The Pharmaceutical Manufacturing Industry Inquiry felt that special Australian standards tended to be set at levels higher than necessary, resulting in greater costs to the consumer, with no extra benefits.31 This Committee believes that unique

Australian standards for therapeutic goods or their manufacture should be instituted on the basis of special Australian needs. The Committee therefore endorses the recom­ mendation of the above inquiry, that: there should not he special Australian standards for therapeutic goods (or their manufacture)

particularly where UK or US standards already exist or are in the process of preparation, unless there is a demonstrable need and the benefits outweigh the costs involved. *-The pharmaceutical industry is critical also of the procedures being adopted by the Commonwealth Department of Health in its implementation of manufacturing standards. The Proprietary Association of Australia stated to the Committee that

proposed manufacturing standards are being enforced by the Department prior to their gazettal and also prior to the National Therapeutic Goods Committee making its recommendations to the Minister.33 That this procedure is taking place was confirmed by the Department of Health. Such practices could involve unnecessary costs to manufacturers should the draft standards be changed before receiving legal status. The Pharmaceutical Manufacturing Industry Inquiry also made mention of this matter in its

50

report, pointing out that the situation arose as a result of long delays being experienced before formal approval of manufacturing standards was achieved.34 Discussions ot May 1979 between the Commonwealth Department of Health and the Attorney-General's Department resulted in an agreement that the Commonwealth

Department of Health could undertake its own legal drafting of standards to be proclaimed under the Therapeutic Goods Act. However, the Department claims that owing to staff shortages it has not been able to take full advantage of this agreement.35

Evaluation

The Australian Drug Evaluation Committee In 1963 the Australian Drug Evaluation Committee was established to advise the Minister and Department on matters concerning the evaluation and use of therapeutic substances.36 Its terms of reference are as follows:

- to make medical and scientific evaluation of such goods for therapeutic use as the Minister refers to it for evaluation; - to make medical and scientific evaluations of other goods for therapeutic use if, in the opinion of the Committee, it is desirable that it should do so: and — to furnish such advice to the Minister as the Committee considers necessary

relating to the importation into, and the distribution within, Australia of goods for therapeutic use that have been the subject of evaluation made by the Committee.37 The Committee is comprised of eminent medical practitioners and specialists in the fields of pharmacology and pharmaceutical science. No departmental officer or industry- representative may be a member.38 A central role is played by the Committee in the consideration of applications to market new drugs in Australia.39 Initially applications are considered by departmental officers, who determine which ones will go before the Committee for evaluation. However, the Committee of its own volition may evaluate a substance. Though not all new formulations are considered by the Committee, all new drugs are. For example, the Department may not refer a "me too’ substance (that is. a substance of which the qualities are similar, if not identical, to other substances already on the market which are of no great therapeutic value)40 to the Committee. The Committee has authority over a number of aspects to do with the marketing of new drugs. For example, should it feel that it has received insufficient data from the applicant company, the Committee has the authority to defer approval of a drug for marketing until such time as satisfactory supplementary information is provided. The Committee may also require that amendments be made to product literature. 11 can reject a marketing application should it feel that the information provided by the company does not indicate a sufficient safety margin for the proposed use. or if claims for efficacy cannot be substantiated.41 As well as making decisions about new drugs, the Committee makes decisions on new information about marketed drugs. From reports of adverse reactions or results of clinical studies on animals, some drugs have been taken off the market. Others hav e been restricted or labels and product information sheets have had to include special warnings.42 The Committee also issues warnings about a certain product (as it did. for example, on rauwolfia) which lead to greatly diminished usage.

Lack o f international uniformity The Committee relies principally for its ev aluation of a drug on the data provided by the applicant company, though it also undertakes its own literature search and makes use of an international computerised information retrieval system known as Medlars.4' In order

51

to supplement this material, and to shorten the period of time currently taken to evaluate a drug, the Commonwealth Department of Health has made representations to drug regulatory authorities in various Western countries with regulatory programs similar to Australia. These countries have included the United States, Canada, Sweden and the

United Kingdom and the approaches were made to assess the possibility of an exchange of evaluation information. According to a Commonwealth Department of Health representative, however, the exercise was somewhat disappointing. Apart from Sweden, the information obtained from those countries "has been nowhere near adequate for us to make a comparison of the standard of evaluation of the drug compared with our own evaluation'.44 Consequently the Department states it has yet to gain confidence in the evaluation procedures of other countries.45

This Committee has commented previously on the importance of international information transfer. The current situation of "locked-in" information by individual countries is unsatisfactory. The Committee believes that there would be great merit in a system of formal links between nations, including international exchange of information and an exchange of officers.

As well as a lack of uniformity between countries regarding evaluation procedures, there is little international uniformity, if any, regarding the presentation of applications for marketing approval. Different countries have different requirements, which means drug sponsors are confronted with extra and unnecessary costs in terms of both time and effort. The Committee agrees with the Pharmaceutical Manufacturing Industry Inquiry

that greater international co-operation regarding evaluations and application format would have many advantages. The Department could process applications more quickly with less cost and staff, the manufacturer could market his product more quickly w ith cost, time and effort savings, and consequently drugs would be released to the public more quickly.4”

The Pharmaceutical Manufacturing Industry Inquiry recommended the following:

that the Department, working in co-operation with the industry and the Australian Drug Evaluation Committee, strengthen its efforts to achieve international co-operation by the development of bilateral agreements with selected countries in relation to standardisation of.

firstly, the method of application for marketing approval and. secondly, drug evaluations. It is also recommended that, as an interim step, manufacturers be allowed the option of submitting data required for chemistry and quality control purposes in either the UK or Australian formal and that the Department examine other ways of allowing flexibility in the method and order of presentation of data.4'

The Committee supports this recommendation.

The time taken to evaluate a drug The Commonwealth Department of Health has had a history of slowness in its evaluation of new drugs. Until 1978. the situation had been such that an application could have been with the Department for 3 or more years before going before the Australian Drug

Evaluation Committee for consideration.4" Between 1 July 1972 and 25 February 1977. 604 applications were received by the Department. By August 1977. 46 per cent of these had been evaluated. 7 per cent deferred and 47 per cent had not been finalised.4” By October 1978 the position had improved5", and figures provided by the Department to the Committee for June 1980 (set out below) show a continuing improvement.

The Department has claimed that one of the major reasons why the evaluation ol applications has proved such a lengthy process has been the instability of stall in the evaluation section. According to the Department, there has been a large stall' turnover.

52

Applications for marketing approval for new drugs

Situation at June 1980 S umber

Not yet passed to evaluators 34

(oldest application received 20 November 1979) With evaluators prior to clearance by ADEC 55

(oldest application received 24 January 1979) Cleared by ADEC but awaiting test results or clearance of product information up to 2 years old 33

2 years old 17

3 years old 4 years old

10

5 years old 3

6 years old or more 1 64

Total on hand 153

(a) Some of the older applications have been the subject of continuing negotiations with the companies because ol data deficiencies relating to manufacturing controls or need for additional information. (/>) The further action required on applications already cleared by the Australian Drug I:\aluaiion Committee is almost e\enl> divided between chemistry quality control data and details of product information.

Source: Commonwealth Department of Health.

and serious difficulties in filling all positions available. There has. however, been greater stability since 1978 which, ow ing to an accumulation of experience, has enabled speedier processing of applications. 51 It appears that a number of factors have contributed to the improved evaluation

position. A system of employing external evaluators was first adopted in 1971 in an attempt to supplement the staff available within the Department, and the Department feels that this has proved particularly successful. The Department also believes that the introduction of what is termed the "Sydney outpost . a mechanism by w hich 6 extra

internal evaluators have been employed in Sydney who would not have been av ailable to the Department had postings to Canberra been mandatory, has hact a substantial influence. The Committee was told that another contributing factor to the improved current

evaluation figures was an all out effort by the evaluation section ol the Department and the Australian Drug Evaluation Committee to have evaluated at the first meeting id the Committee in 1980 those drugs presented to the Department for evaluation prior to December 1978. Virtually all were dealt with.'2

The Department believes that a further possible contribution to the improved position of evaluations has been the replacement of the priority one four system of evaluation bv the "priority or non-priority system in July 1977. Under the priority one tour sy stem, if a druiz was considered by the Committee to be a significant advance, it classilicd

priority one. Such drugs were evaluated comparatively quickly. It. on the othei hand, a drug was classified priority lour (generally. the so-called me too drugs), ev a I nation could take several years. However, though this system enabled a speedier turnover ol evaluations of the more significant drugs, it also created a build-up ol the less significant category three four substances. I he current system whereby applications lot ding

evaluation are categorised as "priority or "non-priority has lessened the waiting time involved in having the less significant drugs evaluated. I hose drugs classified as piiouty substances are generally evaluated within a period ol around 9 months, while those substances classified as'non-priority are dealt with in order of receipt. On average.

evaluation takes about 2 years. The pharmaceutical industry regards this method of classification as fairer than the priority one four system.53 Delays continue within the Department due to processing procedures generally, and the time taken by industry to provide additional information required by the Australian Drug Evaluation Committee.54 The Committee RECOM M ENDS that the continued role of the Commonwealth Department of Health to control drug approvals should be dependent

upon its capacity to undertake this task with efficiency and despatch. The Department should be required to demonstrate at intervals that it is doing so.

Erosion o f patents One ot the ramifications of the delays in processing and evaluating marketing applications from the drug industry is the erosion of patency. In a submission to the Committee, the Australian Pharmaceutical Manufacturers Association stated:

The effect of Australian government demands on type and extent of Research and Development work, coupled with the time taken to evaluate submissions and, finally, to accept a marketed product as a Pharmaceutical Benefit item, is to erode patent protection by about 9 years over

half of the life of the patent. 55 The following chart quantifies the specific period of delay.

EROSION OF 0 I 2 3 4 5 6 7 8 9 10 11 12 13 14 15 If,

PATENT

Patent filed

Animal tests (2 yrs)

Phase I studies ('A yr)

Phase II studies (1 yr)

Phase 111 studies (2 yrs)

Department of Health evaluations (214 yrs)

Pharmaceutical Benefit Listing (1 yr)

Residual patent life available during marketing phase (7 yrs)

Source: Submission to the Committee from the Australian Pharmaceutical Manufacturers Association. Appendix IV. p

The length of time now involved in the development and approval to market a new d'rug has risen substantially in recent years. This trend is not unique to the Australian situation; it is worldwide. It has meant that the original Australian patent legislation which allowed a patent life of 16 years did not foresee the current technological complexities and the need for government intervention. Hence in many cases, over 50 per cent of the patent life is eroded before the drug is commercially marketed.

In a submission to the Minister for Productivity, January 1978, the Australian Pharmaceutical Manufacturers Association stated the following: A request is made that the term of protection in Australian Patent Law. in respect of medicinal substances, be changed to coincide with the UK Patents Act 1977. This change would recognise

the serious problem of patent erosion and harmonise Australian law with current world trends in industrialised nations.56

54

Under the United Kingdom's Patents Act 1977. the term of patency is extended from 16 to 20 years on new patents, and also on existing patents which have more than 5 years of their term remaining.57 The Committee RECOM M ENDS that the request of the Australian Pharmaceutical Manufacturers Association be implemented by the Australian Government.

State legislation and controls The Committee has not attempted to undertake the enormous task of examining individual State legislation and procedures relating to therapeutic goods. Nonetheless, a

number of matters causing concern to the Committee came to its attention during the course of the inquiry. Some of these are discussed below. Others have not been pursued by the Committee due to the enormity of the task of examining and comparing the various States’ legislation. There are, no doubt, still other issues of which the Committee is

unaware. The States are responsible for the formulation and enforcement of controls over locally manufactured therapeutic products and their distribution, determining what goods can or cannot be sold in the State, and who may manufacture and sell goods under

what conditions.58

Control of drugs through scheduling Because divided legislative responsibilities between the States and the Commonwealth result in the States being independent in particular areas of drug control, various problems of non-uniformity have arisen. The situation has created inconsistencies in scheduling among the States and needless obstacles for industry, which ultimately result in more expensive products to the consumer.

The Poisons Schedule Committee (a subcommittee of the National Health and Medical Research Council) and the National Therapeutic Goods Committee were established with the aim of achieving a co-ordinated approach to the legislation and administration of the States, Territories and the Commonwealth. Membership of both

the Council and the Committee comprises representatives from the States, Territories and the Commonwealth. The terms of reference of the Poisons Schedule Committee are as follows: to enquire into the scheduling, labelling, packaging and advertising in public media of drugs,

poisons and other substances hazardous to human health in the States and Territories and to make recommendations to the Council through the Public Health Advisory Committee.-'1 Recommendations of the Committee are referred to the Health Ministers for

consideration and ultimate incorporation into relevant legislation or implementation through new administrative procedures.60 The recommendations ratified by the National Health and Medical Research Council are incorporated into the Uniform Poisons Standards61, which consist of the following schedules: Schedule I Substances which are extremely dangerous to human life Schedule 2 Substances which are dangerous to human life if misused or carelessly

handled

Schedule 3 Substances w'hich are for therapeutic use and which are of a sufficiently dangerous nature to warrant their distribution to be restricted to pharmacists and medical, dental and veterinary practitioners Schedule 4 Substances or preparations, the supply of which, in the public interest.

should be restricted to medical, dental or veterinary prescription, together

55

Schedule 5-

Schedulc 6

Schedule 7

Schedule 8

with potentially harmful substances or preparations pending the eval­ uation of their toxic or deleterious nature Substances or preparations of a hazardous nature which must be readily available to the public but which require caution in handling, use and storage

Substances or preparations of a poisonous nature which must be readily available to the public for domestic, agricultural, pastoral, horticultural, veterinary, photographic or industrial purposes or for the destruction of pests Substances or preparations of exceptional danger which require special precautions in manufacture and use and for which special individual labelling and distribution regulations may be required Substances or preparations which are addiction producing or potentially addiction producing including those so classified by the United Nations Organisation or its agencies

The provisions of the Uniform Poisons Standards, however, have no legal standing until they are incorporated into appropriate State and Territory legislation. Recom­ mendations on scheduling of new drugs are not made before approval to market has been received from the Australian Drug Evaluation Committee and the advice of that Committee may also be sought where the rescheduling of a drug is required.62

The States vary in their scheduling of drugs because, although the Commonwealth makes recommendations on scheduling, the ultimate authority remains with the States. According to the Inquiry into the Pharmaceutical Industry, 'regardless of agreements reached by State and Commonwealth representatives at the meetings of the National Therapeutic Goods Committee, there are instances where State legislation does not conform with those agreements'.62

The Non-Uniformity Review Committee of the Department of Productivity has produced a report on non-uniformity in respect of pharmaceutical products. The report has not been made public as yet. but this Committee was made aware of some of its findings. The Non-Uniformity Review Committee has identified the following major areas of non-uniformity:

registration of pharmaceutical products poisons scheduling standards for therapeutic goods import of pharmaceutical material packaging and labelling

The Non-Uniformity Review Committee broadly estimated that some SI8 million per annum is added to the cost of pharmaceutical products as a result of varying requirements relating to testing, registration, packaging and labelling. This unnecessary cost is borne by consumers of therapeutic drugs.64

One of the major areas where problems occur is the packaging labelling area. In its Report Packaging and Labelling Laws in Australia, the Trade Practices Commission stated: The variation in State labelling requirements is a potential source of confusion to consumers,

and causes additional cost to manufacturers as well as being a significant factor in hindering interstate trade in chemicals and pharmaceuticals.65

It pointed out that a product requiring the label "Poison SC in Victoria and Western Australia needs to be labelled 'Caution. Use Strictlv As Directed" in New South Wales or

5b

Tasmania. On the other hand, a product labelled 'Caution' in Western Australia has to be labelled 'Warning' in Victoria and Tasmania. As well, States vary in their interpretation of schedule classifications. For example, whereas the anti-histamines (anti-allergies) mebhydrolin and diphenhydramine are classified Schedule 3 in New South Wales, in the other States they are classified Schedule 4.66 As a result, in some cases manufacturers produce a product under a particular brand

name, but use a different formulation in different States. This is the legislative situation despite many years of attempts being made to achieve uniformity.67 Thus, because poisons legislation is a State matter, manufacturers are forced to comply with the provisions of a variety of acts and regulations. The Australian Pharmaceutical Manufacturers Association pointed out that this was particularly inefficient where products are available under the Pharmaceutical Benefits Scheme.68 It is also particularly inappropriate in a country with such a small and mobile population.

The Poisons Schedule Committee has prepared a General Labelling Order which is awaiting legal drafting. This has been agreed to in principle by the States and Territories. It will have no legal standing, just as the Uniform Poisons Schedule has no legal standing, until the States legislate accordingly.66 The Committee RECOMMENDS that the States incorporate the General l.abeiling Order into their legislation as soon as legal drafting is completed.

Registration

The Victorian registration system The Victorian Health Act 1958 'provides for the registration of medicines which are for use by persons for preventing, detecting, curing or alleviating any disease, ailment, defect or injury, or for testing for any disease or ailment".76 Exceptions include formulas made

up extemporaneously for individuals or preparations which conform to the standards of the British Pharmacopaeia. the British Pharmaceutical Codex or specified formulae and approved textbooks.71 The Victorian Registration Scheme was introduced in 1948 mainly as a means of controlling 'extravagant promotional claims in relation to patent medicines for human

use'.72 Under the registration system a proprietary medicine must be registered before it can be advertised or sold in Victoria.72 The words "Registered Victoria" plus a registration number must appear on the outside of the container. A substance is registered 'in respect

of, inter alia, a statement of the purposes for which the proprietary medicine is claimed to be efficacious'. The label must not make claims outside this statement.'4 Manufacturers are required to submit an application to manufacture a drug to the Victorian Proprietary Medicines Advisory Committee for its approval. The application is accompanied by data

on the substance concerned, and this information is assessed by the Committee. The Victorian Proprietary Medicines Advisory Committee advises the Victorian Health Commission on matters of registration.75 In the absence of any other registration scheme, the Victorian system plays an

important part in Australian drug control. There are many older drugs (pre-1970) and combinations of drugs that the Australian Drug Evaluation Committee does not consider, and which the Victorian Proprietary Medicines Advisory Committee does. "

Though its authority is limited to the State of Victoria, the scheme has ramifications throughout the other States as well. This is because major manufacturers aim to sell their products nationally, and so ensure that their products meet Victorian standards. The Victorian registration scheme is particularly significant for drugs manufactured locally from local raw materials, as these substances avoid scrutiny by the Australian

Drug Evaluation Committee. Also, because there is often no record of the company s existence, these substances may also avoid testing and inspection by the National Biological Standards Laboratory. Locally manufactured drugs which are not registered

57

in Victoria, however, escape the scrutiny of either system. Such a drug can be put on the market without any prior evaluation whatsoever. This applies to both over-the-counter products and new pharmacological substances. Though the practice with new drugs has been to submit them to the Australian Drug Evaluation Committee for evaluation as a safety precaution, there is no compulsion to do so. A new drug developed in Australia can be placed straight on the market.78

Such was the case with nitrolate ointment, manufactured by Roche Australia. This product was placed on the Australian market "without reference to the Commonwealth Department of Health or the Australian Drug Evaluation Committee at a time when that Committee had rejected an application for a similar product imported into Australia on a number of grounds including lack of satisfactory evidence of clinical efficacy’.79

The Victorian registration system provides some control in an area where it is much needed, but the system itself has significant shortcomings. There are staff shortages in the administrative area. Information storage and retrieval is done on a manual basis and is time consuming and inefficient. There are no inspectorial staff to police drug distributors and ensure compliance with the regulations.80 The Victorian Proprietary Medicines Advisory Committee membership includes trade and industry representatives as well as drug experts and Commission of Health Officers. Hence, the situation lends itself to compromise where conflicts emerge.81 The Victorian system is at a disadvantage compared with the Australian Drug Evaluation Committee in that the Victorian Health Commission does not provide evaluation facilities comparable to those of the

Commonwealth Department of Health. However, in spite of the shortcomings of the Victorian registration system, the fact remains that Victoria is the only State which has attempted to employ some sort of registration requirements. One notable defect in the area of drug assessment and control is the failure to share information between regulatory bodies, particularly between the Commonwealth and the States.82 The Australian Drug Evaluation Committee is able to acquire enormous amounts of information on a substance whereas the States are not. The Victorian

Proprietary Medicines Advisory Committee would particularly benefit from a formalised system of information exchange with the Australian Drug Evaluation Committee. At present there are ‘back door' means of communication, but the Chairman of the Victorian Proprietary Medicines Advisory Committee advised this Committee that such a situation was unsatisfactory. For example, because the Chairman of the Victorian Proprietary

Medicines Advisory Committee is also a member of the National Health and Medical Research Council, he has access to the Australian Drug Evaluation Committee Minutes, which the Victorian Proprietary Medicines Advisory Committee finds very helpful in its deliberations. Were he not a member of that particular Committee, the Minutes would not be available to it.83

At present the Victorian Proprietary Medicines Advisory Committee assesses substances already approved by the Australian Drug Evaluation Committee.84 The Australian Drug Evaluation Committee imposes a very thorough evaluation process on dru'gs which are subject to its scrutiny. Additional delays are incurred by a company wishing to market its product in Victoria by having to submit applications to the

Victorian Proprietary Medicines Advisory Committee, should it wish to market its product in Victoria. The Committee feels that the Victorian Proprietary Medicines Advisory Committee would play a far more beneficial role in drug control if it accepted without further evaluation decisions of the Australian Drug Evaluation Committee, and concentrated instead on those substances not subject to its scrutiny.

The Committee RECOMMENDS that the Commonwealth Department of Health in eo-operation with the States undertake an investigation into the feasibility of establishing a system of information transfer among the relevant regulatory authorities throughout Australia.

58

National registration scheme Defects in the present control system over the evaluation, standards and scheduling of therapeutic substances are largely due to non-uniformity. This in turn is due to the division of powers between the States and the Commonwealth over therapeutic goods goods, and varying legislation and administrative arrangements between the States. It also appears that limited resources in the control area contribute to the shortcomings of the control system. According to a paper produced by the Commonwealth Department of

Health85, further development of the present system of control would not solve the current problems: Although in the face of these inhibiting circumstances goodwill, collaboration, and co­ ordination of activities between the State and Commonwealth governments and industry have

developed to a quite unusual degree in the therapeutic goods area, it is certain that further development of the present system cannot overcome its inherent defects. Nationwide uniformity and evenness of application of the present system cannot be envisaged, given the

almost insuperable barriers to changing those legislative and administrative arrangements which differ among the States.”6 In 1970 the National Therapeutic Goods Committee put forward a suggestion to the Australian Health Ministers’ Conference for a national registration scheme. This was to

be accompanied by a national products register (a complete list of medicines in use in Australia, including the names and quantities of all active ingredients). The Committee was directed to draw up plans for such a scheme, to be submitted to a future Conference. At the 1976 Conference of Australian Health Ministers it was agreed that a national registration scheme and its concomitant products register should be established. The

proposal was then submitted to the National Council of Chemical and Pharmaceutical Industries for its consideration. After a successful request from that Committee that the proposal be further discussed with industry before being acted upon, the matter was referred to the Therapeutic Goods Advisory Committee (op which the National Council

of Chemical and Pharmaceutical Industries is represented). On the advice of this Committee and as a result of opposition from industry to the national registration scheme, the Commonwealth Government rejected the proposal. The Therapeutic Goods Advisory Committee recommended, instead, only the compilation of the national

products register.88 The national registration scheme faced opposition from all parts of the pharmaceuti­ cal industry and particularly from local manufacturers of over-the-counter medicines, whose products (apart from those registered in Victoria) currently have almost no controls imposed upon them. The objections of industry to a national registration scheme

were as follows: There was no demonstrated community health need or demand for a registration scheme.

Schedule 4 and 8 (prescription) items were already fully evaluated in the N DM procedures*, and were also controlled as to labelling, advertising etc. In addition. Victoria has a therapeutic register which 'captures' most medicinals sold in Australia, both prescription and over-the-counter.

Registration procedures overseas were nowhere near as restrictive as those proposed in the 1976 scheme. Industry was concerned that the resource needs put forward by the Department ot Health to run such a scheme were under estimated. This would lead to greater delays in medicines becoming available to the public (Australia is subject to great delays already in this regard. The Ralph Report, page 198, shows that of 149 new drug evaluations outstanding in 1978. 63

were 2 or more years old.)

* Guidelines for preparing applications for the general marketing or clinical investigational use ot a therapeutic substance.

59

Most existing drug products are already the subject of monographs in official compendia. The proposed registration scheme would have cost the industry: Stage 1 2 (registration) $1 650 000

Stage 3-4 (evaluation) 6 985 000

Estimated fees chargeable by Department 1 250 000

Total cost $9 885 000 (1976 values)

To this amount would have to be added the cost of trading margins of wholesalers and chemists, in transmission to the public.

As it seemed unlikely that Victoria would move away from its existing register, and other States might not have accepted a registration scheme along the lines proposed by the Commonwealth Department of Health, industry could forsee additional non-uniformity problems, such as presently exist with Poisons Scheduling.89 In contrast, the State authorities strongly supported implementation of the system.

In view of what this chapter has show n in regard to the inadequacy of the Victorian registration system, the estimated current cost to the community of $ 18 million per annum as a consequence of non-uniformity, and the improved record of the Commonwealth Department of Health’s evaluation section, industry's basis for opposing the scheme must be questioned. As well, Victoria had proposed that once the national registration scheme was introduced, any product which was approved under that system would be exempt from Victorian registration requirements.

Industry also states: We believed . . . that no good purpose would be served by implementation of a registration scheme involving evaluation of existing products, many of which (in particular OTCs)) had been in wide use for many years. On the contrary, there would be tremendous costs and delays which would be detrimental to the community.

In its paper. Proposal to Introduce an Australian National Registration Scheme for Therapeutic and Allied Goods, however, the Department makes clear that the current manner of evaluating new drtigs would not be applied to drugs already in use.1,1 Where over-the-counter products are concerned, the Department has given consideration to the possible introduction of a system of standard monographs. This system is being developed in other countries, including France and the United States.1,2 Under the system:

(i) Where possible, products are classified according to their therapeutic use. (u) For each category of products a standard monograph is prepared. This outlines criteria for acceptability of products in that category and also criteria for the acceptability of the claims and warnings made in labelling and promotion of the

products. Aspects of products which arc unacceptable may also be specified.

hi) A product is registered without further individual investigations provided the product, and the claims and warnings made of it. conform to the criteria laid down in the standard monograph for the relevant category of products.

(iv) Products are refused registration if they have any of the unacceptable features specified in the relevant monograph. (v) Products which are neither acceptable nor unacceptable in terms of the relevant standard products are individually evaluated.93 The Australian system of government control over therapeutic goods by world standards is unusual in that it does not incorporate a national registration scheme. 1 he World Health Organization has recommended to its member states the adoption ol national registration, which has been described as 'the most powerful single legal control mechanism'. Over 70 countries have acted accordingly.94

The paper produced by the Commonwealth Department of I lealth states:

60

Because ot the lack of registration requirements, the present Australian system is cumbersome. unevenly and inconsistently applied, unduly reliant on voluntary co-operation bv the therapeutic goods industries, and therefore less than optimally effective.05 The National Therapeutic Goods Committee views national registration as the most effective means of dealing with these shortcomings.06

A national registration scheme would operate in such a way as to make it illegal for a product to be sold anywhere in Australia without it first being registered. Once a product had been approved it w'ould be allocated a registration number which would be printed on the product’s label as proof of registration. The product and certain basic information about it would be entered into a national products register. Registration would he

reviewed regularly on the basis of more up-to-date information and change in any aspect of the product. Should unsatisfactory features come to light subsequent to registration, the product would be liable to suspension, revocation or non-renewal. A registration board would be established which would he representative of all States

and the Commonwealth. It would be responsible for policy and for decisions concerning the registration of certain products. Expert technical and advisory committees would be appointed to advise the board on medical-scientific and industrial matters.06 Because of the magnitude and complexities of the scheme, it was envisaged that it would be

introduced in stages over several years.90 It is the Committee’s belief that the safety of the community is of utmost importance where pharmacological substances are involved. The inadequacies of the current system threaten that safety. The Committee further believes that a national products register, without the backing of a national registration scheme (though in itself a very valuable

source of up-to-date information), will be of no assistance in the area ot controls. Therefore the Committee RECOM M ENDS that the national registration scheme he instituted as soon as practicable.

imported products for personal usage and borderline therapeutic substances

Imported products for personal usage Under the Customs (Prohibited Imports) Regulations, persons arriving in Australia are allowed to carry non-biological medicaments for their own use or the use ot a member ol their family without any special permission being required. Should an Australian resident

wish to import a therapeutic substance for his personal use. he must fust obtain the permission of the Director-General of Health. Persons making such requests arc often migrants who. being familiar with a certain substance in their native land and wishing to use it. find it is not available in Australia.

Generally the Commonwealth Department of Health has no information which would establish the product's quality, safety and efficacy. Nonetheless the request is normally granted unless there is a quarantine risk, or the product contains a substance specifically prohibited in Australia.100

Where a product would be available in Australia only through prescription, the applicant must submit a prescription from a medical practitioner registered in the applicant’s State of residence, as evidence that the medication will be administered under medical supervision. Normally the quantity of the substance imported is restricted to cover a limited period of treatment.11,1

Borderline therapeutic substances

Herbal remedies Data on therapeutic substances usually required by the Commonwealth Department ot Health are either difficult or impossible to obtain where herbs and herbal remedies are involved. The World Health Organisation has recognised this problem and has

61

recommended the production of adequate criteria against which herbal substances can be evaluated. In the meantime, the Department has formulated an interim procedure with which to handle the processing of applications.102 Departmental policy involves the listing of those herbs which are purported to have only a mild therapeutic effect and of which their hazard potential in normal usage is considered negligible. Substances included on the list may be acquired relatively easily. Applicants need only produce evidence of identity, and submit details of therapeutic claims for assessment. Application for the import of herbal substances not included on the

list requires the more detailed information that is required for therapeutic substances generally. The Australian Herbal List is largely drawn from the British General Sales List, and is subject to revision as information becomes available.103 Prepackaged herbal products are examined for content and presentation, and information may be required to substantiate safety or efficacy of usage. Imported bulk herbal substances are often repackaged locally and sold through "health food’ outlets. Sometimes these are sold as food supplements, but more often, either through labelling or literature, they are promoted as therapeutic substances. The Department is concerned at many of the claims made regarding these substances and is following closely all developments leading towards standardisation of herbal substances and the identification of active principles. The Department is particularly concerned at the mislabelling of some

purportedly "herbal' formulations for which import approval has been sought. Some of these products have been found, on analysis, to contain a variety of undeclared potent substances, and in some cases a variety of formulations occur under the same label.1114 In evidence to the Committee, Mr Yoland Lim, "consultant in acupuncture and Chinese medicine', stated that, due to a lack of technical information and expertise regarding herbal medicines in Australia, raw materials of suspect quality are able to be imported. Ginseng is an example. According to Mr Lim. there are over 100 varieties of the plant in existence, but "99 per cent of these varieties cannot even be used as a food'.11,5

Nonetheless, they enter Australia. The Commonwealth Department of Health confirmed Mr Lim's statements. Though an imported plant must pass through quarantine, and the Department w ill not allow it to enter Australia if the claims made of it appear outlandish or it is known to be unsafe, no evaluation of the product is carried out in this country.1,1,1

Mr Lim further pointed out that his Chinese medicines do not have to be registered in Victoria '. . . because the product is not packed, and you dispense it direct to your patient . . . '107

Therapeutic foods and dietary foods "Therapeutic foods are those products formulated and presented primarily as a food, but designed to be used in the diagnosis, treatment or prevention of a disease or deficiency state'.108 These products are thus foods as well as therapeutic substances. There is also a lack of appropriate standards and guidelines in this area, which makes suitable evaluation difficult. At present minimum data only is required on these products, heavy reliance being placed on the apparent suitability of the formulation for the recommended use, and adequate labelling.109

Food products which make therapeutic claims arc required to be submitted to the Victorian Health Commission for registration before they can be sold in Victoria. The Committee was told, however, that the Commission simply does not have the staff to police this requirement. The Committee was also told that there is a grey area regarding what is a food and what is a medicine. This is a problem confronting all States. "Nim 2'. which is promoted as confectionery but which has added vitamins, is a product in this grey area which is currently of some concern.110 This area of the Victorian food and drug regulations is currently being rewritten with the assistance of the Crown Solicitor.111 Also, the National Therapeutics Goods committee has established a Working Party to

62

draw up a standard for adoption by the States which will control what is to be considered a therapeutic good, and the marketing of such goods.112 As is the case with therapeutic substances generally, there is a lack of uniformity between States in regard to herbal medicines and therapeutic and dietary foods. For

example, therapeutic claims made in Victoria may not be allowed to be made in New South Wales. The whole area of borderline therapeutic substances is one where there is a serious lack ot intormation, which has made the task of instituting appropriate controls a difficult one.

There are virtually no controls in this area. 'Health food' outlets, for example, are subject to very little regulation. In the area of Commonwealth control, the Commonwealth Department of Health claims that it does not have the staff to deal with the area of borderline therapeutic substances adequately. There is a particularly serious situation as borderline therapeutic substances have become and are continuing to become more and more popular, even fashionable.

The Australian consumer has a right to know that the product he is purchasing is of a satisfactory standard of quality. The Committee believes that more technical and expert advice is needed in the area of borderline therapeutic substances to enable skilled examination and evaluation of such substances from the raw material stage on, which in

turn will enable the formulation of proper and effective controls. The Committee therefore RECOM M ENDS that the Commonwealth Department of Health be enabled to recruit the necessary qualified staff to allow the Department to effectively manage the borderline therapeutic substances area.

Conclusions and recommendations

The mechanism for control over therapeutic substances is shared between the Commonwealth and the States. At the Commonwealth level, legislation and evaluation procedures over therapeutic goods other than borderline substances appear to be adequate. While there appear to be no major problems in the area of import procedures

for raw materials, there is a discrepancy in favour of merchant importers as to the amount of information required to be submitted to the Commonwealth Department of Health before import. The Committee has recommended that merchant importers be subject to the same conditions of import as manufacturers (see page 48).

The length of time taken to gain marketing approval and the high standards set down for drug evaluation in Australia have been the subject of criticism over several years. Bearing this in mind, the Committee has recommended that the continued role of the Commonwealth Department of Health to control drug approvals be dependent upon its capacity to undertake this task with efficiency and despatch (see page 54). In recognition of the time taken by present evaluation procedures and of other patency erosion factors,

the Committee has recommended that the patent life of drugs be extended from 16 to 20 years (see page 55). The Committee did not attempt to undertake the enormous task of examining individual State legislation and procedures relating to therapeutic goods. Nonetheless, the Committee became aware of many shortcomings in this area, some ot which pose a risk to the community. The lack of uniformity and co-operation between States, and between the States and the Commonwealth, and the inadequate evaluation of therapeutic- goods within the States, are matters requiring urgent attention. To institute further

‘bandaid’ controls that is. measures to supplement existing regulations where these arc- seen to be inadequate is only to compound the current dilemma of a profusion of diverse controls amongst the States. There is an urgent need for co-ordination of State legislation. The Committee has made a number of recommendations which it believes will

improve the current state of affairs. These include:

63

- that the States incorporate the Code of Good Manufacturing Practice into their legislation so as to enable adequate surveillance of manufacturing quality and standards (see page 55); that once the Code is incorporated into the respective State legislation, both the Commonwealth and State governments ensure adequate staffing of the National

Biological Standards Laboratory Inspection Unit in order for the Unit to meet the requirements of the Code (see page 55); that the General Labelling Order be incorporated into State legislation as soon as legal drafting is completed (see page 57); that the Commonwealth Department of Health in co-operation with the States undertake an investigation into the feasibility of establishing a system of information transfer among all the regulatory health authorities throughout Australia (see page 58); and

that the establishment of a national registration scheme be instituted as soon as possible so as to enable a more comprehensive and effective control over the manufacture and sale of therapeutic substances (see page 61).

Controls relating to the borderline therapeutic goods area arc totally inadequate, and acknowledged to be so by the responsible departments. There is a serious need for a decision on minimum safeguards for consumers. These might include a minimum standard of safety and information. There is also a serious need for more technical information, expertise and resources in this area to enable proper evaluation of the quality, efficacy and toxicity of these products before they arc allowed on the Australian market. There is a subsequent need for regulations relating to the promotion and distributing of these products, with adequate departmental staff available to police these requirements. Therefore the Committee has recommended that the Commonwealth

Department of Health be enabled to recruit the necessary staff to manage effectively borderline therapeutic substances (see page 63).

References

1. Evidence, p. 9. 2. Evidence, p. 10. 3. Evidence, p. 11. 4. Evidence, p. 12.

5. Evidence, p. 12. 6. Correspondence from the Commonwealth Department of Health. 28 May 1980. 7. Commonwealth Department of Health. D irector-G eneral o f H ealth. A nnual Report. 197,V 79. p. 28. 8. Commonwealth Department of Health, personal communication. 9. Commonwealth Department of Health. D ireetor-G enerat of H ealth. A nnual Report 197,S 9.

p. 28.

10. Evidence, p. 19. 1 1. Evidence, p. 21. 12. Australian Pharmaceutical Manufacturers Association, Submission to the Senate Standing Committee on Social Welfare, Appendix VI. p. 1.

13. Pharmaceutical Manufacturing Industry Inquiry. R eport. Canberra. 1979. p. 108. 14. Evidence, pp. 23 4. 15. Evidence, p. 25. 16. Evidence, p. 10. 17. Evidence, pp. 64 5. 18. Commonwealth Department of Health. News release. 'Press Statement by the Minister lor

Health. Mr Ralph Hunt'. 5 September 1979. pp. 2 4.

64

19. Evidence, p. 66. 20. Evidence, p. 66. 21. Pharmaceutical Manufacturing Industry Inquiry, pp. 112-14. 22. Evidence, p. 70. 23. Evidence, p. 66. 24. Australian Pharmaceutical Manufacturers Association. Submission. Appendix VI, p. 5. 25. Evidence, p. 70. 26. Australian Pharmaceutical Manufacturers Association. Submission. Appendix VI. p. 5. 27. Evidence, p. 71. 28. Pharmaceutical Manufacturing Industry Inquiry, p. 113. 29. Commonwealth Department of Health, personal communication.

30. Commonwealth Department of Health, personal communication. 31. Pharmaceutical Manufacturing Industry Inquiry, pp. 112 13. 32. Pharmaceutical Manufacturing Industry Inquiry, p. 113. 33. Evidence, p. 2163. 34. Pharmaceutical Manufacturing Industry Inquiry, p. 1 14. 35. Commonwealth Department of Health, personal communication.

36. Evidence, p. 18. 37. Evidence, p. 149. 38. Evidence, p. 18; Commonwealth Department of Health, personal communication. 39. Evidence, p. 18. 40. Parliamentary Debates, Senate Hansard. Estimates Committee C. 8 September 1977. p. Ill 41. Australian Pharmaceutical Manufacturers Association. Submission. Appendix VI. p. 3. 42. Evidence, p. 157. 43. Australian Pharmaceutical Manufacturers Association, Submission. Appendix VI. p. 1 44. Parliamentary Debates. Senate Hansard. Estimates Committee C. 8 September 1977, p. 115. 45. Parliamentary Debates. Senate Hansard. Estimates Committee C. 8 September 1977. p. 1 15. 46. Pharmaceutical Manufacturing Industry Inquiry, p. 112. 48. Parliamentary Debates. Senate Hansard. Estimates Committee C, 2 May 1978. p. 100. 49. Parliamentary Debates. Senate Hansard. Estimates Committee C. 16 August 1977. Question

333.

50. Parliamentary Debates. Senate Hansard. Estimates Committee C. 20 October 1978. p. 827. 51. Commonwealth Department of Health, personal communication. 52. Commonwealth Department of Health, personal communication. 53. Evidence, p. 1 54.

54. Pharmaceutical Manufacturing Industry Inquiry, p. 1 10. 55. Australian Pharmaceutical Manufacturers Association. Submission. Appendix IV. p. 7. 56. Australian Pharmaceutical Manufacturers Association. Submission. Appendix IV. Sum­ mary of Submission", (vii).

57. Australian Pharmaceutical Manufacturers Association. Submission. Appendix IV . p 9. 58. Commonwealth Department of Health. Proposal to Introduce an Australian National Registration Scheme for Therapeutic and Allied Goods (unpublished paper). 31 October 1977. p. 3. 59. Evidence, p. 79. 60. Evidence, p. 92. 61. Evidence, p. 79. 62. Evidence, p. 81. 63. Pharmaceutical Manufacturing Industry Inquiry, p. I 15 64. Correspondence from the Department ol Productivity. 65. Trade Practices Commission. Packai’iin; and l.ahcllinti l a v s in insiralia. Report to the

Minister for Business and Consumer A11 airs. Canberra. 19". pp. ~6 ' 66. Trade Practices Commission, pp. 76 7. 67. Trade Practices Commission, p. 77. 68. Evidence, p. 1869.

69. Pharmaceutical Manufacturing Industry Inquiry, p. 117 70. Evidence, p. 1096. 71. Evidence, p. 1096.

72. Commonwealth Department of Health. Proposal to Introduce an Australian National Registration Scheme for Therapeutic and Allied Goods (unpublished paper), 31 October 1977, p. 15. 73. Evidence, p. 1096. 74. Trade Practices Commission, p. 72. 75. Evidence, p. 1096. 76. Evidence, p. 1129. 77. Evidence, p. 2189. 78. Commonwealth Department of Health, personal communication. 79. Commonwealth Department of Health, personal communication. 80. Evidence, p. 1128. 81. Evidence, p. 1056. 82. Evidence, p. 1058. 83. Evidence, p. 1131. 84. Evidence, p. 1132. 85. Commonwealth Department of Health. Proposal to Introduce an Australian National

Registration Scheme for Therapeutic and Allied Goods. 86. Commonwealth Department of Health. Proposal to Introduce an Australian National Registration Scheme for Therapeutic and Allied Goods. 87. Evidence, p. 82. 88. Evidence, p. 83. 89. Correspondence with the Australian Pharmaceutical Manufacturers Association. 90. Correspondence with the Australian Pharmaceutical Manufacturers Association. 91. Commonwealth Department of Health. Proposal to Introduce an Australian National

Registration Scheme for Therapeutic and Allied Goods, p. 14. 92. Commonwealth Department of Health, Proposal to Introduce an Australian National Registration Scheme for Therapeutic and Allied Goods, pp. 14-15. 93. Commonwealth Department of Health. Proposal to Introduce an Australian National

Registration Scheme for Therapeutic and Allied Goods, p. 14. 94. Commonwealth Department of Health, Proposal to Introduce an Australian National Registration Scheme for Therapeutic and Allied Goods, p. 1. 95. Commonwealth Department of Health, Proposal to Introduce an Australian National

Registration Scheme for Therapeutic and Allied Goods, p. I. 96. Commonwealth Department of Health, Proposal to Introduce an Australian National Registration Scheme for Therapeutic and Allied Goods, p. 1. 97. Commonwealth Department of Health, Proposal to Introduce an Australian National

Registration Scheme for Therapeutic and Allied Goods, p. 2. 98. Commonwealth Department of Health. Proposal to Introduce an Australian National Registration Scheme for Therapeutic and Allied Goods, pp. 7 8. 99. Commonwealth Department of Health. Proposal to Introduce an Australian National

Registration Scheme for Therapeutic and Allied Goods. ‘Summary of Proposal', pp. 2 3. 100. Evidence, p. 49. 101. Evidence, p. 49 50. 102. Evidence, pp. 31-2. 103. Evidence, pp. 32-3. 104. Evidence, pp. 33-5. 105. Evidence, p. 1 168. 106. Commonwealth Department of Health, personal communication. 107. Evidence, p. 1 170. 108. Evidence, p. 36. 109. Evidence, pp. 36-7. 1 10. Commonwealth Department of Health, personal communication. 111. Evidence, pp. 1 128 9. 1 12. Commonwealth Department of Health, personal communication.

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CHAPTER 5

D i s t r i b u t i o n s y s t e m — i t s s t r u c t u r e and c o n t r o l s

Introduction This chapter is divided into two sections. The first section looks at the structure of the distribution system. It analyses and discusses the role of manufacturers, importers, wholesalers and retail pharmacies. It also discusses the role of the hospital pharmacy and examines the crucial role the doctor plays in providing the necessary and final link

between the consumer and prescription medications. The second section looks at the controls, both legal and voluntary, that arc currently in force throughout the distribution system. It appraises the various regulations, laws and voluntary codes and discusses possible improvements in a number of areas. It also examines briefly the role and function of many of the organisations and associations that

have been established to oversee and discipline their respective members.

Structure Manufacture and importation of therapeutic substances

There arc currently around 1301 companies in Australia manufacturing pharmaceutical products. Most companies are involved in the manufacture of both prescription and over- the-counter medicines. For many companies, their manufacture includes such products as veterinary and agricultural products, cosmetics, toiletries, health care products, chemicals and plastics, as well as therapeutic substances. At present, there are 119 companies (including both manufacturers and importers) supplying items for the

Pharmaceutical Benefits Scheme.2 While the Australian Standard Industrial Classification class. Pharmaceutical and Veterinary Products, includes other goods not under reference in this inquiry, it nonetheless provides a general picture of the broad structure of the industry. 1 able 5.1 gives a break-down of the changes in the key variables within the industry over the past 10 years. The table shows a decline in the number of manufacturing establishments since

1972 73. Other variables have shown increases in money terms over the same period. In real terms, however, these increases are considerably less. In 1974 75 prices, the increase in value added over the 10-year period is only 41 per cent compared to a 253 per cent increase in money terms. Similarly, turnover increased by 48 and 271 per cent respectively

No disaggregated Australian Bureau of Statistics data tor the pharmaceutical industry were available. The Australian Pharmaceutical Manufacturers Association' told the ( ommittcc that employment in the pharmaceutical manufacturing industry had (alien Irom around

14 000 to around 8000 over the last 7 years. It claimed that this was due to the discontinuation of much local manufacture in favour of import replacement I he survey * carried out by the Pharmaceutical Manufacturing Industry Inquiry estimated employ­ ment in 1978-79 to be about 7600.4 Australian Bureau of Statistics employment figures

for the Pharmaceutical and Veterinary Products Industry. however, show a steady level ol employment from 1971 72 to 1978 79. The difference in the figures should be explained

* Based on information from 45 companies which in total accounted lor approximate!) 44 per cent ot Pharmaceutical Benefits Scheme sales in 197' 7X,

6

Table 5.1: Pharmaceutical and veterinary products industry: summary of statistics: 1968/69-1978/79

Pharmaceutical and veterinary products industry (ASIC Class 2723)

1968-69 1969-70 1970-71 1971-72 1972-73 1973-74 1974-75 1975-76 1976-77 1977-78 1978-79

Number of establishments . . . 144 144 150 150 142 120

E m p l o y m e n t ................................ 8 535 9 204 10 672 10 836 11 320 10 862

Wages and salaries ..................... 26 781 31 417 45 753 53 036 62 479 76 087

Turnover ..................................... .($'000) 157 489 172 865 228 899 259 655 288 984 322 419

(in 1974 75 prices) . . . . 257 335 271 374 318 357 340 755 338 785 322 419

Stocks at end of June: Opening ................................ .($'000) 35 524 37 984 n.a. 62 054 64 246 65 932 78 646

Closing ................................ .($'000) 37 372 44 881 64 310 66 010 76 962 109 564

Purchases ................................ .($'000) 73 736 86414 105 932 120 613 137 725 173 849

transfers in and selected expenses Value a d d e d ................................ .($'000) 85 601 93 348 125 223 140 806 162 286 179 488

(in 1974 75 prices) . . . . 139 870 146 543 174 162 184 784 190 253 179 488

Fixed Capital Expenditure . . .($'000) 4 881 8 741 10 460 12 272 11 413 18 152

126

10 475 91 752 386 490 334 623

112 839 110711 186 061

198 302 171 690 19 751

124

10 175 96 731 428 113 332 386

108 742 124 906 222 973

221 305 171 820 16 775

120

10 209 107 602 499 090 354 216

131 142 143 870 252 051

259 767 184 362 24 445

121

10 869 122 746 584 871 380 528

145 154 159 440 296 625

302 533 196 833 30 327

Source: Australian Bureau of Statistics, Catalogue No. 8202.00.

by the larger industry group used to calculate the Australian Bureau of Statistics figures. However, the difference in the earlier figures does not conform to this explanation and therefore it is very difficult to place too much emphasis on one set of figures compared

with another. At best, one could reasonably argue that employment in the pharmaceutical industry has not risen in recent years. The pharmaceutical and veterinary products industry is relatively small compared to other industries within the manufacturing sector. For example, its value added* * represents between 1 and 2 per cent of the total Australian manufacturing industry value added. Its contribution to gross national product is less than 1 per cent.

The pharmaceutical industry is essentially an international industry. The majority of companies are subsidiaries of multinational corporations. The local industry is therefore very much dependent on developments overseas. Table 5.2 shows the extent of local manufacture. In 1978, 64 per cent of total sales were related to activities where raw materials or intermediates were imported and then formulated as drugs and packaged in Australia, while only 15 per cent of the drugs sold were formulated from raw materials manufactured in Australia, then packaged in Australia. In addition. Table 5.2 shows that in 1978 just over 20 per cent of the total sales of pharmaceutical products were accounted for by products that required only final packaging in Australia before sale. These figures do not support the claims by witnesses that imports of finished products are replacing locally produced items.

Table 5.2: Nature of local operations (weighted by total net sales of individual companies)

Category Percentage o f total sales

Products imported in the fully finished and packaged s t a g e ...............................................

1972

17

1978

12

Products imported fully finished in bulk then packaged in A u s t r a l i a ..................................... 7 9

Raw materials (or intermediates) imported which are then formulated as drugs and

packaged in A u s t r a l i a ..................................... 59 64

D ru g s fo rm u la ted from raw m aterials

m anufactured in Australia then packaged in A u s t r a l i a ........................................................... 17 15

Source: The Pharmaceutical Manufacturing Industry Inquiry Report, August 1979, AGPS,p. 15.

The total annual value of the Australian pharmaceutical market can best he seen from the following table: Table 5.3: Australian pharmaceutical market 1978-79 ($ million)

Ex-manufacturer Retail

Pharm aceutical Benefits Scheme ..................... 175 382.8

R epatriation Pharmaceutical Benefits Scheme . 17.3 35.6

Private prescriptions .......................................... 16.1 42.8

Hospital ................................................................ 56.8 56.8

O ver-the-counter medicines ................................ 133.2 250.4

398.4 768.4

Source: See Table 2.9, Chapter 2.

* Value added is the excess o f the value of the firm's output over the value of the materials it purchases from other firms.

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Table 5.3 shows that the total human use market (ex-manufacture) in 1978 79 was around S400 million. This represented a value of around $772 million at the retail level.* Sales made under the Pharmaceutical Benefits Scheme and the Repatriation Benefits Scheme account for about 50 per cent of the Australian market for pharmaceuticals.

Approximately one-quarter of the companies supply about 90 per cent of the Pharmaceutical Benefits Scheme market. The 2 largest firms. Merck Sharpe and Dohme (Australia) Ptv Ltd (including Charles E. Frosst (Australia) Pty Ltd) and Ciba- Cicigy Australia Ltd (including Zyma Pharmaceuticals), supply almost 20 per cent of the market. ' While it cannot be said that the total market is dominated by I or 2 firms there is a high level of concentration within the therapeutic categories of the Pharmaceutical

Benefits Scheme. With over 130 firms competing in the Australian prescription medicine market, it is without question that this industry is highly competitive. The industry is also noted for its marked changes in market shares. This volatility in market shares is brought about by the high rate ot obsolescence of leading products in the industry. The follow'ing factors can cause a dramatic change in the market shares:

(i) discovery of an unexpected adverse drug reaction:

(ii) t h e e x p i r y o f a p a t e n t ;

(hi) rescheduling of drugs; (iv) the dropping of a drug from the Pharmaceutical Benefits Scheme; and (v) discovery of a new and more effective drug.

Every company endeavours to get as many of its drugs as possible listed under the Pharmaceutical Benefits Scheme, because doctors prefer to prescribe the subsidised Pharmaceutical Benefits Scheme drugs to their patients rather than a more expensive private prescription. In order to get his product on the list, the manufacturer has to become price competitive with similar products of rival companies. The manufacturers or importers will automatically achieve a certain degree of market acceptance when their product is placed on the Pharmaceutical Benefits Scheme. However, their cost and pricing policies for Pharmaceutical Benefits Scheme items are closely scrutinised by the Commonwealth Department of Health. According to the manufacturers, this has led to a fall in real prices for many of their Pharmaceutical Benefits Scheme listed products. Table 5.4 agrees with this contention and shows quite clearly that Pharmaceutical Benefits

Table 5.4: Weighted Average Price Indices for major selling products(ti) PBS and other pharmaceuticals

( Manufacturers’ selling prices; excluding CSL)

1972 1973 1974 1975 1976 1977 1973

PBS p r o d u c t s .......................... 100 97 90 91 95 98 . 99

Non-PBS prescription . . . 100 100 100 109 125 158 148

OTC p r o d u c t s .......................... 100 104 114 151 150 167 185

CPI .......................................... 100 108 124 147 162 184 199

(a) These relate to the survey data obtained by the Pharmaceutical Manufacturing Industry Inquirv, and compare average movements in the prices of major selling PBS products with those of major selling non-PBS prescription pharmaceu­ ticals and OTC products.

Note: The survey figures were very similar to data the Pharmaceutical Manufacturing Industry Inquirv obtained from IMS and the Commonwealth Department of Health. See page 47 of the Inquiry's report.

Source: Pharmaceutical Manufacturing Industry Inquiry, Report, Canberra, 1979, p. 45, and Australian Bureau of Statistics.

* If a commercial retail value was calculated for hospital pharmaceuticals, the total retail value would be in excess of S800 million.

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Scheme prices have remained constant over the period 1972 to 1978. Over-the-counter prices have risen at the same rate as the Consumer Price Index, and non-Pharmaceutical Benefits Scheme prices have risen by approximately one-half of the Consumer Price Index over the same period.

Manufacturers and importers of prescription drugs sell their products to hospitals, wholesalers and, in a few cases, direct to the pharmacist. The break-down in sales is as follows6: Hospitals 20 25%

Wholesalers 60-65%

Direct to retailers (pharmacists) 10-15%, The Committee did not receive details of the break-down in sales for proprietary (over- the-counter) medicines but it understands that most of the distribution is done through wholesalers.

The prescription and over-the-counter medicine markets are well catered for by manufacturers and importers. The industry has already been a subject of recent reports” in which its viability and profitability have been examined. The Committee has no intention of duplicating these reports. However, it is concerned with these matters in that they have an important bearing on the marketing and promotion of drugs, w hich in turn can influence levels of consumption. Aspects of this concern are discussed below and in

later chapters.

Wholesaling

The National Pharmaceutical Distributors Association has a membership of 15 companies which accounts for almost the entire wholesaling sector. Generally, wholesalers have either an interest in pharmacy outlets or are associated with the manufacture of pharmaceutical products. Most carry a full range of prescription

pharmaceuticals and over-the-counter lines, and a wide range of non-pharmaceutical products. In addition to wholesaling, many companies are engaged in a number of other activities. For example8, some assist in the arranging of business finance, some provide accounting and managerial advice, some provide a stocktaking service and some arrange the purchase and sale of pharmacies. While these activities are primarily aimed at the pharmacy end of the market, the same wholesalers also provide data and other services to the manufacturer. The wholesaler is in a better position, compared to the individual manufacturer, to provide feedback on the demand for particular products and the general consumption pattern of particular lines of medicines.

The wholesaling sector, like the manufacturing sector, has experienced a decrease in profitability in recent years. This decline in profitability has been claimed by the wholesalers to have resulted from a number of factors. First, due to the decline in profitability of the manufacturers, their margin has been reduced from around 20 per cent to around 15 per cent of the manufacturer’s recommended wholesale price (that is. the price to the chemists).9 Depending on the extent of competition for particular products, this margin can be further eroded by quantity and cash discounts which the wholesaler may need to offer to the pharmacist. However, the Committee is aware that the wholesaler is likely to get similar quantity and cash discounts when dealing with the manufacturer. Secondly, approximately 60 per cent of the wholesalers total sales result from prescription pharmaceuticals, and the wholesalers would point out that the prices of these products have remained virtually constant over the past 5 to 10 years compared to the significant rises in the Consumer Price Index and. in particular, the costs which are directly associated with wholesaling.1,1 (See Table 5.4 above.)

Table 5.5 shows that the wholesalers’ share of the Pharmaceutical Benefits Scheme dispensed price has fallen from 13 per cent in 1972 to 8 per cent in 1979. While this Committee received very little information on wholesaling, it understands from other

71

reports that the squeeze on profits has led to a contraction in the wholesaling sector. Those who remained in wholesaling have reportedly taken steps to offset declining profitability by introducing new warehousing technology, including computerised inventory control.11

Table 5.5: Percentage shares— PBS dispensed price in Australia

Year ending 30 June 1972 1973 1974 1975 1976 1977 1978 1979

M anufacturer . . 51 52 49 46 47 46 44 45

Wholesaler . . . 13 9 9 8 8 8 8 8

Pharmacist . . . 36 39 42 46 45 46 48 47

Source: Commonwealth Department of Health.

The wholesaler’s role is essentially one of a centralising and consolidating agency. In this role, the wholesaler is able to combine products from many different manufacturers into consignments which are more convenient and usable from the point of view of the pharmacist. The pharmaceutical market includes well in excess of 2000 products and around 6500 different packs (that is, almost 3 packs per product).12 It would become a very time-consuming and uneconomical exercise for manufacturers themselves to sell small packs and quantities to the vast number of retailers. The wholesaler’s role has been expanded by his ability to provide the manufacturer with regular and useful marketing data on particular products.

Retail pharmacies

Australia has one of the lowest population to pharmacy ratios in the world. Currently, there is around 1 pharmacy per 2700 persons in Australia.13 It can be seen from Table 5.6 that the population to pharmacy ratio reached an all-time low during the period 1965 to 1970. However, during the 1970s this ratio rose to around 2700.

By comparison with other countries14, France has a ratio of around 1 to 2800. Ireland has a ratio of around 1 to 2600, whereas Canada and Great Britain have ratios of around 1 to 4600, and the United States 1 to 4000. In other developed countries, such as Denmark, the Netherlands, Norway and Sweden, the ratios are all well in excess of 1 to 12 000. It would appear from this broad indicator alone that, by world standards, Australia has far too many pharmacies per head of population.

Table 5.6: Population to pharmacy ratios in Australia

Year (at 30 June)

A ustralia’s population (millions)

Number o f pharmacies Population to pharmacy ratio

1950 ..................... 8.31 3 080 2 698

1955 ..................... 9.31 3 923 2 373

1960 ..................... 10.39 4 696 2 213

1965 ..................... 11.51 5 375 2 141

1970 ..................... 12.66 5 876 2 155

1975 ..................... 13.60 5 565 2 444

1978 ..................... 14.25 5 392 2 643

1979 ..................... 14.60 5 399 2 704

Source: Commonwealth Department of Health, Annual Report of the Director- General of Health.

In order to get a clearer picture of this possible over-population of pharmacies, one would need to look at the number of pharmacists employed in each pharmacy, the actual

72

size and nature of a particular pharmacy and the geographical spread of population. In Australia the number of pharmacists per pharmacy is averaging around 1.5, in France around 1.2, Canada 1.9, Great Britain 1.5, the United States 1.9. Denmark 4.1, Netherlands 1.1, Norway 1.9 and Sweden 5.1.15 No comparable data on the average size

or type of pharmacy or geographical spread were available to the Committee. The pharmacists’ share of the Pharmaceutical Benefits Scheme dispensed price in 1978-79 was around 47 per cent. On a per pharmacy basis this has meant that in 1978-79 each pharmacy received on average an amount equivalent to $23 000. directly funded by

the Commonwealth Government.16 (If the patient contribution is included the average amount per pharmacy would be $33 500). While the $23 000 is by no means a direct subsidy to the pharmacist, it has nonetheless made a significant contribution to his total revenue and thus his livelihood. It could be argued that this has contributed to the existence of a large number of uneconomical pharmacies.

Around 40 to 50 per cent of the total revenue of pharmacies comes from precription medicine sales. Within this segment. Pharmaceutical Benefits Scheme prescription sales account for 84 per cent and Repatriation Pharmaceutical Benefits Scheme and private prescriptions each account for 8 per cent.17 The remaining 50 to 60 per cent of pharmacy

revenue comes from the sale of over-the-counter medicines, cosmetics, perfumes, toilet­ ries, photographic equipment, toys, footwear and in the case of some of the larger super­ market type pharmacies, sales revenue also comes from foodstuffs, hardware and other items. The need to diversify has resulted primarily from the large number of competing

pharmacies, the fall-off in general profitability, and more recently, the abandonment by manufacturers of their "chemist only’ marketing arrangements. Prior to 1978 a number of pharmaceutical manufacturers restricted the sale of certain products to pharmacies only, even though such restrictions were not required by State or Commonwealth poisons (or similar) laws. The Trade Practices Commission did not accept that ‘chemist only" arrangements ensured the most efficient distribution system. They believed these arrangements were anti-competitive and that as a result consumers had to pay higher prices than would be the case with a greater choice of outlets. Since the Trade Practices Commission decision in 1978, products such as health and beauty aids,

baby products, cough remedies, vitamins and single analgesics are now available for sale in many non-pharmacy stores. It would appear that the pharmacists have used the Trade Practices Commission determination to justify their expansion into the supermarket type retailing business. "If we can't beat them, join them!'

Possibly the main reason for the diversification is simply one of survival. In 1979 the Pharmacy Guild Digest claimed that 35.5 per cent of its respondents operated at a loss (after allowing for a proprietor’s average salary to be deducted). Ten per cent earned less than a 2 per cent profit to sales, while a further 42.5 per cent earned between a 2 and a 10

per cent profit to sales.18 This, however, is only one measure of profitability. Other measures, such as return on funds employed and net profit to worth, reveal substantially higher levels of profitability. When one considers the Pharmaceutical Benefits Scheme items only, it would appear

that the pharmacist should be in a better position to maintain or improve profitability (see Table 5.5). The percentage share of the Pharmaceutical Benefits Scheme price for the pharmacist has risen from around 36 percent in 1972 to 47 per cent in 1979. whereas the wholesalers' and manufacturers' shares of the Pharmaceutical Benefits Scheme dispensed

price have fallen considerably over the same period. The pharmacist’s remuneration for the dispensing of Pharmaceutical Benefits Scheme items is determined by the Joint Committee on Pharmaceutical Benefits Pricing Arrangements. The remuneration is comprised of a mark-up on the wholesale price, which is around 25 per cent, plus a fixed dispensing fee of SI .31 (April 1980). The

pharmacist must always charge the patient a set price, currently S2.75. for all

Pharmaceutical Benefits Scheme items. On the other hand, no such restrictions apply for the dispensing of private prescriptions. Charges for private prescriptions currently consist of a dispensing fee of $2.00 plus a mark-up on the wholesale price of the item of around 33.3 to 66.6 per cent (usually 50 or 66.6 per cent).

Table 5.7: Break-down of PBS ( including Pensioner) dispensed price

Year ending 30 June 1972 1973 1974 1975 1976 1977 1978 1979

$ $ $ $ $ $ $ $

Average cost per prescription . . 2.46 2.64 2.68 2.78 3.23 3.71 3.88 4.16

Average cost to pharmacist . . of which . 1.57 1.61 1.60 1.62 1.80 2.01 2.05 2.22

Manufacturer's share . . . . 1.31 1.40 1.40 1.41 1.57 1.75 1.78 1.93

Wholesaler’s share . . . . . .26 .21 .20 .21 .23 .26 .27 .29

Pharmacist remuneration . . . 0.89 1.01 1.18 1.37 .148 1.70 1.88 1.94

Source: Commonwealth Department of Health.

Table 5.7 shows that the average cost to the pharmacist for Pharmaceutical Benefits Scheme dispensed prescriptions has risen by 41 per cent over the last 7 years. On the other hand, the average remuneration to pharmacists has increased by 118 per cent, which is slightly higher than the rise in the Consumer Price Index over the same period. However, since 1979. the change in remuneration has been less than the change in the Consumer Price Index.

On 19 August 1980 the Government announced that from 1 November 1980 manufacturers would receive an extra 20 cents for each Pharmaceutical Benefits Scheme dispensed item.|gTo prevent the pharmacist from automatically receiving the 25 percent mark-up on this increase, the pharmacist’s dispensing fee for Pharmaceutical Benefits Scheme scripts was reduced by 5 cents to $ 1.26 on i December 1980.20 This has been designed to leave the pharmacist no better otf'as a result of the improved remuneration to

the manufacturer. A more detailed examination of these pricing arrangements can be found in the Pharmaceutical Manufacturing Industry Inquiry report. A number of solutions to the oversupply of pharmacies and their lack of profitability have been put forward by pharmacists and their associations. The Pharmaceutical

Manufacturing Industry Inquiry recommended the derestriction of pricing as a means of bringing about a degree of rationalisation to the pharmacy sector. The Committee did not have sufficient information on which to judge the merits or shortcomings of these proposals. However, it would support moves to examine these proposals further.

Pharmacists have suggested that the problem of oversupply of pharmacies could be partly overcome if the Government and/or the patients' contribution to Pharmaceutical Benefits Scheme scripts is increased. The Committee rejects this proposal on the grounds that it would in no way encourage further rationalisation of pharmacies. On the contrary, it could encourage the establishment of additional pharmacy outlets.

Another proposal which has already been introduced in many pharmacies is to increase revenue by introducing more non-pharmaceutical lines. The Committee would see this move as a feasible solution. However, any support for such a course of action would be on the condition that the pharmacist must not allow his professional role to be compromised by his new role as a general retailer. That is, the pharmacist must be on hand at all times to be ready to discuss a particular course of medication, whether it be on

prescription or over the counter. In addition, the pharmacist should retrain from including therapeutic drugs in sales promotion or placing them on 'specials'. A further solution is to decrease the number of pharmacies. Several studies have been done showing that the optimum size pharmacy would be one which would cater lor 5000 people.21 On that basis, it would mean that half the pharmacies currently operating would

74

have to close. However, a pharmacy catering for around 5000 people would require 2 full­ time pharmacists. Therefore, such a move is not likely to affect the total number of pharmacists employed. The development of pharmacy chains and the establishment of fewer but bigger stores could help bring about the required retail pharmacy rationalisation. This could be limited in some States due to laws prohibiting multiple ownership of pharmacies. However, co-operative chains in which individual ownership is maintained but a group of pharmacists operates under a common name could still be permissible under present State laws. The only qualification the Committee would place on this proposal is that services to outlying areas are not placed in jeopardy as a result of any large-scale rationalisation of pharmacy outlets.

Fourthly, it has been suggested that the pharmacist be paid a salary and that that salary not be affected by what the pharmacist does or by the size and turnover of his pharmacy.22 It has also been suggested that pharmacists be brought into line with other professions by establishing a fee for consultation policy.23 The Committee believes such

schemes would not overcome the main problem: the oversupply of pharmacies.

The future of manufacturing, wholesaling and retailing The total picture presented above would lead one to cast doubt on the long-term viability and profitability of the manufacture, distribution and sale of pharmaceuticals in Australia under the present system. In view of other reports24 which have dealt specifically

with such matters as profitability, pricing and industry rationalisation, the Committee has not attempted in this report to undertake an in depth study of these issues. Nonetheless, the Committee does feel it is necessary to shed some light on the operating environment of

the distribution network. With an apparent oversupply of pharmacies and of manufacturing capacity (particularly in compounding, formulating and packaging which are reportedly able to cater for a population of 50 million25), the Committee believes a

number of possible outcomes are likely. First, the manufacturing and distribution sector could be reduced until the supply or capacity to supply was more in keeping with the size of the local market and its level of demand for therapeutic substances. There are indications that this is happening already.

The Australian Pharmaceutical Manufacturers Association claimed that importing final products and local packaging are replacing local manufacturing, which has resulted in a sharp drop in employment in the manufacturing sector.26 The Pharmaceutical Manufacturing Industry Inquiry noted that there had been a trend to fewer wholesalers with the number of corporate entities falling from 23 to 16 in the 3 years to 1978.2 Also, there have been moves within the pharmacy sector to rationalise the number of outlets currently in existence in order to improve the general level of profitability.26 1 hese moves will no doubt bring about a better balance between supply capacity and the size pi the market.

Secondly, if the numbers and composition of the distribution system remain unchanged, long-term viability and profitability would he improved should the markets for pharmaceutical products be increased. Any attempt to increase the demand tor drays within the local market would he strong!v opposed hy this C ommittee. Australia has become one of the largest consumers of drugs per capita in the world.2" Unfortunately, the export

market has not grown as was originally conceived. The Australian Pharmaceutical Manufacturers Association said in evidence that many manufacturers had set up in Australia with the view of obtaining a significant share of the New Zealand. New Guinea and the South Pacific Basin markets.30 However, because of pricing arrangements in

Australia and their effect on profitability, the Australian Pharmaceutical Manufacturers Association claimed that it was not possible to set up a viable export driv e into the South­ east Asian and Pacific region.31 The Australian Pharmaceutical Manufacturers

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Association informed this Committee that these markets have been secured by subsidiary or parent companies located in countries where there are no restrictions on local prices.32 The Committee believes that there is a need for further rationalisation and restructuring within the manufacturing, wholesaling and pharmacy sectors. The process cannot simply rely on economic considerations alone to achieve the desired end. The

Committee also believes that from strategic, welfare and medical points of view, a nucleus of a manufacturing industry needs to be maintained within Australia. The Committee sees the need to ensure that there are adequate supply points for the distribution of therapeutic substances throughout Australia. The way in which these problems are dealt with will ultimately have an important bearing on the use of medication in our society.

The hospital pharmacy

Another important link in the distribution chain is the direct sale from the manufacturer to the public hospital. Hospital sales account for around 20-25 per cent of the total prescription drug market.33 In recent times, centralised purchasing authorities have been established to obtain supplies for a number of small hospitals. This is generally done by way of competitive public tender. Because the order involved is significant, firms attempt to obtain the right to supply this particular market by submitting a very competitive price, which in many cases is well below the recommended wholesale price. For many of the

major public hospitals, their annual drug bill is large enough to enable them to negotiate directly with the manufacturers to obtain a very competitive price. The drug manufacturer is ever mindful of the fact that the use of his drugs in hospitals enables the numerous interns to become familiar with those drugs. This will then influence prescribing patterns when the trained doctor establishes himself in private practice.

In the Pharmaceutical Manufacturing Industry Inquiry34, it was estimated that the price to hospitals was on average 21 per cent lower than the Pharmaceutical Benefits Scheme price to wholesalers. In fact, items no longer under patent and hence subject to competition from other generic manufacturers are most likely to be offered to hospitals at substantial discounts. The Australian Pharmaceutical Manufacturers Association informed the Committee that firms could offer attractive discounts to hospitals because there were less selling costs involved, and the volume of the contract enabled lower per unit cost pricing to be realised. Unlike the Pharmaceutical Benefits Scheme market, the hospital market is very responsive to price; therefore competition can lead to substantially lower prices.35

On the other hand, many new drugs are placed on trial in hospitals before they go into the Pharmaceutical Benefits Scheme. During this period the price of the drugs may be 100 to 400 per cent higher than the price that will be negotiated once the drug is available for widespread use. This is obviously a very lucrative market for drug companies and a great deal of their promotion is directed here (see Chapter 7).

Compared with the retail pharmacy, the public hospital pharmacy does not sell its drugs. The drugs are distributed in the hospital to patients as required. In out-patients facilities, drugs are dispensed free of charge. As there is presently no means test applied to patients who use out-patients facilities, these services are being severely strained in most major suburban hospitals. Until access to these services is more equitably supervised, there will continue to be a growing pressure on the limited resources that can be made available through channels, particularly access to free medication.

Even though drug costs form only a very small percentage of total hospital costs, it is understood that nearly all hospitals monitor very closely the amount of money spent on drugs. Generic prescribing and the use of a collective purchasing system are just two measures that have been advocated by hospital authorities to help contain escalating drug costs in hospitals. In the former case, it is suggested that generic prescribing will help overcome the need to stock a large variety of similar medication. By minimising the choice

76

of drugs in hospitals, tenders will be for large amounts of one particular therapeutic substance. This should enable the centralised purchasing agency to attract a lower price. A public hospital would spend between $1.5 to 3.0 million a year on drugs (depending on bed size and out-patient numbers), and therefore a saving of around $15 000 to $30 000 could be realised for every one percentage point drop in drug costs. Table 5.8 shows the drug expenditure in 1977-78 of selected major teaching hospitals:

Table 5.8: Drug expenditure comparison 1977-78 among selected hospitals

$ Bed Nos. Outpatient Nos.

Royal Perth ................................................................ 2 964 392 1073 418 204

Royal Adelaide ........................................................... 2 056 686 985 417 980

Royal M e l b o u r n e ........................................................... 3019818 728 n.a.

Royal Hobart ................................................................ 1 215 673 606 244 740

Prince of Wales, S y d n e y ................................................ 1 600 000 705 142 325

Source: Submission by the Society of Hospital Pharmacists of Australia. Evidence, p. 824. and personal communication with the hospitals..

The doctor Doctors are not usually involved in the physical side of distribution. The issuing of a prescription by a doctor to a patient provides the necessary and final link in the distribution chain for prescription pharmaceuticals. It is the doctor who makes the decision whether or not a patient is to receive medication on prescription. This decision concerns not only the patient but the pharmaceutical manufacturers as well, because it is

the doctor who has the ultimate choice as to what type of medication and what brand of medication he will prescribe for his patient. Latest figures available to the Committee reveal that around 90 million Pharmaceuti­ cal Benefits Scheme prescriptions and around 7.3 milion Repatriation Pharmaceutical

Benefits Scheme prescriptions are written annually.36 On these figures alone it is quite obvious that every decision to write a prescription has economic significance for manufacturers, wholesalers and pharmacists. The role of the doctor is discussed further in Chapter 10.

Controls Introduction Several aspects of acts, regulations and codes relating to therapeutic substances have been dealt with in the previous chapter. This section examines briefly manufacturing controls,

the Pharmaceutical Benefits Scheme, medical and pharmacy boards, and industry and professional associations. The degree of accountability and monitoring of drugs can vary trom one point in the chain to another and from one therapeutic substance to another. Some substances in

particular are subject to inappropriate (including recreational) use, and hence, there is a continuing need for a system of controls and safeguards to minimise the risk of such use and to prevent diversion.

Manufacturing controls I n addition to compliance with the Code of Good Manufacturing Practice (see C hapter 4. pp. 49-50), the Australian Pharmaceutical Manufacturers Association has laid down guidelines for its members which it believes complement the Code. Briefly, members arc required to carry out the following procedures of checks and controls3 :

establishment of adequate recording and accounting procedures from the initial point of entry of any goods or materials into the plant:

77

provision of adequate and secure storage facilities for raw materials and finished products; - maintenance of batch cards for each production run to enable reconciliation with materials used and goods produced;

ongoing laboratory testing for quality and standards of both raw materials and products; - proper supervision of destruction of spoilt or damaged goods; - maintenance of comprehensive warehousing and despatch documentation; and - full accountability of samples supplied to doctors, hospitals etc.

As w'ith all manufacturing establishments, security arrangements are implemented to safeguard not only the premises and equipment but also the goods which they produce. For most companies this involves the use of security guards and, in the case of some of the larger manufacturers, particularly those who deal with large quantities of narcotics, the security arrangements are more elaborate.

The only concern the Committee has with regard to the control of drugs through the manufacturing and wholesaling stages of the distribution network relate to the legal status of the Code of Good Manufacturing Practice. The Committee has already recom­ mended that the Code be incorporated into State legislation as soon as possible (see Chapter 4, page 000).

The Pharmaceutical Benefits Scheme

The Commonwealth, through the operation of the Pharmaceutical Benefits Scheme, has an influential and indirect control over the supply and distribution of the majority of prescription drugs. Doctors issuing Pharmaceutical Benefits Scheme prescriptions arc bound by the

Schedule of Benefits for Medical Practitioners which sets out the pharmaceutical benefits and their restrictions. This Schedule (which is subject to regular updates) specifics the maximum quantities that can be dispensed, the number of repeats and certain limitations placed on the use of selected drugs.18 The Scheme therefore has a significant influence on the prescribing habits of doctors.

In order to retrieve all outstanding monies over and above the maximum Pharmaceutical Benefits Scheme price (currently $2.75), pharmacists must lodge a claim for payment with the Commonwealth Department of Health. As the Department processes and checks all dispensed precriptions for payment to pharmacists, it can also pick up abnormal prescribing by doctors and general changes in the level of consumption of particular drugs.

Inspectors from the Commonwealth Department of Health can use this information when visiting doctors to discuss the suspected inappropriate or apparent over­ prescribing of Pharmaceutical Benefits Scheme items. The Department told the Committee that the number of visits by departmental pharmacists to doctors depends very much on the resources available.39 Under present conditions this usually means priority is given to only those doctors who are identified as very high prescribcrs ot selected Benefit items. If the inspector believes the doctor or doctors have a case to answer, this is then referred to the Medical Services Committee of Inquiry or. in more serious cases, court action may be taken.40 If a doctor is found guilty, the Minister may suspend

or revoke a doctor’s authority to prescribe Pharmaceutical Benefits Scheme items or he may simply issue a ministerial reprimand which might appear in the Commonwealth Gazette.4I The Committee believes it is inappropriate to operate an inspectorial system based purely on whether or not resources are available. If the Department believes there are

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abuses of the system then resources should be made available to follow up all offenders, not only the major offenders, lithe Department believes that there are many matters that should be followed up, then this Committee would recommend that funds be made available for this specific purpose.

The Pharmaceutical Benefits Scheme does not cover all drugs and it does not cover all prescribing. For example, a fall in the number of Pharmaceutical Benefits Scheme barbiturate prescriptions may only mean a sw'itch to private prescriptions which will allow greater quantities to be dispensed at the one time.

It must also be remembered that the information collected by the Commonwealth Department of Health under the Pharmaceutical Benefits Scheme is used first and foremost for the purposes of payment to pharmacists rather than one of control over the movement and distribution of drugs. Nonetheless, the mere fact that some drugs but not others are listed under the Scheme and are available at subsidised prices to patients means

that the Government does have some control over which drugs are to be used and for what purposes. Other controls over the prescribing habits and dispensing procedures are matters for State medical and pharmacy boards.

Pharmacy boards Pharmacy boards are responsible for the oversight and control of the provisions of the Pharmacy Act within each particular State.4-' Each State Pharmacy Act specifics provisions for the regulation and control of carrying out the business of a pharmacist. Without registration a pharmacist cannot obtain and dispense prescription drugs. If a pharmacist is found guilty of unprofessional behav iour or guilty of non-compliance with the State Pharmacy Act, the board can either reprimand, suspend from practice for a specified period of time, or remove that person from the Register. However, if a pharmacist appeals against a decision handed down by the pharmacy board, he is able to continue practising as a pharmacist until such time as his appeal is heard. The appeal could take several months to be heard due to the backlog of cases before most District Courts. If an appeal is lost, the pharmacist can still continue to work in his pharmacy hut

he is not allowed to dispense drugs. In order to keep his pharmacy operational, he must employ another registered pharmacist to run the dispensary. In most States, pharmacy boards do not initiate action against pharmacists. They have to rely on complaints being laid by other persons to the board.4' The Board w ill then,

on the basis of the evidence before it. decide whether or not a particular pharmacist has a case to answer. Most complaints regarding pharmacists come from the pharmaceutical inspectors employed by the various State health commissions or departments.41 Irregularities in the conduct of business carried out by pharmacists are normally picked

up by the inspectors when they are undertaking their routine inspections ol pharmacies.· The frequency of inspections varies from one State to another in some States they are currently taking place, on average, only once per year. I his can mean that any

irregularities in the distribution of drugs may not be picked up tor several months. It may take several more months for a final decision to be made with regard to a particular pharmacist should he lodge an appeal against the decision handed dow n by the pharmacy board.

The role of a pharmacy board is not simply one of convicting pharmacists who breach the act. It can also play an educative role. For example, the New South \\ ales Pharmacy Board has taken the initiative of informing pharmacists of new developments and possible problem areas by issuing statements of pharmacy practice from time to time.i- In this way pharmacists are encouraged to be aware of their professional responsibilities in

keeping up to date with all changes within the profession. It also enables members ol the profession to be aware of any changes in the trends of so-called fashionable drugs which arc subject to inappropriate use.

Medical boards Medical boards have the responsibility to oversee and control the implementation of the Medical Practitioners Act of their respective State. The main task of each board is the registering of doctors within each State. Without registration a doctor cannot legally practice medicine or prescribe therapeutic drugs. As with pharmacy boards, the proceedings and powers of medical boards differ considerably among the States. The Committee has looked at the systems of New South Wales and Victoria to illustrate this.

Unlike the pharmacy boards, medical boards in most States are not the first avenue for complaints regarding the conduct and practice of doctors. In New South Wales, complaints regarding doctors are brought before an investigating committee which consists of a stipendary magistrate, a member of the Australian Medical Association and a member of the Health Commission.46 This committee considers the case in camera. The committee has three options: it can dismiss the case, it can reprimand the doctor, or it can

refer the case to a medical disciplinary tribunal.47 The tribunal is made up of a district court judge and 4 members of the Medical Board.48 It is generally conducted in an open court hearing.49 The decision handed down by the tribunal is binding on the medical practitioner unless he lodges an appeal within one month.50 This appeal is then heard in the High Court under normal full judicial procedures.

A representative of the New South Wales Medical Board told the Committee of the tribunal’s concern that when a particular person was brought before it his current offence may be his third or fourth, the earlier offences only bringing a reprimand or a strong reprimand from the investigating tribunal.51 The Committee was concerned that this process does not adequately protect the public. The representative from the Medical Board agreed and told the Committee that the Board would like to have greater powers to impose penalties on medical practitioners who breach the Act, and would also like to be able to exercise this power at a far earlier stage in the proceedings.52

In Victoria the procedure is somewhat different. The Medical Board will initially hear a complaint against a doctor. If, on the information it has available it feels there is a case to answer, it will notify the Crown Solicitor. The Crown Solicitor, on the information made available to him, will determine whether or not the Board should prepare a full case. Once a full case is prepared it is heard by the Medical Board acting as prosecutor, judge and jury. Both the Medical Board and the accused have the right to seek legal representation. The full inquiry is held in camera and only the decision of that inquiry is made public. The normal course of appeal by the doctor is through the High Court.

Summary— professional boards

The proceedings and powers of medical and pharmacy boards differ quite considerably from one State to another. The Committee views with concern the consequent non­ uniform manner in which matters concerning doctors and pharmacists are dealt with by their respective medical and pharmacy boards. If the movement and distribution of therapeutic substances is to be effectively monitored and controlled, the Committee believes that a uniform approach with respect to all matters concerning the conduct of doctors and pharmacists is necessary. As well, the Committee suggests that, where

necessary, boards take note of the lengthy delays experienced before matters are heard, the cumbersome procedures that are involved, the unnecessary complexity with which matters are handled and the apparent lack of protection afforded the general public. The Committee RECOM M ENDS that all State medical and pharmacy boards meet with their respective counterparts to establish a uniform code of practice regarding inquiry and disciplinary procedures to ensure that similar matters in each State are dealt with uniformly and expeditiously. In addition, disciplinary charges handed down in one State should automatically be enforced in all other States. This would then prevent a suspended

80

or disqualified doctor or pharmacist who is registered in more than one State from taking up practice in another State.

Industry and professional associations Many associations have an influential role in establishing and maintaining minimum standards of behaviour and/or conduct of business amongst their respective members. The following list is by no means exhaustive but it gives an indication of the w ide variety of associations that can have an influence and say in the distribution, sale, prescribing and dispensing of therapeutic substances within Australia:

the Australian Pharmaceutical Manufacturers Association the Proprietary Association of Australia the National Pharmaceutical Distributors Association the Australian Medical Association

the General Practitioners Society the various colleges associated with the medical profession the Doctors Reform Society the Pharmaceutical Society of Australia the Pharmacy Guild of Australia the Society of Hospital Pharmacists of Australia These organisations are concerned not only with the movement and distribution of drugs

but with many issues concerning the conduct of business by their respective members. All links in the distribution chain can be represented by an industry or professional association. It was not central to this inquiry to undertake an examination of the roles and

functions of the various associations. The Committee therefore makes only the following comment concerning these associations. While they must be supportive of their members, it is in the public interest for every association to follow up any complaint concerning one of its members. This, where appropriate, should be done as publicly as possible. With

regard to the inappropriate use of drugs, swift and firm action taken by an association dealing with one of its members would no doubt have the full support of the public. Such action would demonstrate quite clearly that a particular association is not prepared to

compromise its high standards and will not allow any of its members to bring the association into disrepute. While associations do not have the powers to prevent or disqualify a member from continuing in his profession, peer group pressure is nonetheless a very powerful and effective tool in maintaining high standards of professional

behaviour and practice.

Conclusions and recommendations Many companies, organisations, government departments and individuals arc involved in the distribution and handling of therapeutic substances in Australia. It was not the prime intention of this report to inquire into the structure and v iability ol the various sections within the distribution network. Such matters have already been the subject ol

inquiry in a number of recent reports. However, these matters can and do have a significant effect on the level and nature of consumption of various therapeutic substances. The Committee was concerned with the apparent oversupply ol manufactur­ ing capacity, pharmacies, and in recent times, doctors, because a continued imbalance can lead to a situation whereby demand is unnecessarily increased to match that ot supply

The Committee does see a conflict of interest between medication as a "social good' and the involvement in the manufacture and distribution of medication by private interests. The Committee emphasises that when policy considerations are taken with respect to the long-term viability ol the manufacture and distribution of therapeutic

X I

substances in Australia, attention must be given to social welfare issues as well as normal commercial and economic considerations. Unlike most other commodities in our society, the Committee would be opposed to any policy that proposed the increased use of medication simply to help bring supply and demand back into equilibrium.

The Committee has made no specific recommendations regarding the structure of manufacturing and the methods of distribution. Nonetheless, it has endorsed a number of recommendations or proposals put forward by other committees of inquiry or organisations (see pp. 75-76).

The Committee believes that adequate regulations and procedures for control do exist to enable the safe and proper handling of therapeutic substances throughout the entire distribution network in Australia. However, in some areas these are not being properly enforced because, the Committee has been told, of a lack of resources if controls and

monitoring are given low priority within the respective departments, and if there is a growing concern that therapeutic substances are being diverted or inappropriately used, then this Committee would state that priorities within those departments should be immediately reassessed. However, if resources cannot be reallocated to overcome any shortfalls in the area of distribution controls, the Committee would recommend that funds be made available at both the Commonwealth and State levels to overcome any manpower shortages. The Committee believes that the public has a right to expect that every possible step be taken to avoid the diversion of therapeutic substances away from

their intended medical use. Lack of uniformity in legislation and procedures between States and between States and the Commonwealth is seen by the Committee as a major cause for concern. However, the Committee does believe that more ell'ective control can be achieved under existing regulations and procedures by either:

(i) channelling more resources into those areas where a need has been de­ monstrated; or (ii) the States simultaneously responding to and acting on any recommendations made by the National Standing Control Committee on Drugs of Dependence,

the Poisons Schedule Committee of the National Health and Medical Research Council and the National Therapeutic Goods Committee.

In particular, the Committee has recommended that all State medical and pharmacy boards meet with their respective counterparts to establish a uniform code of practice regarding inquiry and disciplinary procedures to ensure that similar matters in each State are dealt with uniformly and expeditiously (see page 80).

References

1. Australian Pharmaceutical Manufacturers Association. Fact Rook The prescript ion medieim industry in Australia, 3rd cdn. Sydney. 1977, p. 9. 2. Commonwealth Department of Health, Pharmaceutical Benefits. August 1980. 3. Evidence, p. 2904. 3. Evidence, p. 2904. 4. Pharmaceutical Manufacturing Industry Inquiry. Report, Canberra. 1979. p. 13. 5. Pharmaceutical Manufacturing Industry Inquiry, p. 154. 6. Pharmaceutical Manufacturing Industry Inquiry, p. 78: ΑΡΜΑ Fact Book. p. 1 9; Table 2 . 9. 7. (a) Pharmaceutical Manufacturing Industry Inquiry. Report. Canberra. 1979.

(b) Industries Assistance Commission. Report on Pharmaceutical and Veterinary Products. Canberra. 1977. (c) The House of Representatives Select Committee. Report on Pharmaceutical Benefits. Canberra. 1973. 8. Pharmaceutical Manufacturing Industry Inquiry, p. 78.

82

9. Pharmacy Jubilee Conference, Post Conference Report, The Pharmacy Guild of Australia. Canberra, April 1978, p. 17. 10. Pharmacy Jubilee Conference, p. 17. 11. Pharmaceutical Manufacturing Industry Inquiry, p. 79. 12. Pharmacy Jubilee Conference, p. 13. 13. Pharmacy Jubilee Conference, p. 46; Pharmaceutical Manufacturing Industry Inquiry, p. 81. 14. Pharmacy Jubilee Conference, pp. 53, 54. 15. Pharmacy Jubilee Conference, pp. 53, 54. 16. Commonwealth Department of Health. Annual Report of the Director-General of Health.

1978-79. p. 210. 17. See Chapter 2, Table 2.9. 18. The Pharmacy Guild of Australia, The Guild Digest A survey of private practice pharmacy operations, 1979, p. 64. 19. Commonwealth Department of Health. 20. Commonwealth Department of Health. 21. Dr J. S. Deeble, Health Expenditure in Australia 1960-61 to 1975-76. Canber r a. 1978;

Phar macy Jubilee Conference, p. 46. 22. Evidence, pp. 787 9, p. 2553, and submission by the Victorian College o f Pharmacy Ltd. 23. Evidence, p. 782. 24. Refer to Reference No. 7.

25. Pharmaceutical Manuf act ur i ng Industry Inquiry, p. 73. 26. Evidence, p. 2904. 27. Pharmaceutical Manuf act ur i ng Industry Inquiry, p. 78. 28. Phar macy Jubilee Conference, pp. 43-8.

29. The Bulletin. July 29, 1972, p. 21; Choice. March 1979. p. 90; Evidence, p. 2148; Denis N. Wade. "The Background Pattern o f Drug Usage in Australia". Clinical Pharmacology and Therapeutics Journal 19, 5. Part 2, p. 655. 30. Evidence, p. 2904. 31. Evidence, p. 2946. 32. Suppl ement ary evidence submi t t ed by the Australian Pharmaceutical Manufact urers

Association. 33. See Table 2.9. 34. Pharmaceut i cal Manuf act ur i ng Industry Inquiry, p. 24. 35. Suppl ement ary evidence submitted by the Australian Pharmaceutical Manufact urers

Association 36. Commonweal t h Depar t ment o f Health and Depar t ment of Veterans' Affairs. 37. Evidence, pp. 2922-5. 38. Evidence, p. 52. 39. Evidence, p. 54. 40. Evidence, p. 54. 41 Evidence, p. 54. 42. Evidence, p. 2854. 43. Evidence, p. 2855. 44. Evidence, p. 2857. 45. Evidence, p. 2875. 46. Evidence, p. 3095. 47. Evidence, p. 3095. 48. Evidence, p. 3095

49. Evidence, p. 3095. 50. Evidence, p. 3095. 51. Evidence, p. 3097. 52. Evidence, p. 3099.

CHAPTER 6

M o n i t o r i n g d r u g s o f d e p e n d e n c e —t h e n e e d f o r a c c o u n t a b i l i t y

Introduction

As the chapter heading suggests, the Committee sees the need for close monitoring of the importation, production, distribution and consumption of all drugs of dependence. The diversion of these drugs into illicit markets and subsequent inappropriate use do have a devasting effect on various sectors within the community. In our society, the potential for inappropriate use is ever present. Because many of the drugs of dependence have a worthwhile contribution to make in the recognised medical area, it would disadvantage many people in the community if a policy of total prohibition was recommended. The Committee does not believe this to be a realistic policy. This chapter considers the controls that are currently in force and their adequacy, and what steps can be taken to improve the system.

Importation of drugs and dependence

Under the Customs (Prohibited Imports) Regulations, a licenced importer of narcotic drugs must apply for a permit for each individual shipment of drugs. The permit must be approved by the Director-General of Health. This control is in line with the two major

United Nations conventions relating to drug control the Single Convention on Narcotic Drugs, 1961 and the Convention on Psychotropic Substances, 1971. These Conventions are briefly summarised as follows1:

Single Convention on Narcotic Drugs. 1961 The Single Convention controls:

(a) the cultivation of narcotic-producing plants (that is, opium poppy, coca bush and cannabis); and (b) the manufacture, trade, possession and use of narcotic drugs.

The Single Convention is the culmination of a series of conventions and protocols that began with the Chinese British Agreement of 1908 and the International Opium Convention signed at The Hague in 1912. It combines in one single convention most ol the provisions of previous international agreements on measures aimed at limiting the use of narcotic drugs to legitimate medical and scientific purposes.

The drugs controlled under the Single Convention are:

opium, morphine, morphine derivatives (for example, heroin and codeine) and morphine substitutes (for example, pethedine and methadone):

cocaine; and cannabis (Indian hemp).

Convention on Psychotropic Substances. 1971

This Convention was concluded in February 1971. following several years of discussion and drafting. It provides for 4 levels of control measures depending on the degree ol

84

usefulness of a drug for medical or scientific purposes balanced against the extent of harm caused by its inappropriate use. The 4 schedules include:

Schedule 1 — hallucinogens (for example, lysergic acid) Schedule 2—amphetamines Schedule 3—hypnotics (barbiturates, glutethimide)

Schedule 4- -stimulants, sedatives and minor tranquillisers International control takes the torm of an import export authorisation system for narcotics, hallucinogens and amphetamines. Each country establishes an annual estimate ot requirements. The responsible authority in the importing country provides licensed importers with import authorisations as required up to the limit of the estimates. An exporting country will not permit the export of a drug until it has received from the

importing country an import authorisation covering the particular shipment. In this way an attempt is made to:

(a) prevent diversion during transhipment from one country to another: and (b) limit world production to world medical and scientific requirements.

The Conventions have been discussed in an earlier report of this Committee. Drug problems in Australia—an intoxicated society?, and in an earlier Senate Select Committee Report Drug Trafficking and Drug Abuse in relation to some inconsistencies in classifications and concepts. The Committee reiterates its view that changes need to be

made to have cannabis moved to an appropriate Schedule in the United Nations Convention on Psychotropic Substances. Table 6.1 records Australia’s estimates for the requirement of narcotic drugs ox er the last 3 years to 1980:

Table 6.1: Estimates of Requirements of Narcotic Drugs 1978 to 1980 (all quantities expressed in grams)

Drug 1978 1979 I9SO

Cannabis ........................... 100 100 200

Cannabis resin . . . . 25 25 100

Cocaine ........................... 24 935 34 717 22 760

Codeine ........................... 4 884 545 4 391 874 3 765 966

Diethylthiambutene . . 2 406 1 633 2 095

Dextromoramide . . . 14 201 14 539 15 674

Dihydrocodeine . . . . 127 210 153 993 258 362

Diphenoxylate . . . . 107 147 1 10 585 120 605

E t o r p h i n e ........................... 20 10 10

Ethylmorphine . . . . 15 110 12 942 1 3 352

Fentanyl ........................... 55 273 253

Ileroin ................................ 15 15 20

H y d r o c o d o n e..................... 6 845 4 363 4 397

Hydromophone . . . . 295 381 322

Levorphanol ..................... 20 12 10

Methadone ..................... 56 638 40 744 59 1 39

M o r p h i n e ........................... 88 180 76 31 2 97 918

Normethadone . . . . 17 267 12 842 12 122

Opium preparations . . 283 997 224 471 178551

Oxycodone . . . . 18 355 20 841 26 236

Pethidine ........................... 401 218 375 364 445 490

Pholcodine ..................... 251 575 220 732 268 057

Phenoperidine . . . . 400 420 395

Source: Supplementary evidence from the Commonwealth Department of Health.

Drugs of Dependence Monitoring Scheme

The National Standing Control Committee on Drugs of Dependence was formed in 1969 to co-ordinate Commonwealth and State activities in controlling the production, distribution and use of dependence-producing drugs and in combatting the inappropriate use of drugs.2 The National Standing Control Committee comprises senior officers from

Commonwealth and State departments concerned with health and law enforcement matters. These members report to their respective Ministers, who in turn report to their respective Parliaments. In 1970, the Drugs of Dependence Monitoring Scheme was introduced as a result of growing concern by governments about the increasing use of narcotics and central nervous system stimulants. At that time it was generally considered that a significant number of drugs were being diverted from legal markets into an illegal drug trafficking system. However, there were insufficient data to prove either that the diversion was

occurring, or the significance of the illicit market. The Scheme relies entirely on the co­ operation of the pharmaceutical industry to provide the data required as there is no legislation to enforce compliance with the Scheme. The Scheme requires all reporting authorities (that is, licenced importers, licenced exporters and pharmaceutical manufacturers) to report their transactions every week. The system also requires the same reporting at the wholesale level. In this way the movement of every narcotic drug and some dependence-producing drugs is monitored from their moment of import or manufacture until they reach their final distributor.

The information collected by this Scheme is collated and processed and a number of reports are produced. These reports are then made available to the Commonwealth Department of Health as well as to State health authorities. Selected information can also be made available to any of the participants for information and analysis. This information enables the early detection of any changes or unusual trends in the consumption of these drugs.

In brief, the following reports are available to the State health authorities to enable them to control the licit drug market h

Four-weekly reports 1. Movement reports These reports facilitate the reconciliation of manufacturers', wholesalers', pharmacists', and medical practitioners' (those who have authority to dispense drugs) records. All reported inward and outward transactions,

together with computer stock ba I a rices for each manufacturer, importer, exporter and wholesaler, arc printed every 4 weeks and forwarded to the appropriate State health authority. This allows checks against excessive losses in formulation or manufacture. Processing yields can be compared with raw material usage. Imports and exports can be checked against Department of Customs and Excise written authorisations to ensure an authority has been issued for each consignment.

2. Interstate movement reports Interstate purchases of the specified drugs by retail pharmacies, hospitals and medical practitioners from wholesale sources arc also listed in 4-weekly reports. These are forwarded to the State health authorities where the purchaser is located.

3. Exception reports High volume purchases of the specified drugs by retail pharmacies, hospitals, medical practitioners etc. are brought to the attention of State health authorities by means of exception reports. These contain details of purchases where a predetermined maximum purchase level has been exceeded. This is based on a 3-month purchasing period. 4. Estimated consumption reports The Monitoring Scheme also gives estimated

consumption figures on a State by State basis. Estimated consumption reports list

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total drug quantities moved from the reporting authorities to the non-reporting authorities (for example, supplies to retail pharmacies, hospitals, medical, dental and veterinary practitioners). Figures for the last six 4-weekly report periods, plus a year-to-date figure, are also printed to allow observation of seasonal trends.

As well as the regular reports produced every 4 weeks, other reports are made available on request. These include reports on purchases by retail pharmacies, hospitals, approved clinics and medical practitioners who have an authority to dispense drugs. They describe all purchases by form, strength, brand and packsize, as well as the date of purchase and from whom. They can cover any period within the 2 years preceding the current date. Similar reports are also produced to help determine import quota

allocations and to enable Australia to fulfil its commitments to the United Nations drug control agencies.

The Drugs of Dependence Monitoring Scheme in theory enables all transactions to be checked off against another point in the distribution system. Any transactions that fail to match can be detected quickly. In this way the risk of losses or thefts of drugs in transit is substantially minimised. The Commonwealth Department of Health claims that in practice the Scheme is 100 per cent effective to the pharmacy and hospital level. Any deversion from licit to illicit markets, the Department claims, occurs at the pharmacy and doctor levels of distribution, that is, diversion as a result of pharmacy break-ins. forged prescriptions, stolen prescription forms, patients feigning symptoms and in some cases

unscrupulous doctors and pharmacists.4 In line with this monitoring system, the Australian Pharmaceutical Manufacturers Association told the Committee that pharmaceutical manufacturers applied very tight security and controls on all narcotic substances and drugs that passed through their establishments. These include5:

placement of all narcotics in vaults with limited access to only a few senior company executives; maintenance of a comprehensive inventory register and stock audit system: and

maintenance of a fully detailed despatch system and proper supervision of any destruction of old or damaged stock.

State health department (or State health commission) inspectors have been able to use information from the Drugs of Dependence Monitoring Scheme prior to carry ing out their routine inspections of pharmacies. In this way they are able to use these data to check against entries in the pharmacist’s drug register, it has also been claimed by the

Commonwealth Department of Health that the sy stem has developed a greater aw areness of people who are involved in the handling of these drugs of dependence and has encouraged the development of better systems of recording and stock-taking.'1 The Committee RECOM M ENDS that any drug of dependence that is subject to

inappropriate use, in particular recreational use, should be monitored. In addition, the Committee RECOM M ENDS that the Drugs of Dependence Monitoring Scheme be extended to the patient doctor level. An extended monitoring scheme is presently in operation in Tasmania. It enables far earlier detection than that occurring in other States as a result of overprescribing by doctors, multiple prescriptions being obtained by patients and the use of stolen or forged

prescriptions. In Tasmania, when a monitored drug is dispensed, the pharmacist is required by law to supply to the Department of Health Serv ices each month the name of the prescribing doctor, the name of the patient, and the type and amount of the drug dispensed. This enables far earlier detection of diversion or inappropriate use. In other States, the detection of inappropriate use may only be picked up during the infrequent pharmacy inspections by State health inspectors. (Inappropriate use could also be

X7

detected by the Commonwealth Department of Health if prescriptions come under the scrutiny of the National Health Scheme.) As Pharmaceutical Benefits Scheme and Repatriation Benefits Scheme prescriptions are already submitted to the Commonwealth

for full or part reimbursement, the Committee does not believe that this recommendation would place an unmanageable workload on the pharmacist. Additional notations on the prescriptions where monitoring is deemed necessary would be required, and private prescriptions for monitored drugs would need to be submitted to the Commonwealth

Department of Health. Alternatively, facilities could be made available to the pharmacies for the coding of this information. This would enable a comprehensive check to be maintained on all movements and use. A system developed along these lines would ensure that any diversion of monitored drugs from licit sources or inappropriate use of monitored drugs would be detected very quickly. Appropriate action could then be taken against the offender.

Responsibility of doctors and pharmacists

The Committee has discussed the role of medical and pharmacy boards and professional associations in Chapter 5. The recommendations and suggestions made by the Com­ mittee in the previous chapter are very much applicable when it comes to doctors and pharmacists dealing with drugs of dependence. It is the inappropriate prescribing and dispensing of drugs of dependence that has brought several doctors and pharmacists before their respective boards for disciplinary action.

The system of accountability outlined above enables a very close check to be kept on all monitored drugs of dependence from the point of import or manufacture to the point of sale to the pharmacy. The Committee's recommendations to expand the Drugs of Dependence Monitoring Scheme to the doctor -patient level, and to cover all drugs of dependence subject to inappropriate use, will help ensure that doctors and pharmacists arc made to account for the prescribing and dispensing of such drugs. During the course of its inquiry, the Committee was told on numerous occasions that the diversion of drugs of dependence was most common at the doctor pharmacist end of the distribution chain.

It is against this background that the Committee reiterates the need for professional boards to deal swiftly and firmly with any of their members who do not take enough care and professional pride in dealing with drugs of dependence.

Law enforcement The Committee was told by Detective Chief Inspector Baker that in Victoria, at the time he gave evidence (26 June 1980) it was an offence to supply or possess a restricted substance (Schedule 4 or Schedule 8 substance) without the proper authority." However, at that time, the maximum penalty for the illegal sale or possession of a Schedule 4 substance (for example, barbiturates) was only $100.8 The time and effort involved in obtaining a conviction was claimed to be out of proportion with the penalty imposed. Therefore the Poisons Act as it currently stood was ineffective with respect to this area of

law enforcement. On 21 October 1980, the Victorian Government announced tough new legislation dealing with drug traffickers and users. A person found guilty of trafficking in barbiturates is now liable to a jail sentence of up to 10 years or a fine of up to $50 000, or both. A person found guilty of possession of a restricted substance is now liable to 2 years and. or a $5000 fine.

In New South Wales, the penalties for illegal supply or possession of restricted substances differ quite markedly from those applying in Victoria. As a result of the new Victorian legislation, penalties for possession and trafficking of restricted substances are

88

higher in Victoria than in New South Wales. Prior to 21 October 1980. penalties in New South Wales were more severe than those in Victoria. Under Section 18 ot the New South Wales Poisons Act. the illegal supply of substances specified in Schedules 1.2. 3 or 4 of the Poisons List shall be liable to a penalty not exceeding $800, or to imprisonment fora term not exceeding 6 months. Under Section

18A of the Act the penalty can be as high as $2000 or two years" imprisonment." (Section 18A refers to trafficking offences and it also includes cases where people are found to have in their possession an excess of a specified amount of a substance. In the latter case, the onus is on the individual to prove that he did not possess that quantity with the view to trafficking.)

In South Australia, the Narcotic and Psychotropic Drugs Act. 1934 1978 deals with both supply and possession offences. The drugs subject to this Act broadly coincide with drugs listed in Schedule 8 of the Poisons List.10 The Act allows for other drugs to be brought within the scope of the Act by proclamation.11 Traffieking offences under the Act can be very severe with penalties ranging up to a maximum of $100 000 or 25 years'

imprisonment.12 Possession and use offences can range up to $2000 or 2 years' imprisonment. In the other States, similar offences for possession, trafficking or supply can result in a

wide variety of penalties. Uniform penalties for similar offences amongst the States appear to be non-existent. The Australian Royal Commission of Inquiry into Drugs noted:

To the present time, abuse of drugs of dependence has not been treated by Australian legislature as one topic. A number of witnesses saw this as a grave disadvantage and urged the need for uniformity of legislation.11 The Australian Royal Commission of Inquiry into Drugs made a number of

recommendations regarding the introduction throughout Australia of more uniform legislation, such as uniform Drug Trafficking Acts and uniform Drugs of Dependence Acts.14 The National Standing Control Committee on Drugs of Dependence has made a number of recommendations concerning uniform penalties for drug traffickers and illegal possession. Even though all States are represented on the National Standing Control Committee, recommendations and, or guidelines are not binding and each State may act

quite differently and independently of one another. The Committee is at a loss to understand why the States do not uniformly implement the recommendations of then- own representatives on the National Standing Control Committee on Drugs of Dependence. The Committee can only reiterate that effective control would he improved

by each State adopting a more uniform approach not only to law enforcement aspects of drug distribution but to all other aspects associated with the movement, manufacture and distribution of therapeutic substances w ithin each State.

( onclusions and recommendations Accountability for drugs of dependence is strict to the pharmacy level. I he ( ommittee docs not see the need for a tighter control mechanism above this point in the distribution system. How-cvcr, there is a need to enable the present mechanism to monitor any drug of dependence that is the subject of inappropriate use. The Committee has therefore

recommended that any drug of dependence that is subject to inappropriate use. in particular recreational use, be monitored (sec page 87). On the other hand, the Committee sees the need for greater accountability at the pharmacist, doctor and patient levels. It believes that the extension of the Drugs of Dependence Monitoring Scheme to

the patient doctor level as already operational in Tasmania would help overcome some of the shortcomings in this area. The Committee has recommended that all other States

89

adopt this approach (see page 87). More uniform, quicker and firmer action by pharmacy and medical boards in each State would further improve the accountability at this level.

References

1. Evidence, pp. 1665-6. 2. Commonwealth Department of Health, Submission to the Committee, Appendix 10. 3. Evidence, pp. 77-8. 4. Commonwealth Department of Health, personal communication.

5. Evidence, pp. 2920-2. 6. Commonwealth Department of Health, Submission to the Committee, Appendix 10. 7. Evidence, p. 3253. 8. Evidence, p. 3253. 9. Evidence, p. 1664.

Poisons Act, 1966, No. 31, New South Wales, pp. 26. 27, 50, 51; Poisons (Amendment) Act, 1979. No. 147, New South Wales, pp. 2, 3, 4. 10. Royal Commission into the Non-Medical Use of Drugs, South Australia. Final Report, Adelaide, 1979, pp. 234, 235. 11. Royal Commission into the Non-Medical Use of Drugs, South Australia, p. 235. 12. Royal Commission into the Non-Medical Use of Drugs, South Australia, p. 236. 13. Australian Royal Commission of Inquiry into Drugs, Report, Canberra, 1980, p. D49. 14. Australian Royal Commission of Inquiry into Drugs, pp. D29. D49, D50. D1 19. D120.

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CHAPTER 7

Dr u g p r o m o t i o n

The intention of this chapter is to describe and examine the manner in which drugs are promoted, and to outline and analyse the adequacy of existing controls over such promotion. The purpose of promotion and its effect on consumption is also discussed. Many people have suggested that sales promotion activities provide an important

source of information for doctors and pharmacists. They can provide information concerning quality, toxicity, efficacy, dosage and adverse drug reactions. The Committee strongly believes that while advertising and promotion do provide information, they

should not be regarded as the only source. Doctors and pharmacists who rely on this source of information only should be harshly criticised. Where appropriate, the Committee has made comments on the information content (or lack) of certain promotional material. The need for advertising revenue to enable the continued dissemination of non-company information in medical journals is also discussed.

Types of promotion The main sales practices used in the pharmaceutical industry are:

1. advertising in medical and pharmacy journals; 2. medical representatives calling on doctors and pharmacists:

3. literature mailed to doctors, pharmacists and hospitals; 4. product samples; 5. medical exhibits and symposia; and 6. doctor peer group and continuing education programs.1

Proprietary products are also advertised in newspapers and magazines, and on television and radio. As well, they are promoted through shop display s, representations to pharmacists and other retailers, and through product samples.2

Expenditure on promotion The latest available estimate for the cost of promotion of prescription medicine is the 1778 estimate of $44 million, which represented 15.3 per cent ot sales.1 The industry has estimated that about 50 percent of promotional expenditure is spent on representatices.

30 per cent on journal advertising and the remainder on literature through the mail, samples and education aids.4 The Pharmaceutical Manufacturing Industry Inquiry has examined the trends ol promotion cost as a percentage of sales for Pharmaceutical Benefits Scheme drugs I he results arc set out in the table below.

Sales of Pharmaceutical Benefits Scheme drugs account for only about 71) per cent ol total ethical pharmacy sales and 66 per cent ol all prescribed drugs.' This accounts lor the difference between the percentage ot sales shown in the table (17.1 per cent) and the estimate for all prescription drugs shown above (15.3 per cent).

These estimates of the proportion of sales spent on promotion are high compared with expenditure in other industries and also with overseas pharmaceutical manufactures.

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Table 7.1: Advertising and promotion costs as percentage of sales— PBS pharmaceuticals sector

1972 1973 1974 1975 1976 1977 1978

Advertising ........................... 4.1 4.6 4.8 4.0 3.9 3.7 3.9

Representatives' costs . . . 8.0 8.6 9.0 9.1 8.7 8.7 8.6

Other promotions . . . . 2.1 2.4 2.4 2.3 2.3 2.2 2.4

Marketing promotion m ana­ gerial expenses ..................... 3.2 4.0 4.7 4.6 4.5 4.5 4.2

Total ..................................... 17.4 19.6 20.9 20.0 19.4 19.1 19.1

Source: Pharmaceutical Manufacturing Industry Inquiry Report, Canberra, 1979, p. 66.

Table 7.1 reveals that there has been a small increase in the ratio of promotion costs to sales for Pharmaceutical Benefits Scheme items during the period 1972 to 1978. According to the Pharmaceutical Manufacturing Industry Inquiry, most of this is accounted for by increased managerial expenses.7

The amount of money spent on promotion is not of prime concern to the Committee.* Rather, the Committee is more concerned with the quality and intent of promotional material.

Advertising in journals From the evidence received by the Committee it appears that advertising in journals is the greatest area of concern with regard to drug promotion. Consequently it is discussed in some detail in this chapter.

Cost

The National Medical Media Council has supplied details of expenditure on advertising (money value) for the major medical publications produced between 1972 and 1978. This information is set out in Table 7.2.

Table 7.2: Total pharmaceutical advertising expenditure in major medical publications 1972-1978

Year

1972 .......................................... 2 400 2 400

1973 .......................................... 2 740 2 533

1974 .......................................... 3 174 2 560

1975 .......................................... 2 952 2 036

1976 .......................................... 3 240 1 988

1977 .......................................... 3 240(a) 1 751(a)

1978 .......................................... 3 700(a) 1 859(a)

(a) Estimate.

Source.· National Medical Media Council Submission to the In­ dustries Assistance Commission concerning the Commission’s Draft Report on the Publishing Industry, 1978, p. 10.

Table 7.2 shows that advertising has increased in money terms between 1972 and 1980. In real terms, however, expenditure has fallen, particularly in 1975, though there are signs that in 1978 real expenditure increased slightly. This decline is also seen by the overall tall in the number of pages of advertising placed in medical publications between 1972 and

* The Committee would he concerned if excessive promotional expenditure was automatically included in the Pharmaceutical Benefits Scheme pricing formula. According to the C ommonwcalth Department ot Health, this is not the case.

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1980. These figures are shown in Table 7.3. Once again, the drop was most noticeable in 1975, but since that time there has been no appreciable decline. It is also noted that the estimated increase in real expenditure in 1978 is supported by the actual increase in the number of pages of advertising placed.

Table 7.3 Number of pages of advertising placed in the major medical publications 1972 to 1980.

1972 1973 1974 1975

1976 1977 1978 1979 1980

Source: National Medical Media Council.

6 163 6 159 5 277 3 860

3 605 3 824 4 499 3 945 3 666

One of the main aims of advertising is to try to increase sales, and it would be naiv e of anyone to suggest otherwise. However, if every firm advertises, the end result may only be a change in market shares. With many new drugs coming onto the market, sometimes replacing existing drugs, it is very difficult to prove that total markets for particular drugs are increased as a result of advertising. A fall in advertising may lead to a fall in consumption and this could be seen as beneficial. On the other hand, reduced advertising

revenue can place at risk the financial viability of many medical and pharmacy journals. These journals perform a valuable role in providing other sources of information and their disappearance would be unfortunate. The dilemma is to decide what trade-off is desirable between unrestricted advertising,

the aim of which might be to increase unnecessarily total consumption, and the loss of the publication of several reputable journals. Research to date docs not indicate clearly to what extent advertising increases markets as opposed to market shares. The cost of advertising over-the-counter products is more difficult to estimate. Bruce

Tart Research Service Pty Ltd collects figures on national advertising of pharmaceuticals in magazines, newspapers, television and radio and these totals are given in Table 7.4.

Table 7.4: National advertising of over-the-counter products 1976-1979

$'000

1976 1977 m i s 1979

Money value .....................................

Real value (in 1976 prices) . . .

. . . . 12 677

. . . . 12 677

13 722 12 143

17 876 14 652

20 254 15 229

Source: Bruce Tart Research Service Pty Ltd; personal communication.

Table 7.4 shows that expenditure on advertising of over-the-counter drugs in the national print media is increasing in real terms in contrast to prescription drug advertising. The use of over-the-counter drugs for self-medication can be an effective and efficient

way to treat minor illness. The general public w ill rely almost exclusively on advertising to obtain their information about remedies available. Bearing this in mind, we need to ensure that the content, format and orientation of these advertisements produce the

desired social outcomes. Controls and the effect of advertising on consumption are discussed later in this chapter.

93

Content of advertisements in journals Some witnesses before the Committee were dissatisfied with the content of advertisements for prescription drugs directed to doctors. The most common criticism was that advertisements present stereotypes of people8 (especially women9) and of situations.

A study by Mant and Darroch in 1975 examined the content of 487 drug advertisements in a sample drawn from 7 years' publications of 2 leading Australian medical journals.10 Each advertisement was coded according to the name of the drug advertised, whether or not the advertisement showed a picture of a patient, and the sex of the patient (where this could be determined). Subsequently, the drugs were coded into

9 categories by mode of action and one residual category. Seven of the mode of action categories and the residual category are shown in Table 7.5. Thirty-three advertisements for gynaecological products and iron supplements have been omitted because of the sex bias of these categories.

Table 7.5: Drug category by number of advertisements and sex of patient shown in advertisements

Sex identifiable advertisements

Drug category Female Male No sex Total Ratio F:M

Skin preparations .......................................... 8 6 12 26 1.3:1

A n t i a r t h r i ti c s ..................................................... 4 7 10 21 1:1.8

A n a l g e s ic s .......................................................... 7 12 11 30 1:1.7

Mood m o d i f i e r s ................................................ 36 17 8 61 2.4:1

Antibiotics ..................................................... 19 18 60 97 1.1:1

Antihypertensives .......................................... 9 21 18 48 1:2.3

Antihistamines ................................................ 10 9 20 39 1.1:1

Other ............................................................... 23 32 77 132 1:1.4

Total ............................................................... 116 122 216 454

Source: A. Mant and D. B. Darroch, ‘Media Images and Medical Images', Social Science and Medicine, 9, 1975, p. 615.

The table shows that the most commonly advertised drugs are antibiotics (20 per cent of all advertisements), followed by mood-modifiers (12.5 per cent) and antihypertensives including diuretics (10 per cent). Of the sex-identifiable advertisements for mood modifiers, 36 (68 per cent) referred to women and only 17 (32 per cent) to men.11 Advertisements for antihypertensives and diuretics, antiarthritics and analgesics were more likely to refer to men than to women, while advertisements for antibiotics, skin ointments and antihistamines were fairly equally distributed between the sexes. Mant and

Darroch conclude that: Overall ads showing both women and men were highly stereotyped as to sexual and social roles.1’ ■

The Committee believes that the stereotyping of people in sexual and social roles max have systematic effects on prescribing habits and is therefore undesirable. The above study indicates that advertisements for some prescription drugs do illustrate this stereotyping. Simon Chapman has conducted interviews with former employees of advertising agencies involved in the promotion of pharmaceutical products. He concludes

that advertisers use and dramatise, but do not create, the stereotype. They probably reinforce and perpetuate the stereotype that already exists.1·1 Drug manufacturers have asserted that it is their role to assist in the education of doctors and that the advertising of their products provides doctors with informative material. In the submission to the Australian Pharmaceutical Manufacturers Association to the Pharmaceutical Manufacturing Industry Inquiry, it was stated:

94

The history of the development of new and improved pharmaceuticals has demonstrated the necessity for the manufacturer to play a key role in disseminating essential information to the medical and pharmaceutical professions.14 Pharmaceutical promotion is much more than mere advertising it is an information

service providing a vital communication link between the research laboratory and the doctor.15 The Committee believes that this is a responsible role undertaken by the pharmaceutical industry, but at present it seems that the educational potential of advertising is not considered sufficiently when the advertisements are being framed, for example, the submission by the Australian Pharmaceutical Manufacturers Association to

the Pharmaceutical Manufacturing Industry Inquiry stated 'as with the rest of us, doctors get the kind of advertising which market research suggests we are most responsive toward (or deserve?). For the most parts adverts are "attention grabbers’" . 16 It may appear to be a 'no win' situation for companies in that they can be criticised for

too much aggressive advertising but they will also be criticised if they cut back significantly on promotional advertising. Because the companies want to provide educative information and promote the sales of their goods at the same time, they must be

prepared to supply more than just ‘attention-grabbing’ material in their advertisements. The Committee realises that there is a difficult trade-off to be negotiated between economically effective advertising on the one hand and advertising that has significant educational potential on the other.

Professor W. Louis, Member of the Pharmaceutical Benefits Advisory Committee, presented to the Committee an advertisement that was published in an American journal (Exhibit 24) as an example of good educational advertising of d r u g s . T h e 2-page advertisement was a promotion for a particular treatment of diabetes but 75 per cent of the space was devoted to information about a suitable diet for a diabetic patient. This type of advertising, where information about supplementary non-pharmacological treat­ ments, prevention or other relevant material is presented, is commendable. The Committee, however, has not examined the costs of educational advertising.

In order to foster this educational emphasis in advertising, the Australian Medical Association has suggested that the pharmaceutical manufacturing industry should be encouraged to establish a body to voluntarily control and monitor the advertising of prescription pharmaceuticals. The aim of such a bodywould be to orient promotional

material towards educational rather than purely competitive objectives. The Australian Medical Association believes that it would be desirable for the organisation to include representatives of both the medical and pharmaceutical professions.18 The Committee RECOM M ENDS that representatives from the Commonwealth

Department of Health, the Australian Pharmaceutical Manufacturers Association, the Australian Medical Association and other interested parties come together to Irame appropriate values and standards of advertising. The Committee also RECOMMENDS that this group look into the need to promote and inform doctors about the \ ast number of less

profitable (and in many cases non-profitable) drugs. Normal market strategy would direct firms to actively promote and advertise only their most profitable range of drugs. From an educational point ot view, information (whether it be by way of advertising) should be available for all therapeutic drugs. In addition, the Committee RECOM M ENDS that a certain percentage of advertising revenue be specifically earmarked for educational advertising. (The Committee will monitor the effect that this recommendation has on the advertising in the Medical Journal of Australia.)

Medical representative

As mentioned above, the amount spent on medical representatives (detailers) accounts lor 50 percent of the total expenditure on promotion of therapeutic drugs. For 1978. this was

95

about $22 million. The Australian Pharmaceutical Manufacturers Association stated that medical representatives are the foundation of a company's information program.19 They are obviously regarded by the companies as an effective means of conveying information about their products to doctors.

Each company employs an average of around 21 medical representatives. Their performance is assessed by individual senior company executives visiting medical practitioners in the field, either in the presence of the representative or separately, and by reports to obtain the reaction of medical practitioners to representatives and the work performed. The companies also have information on sales in each detailer's area and in this way his performance as a salesman can also be assessed.

Medical representatives undertake a training program which covers the essential elements of anatomy, physiology, microbiology, general disease states, medical terminology and ethics. Examinations are held and a certificate of proficiency is awarded to successful candidates. Since the inauguration of this program in April 1973, 1055 of the total number of 1094 detailers working in Australia today have successfully completed the course.20

Dr H. Thompson, Vice-President, Australian Medical Association, said that this training has improved the quality of promotion by detailers and he commented: We are particularly pleased to note that the pharmaceutical manufacturers have now . . . produced a training course for detailers and . . . the quality and accuracy with which

the pharmaceuticals are detailed to-day are ever so much better than they used to be . . ,21 The Commonwealth Department of Health has been critical of medical detailers. Representatives from the Department who appeared before the Pharmaceutical Manufacturing Industry Inquiry stated that ‘much of the drug promotion (mainly carried out by ‘medical representatives' or "drug detailers’) is unnecessary, must obviously include a significant bias and should be largely replaced by objective information to doctors from authoritative and non-biased sources, for example the Australian

Prescribe!·' 11 The Committee believes that the provision of objective unbiased information is essential. It docs not object to the use of medical representatives and believes that it would be improper to deny doctors access to this sort of information. What must be remembered, however, is that detailers are sales representatives for a particular company and should be recognised as such. That is, they should not be regarded by the

medical and pharmacy professions as educators and disseminators of unbiased information. A survey of 35 companies conducted by the Australian Pharmaceutical Manufac­ turers Association in 1978 revealed that the number of representatives promoting ethical drugs decreased by 10 percent during the period 1974 to 1978. Representatives promoting over-the-counter products (survey of 13 companies)decreased by 14 percent and hospital representatives (survey of 23 companies) increased by 8 per cent.2 ’ Therefore overall it appears that, like journal advertising, this form of promotional activity is decreasing.

There is some concern within the Commonwealth Department of Health that hi tiding for the journal Australian Prescriber may cease in the near future. The Committee feels that this journal is a valuable source of educational material for doctors and RECOM M ENDS that the Australian Prescriber continue to receive government funding.

Direct mail and other types of promotion

Direct mail is another form of promotion used by the pharmaceutical companies. As mentioned below, the ‘product information' of new imported drugs is scrutinised and approved by the Commonwealth Department of Health for the first 3 years of marketing.

Other forms of promotion include medical exhibits and symposia, the issuing of drug

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samples, which can provide the doctor with some form of personal evaluation of the drug, contact with other doctors and continuing education programs.

Controls on promotion Prescription drugs

The Commonwealth Department of Health reviews the Product Information documents when new therapeutic substances are being evaluated. This document contains essential comprehensive information about the drug.24 All supplementary promotional literature (excluding journal advertisements) distributed by the company is also scrutinised and

approved by the Department for the first 3 years of marketing. After this period the company is permitted to distribute promotional literature without prior approval, provided it is based on and includes the approved Product Information document.25 Under the Broadcasting and Television Act, the advertising of prescription drugs on

radio and television is prohibited. Legislation in all States prohibits the advertising of prescription drugs in the lay press, posters and other public places.20 There is no direct Commonwealth control over the content of advertisements in professional journals.: ~ Until 1973 the control of advertising in medical journals had been the responsibility of

the editor or publisher.28 However, in April 1973 the National Therapeutic Goods Committee presented to the Health Ministers' Conference proposals to be enforced by legislation for controlling the promotion of medication. In relation to prescription drugs,

the Committee proposed that advertisements should contain full disclosure, that is a statement of the active constituents of the product, its indications, the therapeutic dosage regimen, any contra-indications or adverse reactions, the degree of dependence potential, and a statement of likely interactions.29 The Committee also outlined criteria under w hieh

an advertisement could be considered false or misleading and therefore prohibited. In a counter-move, the medical publishers established in 1973 the National Medical Media Council. This was in response to what they perceived as "bureaucratic intervention’.30 The Council adopted a code of business ethics which, according to the

National Medical Media Council, ‘establishes standards intended to maintain the high reputation of medical publications, prevent the admission to the Council ol any undesirable publications and permit Council to reprimand and or expel a member should it not maintain those standards".31 However, as membership is not compulsory and the Council’s findings are not legally enforceable, this is not the full answer.

Upon its formation, the Council established a Liaison Committee with the Australian Medical Association, the Australian Association of National Advertisers, the Australian Association of Advertising Agencies and the Australian Pharmaceutical Manufacturers Association, and formulated the Code Relating to Ethical Advertising. '- lo ensure compliance with this Code, the National Medical Media Council also set up the

Advertising Approval Authority to examine advertisements before they were published. (This Authority was terminated soon after establishment.) On 30 October 1973 the National Medical Media Council met with the National Therapeutic Goods Committee and opposed the National Therapeutic Goods

Committee's draft proposal for legislative controls on advertising on the following grounds: (i) (It would) introduce requirements which would make a great deal of advertising counter­ productive and incite advertisers to look tor means of promotion other than medical

journals. Yet journals have a v ital role in continuing the Australian doctor's postgraduate education and advising him of news and developments in the political and business areas, and rely heavily on pharmaceutical advertising to carry out that role.

(ii) The requirements would increase the cost of communicating with the doctor Λ full page advertisement might need to be expanded to I to 2 pages to meet the requirements.

(iii) The pharmaceutical industry probably would be forced to increase their comparatively expensive detailing efforts; the doctor would be obliged to spend a great deal more non­ productive time talking to them in the hope of keeping up with new drugs and therapy.33

The Australian Medical Association also opposed the National Therapeutic Goods Committee’s proposals and set out its reasons in a letter to the Chairman of the National Therapeutic Goods Committee in July 1974. They were; 1. The proposals for the control of advertising of therapeutic goods, as set out in the document

‘Proposed Requirements for the Advertising of Therapeutic Goods Recommended by the National Therapeutic Goods Committee", particularly the proposals for 'full disclosure", are unnecessarily far-reaching and restrictive.

2. With the increased volume of information proposed to be disclosed in advertisements, the issues of primary concern intended to be conveyed to the recipient of the message are likely to be confused and concealed, and the proposals counter-productive through resulting reduced readership.

3. Reduced effectiveness in conveying the intended message will lead to reduced advertising, with a resulting reduction in the revenues on which depend the continued viability and survival of scientific and educational publications, such as The Medical Journal o f Australia and the journals of academic bodies, such as the clinical colleges. The small circulations of such publications, because of the small population in this country, precludes costs of production being met from subscription revenues. These publications play a major role as a means of communication with practising doctors for: (a) continuing medical education; (b) distribution of information on advances in medical treatment; (c) communication of other information of clinical, educational or professional impor­

tance.

4. The introduction of a bureaucratic system of restriction and control before the voluntary code for ethical advertising of the National Medical Media Council has been allowed to demonstrate its effectiveness is both unnecessary and undesirable.34 In June 1974 the Australian Pharmaceutical Manufacturers Association resolved to support the Council and adopted the National Medical Media Council's Code Relating to Ethical Advertising.35 In 1975 this Code was incorporated into a wider code called the Code of Conduct for the Pharmaceutical Industry, which received clearance under the

Trade Practices Act 1974, on 30 June 1977.36 Because the Australian Pharmaceutical Manufacturers Association adopted the Code Relating to Ethical Advertising, the National Medical Media Council felt that the Advertising Approval Authority w'as no longer necessary and in 1976 it was terminated.37 The responsibility of assessing advertisements is now left to the individual publishers.

The Code Relating to Ethical Advertising (see Appendix 3) follows vary closely (with some exceptions) the guidelines of the National Therapeautic Goods Committee’s proposals for full disclosure advertisements. There is, however, a significant problem with the Code. It has separate provision for ‘reminder advertisements’ which are advertise­ ments that do not contain full disclosure about the drug. This type of advertisement makes up about 90 per cent of advertising.

There are only 2 essential requirements for 'reminder advertisements’. These are:

1.1 The "approved' name of the preparation must be stated. Sometimes, but certainly not always, depending on the particular drug, it may be necessary to indicate the particular chemical form of the preparation (for example, fluphenazine enanthate or dccanoatc etc ).

1.2 The name of the company which either manufactures or distributes the drug must be stated. (See Appendix 3.) There are 6 optional inclusions about indications, dosage forms and availability which, because they are optional, are totally meaningless. There is also a list ol 4

98

unacceptable inclusions which prohibit the mention of (1) dosage. (2) adverse reactions. (3) comparison with other preparations or (4) the inclusion of references. In the Committee’s opinion, (1), (2) and (4) of the above are desirable inclusions in advertisements and the Committee is disturbed that they should actually be prohibited.

The last item of the Code is totally meaningless. It reads:

4.1 The amount of'promotional’ material will be minimal. It is not possible to be more precise in this area without unnecessarily restricting the freedom of advertisers to promote. The limits can therefore only presently be defined by precedent.

The Committee believes that this is a most unsatisfactory Code. It does not believe that all advertisements should necessarily contain a full disclosure about the drug. Such advertisements can be large and expensive and may have the effect of reducing the amount of journal advertising. Because journal advertising is necessary for the viability of many valuable medical journals, the Committee docs not wish to decrease the quantity of advertising. However, it does wish to establish some standards on the quality of

advertising. The Committee therefore RECOM M ENDS that the Australian Phar­ maceutical Manufacturers Association, the National Medical Media Council, the Australian Medical Association and other relevant organisations draw up a new code relating to ‘reminder advertisements’. During the formulation of this code, consideration

should be given to the Committee’s recommendation regarding educational advertise­ ments. If a more satisfactory voluntary code cannot be formulated by the abovementioned bodies within 6 months of this report appearing, the Committee RECOMMENDS that

the National Therapeutic Goods Committee draw up proposals (which do not require full disclosure of the drug but do set out adequate standards of advertising) to be enforced by legislation for controlling the promotion of prescription medication.

Over-the-counter drugs All advertisements on radio and television for over-the-counter drugs arc subject to Section 100 of the Broadcasting and Television Act w hich states that "a licensee shall not broadcast or televise an advertisement relating to a medicine unless the text ol the

proposed advertisement has been approved by the Director-General ot Health or. on appeal to the Minister (for Post and Telecommunications) under this Section, bv the Minister.'-38 There is a legal provision relevant to over-the-counter advertising in the Irude

Practices Act 1974 which states in Section 52, Part V that 'a corporation shall not. in trade or commerce, engage in conduct that is misleading or deceptive'. In New South Wales. Regulation 31A of the Therapeutic Goods and Cosmetics Act 1972 contains restrictions on advertising which are based on the national Voluntary Code discussed in the follow mg

section.30 There are also relevant Acts in other States which govern print advertising.411 The Voluntary Code for the Advertising of Goods lor Therapeutic l se (Exhibit 25) is the principal control over advertising of over-the-counter products. The Code was formulated in 1977 by officers of the Commonwealth Department ol Health and a body now known as the Therapeutic Advertising Council. The Council, w hich ensures that the Code is adhered to, represents the following organisations:

Australian Newspapers Council Australian Accreditations Bureau Federation of Australian Commercial Telev ision Stations Federation of Australian Radio Broadcasters

Australian Association of National Advertisers Regional Dailies of Australia Limited Australian Provincial Press Association Australian Magazine Publishers Association

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Advertising Federation of Australia Proprietary Association of Australia Australian Pharmaceutical Manufacturers Association Pharmacy Guild of Australia41 The Council is heavily weighted in favour of media organisations. The Committee is at a loss to understand why formal medical representation is not included. Even though over-the-counter drugs do not require a doctor’s prescription, this Committee regards it as essential that medical profession input be available in any discussion about such drugs. Ί he Committee RECOM M ENDS that the Therapeutic Advertising Council as a matter of urgency invite representation from one or more of the medical associations.

The Code has been adopted as a basis for approval of radio and television advertising scripts by the Commonwealth Department of Health (discussed above) and the Australian Newspapers Council uses it as the basis for the approval system which it applies to its members.42

It is an extremely comprehensive document and the Committee believes that if it is adhered to, advertisements for over-the-counter products would be satisfactory. From the available evidence it seems that compliance with the Code is good. Dr D. de Souza (then First Assistant Director-General, Therapeutics Division) of the Commonwealth Department of Health said in evidence to the Committee that the Code works well.42

It appears that advertisements which are associated with any of the 13 members (mentioned above) of the Therapeutic Advertising Council are well controlled. However, there are no sanctions on companies who are not associated with this group. The Committee was shown some advertisements for vitamins in a free minor publication which do not comply w ith the Code. The company concerned was not registered to make

therapeutic goods.44 This problem could be overcome if the national registration scheme proposed by the National Therapeutic Goods Committee and recommended in Chapter 4 by this Committee was introduced. The proposals put forward for this scheme include provision for the scrutiny of the promotional literature associated with all products.

The Committee’s attention was also drawn to advertisements for vitamins and analgesics which were being advertised at discount prices.45 Although the voluntary Code­ does not prohibit this practice, the Committee considers that it is undesirable as it may encourage the buying of a large quantity of these substances. No concrete evidence is available to substantiate the Committee’s fears. Nonetheless, the Committee believes that discounting is an undesirable marketing practice for drugs and RECOMMENDS that a clause forbidding the advertising of therapeutic substances at discount prices be inserted into

the Voluntary Code for the Advertising of Goods for Therapeutic l sc.

The effect of promotion on consumption The Committee has no doubt that the main aim of pharmaceutical manufacturers when they promote their products is to increase sales either by persuading people to change brands or by increasing the overall market. In a submission to the Pharmaceutical Manufacturing Industry Inquiry, the Australian Pharmaceutical Manufacturers Associ­ ation said: "From the perspective of the individual firm, promotion oilers, along with

price, quality and innovation, the opportunity to extend the overall product market and or its market share.'41’ The committee emphasises their words ". . . to extend the overall product market . . .". It is not clear, however, to what extent the manufacturers succeed in their aim ol increased consumption. Several witnesses pointed out that it is logical to assume that advertising does increase sales, for otherwise the manufacturers would not spend such large sums on promotion.4" The Australian Pharmaceutical Manufacturers Association affirmed this in its submission to the Pharmaceutical Manufacturing Industry Inquiry.

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The submission stated that up to the optimum level, promotion will certainly speed up the market ascent of a new product.48 Since one of the Committee’s concerns is with inappropriate use of some drugs and with Australia’s high per capita consumption, it is disturbed at the consequences of this promotional policy.

The effect of advertising on prescribing has been studied by several researchers and a review of some of these studies was conducted by Smith in 1977. He made the follow ing conclusions:

Journal advertisements may, and probably do. affect prescribing in the presence of other prior, subsequent and conterminous stimuli. Separation of the effects of the advertisements from these other stimuli and separation of the good effects from the bad effects is possible, but unlikely outside the artificial, experimental situation.

. . . we are forced to conclude that, while the logic and rhetoric is often persuasive, there is little 'hard’ evidence that journal advertising alone has adversely affected the quality of prescribing. Conversely, there is no (or little) evidence that such advertising has had any positive effect on that prescribing.49

In Australia there have been several studies of the factors influencing prescribing habits. Rowe examined the prescribing of psychotropic drugs by general practitioners by using the data from the 1970-71 Australian Morbidity Survey, w hich studied 796 doctors. In relation to the factors which influence prescribing he asserted ’it cannot be denied that

he (the doctor) also is considerably influenced by advertising, both by mail and by personal visits by representatives of the pharmaceutical firms’.50 A study by McNair Anderson in 1978 examined the attitudes of 289 Australian doctors on various sources of information.51 They were asked to rate each of 6 media

sources in order of importance with regard to the information that they provided doctors in their practice of medicine. The 6 media sources were (1) audiovisual presentations. (2) direct mail, (3) discussions with colleagues. (4) medical detailers. (5) medical journals and (6) seminars.

The results revealed that most doctors believe that they depend mainly on objective sources for information. Direct mail and medical detailers are rated by most doctors as poor sources of important information, and very few doctors (5 per cent) acknowledge that they rely on them as their most important source of information. However, there are

limitations to the validity that can be attached to this survey, f irst, the data were collected by mailing a questionnaire to a representative sample of 900 doctors of whom only 289 (32 per cent) responded.52 Secondly, there may have been observer bias in that doctors perceive information received from industry sources as being ot low status and their

response is, consciously or not. to downgrade it irrespective ot their use of or reliance on it. Further evidence that promotion increases sales of a particular brand was given by Πι- S. McLean, Senior Lecturer of the School of Pharmacy at the University of Tasmania.

He asserted that the pharmacist is often aw are of which detailer has visited a physician by an influx of prescriptions for the company’s products. " There are. how ever, no hard data to substantiate this statement. From all of the above "soft" evidence, the Committee concludes that promotion of prescription drugs may influence doctors and probably causes an increase in prescribing for the advertised brand. However, there are no hard data to show that promotion causes inappropriate prescribing.

In relation to advertising of over-the-counter drugs, the Association of Retail Pharmacy Employees of New South Wales asserted 'advertising seeks to persuade rather than inform, to sell rather than caution'.54 It felt that advertising leads to the inappropriate use of drugs.55 The Association however, had no hard data to support this

later allegation. To the Committee’s knowledge no such data exist and hence no conclusions are possible.

HU

There are, however, some inferential data on advertising being associated with inappropriate use. In the report Drug problems in Australia an intoxicated society'!, the Committee showed that in New South Wales and Queensland expenditure on the advertising of compound analgesics was at that time proportionally much greater than expenditure on the advertising of single analgesics. It also showed that consumption of compound analgesics (and the incidence of nephropathy) is higher in New South Wales and Queensland.56 There is no hard evidence that these factors have a causal relationship (indeed the relationship could be merely coincidental) but it is possible. Since that report was presented the matter of compound analgesics has been satisfactorily resolved in all States, though it is still under consideration in the Northern Territory.

The Committee sees no merit in calling for a total ban on over-the-counter drug advertising. Part of the concept of over-the-counter medication is its accessibility to people. Self-medication is widely practiced for a number of minor illnesses. Provided advertising of these drugs is done in a responsible and informative way, it can enhance the concept of self-medication. The mechanisms for controlling and regulating advertising in

this area have been satisfactory. However, there is no room for complacency. Though the Committee does not see the need for any further restrictions at this time, it strongly urges those concerned to be conscious of possible areas of inappropriate use of over-the- counter medication and ensure thal promotion of these products does not create a

problem.

Conclusions and recommendations The latest figures available show that $44 million was spent in 078 on the promotion of prescription products. This overall promotion expenditure has not increased for about the last 8 years and in fact the real expenditure on advertising in medical journals has actually decreased. Because the viability of many valuable medical journals depends to some extent on journal advertising, the Committee feels that this decrease may be detrimental to the availability of adequate information on therapeutic drugs. This is a situation which should be given consideration when controls are being proposed for journal advertising.

There are no complete statistics for the advertising of over-the-counter products but expenditure on national advertising in the press and electronic media for 1979 was about $20 million. There are indications that there has been an upward trend in real expenditure on over-the-counter advertising over the last 5 years. At present the controls over the content of these advertisements appear to be adequate and the Committee therefore sees

no merit in calling for a total ban. However in the Committee's previous drug report a positive correlation between the amount spent on advertising and the consumption ot compound analgesics (and the incidence of nephropathy) was demonstrated. Because of this the Committee is concerned at the upward trend in expenditure.

Evidence suggests that advertisements for prescription drugs in medical journals do stereotype people. Although the Committee does not believe that the responsibility to educate doctors lies solely with pharmaceutical companies, the companies themselves have indicated that they see this function as part of their role. The Committee has no objection to this and feels that one way in which the companies might assist is to change the emphasis in their advertisements so that they become more educationally oriented. In particular, the Committee has made 4 recommendations relating to the educational aspects of advertising:

(a) that representatives from the Commonwealth Department of Health, the Australian Pharmaceutical Manufacturers Association, the Australian Medical Association and other interested parties come together to frame appropriate values and standards of advertising (see page 95);

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(b) that this group look into the need to promote and inform doctors about the vast number of less profitable drugs which are not advertised (see page 95):

(c) that a certain percentage of advertising revenue be specifically earmarked for educational advertising (see page 95): and (d) that the Australian Prescriber continue to receive government funding (see page 96).

At present a Voluntary Code consisting of 2 parts exists to control prescription drug advertising. The first part of the Code relates to full disclosure advertisements and is very comprehensive. The second part relates to reminder advertisements (which make up the vast majority of journal advertising) and is completely inadequate. The Committee

has recommended that the Australian Pharmaceutical Manufacturers Association, the National Medical Media Council, the Australian Medical Association and other relevant organisations draw up a new code relating to 'reminder advertisements" (see page 99). If a more satisfactory voluntary code cannot be formulated by the abovementioned

bodies within 6 months of this report appearing, the Committee has recommended that the National Therapeutic Goods Committee draw up proposals which do not require full disclosure of drugs but do set adequate standards of advertising to be enforced by legislation for controlling the promotion of prescription medication (see page 99).

The Voluntary Code for the Advertising of Goods for Therapeutic Use which exists to control the promotion of over-the-counter drugs appears to be working well for those bodies who have accepted the Code. However, the Committee sees one shortcoming with respect to the composition of the Therapeutic Advertising Council (established to oversee

the adherence to this Code) and that is the lack of any formal medical representation on the Council. The Committee has recommended that this omission be rectified as soon as possible (see page 100). There are a few unregistered companies which have not accepted the Code and do not conform to the requirements. However, if the national registration

scheme (which requires scrutiny of promotional material) proposed by the National Therapeutic Goods Committee is put into operation, this situation will be improved. Another problem associated with proprietary drug advertising is the practice ot selling therapeutic substances at discount prices. Although the Voluntary Code does not

prohibit this practice, the Committee considers that it is undesirable as it may encourage the buying of a large quantity of these substances. The Committee therelore has recommended that a clause forbidding the advertising ot drugs at discount prices be inserted into the Voluntary Code for the Advertising of Goods for Therapeutic l se (see page 100).

References 1. Australian Pharmaceutical Manufacturers Association. Submission to Pharmaceutical Manufacturing Industry Inquiry, November. 1978. p. 200. 2. Evidence, p. 1507.

3. Australian Pharmaceutical Manutacturcrs Association, personal communication 4. Australian Pharmaceutical Manufacturers Association. Submission to the Pharmaceutical Manufacturing Industry Inquiry. November 1978. p. 206. 5. See Tables 2.9 and 2.12. 6. Pharmaceutical Manufacturing Industry Inquiry. Report. ( anberra. 1979. p. 6

7. Pharmaceutical Manufacturing Industry Inquiry. Report. ( anberra. 1979. p. 66. 8. Evidence, pp. 725. 1332. 9. Evidence, p. 1430. 10. A. Mant and D. B. Darroch. Media Images and Medical Images'. Six uil Si tent e and \tedn mi

9. 1975. pp. 613 8. I 1. Mant and Darroch. p. 615. 12. Mant and Darroch. p. 61 3.

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13. Evidence, p. 1386. 14. The Australian Pharmaceutical Manufacturers Association, Submission to the Pharmaceuti­ cal Manufacturing Industry Inquiry, November 1978, p. 200. 15. The Australian Pharmaceutical Manufacturers Association. Submission to the Pharmaceuti­

cal Manufacturing Industry Inquiry, November 1978, p. 214. 16. Australian Pharmaceutical Manufacturers Association, Submission to the Pharmaceutical Manufacturing Industry Inquiry, November 1978, p. 207. 17. Evidence, p. 1083. 18. Evidence, p. 1201. 19. Pharmaceutical Manufacturing Industry Inquiry, p. 66. 20. The Australian Pharmaceutical Manufacturers Association, personal communication. 21. Evidence, p. 1244. 22. Pharmaceutical Manufacturing Industry Inquiry, p. 67. 23. The Australian Pharmaceutical Manufacturers Association, Submission to the Pharmaceuti­

cal Manufacturing Industry Inquiry, November 1978, p. 235. 24. Evidence, p. 26. 25. Evidence, p. 86. 26. Evidence, p. 87. 27. Evidence, p. 87. 28. Evidence, p. 1800. 29. Proposed requirements for the Advertising of Therapeutic Goods Recommended by the

National Therapeutic Goods Committee, pp. 3 4. 30. Evidence, p. 1801. 31. Evidence, p. 1804. 32. Evidence, p. 1809. 33. Evidence, p. 1810. 34. Evidence, pp. 1810 II. 35. Evidence, p. 1812. 36. Australian Pharmaceutical Manufacturers Association, Code of Conduct for the Phar­

maceutical Industry. 37. Evidence, p. 1812. 38. Evidence, p. 88. 39. Evidence, p. 1678. 40. Joint Committee Voluntary Proprietary Medicine, Advertising Code. 41. Evidence, pp. 89 90. 42. Evidence, p. 90. 43. Evidence, p. 272. 44. The Proprietary Association of Australia, personal communication. 45. a. The Canberra Times 8 August 1979.

b. Daily News (Western Australia) 31 Oct ober 1978. 46. Australian Pharmaceutical Manufact urers Association. Submission to the Pharmaceutical Manufacturing Industry Inquiry, November 1978, p. 204. 47. Evidence, pp. 1217. 1437. 1454. 48. Australian Pharmaceutical Manufact urers Association, Submission to Pharmaceutical

Manufacturing Industry Inquiry, November 1978, p. 208a. 49. M. C. Smith, ' Dr ug Product Advertising and Prescribing: A Review of the Evidence', American Journal of Hospital Pharmacy 34. November 1977. p. 1221. 50. I. Rowe. Prescription o f Psychotropic Drugs by General Practitioners: I General' . The

Medical Journal o f Australia 24 March 1973. p. 592. 51. McNai r Anderson. Doct ors' Sources of Information, Australia' . December 1978. 52. McNair Anderson, pp. 3 4. 53. Evidence, p. 780. 54. Evidence, p. 2319. 55. Evidence, p. 2320. 56. Senate Standing Committee on Social Welfare, Dray problems in Australia an intoxicated

society'.'. Canberra 1977. p. 122.

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SECTION THREE

U n t o w a r d e f f e c t s o f d r u g s

CHAPTER 8

A d v e r s e d r u g r e a c t i o n s

The ideal drug, if it were available, would cure all persons of the illness for which it was prescribed and in no case would a patient experience any ill effect as a result of taking it. No drugs available for use in clinical medicine live up to these ideals. In the first place, drugs are rarely totally effective for all patients who use them. Secondly, most are responsible for various unintended adverse effects in at least a proportion of those persons receiving them. These unintended adverse effects are generally referred to as adverse drug reactions.

The term adverse drug reaction covers a wide range of effects ranging from minor problems such as mild nausea to life-threatening complications with carcinogenic effects. Some may be anticipated in advance from a knowledge of the way the drug works, such as when a preparation given to control diarrhoea produces constipation as a side-effect. Others are unforeseen in the sense that, while a doctor may realise and expect that perhaps one in a thousand patients given a particular drug will experience side-effects, he is unable

to tell in advance which person will be affected. The World Health Organization definition of an adverse drug reaction is a response to a drug that is noxious and unintended and one which occurs at doses used in man for prophylaxis, diagnosis or therapy of disease’.1

Surveys of incidence Most of the surveys on adverse drug reactions have been conducted in hospitals and the reported incidence varies markedly. Hospital studies must be used with caution because the samples are not representative of the general population. One study which reviewed

the available evidence on adverse drug reactions states that the incidence of adverse drug reactions in hospitalised patients has been variously reported to be between 1.5 and 35 per cent.2 The differences have been attributed to the use of varying sample populations, criteria for evaluating adverse reactions and surveillance techniques. ’

One widely quoted study is a survey of 1268 hospital in-patients conducted in Belfast in 1969 by Hurwitz and Wade. Drug reactions were found in 10.2 per cent of the I 160 hospital in-patients who received drug therapy while in hospital. Of the 586 patients who were admitted to medical wards and received drugs. 16.4 per cent had adverse drug reactions.4

Very few Australian studies on the incidence of adverse drug reactions in hospital patients have been conducted. One study (by Gcrke et a 1.5) of 85 patients, conducted in 1974 in a medical ward of the Royal Adelaide Hospital, found an overall incidence of 16.5 per cent of adverse drug reactions. This finding is very similar to the results rev ealed in the

study by Hurwitz quoted above. On the other hand, the incidence of adverse drug reactions responsible for admissions to hospitals has shown less variation. A report entitled "Adverse Drug Reactions in the United States', which reviewed available studies, concluded that adverse drug reactions "have been reported to be responsible for 1.0 to 3.5 per cent of admissions to general

medical wards, and of 0.3 to 1.0 per cent of general hospital admissions’." The probability of an adverse drug reaction occurring increases with the number of drugs being taken. This point was illustrated by a study of 1042 hospital patients conducted in 1969 in the United Kingdom.’ It was found that the daily consumption of 5

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or less drugs was attended by adverse reactions in 18.6 per cent of patients, whereas 81.4 per cent of patients taking 6 or more drugs suffered such effects. In Australia, a survey called the 'Australian General Practice Morbidity and Prescribing Survey’ was conducted between 1969 and 1974. More than 1.5 million disease contacts were made during this time and adverse drug effects were reported at 0.1 per cent

of these encounters.8 Using this estimate, there would be about 60 000 episodes of adverse drug reactions in Australia per year.9 The incidence of adverse drug reactions reported in the studies cited above may appear high. It should be remembered, however, that many of these reactions are minor. The United States report on "Adverse Drug Reactions in the

United States’ concluded that "the majority of reported adverse drug reactions are minor functional gastro-intestinal disturbances, and together with rash, itching, drowsiness, insomnia, weakness, headache, tremulousness, muscle twitches and fever, account for up to 71 percent of reported adverse drug reactions’.10 The United States report also pointed out that many of the so-called adverse reactions occur in people who are not taking drugs:

‘As many as 84 per cent of healthy individuals and patients not on medication have reported symptoms which could be interpreted as adverse drug reactions if the person were taking a drug.’11 Because of the complexity of the problem, surveys of adverse drug reactions which fail to distinguish between mild, severe, anticipated, and the unexpected adverse reactions provide an incomplete and often distorted picture of the ill effects of drug therapy. However, sufficient information can be gained from such surveys to suggest that a significant proportion of hospital admissions arc primarily caused by the ill effects of drugs.

Some adverse drug reactions are an unavoidable consequence of modern drug therapy. Before treatment is instituted for the treatment of any disease, the medical practitioner must balance the consequence of the disease against the ill effects that could occur as a result of the treatment. In conditions such as some forms of cancer, where the fatality rate untreated approached 100 percent, it is justifiable to use drugs with a high risk of serious side-effects in return for a small chance of cure. On the other hand, when the disorder is of small nuisance value, such as insomnia, even minor side-effects of therapy may be unacceptable. Most medical conditions lie between these two extremes and considerable judgment is required to determine what is an acceptable price (in terms of drug side-effects) to pay for the degree of beneficial effect that may be expected from the drug.

Thus, when deciding if adverse reactions are a problem, the benefits of the therapy must also be considered. The Committee agrees with Professor Bridgcs-Wcbb, who said: The significance of the extent of adverse reactions lies in the degree to which they are avoidable without reducing the benefits to be obtained from appropriate prescribing. Further information

is needed to enlighten any moves in this direction. Mere restriction of prescribing is both illogical and of unproved value.12

Undergraduate and continuing medical education An important component of medical education is to provide doctors with the background knowledge to enable them to make sound risk benefit decisions when prescribing drugs. In particular, they need to know' what side-effects occur with the drugs they use. how frequently these occur and the ways in which their frequency may be minimised. The last of these is of particular importance since it is frequently possible to identify subgroups of patients (for example, the elderly, or patients suffering from certain conditions) who are at particular risk of developing side-effects when administered certain drugs. In addition, an understanding of the likely interactions between drugs should be know n.

In view of the steady introduction of new drugs and the increasing information available about the established ones, serious consideration must be given to improving the

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knowledge of both undergraduates and graduates in the fields of pharmacology and therapeutics. Elsewhere in this report we comment on the consumption of drugs by Australians and the fact that 90 000 000 prescriptions were dispensed in 1980, under the Pharmaceutical

Benefits Scheme alone, for a population of 14.5 million. Many witnesses stressed the need for the establishment of separate departments of clinical pharmacology within the universities.13 The Committee was more concerned about the repeated references to the lack of teaching in the various clinical schools to medical undergraduates.14 If the establishment of separate departments of clinical pharmacology would overcome this apparent lack of teaching, then the Committee would wholeheartedly support moves to achieve such a goal. The Committee supports the urgent need for continuing education of medical practitioners in this discipline.

Adverse drug reaction surveillance A concern of many people involved with drug regulation is that the information available about drugs is often insufficient to allow a proper appreciation of potential side-effects. There are several reasons for this. The testing of drugs by drug companies before their

widespread release provides much important information but is incapable of detecting all the problems likely to be associated with their use. Among the reasons for this are that animals used in the testing procedures may react differently to the drug than does man and generally the emphasis in early human testing is on the intensive follow-up of small numbers of patients. This means that the adverse reactions that are rare, or occur only after prolonged treatment, may not be identified for some time.

Following the release and widespread marketing of a drug, additional information often becomes available from ad hoc surveys on the incidence of various ill effects experienced by patients receiving the drug. Additional information may also be obtained from isolated cases of ill effects reported to medical journals or to drug regulatory agencies. Much of this information is difficult to interpret because adverse reactions to drugs are frequently indistinguishable from illnesses that occur either separately or as a consequence of the illness for which the drug is being given.

Recent experiences suggest that these rather informal methods of monitoring drug safety after marketing are no longer adequate. In Chapter 4 of this report we expressed concern at the length of time it took for drugs to gain marketing approval. The Committee is very careful to point out that this concern should in no way be interpreted to suggest

that the Committee believes that drugs must be placed on the market as soon as possible at any cost. On the contrary, the Committee supports any move to ensure comprehensive pre and post marketing evaluation and surveillance. Despite the acceptance of the need

for stricter surveillance of drugs that followed in the aftermath of the thalidomide disaster, recent events have demonstrated that the possibility of further major adverse drug reactions cannot be ruled out. Between 1970 and 1974, 700 patients in various countries received the drug practolol for high blood pressure and as a result sustained

serious and irreversible eye damage. At that time Australian usage of this drug amounted to around one-third of total world usage. The converse may also be harmful. For example, if allegations are made that a widely used drug causes cancer or deformities in the unborn foetus, then its use is likely to be curtailed and treatment with more dangerous, less tried or effective drugs may be

instituted instead. In such cases it is essential to have valid data on hand to confirm or refute such claims with a minimum of delay. Once a company has received marketing approval for a product it is required to report to the Commonwealth Department of Health annually for 3 years. The report must

contain details of the distribution of the drug and any new information, whether pub-109

lishcd or not, which has become available locally or overseas. Adverse reactions brought to the company's attention must be reported immediately.15 Further, any amendments to product literature, changes in dose form and so on must receive Australian Drug Evaluation Committee approval before implementation.16

The Commonwealth Department of Health maintains a National Registry of adverse reactions to drugs which provides a compendium of Australian experience with new drugs. The collection of information for the Registry is based principally on a voluntary reporting system which is facilitated by the distribution of reply-paid reporting forms to professional persons, including doctors, dentists and pharmacists.17 Further information is gathered through hospital discharge summaries on patients who have experienced adverse drug reactions during their confinement in hospital; compulsory reporting by pharmaceutical companies and clinical investigations during the period of clinical trial: and, once it drug has been marketed, by pharmaceutical companies, general prac­ titioners, specialists, hospital authorities, dentists, pharmacists, private individuals etc. Local data are supplemented by the World Health Organization Drug Monitoring Project, which gathers information throughout the world.18

The Adverse Drug Reactions Advisory Committee was established in 1970 as a subcommittee of the Australian Drug Evaluation Committee specifically to monitor adverse reactions to therapeutic substances. The Registry provides data for this subcommittee. The subcommittee also reviews notified adverse drug reactions and keeps abreast of reports on adverse reactions in world literature. It makes recommendations to

the Australian Drug Evaluation Committee regarding appropriate actions in this area.1,1 Unfortunately, the Adverse Drug Reactions reporting system is at present inadequate. Only about 2500 reports are received by the Commonwealth Department of Health each year. This represents somewhere between an estimated 1 to 3 per cent of all adverse drug reactions. In 1978. 47 per cent of reports came from hospitals, 30 per cent from general practitioners, 15 per cent from specialists, and 8 per cent from others including dentists, pharmacists, and pharmaceutical companies. Analysis of the situation has shown that fewer than 1 in 10 medical practitioners have ever contributed even a single report.

The inadequacy of our reporting system is not due to any shortcoming of the Commonwealth Department of Health, and neither is it unusual. International comparison show s that the Australian rate of reporting is quite high. The World Health Organization correlates the experiences of 22 member countries and receives only about 2000 reports a month. Rather, the deficiencies of the system are a result of the reliance on voluntary reporting. According to one of the Committee's witnesses, there is "indifference and inertia' amongst the medical profession regarding the adverse drug reaction reports. The Committee was also told that workloads may create problems. A doctor may intend

to report an adverse reaction but at the end of a consultation "it has slipped his mind'.2" As stated above, the reporting system at present is anecdotal and unrepresentative. Only a small percentage of drug reactions is reported. Even if the Commonwealth Department of Health could double the number of reports, the data base would still be

inadequate because the sample of reports received is non-random and therefore is not statistically adequate. Dr J. Frew, a member of the Australian Drug Evaluation Committee, observed that "the present method is haphazard'.21 The Department nonetheless v iews the voluntary reporting system as the "keystone of the surveillance of

the safety of marketed drugs', but believes that it requires supplementation.22 The Commonwealth Department of Health has given consideration to a number of programs for use as a means of supplementing the voluntary reporting system. One such program is "Phase IV Monitoring". During its development, and marketing, a drug goes

through 4 main phases of evaluation. In Phase I. single-dose studies of the drug arc carried out in human volunteers under carefully monitored conditions. Subsequently , in

Phase II, more extensive studies are done in small numbers of volunteers and patients to whom the drug is expected to be of benefit. This is followed by a series of more intensive clinical trials in appropriate patients (Phase III). At the end of this period the company

makes a submission to the regulatory authorities in which it includes all the Phase I to III data together with animal toxicity and pharmacology data and chemistry and quality control information. On the basis of this evidence, the company is given permission to market the drug and the drug enters the immediate post-marketing period, which is commonly known as Phase IV. During this period there is a certain degree of surveillance

of the drug but in most cases this is not a condition of registration. In some cases, post-marketing surveillance, or Phase IV Monitoring, may be a condition of marketing and this type of surveillance is usually instituted because of some concern about specific toxic effects. When this happens it is referred to as 'Monitored

Release". It should be remembered that most drugs are given marketing approval on the basis of limited human studies. In some instances, world-wide experience with the drug may be less than 2000 patients.2-’ It is also unusual for many of the patients to have been treated continuously for more than 2 years and in some cases treatment may have been only for a few weeks.24

Three beta-blocker drugs which might have been expected to achieve considerable use in the treatment of hypertension were placed under the Monitored Release scheme. Another drug used to treat certain uncommon neurological conditions was monitored also under this scheme but was restricted to hospital use only.25 After this scheme was

used for only 4 drugs, it was terminated due to the disappointing results. This was brought about by inadequate numbers of patients being registered w ithin the program, lack of co-operation by the pharmaceutical companies, and the poor quality of the information submitted.2,1

The Commonwealth Department of Health has looked subsequently at some other forms of Phase IV Monitoring which may provide more encouraging results, f irst, at the instigation of the Australian Drug Evaluation Committee, the National Health and Medical Research Council has invited applications from universities and other research bodies for a project to both propose and test a methodology for the post-marketing surveillance of a new drug, the first substance to be so treated being Cimetidine. At the

time of w riting this report, no decision had been made as to which body would undertake the post-marketing surveillance. Secondly, the Australian Drug Evaluation Committee, through the Adverse Drug Reactions Advisory Committee, has presented a Discussion Paper to the Australian

Medical Association and the Pharmaceutical Society of Australia in regard to a technique called "Recorded Release", which has been successful in New Zealand. Under this scheme, a drug is designated and patients taking it are identified by the pharmacists dispensing the drug. The prescribing doctors arc subsequently asked to record events occurring during

the period of drug exposure. Events sought are not only those suspected ol being drug related but include any unusual or unexpected factor. Like other methods. Recorded Release detected already known effects as shown in a comparison of labetalol and metoprolol; there w as a significantly greater incidence of scalp tingling w ith labetalol than with metoprolol. In addition, because Recorded Release requires the reporting ol all changes (both major and minor), a hitherto unsuspected association was that ol thirst

with labetalol which was described significantly more often than with metoprolol. W hile this particular effect is not of great clinical significance, the survey does demonstrate the potential usefulness of the technique.2-The Australian Drug Evaluation Committee is conv meed that studies of this tv pe need to be undertaken in Australia. As a result they have commissioned the Adverse Drug

Reactions Advisory Committee to investigate the matter. The New Zealand Recorded Release system relies very heavily on a voluntary

reporting system. The Committee has already noted that other schemes using a voluntary reporting system have not proved satisfactory in the past. On the other hand, the Committee believes that if the voluntary reporting is limited to only 1 or 2 drugs at a time, and if the reasons for monitoring these drugs are fully explained, the response rate should be higher. However, if the scheme is to be feasibly implemented it would, as with other schemes, have to rely on only a sample of the total population using a particular drug. Consequently it might still be confronted with the problem of obtaining a

representative sample. It is important that valid statistical data be available on adverse drug reactions so that rational decisions can be made with regard to controls on medication. The Committee therefore encourages the Commonwealth Department of Health in its endeavours, and RECOMMENDS that the Government provide the Department with any financial assist­ ance it requires to implement its schemes. It is essential that adequate procedures are developed for post-marketing surveillance. Such a procedure would permit the ready

testing of hypotheses concerning the safety of marketed drugs which are not initially perceived at the time of approval. Where it is necessary for a drug to be recalled as a result of it being found substandard or potentially hazardous, the National Therapeutic Goods Committee has instigated a

uniform drug recall procedure.28 Should a complaint be made to the Commonwealth Department of Health about a particular product, the National Biological Standards Laboratory will sample the product and at the same time the manufacturer will be alerted as to a possible problem. If a recall proves necessary, retailers and if necessary the public will be informed. Three hundred and forty-five recalls have been made since the system's inception in 1979. One cannot determine from this figure, however, the success or otherwise of the scheme.2g

The National Therapeutic Goods Committee is responsible for the co-ordination of the drug recall throughout Australia, and as such works closely with the Health Department (or Commission) of the State where the manufacturer is located.

Hospital drug monitoring Whilst hospitals may monitor the costs of drugs, the monitoring of drug usage within hospitals is very poor. The Committee was told that patient admission and readmission into hospital because of incorrect therapy or drug interactions has become a common occurrence. It was also put to the Committee that added to these factors arc the error-

prone drug distribution systems operated in most hospitals.8" It has even been suggested if there is an abnormally high usage of a particular drug, hospital authorities (usually through their drug committees) query the appropriateness of such usage. Professor D. Wade told this inquiry31 that St Vincent's Hospital in Sydney monitors from time to time various drugs used in the hospital, but this is only done for one month at a time. Over a period of time the hospital would gather data on prescribing habits and patterns of virtually all drugs but it would be unable to show a change from one month to the next.

From the information available to this Committee it appears that there is no standard approach to drug monitoring in hospitals. Even the development of computer systems to record and retrieve data on drug usage is very much in its infancy in Australian hospitals. Lack of monitoring and or lack of accountability of drug usage in hospitals give cause for concern. Hospitals use around 20 25 per cent of all prescription medicines. The limited availability of data on which to reconcile drug purchases and drug usage in hospitals must raise doubts about the ability of hospital authorities to detect possible diversion of their drugs into illicit markets. Until such time as hospital authorities develop more effective and comprehensive data collection and retrieval systems, the Committee can only surmise as to the extent of inappropriate use or diversion of drugs in this area.

112

The development of such systems would not only benefit hospitals from the point of view of monitoring and accountability but the data would provide valuable information on patterns and levels of drug consumption. This would also enable an immediate follow-up of patients who are using or have used a drug which is now proved to cause severe adverse reactions.

It has been suggested that the minimum requirement for drug surveillance is a widespread system of computerisation of the pharmacy records of major hospitals, and a method of record linkage of drug prescription data to records of subsequent illness or death. The major alternative is to mount an expensive ad hoc study whenever a question of drug safety is raised or to wait until the answer is supplied from overseas. Record linkage of this type would clearly present concerns regarding individual privacy, but there are few areas where a minor surrender of privacy (which could be made voluntary) could have

such widespread benefit. The Committee was attracted to the Canadian approach. The Canadian Council on Hospital Accreditation is a non-government body, which accredits each hospital in Canada for providing health care. The Council's "guide to hospital accreditation" gives guidelines for monitoring and reporting adverse drug reactions. This recognition and concern by the Council are already having an impact on the development of adverse drug

reaction surveillance programs within hospitals. Theoretically, with each hospital striving to better its "accreditation", all hospitals will eventually have monitoring programs. The Committee notes that Australia has recently developed a hospital accreditation system and RECOM M ENDS that the establishment within hospitals of adequate monitoring and reporting of adverse drug reactions be a necessary requirement for accreditation.

Conclusions and recommendations No drug is free of adverse reactions, though in many cases these may be very small. The doctor must make the appropriate risk benefit decision when prescribing any course of medication.

Because the clinical trials and the evaluation prior to marketing are limited, it is necessary to adopt procedures which will enable adequate post-market surveillance and help in the early detection of any unknown adverse drug reactions. No matter how thorough the research and evaluation is prior to the release of a drug, there is always the likelihood that unexpected adverse reactions may appear after many years of carefully supervised medical use. In the event that such a situation arises, the medical profession needs to be able to follow up immediately all patients who have used the drug.

It is in this regard that the Committee has made the following recommendations: (a) that the Government should provide the Commonwealth Department ol Health with any financial assistance it requires to help implement the establishment ol adequate and effective schemes designed to monitor and detect the occurrence ot

adverse drug reactions (see page 109): and (b) that hospitals should be required as part of their accreditation system to establish adequate facilities for monitoring and reporting adverse drug reactions (see page 1 1 2 ).

References

1. K. A. McMahon, ί). B. F rewin. E. Gail Easterbrook. Elizabeth A. Hender.T. I. Lee and R. k Penhall. "Adverse Reactions to Drugs: A 12-month Hospital Survey". Australian and Xew Zealand Journal of Medicine 7. 1977. p. 382. 2. Cited in McMahon ct al.. p. 382.

113

3. F. E. Karch and L. Lasagna. Adverse drug reactions: a critical review'. Journal of the American Medical Association 234, 1975, p, 1236, cited in McMahon et al., p. 382. 4. N. Hurwitz and O. L. Wade, 'Intensive Hospital Monitoring of Adverse Reactions to Drugs', British Medical Journal 1 March 1969, pp. 532, 535. 5. D. C. Gerke, E. G. Eastcrbrook, D. B. Frewin, T. I. Lee (1975) "Extensive Drug Surveillance

A Pilot St udy’, Australian and New Zealand Journal o f Medicine 5, p. 336. 6. Commonweal t h Depart ment of Health, supplementary evidence. 7. Hurwitz, cited in F. A. Whitlock and L. E. J. Evans, "Drugs and Depression", Current Therapeutics April 1978, p. 97. 8. C. Bridges-Webb, Monitoring Adverse Dr ug Effects in General Practice, unpublished paper,

1979, p. 1. 9. C. Bridges-Webb, p. 1. 10. F. Karch and L. Lasagna, "Adverse Dr ug Reactions in the United States', a report prepared for "Medicine in the Public Interest', conclusions and synopsis, Washington D C., 1975. 11. F. Karch and L. Lasagna, conclusions and synopsis. 12. C. Bridges-Webb, Moni t ori ng Adverse Dr ug Effects in General Practice, unpublished paper,

p. 9.

13. Evidence, pp. 740, 1215. 14. Evidence, pp. 735. 1215, 1221. 3074. 15. Evidence, p. 57. 16. Australian Pharmaceutical Manufact urers Association, Submission. Appendix VI. p. 3. 17. Evidence, pp. 58, 170 1. 18. Australian Pharmaceutical Manufact urers Association, Submission. Appendix VI, p. 4. 19. Evidence, p. 57. 20. Evidence, p. 246. 21. Evidence, p. 243. 22. Commonweal t h Depart ment of Health, supplementary evidence. 23. Personal communi cat i on with a member o f the Australian Drug Evaluation Committee. 24. Personal communi cat i on with a member o f the Australian Drug Evaluation Committee. 25. Commonweal t h Depart ment of Health, supplementary evidence. 26. Commonweal t h Department o f Health, supplementary evidence. 27. Commonweal t h Depart ment of Health, supplementary evidence. 28. Evidence, pp. 75 6. 29. Commonweal t h Depart ment o f Health, personal communication. 30. Evidence, p. 825. 31. Evidence, p. 3066.

SECTION FOUR

M e d i c a t i o n —t h e s o l u t i o n t o s o c i e t y ' s ills?

CHAPTER 9

W h y m e d i c a t i o n ?

Since the Committee’s report Drug problems in Australia an intoxicated society'.'' was published in 1977, there have been several Royal Commissions of Inquiry and books published which have drawn attention to the problems associated with the inappropriate use of drugs.1 The Committee’s report, as well as some reports or books that have

followed, attempted to document the use of both legal and illegal drugs in Australia. While many of these reports or books have attempted to examine why people have sought the use of drugs for non-medical or recreational purposes, very little has been said as to why society has actively supported the medical use of drugs. The Committee believes that the community needs to have a clearer understanding of why society has so willingly accepted the use of medication.

Methods of coping with illness Man has used many methods to try to cope with illness. It can be argued that medicine began in mystery early in the history of civilisation. During that time illness or dysfunction inflicted on man was believed to be the result of evil spirits or punishment

handed out by the gods. The rituals, sacrifices, and crude medicine that were utilised were associated with random success and their methods lacked any scientific basis. Over the last 50 years in particular, the scientific method has come to dominate our approach to the treatment of illness. There is no doubt that the adoption of this approach

has moved medicine out of the Middle Ages2, produced substantial benefits and led to a host of new chemical cures. Many new drug discoveries were made in the period after 1930\ and the combination of'wonder drugs’ and the scientific method has continued to dominate our approach to the treatment of nearly all illness and dysfunction.

It is against this background that we can begin to appreciate why medication has become such an integral part of our society. We have come to develop and use a medical model of illness and dysfunction which concentrates on the cure control aspects of illness rather than the cause prevention aspects, and depends heavily on the availability and use of a vast battery of therapeutic substances.

Mystique of medication Even though medication has developed substantially over recent years, many early aspects of medicine, particularly ritual and mystique, still play an important role. It has been recognised by some writers that man wants magic to cure his ills. George Bernard

Shaw wrote: 'What the public wants . . . is a cheap magic charm to prevent, and a cheap pill or potion to cure all disease'.4 S. Gilder wrote in 1962: However hard the person of the sixties may protest that he wants facts and nothing else, he is often deceiving himself. He wants a bit of magic . . .'5

To some people therapeutic drugs represent this needed magic. Many have the belief, partly formed by experience with antibiotic drugs, that all medication is a "magic bullet which seeks out and destroys the disease without harm to the rest of the organism.

The mystique is further reinforced by the existence of some highly effective and beneficial specific drugs such as contraceptives. It is also given impetus by sensational newspaper reports which proclaim the 'wonders of new drugs before any evidence is available about their efficacy, or even where available evidence points to them being

117

ineffective or dangerous. One notable example of this was the drug laetrile which was hailed by the press as a breakthrough in cancer therapy even though there was, and still is, no evidence to show that it was in any way effective.

Placebo effect

The term "placebo effect’ describes the phenomenon of symptom relief due to suggestion rather than to specific therapeutic effect.* The strength of the mystique surrounding drugs is shown by the placebo effect. The reassurance that is associated with placebo administration may be accompanied by measurable changes in body function. Havard and Pearson have said that ‘on average one-third of patients with symptoms such as pain or cough will respond to placebo medications and an even higher proportion of patients with psychological symptoms such as anxiety or insomnia is relieved'.0 Mendelson has reviewed several studies and said that ‘it is generally accepted that the ‘placebo response" in pain patients is about 35 percent and some have claimed it to be as high as 50 percent'.7

Symbolic aspects of medication In our society the giving of medication is a symbolic act of caring. This symbolic gesture is an important property of medication quite apart from any physical therapeutic effect it may have. It is common for people to give friends headache remedies or cough lozenges to ease symptoms. The cigarette put in the mouth of the wounded soldier, the cup of tea given at times of crisis, these too have similar symbolic value. The desire to ‘give you something to make you better’ is strong. To many, the handing over of a prescription by the doctor to the patient signifies that the doctor cares, that he has recognised that a problem does exist and has understood its nature, that the transaction is complete and that recovery from the dysfunction can be expected.

The mother attending to her sick child may indirectly share the suffering and discomfort, but both she and the child will feel much better if she is able to treat that sickness in some tangible way by offering medication. In many cases (he medicinal benefit is probably minimal but the psychological benefit of a caring gesture may be considerable. This 'caring gesture’ has very strong placebo implications.

Ritual (doctor patient roles) The mystique that surrounds the medical profession has contributed to the establishment of roles which the doctor and patient arc expected to play. The claim that doctors possess knowledge and skills that are too esoteric to be freely shared with lay persons has placed them in a position which many regard with awe. This attitude is reinforced by folklore, popular fiction and the many television series which depict doctors as wise, paternal and infallible. This is also, in some cases, fostered by the medical profession and by the associated helping professions.

Gordon and Carlson" have claimed for a number of reasons that the role play in hospitals is very rigid and the patient in particular must be submissive and unquestioning and is sometimes expected to exhibit a degree of credulity. How has this ritual and role play fostered the use of medication? In a submission to this inquiry. Dr J. Straton. Lecturer in Social and Preventive Medicine at the University of Western Australia, describes the type of relationship between doctor and patient which occurs too frequently and leads to the inappropriate distribution and use of therapeutic drugs.

Dunne his training the medical student is imbued with the idea that diseases are a definite entity curable with appropriate medical or surgical treatment. In practice after graduation.

* While a placebo response could he elicited by many interventions, fake therapeutic drugs are by far the most commonly used.

I 18

faced with disease and vague indefinable symptoms, he tends to label them as a disease (e.g. anxiety state) so that he can legitimately treat it. This attitude is reinforced by the promotional material of the pharmaceutical industry. Since the doctor is not usually trained in alternative ways of handling psychosocial problems he automatically writes a prescription. The general

public has also come to expect "miracle cures' from "wonder drugs' through the influence of the mass media. The patient's expectation that drug therapy is the appropriate treatment is reinforced by the doctor’s prescription, and so the vicious cycle continues. The doctor feels pressure from the patient to take some definite action, and he is rewarded by the patient's

response to the writing of the prescription (Blackwell. 1973). Moser (1974) has likened the family physician’s work to a series of one-act plays in which there is a definite sequence of events and the patient and the doctor each have their role to play. Both are disappointed if the play does not end with a climax - the giving of definite treatment.g The Committee believes that there is recent evidence to suggest that these attitudes are slowly changing. In psychiatry, the treatment of psychosocial problems is relying more on behaviour therapy and rather less on chemotherapy. Because there is now more information about therapeutic drugs available to the public, more people are asking the reasons for the use of medication for themselves and hence the expectation for a prescription is not as high. These changes in attitude are certainly a positive step which may lead to improvements in the appropriate use of medication.

Tacit government support Government policy on therapeutic drugs reinforces the idea that medication is "good" for you. On the one hand, government bans certain recreational drugs and spends money to ensure that they are not consumed. These drugs have a negative public image. On the other hand, government subsidises (albeit for good reasons) the cost of therapeutic drugs,

thereby declaring its faith in their value and giving them an imprimatur in the public mind.

Economic aspects of medication One of the major reasons that drugs are used to treat conditions in preference to other therapies such as psychotherapy or manipulative treatment is that drugs are far cheaper in terms of money as well as time and effort and therefore, in that sense, more efficient.

The action of government in limiting subsidies mainly to medical practitioners encourages people to seek treatment from the profession which traditionally prescribes drugs. These drugs are further subsidised by the Pharmaceutical Benefits Scheme. Government therefore encourages people by its systems of subsidy to seek drug therapy in

preference to other treatment. The effect of this bias has been too little studied.

Benefits of medication Data presented in Chapters 2 and 3 have clearly shown the extent ol drug consumption in the community at all ages. This fact alone is disturbing. Against this major concern we have to acknowledge the many benefits that medication has brought to the individual and society. Sir Derrick Dunlop has said:

It is superfluous to e la b o rate on the great benefits to society conferred by m odern drugs. The average expectation o f life o f a new born baby has increased since the beginning ol the century by 25 years. Early in the century this was mostly due to improved hygiene, housing and

n u trition, but in the last 30 o r 40 years mostly to m odern drugs. Quite apart from their beneficial effects on m ortality statistics, the relief from suffering resulting from their purely sym ptom atic use an d the saving to o u r eco n o m y due to diminished morbidity are vast hut more difficult to c o m p u t e .111

From the point of view of the individual, the benefits of medication arc substantial. They provide a vast improvement in the quality ol life. Antibiotics, by shortening the period of morbidity, reduce suffering; analgesics provide invaluable relict from pain. Anaesthesia has greatly advanced the field of surgery so that reparative and other

procedures can now be undertaken which formerly were technically impossible. Also, they can now be performed painlessly and, on the whole, safely. Other benefits which are important to a minority of the population flow from endocrine replacement therapy, for example, for disorders involving the adrenals, pituitary, parathyroid, ovary and thyroid." Further benefits important to a minority of the population include insulin, which has saved the lives of many diabetics. Vitamin B12. which is invaluable in the treatment of pernicious anaemia, and immunological prophylaxis which prevents most cases of hemolytic disease of the newborn.12

Contraception has had a beneficial impact from both a social and medical point of view. Sir Derrick Dunlop believes that the contraceptive pill 'may represent the most important recent advance in pharmacology’. 13 Even bearing in mind the number of side elfects of the Pill, the benefits to the individual and as an aid to family planning are

undisputed. These benefits have been widely enjoyed by people living in the industrialised Western countries including Japan.14 Unfortunately, in developing third-world countries where the benefits of the Pill would be enormous, social and economic constraints have prevented its widespread use.15

Summary—benefits The list of specific benefits resulting from the introduction of new and improved medications could fill several volumes of a report. The Committee has endeavoured to discuss briefly a selected number of major and widely recognised benefits of medication. As this is not a technical report, it has avoided detailed medical discussion and appraisal of therapeutic drugs.

in general, the benefits of medication can be summarised as follows:

Medication has increased our ability to cope with, control or cure many illnesses and dysfunctions within our society.

It has helped change the natural history of many diseases. In fact, a large number of diseases have been eradicated.

It has provided greater mobility, flexibility, comfort, pain relief and dignity to many patients, often those with long-term or incurable diseases.

As well as providing direct benefits in the health area, it has been responsible for significant economic and social benefits in many countries, for example improved labour productivity and family planning.

It has provided the impetus for further research and development in the quest to find cures for the remaining diseases that still afflict mankind.

Conclusions There is clear evidence of overuse of drug therapy in the community and an increasing dependence on medical care for non-medical reasons. The causes of this are complex.

Modern medical care is highly valued in our society because of its obvious success in so many areas. However, the reasons for its acceptance go further. It preserves the status quo by defining dysfunction (which may be caused by faults in our society) as 'illness', thereby eliminating the need to examine more basic issues; it places the problem of dysfunction in a manageable arena and it enables some people to transfer responsibility for their own lives to an outside person usually the doctor.

The giving of medication is steeped in mystique and ritual. The apparent 'magical' and, at times, dramatic effects of some drugs have helped promote the use of all drugs. In many cases the placebo effect is quite significant, which highlights the great expectations and faith people have in medication. The need to receive something tangible from a

medical consultation is still very strong and this further promotes the use of therapeutic

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drugs as opposed to other therapy. The giving of medication is seen as an act of caring in our society. Finally, government subsidisation of medical consultations and prescription medicine makes drug therapy more attractive and convenient than other forms of therapy.

Even though there is now evidence to suggest that some of these attitudes towards medication are beginning to change, the use of medication will continue to dominate our approach to the treatment and control of illness and dysfunction in the foreseeable future. The benefits of modern medication are substantial and this has obviously fostered the use

of all forms of medication. Along with the benefits of medication, however, flow a number of problems stemming from various forms of inappropriate use. Of these the community needs to be aware.

References

1. Royal Commission into the Non-Medical Use of Drugs South Australia. Final Report. Adelaide, 1979. Progress Report from the Joint Committee of the Legislative Council and Legislative Assembly upon Drugs (New South Wales), Sydney, 1978. Australian Royal Commission of Inquiry into Drugs. Report. Canberra. 1980.

New South Wales Royal Commission of Inquiry into Drug Trafficking, Report. Sydney. 1979. The Report of the I nt ernat i onal Worki ng Party on the Drug Problem in Victoria, 1980. 2. R. J. Carlson, The End o f Medicine. New York. 1975. p. 196. 3. Sir Macfarl ane Burnet, Genes. Dreams and Realities. Pelican. 1973. pp. 8 9. 4. D. Tr aver s and J. Smar t (eds), Drugs, Man and Society. Victorian Foundat i on on Alcoholism

and Dr ug Dependence, p. 39. 5. Cited in D. Go r d o n , "Health, Sickness and Society'. St Lucia, Qld. 1976, p. 68 6. C. W. Havar d and R. M. Pearson, "The Use and Effect of Placebos'. Australian Prescriher 2. 6. p. 1 39.

7. G. Mendelson, 'Acupuncture Analgesia: Review of Clinical Studies . Australian and Sew Zealand Journal o f Medicine 7, 1977, p. 647. 8. D. Go r do n , p. 72: R. Carlson, pp. 211 12.

9. Evidence, pp. 328, 329. 10. Sir Derrick Dunlop, "The I nnovation, Benefits, Drawbacks and Control ot Drugs . Journal of the Royal Society o f Medicine 71, May 1978, p. 326. 11. L. Thomas , "On the Science and Technology o f Medicine", in Daedalus (Winter. 1977), p. 37.

quot ed in T. McKeown, The Role o f Medicine: Dream. Mirage or Seme sis'.'. Oxlord. 1979. p. 108. 12. Thomas , quot ed in McKeown, p. 108. 13. Dunl op, p. 326.

14. B. Furnas, "Changing Patterns o f Health and Disease', in M. Dicsendorf (ed.l. The Magic Bullet: Social Implications and Limitations of Modern Medicine. An Environmental Approach. Canberra, 1976, p. 23. 15. Furnas, p. 23.

1 2 1

CHAPTER 10

S o m e a s p e c t s o f i n a p p r o p r i a t e u s e

Non-compliance The solution to society's His? - Barbiturates

Introduction The Committee's terms of reference refer to the ‘abuse’ of drugs, a term also employed in an earlier Committee report. Drug problems in Australia an intoxicated society'?, and in the Senate Select Committee Report, Drug Trafficking and Drug Abuse. Throughout this inquiry, however, the Committee has become more and more aware of the difficulties associated with the use of such a term, to the point of dismissing it as unsatisfactory.

One of the difficulties associated with using the term ‘abuse’ applies also to the use of other terms such as 'habituation' and ‘addiction’. In the minds of the general public these words relate to the so-called "drug problem’, with which the public does not identify. Heroin, syringes, dirty back rooms, crime the fringe of society. Hence the community disassociates itself from the problem. Too often we fail to realise that the drug problem is much broader. This chapter will show that at some time probably each of us has contributed to it.

Another difficulty with the term ‘abuse’ arises from its complementary term, "misuse'. The Committee found itself unable to clearly separate these terms, to make black and white out of what is often a grey area. The ever present question is: where does misuse cease and abuse begin'.' For example, the person who on rising each morning habitually

takes a Vincents to ‘get me through the day’ is he misusing or abusing a drug'.’ The Proprietary Association of Australia, in its submission to the Committee, defined the terms as follows:

Misuse is the taking of a product or substance in other than Ihe recommended appropriate amount, frequency, strength and manner, which may result in damage to the person’s health or general well-being. Abuse another form of misuse occurs when a person deliberately takes a product or substance for the purpose of achieving a desired effect which is not intended or recommended.1 The above example could be regarded as both misuse and abuse. Of course, one can

redefine the terms, but to do so does not remove the problem: one simply shifts the grev area. The Committee believes that the term ‘inappropriate use’ is preferable to other terms.:

Because of its broadness the term incorporates both misuse and abuse one is not confronted with having to categorise the grey area. The Committee acknowledges that within the grey area individuals w ill differ as to what they consider to be appropriate and inappropriate use. For example, some will argue that recreational use of drugs is not ‘inappropriate’ that where one generation has alcohol and tobacco as its acceptable social drugs, another generation should be entitled to have the social drug it prefers. The Committee, however, has regarded the appropriate use of a substance as any use which complies with the instructions of either the doctor, pharmacist or manufacturer.

Inappropriate use is any other form of use. Throughout this report the Committee has deliberately used a variety of terms to describe a chemical substance. They include drugs, therapeutic goods, medicine and remedies. The Committee’s purpose for so doing w as to stress to the reader that the terms are equivalent. The Committee believes that to a proportion of the population, ‘medicine' is considered "good’, drugs (associated with the illicit market heroin, morphine. LSI)

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etc.) are considered ‘bad’. The Committee is keen to impress upon the reader that the caffeine one consumes in a cup of tea or coffee, the nicotine one inhales from a cigarette, the alcohol one absorbs from a glass of beer, or the sedative or tranquilliser one takes are also drugs.

In the period since 1970. 6 government-instigated reports have been written on the 'abuse' and ‘misuse’ of drugs. These are: - the Senate Select Committee Report on Drug Trafficking and Drug Abuse, 1971. and the supplementary report, the Continuing Oversight of the Senate Select

Committee Report on Drug Trafficking and Drug Abuse, 1975; - Drug problems in Australia an intoxicated society 's 1977; - the Progress Report from the Joint Committee o f the Legislative Council and Legislative Assembly upon Drugs, 1978 (N.S.W.);

the Royal Commission into the Non-Medical Use o f Drugs. South Australia. 1979; the Australian Royal Commission of Inquiry into Drugs. 1980; and the Report o f the Interdepartmental Working Parly on the Drug Problem in Victoria, 1980. Most of these reports have concentrated on the ‘drug problem". Several have asked the fundamental questions: why do people ‘abuse’ drugs and w hat can society do to prevent drug "abuse’? The Committee feels that it can add little to the discussions which have already taken place. This chapter considers ‘another side" to the drug problem.

The Committee has focused its attention in this report on 3 areas which it feels constitute a major part of society’s inappropriate use of drugs. There are other aspects to the problem, such as drug-related suicides, tobacco and alcohol, hospital, nursing home and psychiatric drug usage, the relationship of the medical profession and industry, and

industry and government, to mention just a few. Tobacco and alcohol have been discussed in the Committee’s 1977 report: Drug problems in Australia an intoxicated society?. One area in particular where the Committee believes further research is necessary is the extent to which drugs have become a key factor in the incidence of suicides in Australia. For example, in 1978, out of a total 1595 suicides3, drug overdoses were found to be responsible for at least 22 per cent of that total.4

In this chapter the Committee has concentrated on patient non-compliance, the use of drugs to treat social problems and the deliberate inappropriate use of a prescription drug, namely barbiturates.

Non-compliance 'Failure of ambulant patients to comply with prescribed medication is so great and widespread that it constitutes a major, if not the major, problem of drug therapy ' Non-compliance occurs whenever a person uses medicine in a way other than that which the doctor directed (in the case of prescription medicines) and in a w ay other than

that suggested by the manufacturer or pharmacist in the case of over-the-counter products. It takes various forms. For example, a course of medication may not he completed, or indeed, not taken at all; more or less than the prescribed dose may he taken at any one administration or during the day: the patient may he taking the same medication twice under different brand names (particularly so when the patient visits

more than one doctor or when the patient leaves hospital with a particular medication but also returns to his doctor for further consultation): or the patient may cease taking the medication because of irritating but not serious sidc-etlccts. The magnitude of the non-compliance problem is demonstrated by a number of

overseas studies which report a non-compliance rate of 30 50 per cent and higher/ I here are little Australian data on compliance. However, estimates by researchers of several

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Australian universities have suggested that as much as $200 million worth of prescribed drugs are wasted annually.7 One Australian study that has taken place was conducted by Jocelyn Abrahams and consisted of a survey of one general practice in a Queensland city. Of the 250 pieces of

advice given (to 114 patients), 78 per cent were complied with. This study obviously compares particularly well with studies conducted overseas. The following table shows the compliance rates in each treatment category.

Table 10.1: Compliance rates found in each treatment category

Category % compliance Total numbers

%

A n t i b i o t i c s..................... . . . 59 (23) 39

T o p i c a i s .......................... . . . 67 (12) 18

A c t i v i t y .......................... . . . 73 (19) 26

Reconsultation . . . . . . 84 (49) 58

Other medication . . . . . . 88 (42) 48

R e f e r r a l.......................... . . . 92 (24) 26

Other ................................ . . . 71 (25) 35

Overall .......................... . . . 78 (194) 250

Source: J. Abrahams, ‘Patient Compliance in General Practice’, Australian Fam­ ily Physician, 6 September 1977, p. 1201.

On average 2.2 instructions were given to each patient. Abrahams points out that those patients given 4 or more instructions proved to be poor compilers.8 Some indication of the amount of drugs wasted can be gauged by various 'medi-dump' programs conducted throughout Australia. These projects involve the collection of unwanted drugs within a certain locality and over a set period of time. One such program was conducted in Perth over a 2-week period in July 1978. The campaign originated in the pharmacy department of the Western Australian Institute of Technology. Substantial publicity through radio, television and newspaper advertising took place.9

The total amount of material collected amounted to 3500 kg, w hich consisted of 650 kg net weight of solid medicines and 550 litres of liquid material. The organisers of the campaign, however, felt that only a small fraction of unused drugs throughout Perth had been collected. Eight percent of the material showed visible signs of deterioration, which

might suggest that deterioration on the whole would be of a higher proportion.10 It is interesting to note that 17 per cent of returned material was in the

antibiotic antibacterial category. This is particularly significant as the importance of completing these courses for them to be of benefit is necessary1', and the consequences ol not completing the course can be a build-up of resistance against the particular antibody.12 Throughout the various medi-dump campaigns the collection of antibiotics

featured significantly. The mere presence of large amounts of medication in people's homes and the easy availability of drugs encourages the inappropriate use of drugs. Without medical advice, confusion, particularly in the elderly, as to which medication should be taken probably contributes to the incidence of accidental overdosage.

In an assessment of the drug wastage costs of 29 families in South Australia. 57 per cent of the drugs stored in homes was considered by the participants to be "wasted'. This amounted to an average cost of $17.04 to each family and a total cost of $376 to the government.13

It would appear that there is a large proportion of our population w hich is either not taking its medication at all, or is taking it incorrectly, and yet remaining healthy. One

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must consequently lace the question of whether or not there was a need for the medication or at least as much medication as was prescribed in the first place. Many other patients clearly suffer from not taking their medication correctly. A survey conducted by the Chief Pharmacist for the Pharmaceutical Society. Lee Ausburn. of patients in 3 medical wards of a major Sydney hospital, showed that 25 per cent of those patients were probably there as a result of not following their doctor’s instructions with regard to taking their medicine. Each patient was in hospital for an average of 8 days, resulting in a cost of about $1300 per patient. Should this trend be typical of other hospitals, this would represent an annual cost of hundreds of millions of dollars. Forty- five per cent of patients interviewed stated they had not taken the medicine prescribed by their doctor. The majority of the rest admitted that they had not followed the instructions printed on the bottle.14

Why is it that patients do not follow the doctors', pharmacists' or manufacturers' instructions? There appears to be a host of reasons. A study carried out in the United States gives the following: The patient forgot to take a dose.

The patient thought the drug had stopped working.

The patient thought he was cured and stopped taking the drug.

The patient disliked taking medicine.

The patient lost the bottle.

The patient mixed up his medications.

The patient thought he needed the extra dose.

The medication made the patient ill.

The patient did not understand instructions.15 Professor J. Thomas, Associate Professor of the Sydney University Pharmacy Department, believes the following reasons contribute to non-compliance:

non-comprehension of the regimen; complexity of the prescribed regimen; confusion of a new regimen with drug treatment taken prior to the new

prescription; confusion under a multiple dosage regimen; - patient’s perception of the cause of the drug treatment as being cured or unimportant enough to disregard treatment.16 Professor Thomas saw the following as influencing non-compliance:

the type and duration of the illness chronic, few ov ert symptoms, no serious risk to life (for example, hypertension); the social and personal condition of the patient isolation, lack of superv ision,

extremes of age, denial of illness, language difficulty, independent or hostile personality; complexity of medication and incidence of side-effects; poor patient rapport with clinician and or pharmacist: and

lack of explanation on the part of the clinician and or pharmacist regarding treatment or lack of awareness of non-compliance.1 There are many factors which contribute to a patient s failure to comprehend or remember instructions and these arc not always within the patient s control. One important factor is communication difficulty. Communication problems occur both

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within the English and non-English speaking communities in Australia. Ausburn found that within the Australian community a significant number of native-born Australians are illiterate. Such persons were unable to read the doctor's instructions printed on the label, and consequently had to rely on their memory, which was especially difficult when a number of medicines were involved.18

The magnitude of the problem with regard to the non-English speaking community may be considerable. For example, approximately one-third of out-patients at the Royal Melbourne Hospital do not speak English as their native language.19 Surveys conducted by Shaw and Hemming in 1977 compared English and non-English speaking out­ patients’ understanding of what their therapy was intended to do, and the way in which it was to be taken (including advisory material on labels). Patients whose native language was not English were found to have twice as many gaps in their knowledge as those whose native tongue was English. It was also found that prevalence of the deficiencies was directly proportional to the degree of communication difficulty present.20

Often interpreters were not sought by the medical staff for persons whom they believed to speak some English. The decision may have been based on little more than the patient being able to recite in English his name, address and occupation. Such persons, without the help of an interpreter, may not comprehend the nature of their illness, the importance of their medication, or their regimen when this information is given in English. Shaw and

Hemming also found that the use of members of the family and workmates as interpreters proved unsatisfactory.21 Another factor which may contribute to patient non-compliance is the label. Professor Thomas-Stated that in a study where patients were asked to interpret a label stating 'Penicillin G. Take 1 tablet 3 times a day and at bedtime’, nearly 90 percent stated

that they would take the drug at mealtimes and on going to bed. Yet penicillin needs to be taken on an empty stomach.22 The printing of brand names on the label rather than generics can be misleading, particularly to the patient w-ho visits more than one doctor. The different names of the medication on the label may lead the patient to believe he is

taking 2 different formulations, where in actual fact the medication is the same. This means the patient is taking twice the amount of the drug as directed. Perhaps one of the most important factors affecting compliance is the way in which information is communicated to the patient. It appears that the degree to which the patient is satisfied with a consultation is strongly associated with whether or not he or she will comply with advice.23 One large-scale study has shown that of patients happy with the consultation. 53 percent complied with their regimen, while only 17 per cent of those who were dissatisfied did so.29

Ley believes that the patient’s failure to comply often results from a failure to understand and to remember, which in turn is due to various factors. Where a lack ol understanding is the problem, this may result from the following situations: The patient has a lack of elementary technical medical knowledge.

The patient has misconceptions (for example, that medicine may be discontinued once the patient feels better). The patient feels diffident in front of doctors and nurses and hence does not ask questions when he does not understand (and so he remains confused).

The material presented to the patient may be too difficult for him to understand.

Where failure to remember occurs, this may be due to:

the patient being alarmed by what he is told of the nature of his condition: the tendency for the patient to remember best what he is told first: and vague statements being made rather than specific instructions given.25

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What can be done?

It is the doctor who diagnoses the problem and determines what the treatment will be. He should not assume that because he is the doctor and he says to take a particular medicine in a particular way that the patient will automatically do so. What the physician must realize is that ultimately it is the patient who decides whether or not. and how. to take the medication prescribed. As well, the patient will determine what other remedies he will take with his prescribed medication.26 The doctor needs to gain the patient's confidence and to convince the patient of the importance of his compliance.

To do so the doctor needs to ascertain the patient's worries and expectations, and if the latter cannot be fulfilled, to explain why not. He also needs to ensure that the patient has understood the cause and nature of his illness, the reason for his particular treatment and the medication regimen. This will require the doctor to use layman's language and avoid medical jargon27, and to keep his treatment programs simple.

More thought needs to be given to producing simply written patient information sheets which the patient can refer to easily, and which explain his illness and the treatment proposed. These could be prepared in advance to cover most consultations. This is an area where the medical, pharmaceutical and manufacturing associations could combine forces to produce satisfactory patient information sheets.

Finally, the manner of communication is important. According to Ley, the patient will more readily follow the doctor’s advice if he is seen to be friendly rather than businesslike.28 Of course doctors are individuals and hence differ, and the relationships which one doctor may develop with his patients may not be within the capacity of

another.29 But doctors need to bear in mind that they arc in a position of confidence. Often he or she is the only person to whom the patient discloses his problem. Many patients may be seriously concerned as to the state of their health, and look to their doctor as their sole means of reassurance.

The pharmacist’s role should be one of reinforcement. He is the‘middle man" between the doctor and the patient, and the last member of the health team to see the patient before he begins his course of medication. For best results the pharmacist needs to have effective communication with both the patient and the doctor, and to be able to properly reiterate

to the patient the instructions which the doctor has detailed. The doctor can be of substantial assistance here simply by ensuring that his handwriting is legible. In its submission to the Committee the Australian Medical Association stated that discussions have taken place between it and the Pharmaceutical Society ot Australia aimed at developing a procedure for liaison between the medical and pharmaceutical

professions. Their intention is to improve the professional relationship and encourage interaction between doctors and pharmacists.30 The Committee encourages these moves. The following points need to be conveyed to the patient by both the doctor and the pharmacist:

name of the medication (generic and brand); purpose of the medication; method of administration: special time of administration: maximum amounts of medication that can be used in one day: duration of use of the medication;

pertinent side-effects which the patient can recognise and manage (if appropriate): pertinent adverse effects which could prompt the patient to notify the physician: drugs (including alcohol), food or additives to avoid:

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proper storage; and refill procedures.31 1 he Committee RECOMMENDS that representatives from manufacturers, medical associations, the pharmacy guilds and the Commonwealth Department of Health meet together to draw up standard instruction sheets for various courses of medication. These sheets need to be comprehensive but at the same time easy to understand. Thought also should be given to allowing for additional instructions to be added by the doctor to suit

the individual patient’s course or multiple course of medication. Once this group has drafted the required sheets, the Commonwealth Department of Health should arrange to have multiple copies dispatched to all practising doctors. The Committee does not see this means of communication as doing away with package inserts but rather as a complementary procedure to help improve the level of compliance and minimise any

unnecessary adverse drug reactions. It is up to the pharmacist to establish that the patient's interpretation of the instructions is correct. This is particularly true for over-the- counter medication, because the pharmacist is the last point of contact with the patient. Some pharmacists have adopted counselling as part of their responsibility as a

pharmacist. Too often, however, when a prescription is dispensed, the only contact is with the shop assistant. The manufacturer can contribute to patient compliance through thoughtful packaging and concise and readily understandable directions, either through labelling or package leaflets. The contraceptive pill is an example of packaging which aids in patient compliance. This type of packaging is, of course, limited in its application. Not all

regimens are so simple or fixed32, but it is an example of what can be done in the packaging area to aid compliance. Package inserts are a particularly useful way of providing the patient with all the information he needs to have about a particular drug. The system of including package inserts with medicines could readily be applied to more products by manufacturers. These inserts should complement the instruction sheets that the Committee has recommended. Providing essential information in a number of languages would be of particular benefit to our migrant population, and, considering the results of the survey by Shaw and Hemming referred to above, would seem necessary.

No matter how diligently the manufacturer package, the doctor instructs and the pharmacist reinforces, ultimately compliance or non-compliance is dependent on the patient. It may be that some patients, due to personality factors, will probably not comply with the advice given, despite clear and concise directions.33 The patient's degree of concern or discomfort will no doubt influence compliance, but to what extent it is difficult

to estimate. Nonetheless, he or she is far more likely to comply if the other 3 members of the 'compliance team" the doctor, the pharmacist and the manufacturer have fulfilled their roles.

Medication— the solution to society’s ills? If we consider that the function of drugs is in the solution of medical problems then the extent of their use will depend on the interpretation of what is and is not a medical problem. Today the scope of medical problems has been expanded, largely by the pharmaceutical industry, to include anxiety, loneliness, boredom, unhappiness etc. all of which were considered, before the advent of drugs, as part of the everyday problems of life. Through this relabelling and

redefinition the production of a drug claiming specific curative effects for almost any human condition is legitimised. This legitimacy is reinforced by physicians and patients who are convinced that drug intervention is required in more and more aspects of everyday human behaviour, interactions and conflicts. u To treat normal, everyday, social problems which might include depression and loneliness on the part of the elderly, anxiety on the part of the executive, and boredom on

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the part of the factory worker with a medical solution (tranquillisers, sedatives, stimulants, analgesics) is to do two things. First, it serves to reduce the problem from social dimensions to the individual. That is, it is the individual who is regarded as the problem, not society. So the individual is 'treated' to enable him to cope with his surroundings. Receiving medication for his illness reinforces to the "patient" and those around him that his is a medical problem, of which others are not a part. Consequently, stimulus for necessary social change be it to family life, occupation, environment etc. does not occur.35 Secondly, such treatment may enable a person to cope with and live

more comfortably in otherwise intolerable, but unchangeable, surroundings. Community and individual expectations have a considerable influence on the use and sanctioning of drug therapy. There are expectations of medication itself, and of what life should offer. Technological advances in medicine, which the media tend to publicise as

'breakthroughs’ or 'discoveries of new miracle drugs’, have encouraged people to believe that for every difficulty there is an appropriate medical antidote. People are persuaded to believe the fantasy that medicine can end all personal suffering and the medical profession is responding by finding that an increasing range of problems of living are

suitable for treatment.36 Both analgesics and psychotropic drugs are turned to by the community as solutions to social problems. Substantial coverage of the inappropriate use of analgesics has already been given by this Committee in its report of 1977. Drug problems in Australia an intoxicated society? This section deals almost exclusively with psychotropics.

Two groups in particular are especially vulnerable to being diagnosed by doctors as requiring drug therapy women and the elderly. There is a third group that may also require attention where drugs are concerned children. Little evidence is available in this area, but the Committee is particularly concerned about the administration of drugs to

the very young. These 3 groups arc considered below.

Women That women take almost tw-ice as many psychotropic drugs as do men is an often quoted statistic and also supported by the Committee's data. One may well ask why? Why women

more than men, and why drugs? One of the major factors which must be considered w hen viewing women and drugs is the role of women in society. That role has changed over the last 15 to 20 years. Whereas once the man was considered the breadwinner and the woman's role was one of

maintaining the home, the situation in current times is often one of the woman having both a full-time occupation and maintaining her full-time role as mother housew ife. This situation poses considerable stress on the individual as well as the family.3' It is interesting to note, however, that current evidence suggests that women with several roles have less illness, and take fewer tranquillisers and sleeping medications, than women who fill the traditional female role of housewife.,s

Many women workers are involved in low-paid, low-skilled occupations with limited job security. The work is uninteresting and monotonous. Consequently, they often turn to psychotropics or analgesics to help them cope. In the view of the Working Women s Centre:

Whereas men whose work is boring use defence mechanisms such as increased turnover, withdrawal of commitment, industrial sabotage and alcohol to cope with the situation, many women expect to perform dull jobs and accept their lot. Women feel they must just struggle on as they see no hope of changing things. So they turn to the only props they know which are easily obtainable and relatively cheap analgesics and

tranquillisers.39 Two groups of women have been identified by Elizabeth Campbell as particularly vulnerable to the use of psychotropics: housewives with young children (who often leel

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isolated, particularly if they reside in 'dormitory suburbs'), and housewives who, having devoted themselves to their children and home, find that the children have grown up and their role no longer exists.40 In a survey of users of benzodiazepines conducted by Leonard and Cooperstock, it was found that the majority of females took these drugs to maintain their role or roles which they found difficult or intolerable without the drug.41 An important function of the benzodiazepines expressed by those surveyed was to sustain strained social systems, such as marriage. Though a number of women felt anger and resentment towards their spouse, at the same time they saw no alternative to maintaining their roles as mother housewife.42

Ginzberg has found that the use of tranquillisers may be particularly prevalent among women in role conflict, for example mother housewife versus frustrated career, own interests.43 Feelings of inadequacy in the mother role resulting from difficult or demanding children also led to tranquilliser use amongst those women surveyed by

Lennard and Cooperstock. The men studied typically related their symptoms to the work environment (for example, relieving occupational stress) whereas the women related their problems to the traditional roles of mother, wife and houseworker.44 Because so often the problems of persons taking psychotropic drugs are social rather than individual, to bring about the necessary structural change may be beyond the individual’s control. Where no alternatives are available, should society condone the use of a drug as the 'solution' to a social problem? The Committee believes that there is a place

here for the psychotropic drug on a short-term basis but emphasises the importance of the doctor appreciating fully his patient’s circumstances before making his decision to prescribe. Having considered why women more so than men take psychotropic drugs, it is necessary to consider: why drugs?

For a start, drugs are easy. Much easier for the over-tired, irritable mother to take a Valium than, for example, to change her attitude towards, or her relationship with, her family, or to organise herself and her young children off to some form of recreational pursuit. And drugs are cheap. Recreation may involve costs of travel and admissions that cannot be afforded. Drugs are also socially acceptable.

Just as drinking has been for so long an acceptable way of coping with life for men, drug taking has been adopted by more and more women as their means of coping with stress.45 Then there is the doctor. It is to him that women turn for help. They come because they are lonely, depressed, anxious, dissatisfied, or unhappy. And more

often than not they are troubled because they are finding it difficult or impossible to measure up to prevailing social prescriptions and ideologies as to what one ought to get out of life.4" The doctor, in many instances, unable to help them with their problems in any other way, does what he has been trained to do, and prescribes a drug.

The elderly . . . 45 per cent of psycho-active drugs . . . (go) to elderly people, who constitute less than lOper cent of the population.4' . . . probably only 20 per cent of drugs taken by the elderly (arc) necessary.4*

. . . 48.1 per cent of patients (in a Sydney nursing home) took psycho-active drugs helore admission to the home. After admission the figure rose to 92.5 per cent.41' . . . a significant number of elderly people were in institutions because of drugs prescribed by doctors who failed to appreciate that the elderly had a reduced tolerance of many agents. In

many cases the drug dose should be halved.50 Statements such as these suggest that drug taking by the elderly is an area for serious concern.

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Difficulties with compliance are part of the problem confronting the elderly. Where, as we have seen above, the taking of medication by the general population is fraught with problems of non-compliance for reasons of confusion, forgetfulness etc., the elderly, often with failing vision, memory and other mental faculties, are perhaps least able to cope. Yet often they are faced with a multitude of medicines being prescribed for them.

It is not uncommon for the elderly to have a collection of drugs which has been ‘hoarded’ from previously prescribed medications and from products bought over the counter. With an array of drugs, some of which may be toxic in combination, the elderly patient is in a potentially dangerous position.51 The Doctors Reform Society has stated

that ‘over 25 per cent of admissions of elderly patients to psychiatric units are directly precipitated by intoxication with psychotropic drugs’.52 One means of reducing this problem is to ‘streamline’ drug therapy for the elderly, limiting the treatment to the fewest drugs possible.53 Dr Eppo Van Der Kleijn, head of clinical pharmacy at the University of Nejmegen in the Netherlands, believes that pharmacists should take a greater part in prescribing drugs. He suggests that a person requiring multiple medication should have his drugs individually prepared so that only

1 or 2 tablets adapted for him need be taken.54 There are problems in the practical application of this suggestion. For example, in our modern day pharmacy of pre-manufactured drugs, w'ould the pharmacist find it viable or practical to stock the raw ingredients required to constitute a multitude of extempo­ raneous preparations? One must also consider the chance of error involved in formulating these compounds. In some cases, however, extemporaneous preparations may prove a suitable replacement for a combination of individual drugs.

Where a number of drugs is being prescribed, the doctor would do well to confer w ith the pharmacist as to the best possible method of distributing the substances to the elderly patient for ease of his administration and, as mentioned above, the doctor should issue an instruction sheet to the patient.

One fundamental question which must be asked by every doctor before prescribing for the elderly is: how necessary for this patient is drug therapy? According to Dr Brian Learoyd, it is estimated "that about a quarter of the people in nursing homes w ould not be there if anyone had taken the trouble to assess them properly initially’. 55 Learoyd points out that often their problems result from strain within the family, for example feelings of

neglect or rejection. Drugs are not the solution to such problems. Indeed, they may only serve to exacerbate the situation by reinforcing the family’s belief that the problem is a medical one, and hence outside their responsibility. As well, by "medicalising the

problem, the family may be encouraged to seek "proper’ treatment nursing home care and so more rejection occurs.56

Children Substantial attention has been focused via conferences, surveys, journal articles, the media and so on, on the problems of women and the elderly and their drug usage. Where children are concerned, however, there is little information available. Perhaps the biggest

problem in this area is to determine w hether or not there Z .v a problem and. if so. of what magnitude? Dr Ann Schlebaum, child and family psychiatrist at the North Ryde Psychiatric Centre, believes there is need for concern. In a paper presented by Dr Schlebaum to the

First Pan-Pacific Conference on Drugs and Alcohol in Canberra. 1979. she states: During this past International Year of the Child and in recent publications, considerable attention has been paid to the physical, emotional and sexual abuse of children, but suspiciously little to a fourth, often hidden and deceptively ’silent' form of assault on children: chemical abuse.

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This has hardly been recognised and investigated, is not legally defined and controlled and yet is quite prevalent, and a cause tor great concern.57 Individual cases of drugs being given deliberately to children by parents or others with intent to harm have been cited.58 However, there are no general studies available, and the Committee is consequently unable to comment in this regard. What also concerns the Committee is the indication from the data available that the Australian perception of medication as a ready solution to a broad range of ills is being applied, and consequently transferred, to our children. The Committee is fearful that by offering children medication as a matter of course when they are unable to sleep, have minor pains, as supplements to their diet etc. we are encouraging them to rely on drugs as a support rather than on their own resources. Rather than learning to take responsibility for their health through proper diet, lifestyle and adequate exercise, our children arc learning to "pop pills’.

According to a survey conducted by the Australian Bureau of Statistics, 30 percent of Australian children take some form of medication regularly. Indeed, the Bureau’s figures may understate the situation, as respondents were only questioned in regard to medication taken over the 2 days prior to the interview. The survey questioned around 45 000 people, and the results were extrapolated to the whole population.

The results of the survey showed that more than 190 000 5 to 14-year-olds took cough or cold remedies during the 2 days, and over 23 000 took tranquillisers, sedatives and sleeping pills. Particularly alarming is the finding that less than 25 per cent of the 170 000 children taking pain relievers had received prescriptions for them. As well, only 18 per cent of the 241 000 children taking vitamins and tonics were doing so on doctors’

prescriptions.59 In a survey conducted in Adelaide of 406 interviews with mothers of 6-month-old babies. Professor T. Murrell and Dr J. Moss found that during the first 6 months of life. 31 per cent of babies had been given sleeping medicines at some time, and 66 per cent had at some time received analgesics. Almost half of the babies taking sleeping preparations had been doing so for 7 consecutive days, and 10 babies had been taking these drugs every night for almost the entire 6 months.

Tw'enty-one per cent of the drugs administered to the babies were cough medicines. 30 percent were pain relievers, 16 percent were sleeping preparations, and 13 percent were antibiotics. Another 236 individual items, such as nappy rash creams or teething preparations, were being externally applied to the babies. It is particularly interesting to note that 54 per cent of the mothers had taken a pharmacologically active drug during the fortnight prior to the interview.

Approximately 45 percent of the drugs were obtained through a doctor’s prescription. 51 per cent from a chemist, 2 per cent from infant welfare nurses, and 4 per cent from friends or relatives. Professor Murrell and Dr Moss point out that parents of young children are apparently insufficiently aware of the normal behaviour patterns of their infants. ". . .

their (the parents’) anxieties arc being met by resorting to medication." They state. It is our belief that we arc beginning to accumulate evidence that drug giving by the parents is for them a learned behaviour, that children are exposed to parental modelling of drug-taking behaviour from an early age and we wonder whether in this way children arc being conditioned to ’non-medical’ use of drugs that may establish life-time patterns in which drugs may be a preferred method of coping. The notion that drug taking is a solution to life’s stresses and strains may be patterned at this early level. It is also an appropriate place to break the chain.

However. Professor Murrell and Dr Moss make a plea that their concepts be regarded with caution. We should not as a matter of course encourage parents to give their infants less drugs. Rather, in many cases we might do better to ‘leave well alone’. Tor example, withdrawing a relatively harmless drug may cause a previously marginal coping situation

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to become unstable, whereas the use of medication may be preventing more serious parental problems. Professor Murrell and Dr Moss made the following recommendations to the South Australian Royal Commission into the Non-Medical Use of Drugs:

Health education that more accessible and relevant health education focusing on more effective means of coping be made available at the level of the community health centre, general practice, infant welfare clinic and the local pharmacy, with the maximum input at the time of the first baby. That health education in schools include patterning and modelling behaviour and

how it starts with babies.

Health care practice that, in view of the overlap of roles, there be greater integration, teamwork and understanding between those providing parental and child care. That these services continue to foster a helping environment that is less drug oriented, in which there is a valid role for self-help groups, and in which there is greater attention to the educational role of the professional, in working both with patients and other professionals.

This Committee endorses these recommendations. The Committee views with concern the trends in drug usage that the above statistics suggest. How much harm are we doing our society of tomorrow by instilling in our children’s young minds the acceptability of drug taking? The Committee believes that

more studies need to be undertaken in all areas of drug usage by children to supplement the current inadequate amount of data available in this area. From the information collected, some form of national campaign regarding children and drug taking may prove necessary.

Responsibility— the doctor

It has been estimated that 60 per cent of patients who consult a doctor do so for non­ medical reasons61, often because they need to confide in "someone who cares’. The doctor, however, is trained to handle medical matters. When he is confronted with a problem which is social rather than medical, his tendency all too often is to redefine that problem into medical terms and treat it accordingly, as stated above, with psychotropic drugs.

Doctors must recognise that they play a very important role in determining whether, in the long term, a social problem will be treated with chemical solutions or social solutions.62 Doctors cannot be all things to all men. They are only one part of the health team.

With the community’s tendency to turn to the doctor with a range of problems, the doctor needs to be particularly aware of his limitations. Closer liaison w ith other health workers would be particularly valuable. Just as with medical problems, where the general practitioner refers a patient to specialist attention when he feels it necessary, the doctor

needs to recognise social problems which require assistance outside his field of knowledge and refer the patient accordingly, be it to a counsellor, psychologist or some other "team member. "Whatever the pressures on him, it is the final responsibility o! the doctor to write

the prescription.’63 Health centres can provide a link between the doctor and access to government and community support systems such as social services, child-minding centres, recreational facilities, community groups, and specialised care, which may be the better answer to the "patient's’ problems than medication. The Committee supports their

operations. There are a number of factors which undoubtedly have varying degrees of influence on the doctor's approach to prescribing. Principally these include his training, his attitude to drugs and their place in medicine, the promotion of products by pharmaceutical

manufacturers, his perception of his patients’ expectations, and his reading. Other influences include practice arrangements (for example, group or single practice), government (for example, the Pharmaceutical Benefits Scheme, or restrictions on certain substances) and other health professionals.

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The Australian Council of Social Service Incorporated believes that it is the doctor’s training which is critical to the drug he chooses because often, due to a lack of time, he is unable to read journals and other medical references. In addition, the Council believes that the continual inundation of the doctor by the drug companies leads to the doctor prescribing "on the basis of impressions created by the drug companies rather than on actual information’.64 Doctor Andrea Mant notes that 65-70 percent of prescriptions for psychotropic drugs in Australia are written by general practitioners65, and it appears that the longer the surgery hours the greater the prescription rate.66 Doctors with higher medical qualifications tend to prescribe less of any type of drug.67

It seems that a contributor to the manner of prescribing psychotropics by doctors is inadequate medical education, particularly in clinical pharmacology and therapeutics.68 The Committee has commented in Chapter 8 on the current lack of undergraduate training in clinical pharmacology and therapeutics, as well as the need for post-graduate medical education, to keep doctors up to date on new drugs. As drug manufacturing becomes more and more specialised, doctors can hardly be expected to evaluate new drugs objectively without assistance.

It is often stated that patients expect and desire a prescription to be the outcome of a consultation. This, it is said, results largely from their high expectations of the capabilities of drugs. The patient's belief that drug therapy is the appropriate treatment is reinforced by the doctor’s prescription.69 The Australian Medical Association is of this view and has attempted to "alter community attitudes and expectations in relation to the benefits that prescribed drugs may provide" through the means of a poster campaign in doctors' surgeries.70 The campaign is aimed solely at the patient.

In one study'1, 80 per cent of doctors believed that their patients expected some form of medication and doctors commonly complain that women pressure them into prescribing. Doctors also state that if one does not prescribe, the patient will go to someone who will.

Recent evidence, however, suggests that patients' expectations for a prescription are not as high as doctors think72, and there is no evidence to show that patients will seek out another doctor who will prescribe for them. Indeed, in a study of pseudo-patients in 1974. 78 per cent were prescribed psychotropic drugs though no request was made for medication. Wyndham makes a poignant point in regard to prescribing for women when she states:

The view that women get more pills because they visit doctors more should . . . be questioned. A visit should not automatically result in a prescription; if it does, that should be questioned. ' 1 In view of this evidence, the Committee believes that the Australian Medical Association should extend its campaign to include the doctor as well as the patient.

Responsibility— industry The drug companies are primarily concerned with expanding markets by labelling more and more everyday problems as appropriate targets for drug treatment. This creates a potentially unlimited market.-4 To what extent the pharmaceutical industry is responsible for the expansion of the medical field to incorporate social problems is impossible to determine. One thing seems certain it has a substantial influence. This is felt in a number of areas, principally

through advertising. Advertising is of 2 types: that directed at doctors and concerning prescription medicines, and that directed at the public regarding over-the-counter products. The doctor is approached through the mail, in medical literature, through "educational' publications which contain reports of the company's drug trials, and drug company representatives. Often the doctor's "lack of time’ and inability to cope with "non-specific problems' are played on.-5

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The Australian Council of Social Service Incorporated states that advertisements are indicative of the high expectations that doctors and the public are encouraged to have of drugs. They also state that perhaps one of the greatest influences of drug advertising is that it tends to ‘(legitimise) the acceptability of drugs as a way of life'."6

The Committee has already discussed several areas where industry can play a responsible role in the promotion and use of drugs. In Chapter 7. the Committee drew attention to the need to develop more educative, promotional material and urged the manufacturers not to exploit or create stereotypes which reinforce drug-taking habits. In

the section on non-compliance in this chapter the Committee has spelt out the industry's responsibility with respect to instruction sheets and package inserts.

Responsibility— the individual

With television, radio, magazines, papers, posters, etc. telling him that drugs will make him feel better and help him be the person he should be, with the doctor happy to prescribe a drug for him, and the government willing to help him pay for it, the average man in the street can hardly be expected to critically appraise the benefits or otherwise of medication.

We live in a society that believes medication is ‘good’. And. as the Committee has stressed throughout this report, in its proper place the value of medication cannot be questioned. But chemical solutions are not necessarily the answer to social problems, despite the impressions created by industry. In some cases they may be ‘better than nothing', where no alternative exists. But the individual needs to become more aw are of the alternatives to medication available to him, and more aware of his own responsibility towards his health mental as well as physical. Too often drugs are turned to because they are convenient, and require little effort on the part of the individual. And too often drugs,

rather than being a solution, merely mask the problem. Judith Straton states that there needs to be a fundamental change in society's attitudes, more emphasis being given to alternative, non-chemical means of coping w ith the problems of life, and to changes within society so that various problems are less likely to occur.77 The alternatives to medication will vary according to the individual problem.

In some cases regular exercise or relaxation classes may be all that is necessary. Sell- discipline may be the answer for others. Some problems may need wider reaching measures for solution. ‘Social services, housing improvements, child care, political activism or legal and economic remedies . . .' may be more appropriate than medical

remedies.78 The individual's attitude towards himself and towards life, as well as his social situation, will have significant bearing on his motivation and consequently the solution he seeks. The Committee has left a discussion on what specific steps can be taken to lessen society’s dependence on drugs to the following chapter.

Barbiturates— a model Towards the end of the Committee's inquiry, substantial publicity by the media was given to the inappropriate use of barbiturates by the young. The Committee was sufficiently concerned by the reports to hold subsequent public hearings in an endeavour to establish

whether or not the barbiturate problem was of the dimensions the media indicated From its hearings, the Committee established what it had already suspected. There is nothing new about the problem with barbiturates except the drug itself. W hereas in the 1960s, LSD and the amphetamines were the fashion, and in the early I970s it was methaqualonc (mandrax). today it is barbiturates. The "answers' given to the ( ommittee

to the fundamental questions of drug use (why do people deliberately inappropriately use- drugs, and what can society do about it) were no different with regard to barbiturates than those given in the earlier reports referred to above.

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The community needs to put barbiturates into perspective. They are a fashionable drug, probably turned to by the young to fill a 'vacuum' once methaqualone was restricted. If barbiturates are similarly restricted, some other substance will take their place in the same manner. Barbiturates are cheap, readily available and 'effective'. That is all they need be to recommend themselves highly as a drug for inappropriate use.

There is no categorical evidence as to where the barbiturates available on the illicit market are originating, but the Committee received the impression from its evidence that the supplies are mainly from doctors’ prescriptions. These are either deliberately (it would seem in very few cases) or unwittingly written, or forged on stolen prescription pads. Some supplies would also be coming from burglaries of pharmacies and doctor’s surgeries. The Committee does not dismiss the possibility that supplies are originating from other sources. For example, the Committee was told by one of its witnesses that for a pharmacist to sell barbiturates illegally would not be difficult; there would be only a very small risk of detection.79 No evidence is available, however, to suggest that this, or any other illegal form of supply, may or may not be occurring.

Indeed, there is very little hard evidence available generally in regard to inappropriate barbiturate use by the young. It is particularly difficult to determine the extent of the problem. The statistics available on barbiturate suicides or accidental poisonings reveal little. Barbiturate usage was a major problem about 12 years ago. In 1966- 69 around 5 million Pharmaceutical Benefits Scheme prescriptions were written for the drug.80 Progressive restrictions led to the number of Pharmaceutical Benefits Scheme pre­ scriptions declining in a linear fashion. By 1977-78 there were approximately 1 million

Pharmaceutical Benefits Scheme prescriptions for barbiturates.81 The figures in the tables listed below show a corresponding decline in deaths. They do not suggest any trend that might be interpreted as indicating the resurgence of a widespread barbiturate problem. The Committee was told, however, that reports by the media that hundreds of young people are dying throughout Australia each year from the inappropriate use of barbiturates appear to be correct, but it was unable to substantiate these claims.82 Nonetheless, figures available from New South Wales show' that, in 1978 -79, about 80 persons under the age of 30 years died as a result of barbiturate overdose (accidental and deliberate).88 To what extent the problem is occurring in country areas and schools the

Table 10.2: Victoria— toxic levels of drugs found at post-mortem, 1974-78

1974 1975 1976 1977 1978

Barbiturates . . . . . . . 83 67 66 68 55

Source: Senior Chemist, Medico-Legal Laboratory, Coroner’s Court, Melbourne, Victoria.

Table 10.3: Tasmania— toxic levels of drugs found at post-mortem examination, 1975-76 to 1978-79

1975 -76 1976-77 1977 ■78 1978 79

(a) ( b) (a) (h) (a) (6) (“) (A)

Barbiturates . . . . . 4 1 4 1 7 3 3

(a) drug present alone. (b) drug in combination.

Source: Assistant Government Analyst, Government Analyst Laboratory, Hobart, Tasmania.

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Table 10.4: Sydney, New South Wales— toxic levels of drugs found at post-mortem, 1972-1978

1972 1973 1974 1975 1976 1977 1978

(a) lb) (a) (bj (a) (b) (a) (b) (a) (b) (a) (bj (a) (b)

Barbiturates alone . . . . 102 38 107 24 80 29 72 53 66 34 37 30 38 29

(a) suicide. (b) ‘open’ or accidental findings.

Source: The Senior City Coroner, Sydney, New South Wales.

Table 10.5: Queensland— toxic levels of drugs found at post-mortem, 1968-69 to 1977-78

68-69 69-70 70-71 71-72 72-73 73-74 74-75 75-76 76-77 77-78

Barbiturates . . . . I l l 93 128 101 79 65 81 57 58 56

Source: ‘Annual Report of the Health and Medical Services of the State of Queensland’, 1968 69 to 1977 -78.

Table 10.6: South Australia— toxic levels of drugs found at post-mortem examination, 1978.

1978

[a] lb)

Barbiturates . . . . . 15 1

(a) drug present alone. (b) drug in combination.

Source: Director of Chemistry, Chemistry Div­ ision, Department of Services and Supply, Adelaide, S.A.

Prepared by Dr L. R. H. Drew, Senior Advisor, Alcohol and Drug Dependence, Commonwealth Department of 1 lealth

Tables 10.2-10.6 are reproduced from Technical Information Bulletin, No. 61, January 1980, National Information Service on Drug Abuse, Commonwealth Department of Health, pp. 18 -22

Committee was unable to determine. However, one of the Committee’s witnesses did point out that it appeared that schools are not currently an area for concern.84 The problem with barbiturates today would seem to be a substantially different one from that of the 1960s. The earlier period experienced a problem with middle-aged women

who were part of the general community. The tragic part of the current situation is that the age of those concerned is half of what it was then. Persons involved today appear to be a ‘fringe’ of society. In the main they do not restrict their drug usage to barbiturates alone, but use a variety of substances.85 It would appear that often their introduction to

barbiturates is based on experimentation and peer group pressure hardly likely to have been reasons encouraging usage by middle-aged women. There is an argument put by some that in a democratic society the basic right of freedom of the individual must be acknowledged when considering the inappropriate use

of drugs. The argument holds that society has no right to interfere with an individual's actions whilst those actions arc of harm only to himself. The Committee does not support this view as it does not believe that the actions of an individual with regard to his health will remain isolated in their effects. Rather it believes that in an integrated society those

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actions will in one way or another have bearing on others, the effects ranging from hospital costs to family trauma. Nonetheless, one must face the question of the effectiveness of intervention in the form of government controls. Restrictions on the amphetamines and methaqualone did not solve the wider problem of inappropriate drug usage. Another drug more readily accessible simply replaced them. Criminal legislation has not ridden society of illicit drug trafficking, and there is the consequent possibility of black marketeering developing. Further restrictions may provide only short-term solutions at best.

Two factors in particular, however, have concerned the Committee to such an extent that it believes it necessary to make recommendations for further 'non-criminal' restrictions despite these limitations. The first factor is the age group currently involved with barbiturates, many of the barbiturate users being little more than children often in the age group of 13 to 16 years.86 The second factor is the nature of the drug itself. The Committee received evidence that the barbiturate has little to offer. Professor Denis

Wade, Director of the Department of Clinical Pharmacology at St Vincent's Hospital. Sydney, stated in evidence: 1 cannot think of much to recommend the barbiturates other than those that are used as anaesthetic agents or anti-epileptic compounds. They really have nothing to recommend them

as hypnoscdatives at all. Everything is wrong with them.87 Barbiturates are also a particularly dangerous drug. Tolerance to the barbiturate does develop, but there is an upper limit to the size of the dose to which a person may become tolerant. This limit differs

with the individual use and varies widely. Following the withdrawal of barbiturates, tolerance is rapidly lost, and some patients may become more sensitive to barbiturates than they were prior to their chronic intoxication with these drugs.88 If the drug is stopped, the ensuing withdrawal symptoms can cause death, especially where appropriate medical care is not available. The benzodiazepines have provided a much better and safer replacement to the barbiturates. The Committee RK( OM M ENDS that barbiturates be scheduled as Schedule 8, which incorporates narcotic drugs and drugs of dependence. To avoid disruption to the treatment of a small number of middle-aged and elderly patients w ho have been using barbiturates for many years, and to other legitimate users of barbiturates referred to above, the C ommittee RECOMMENDS that doctors prescribing barbiturates for a regular patient who uses that drug appropriately and whom the doctor would prefer to remain on that drug, be enabled to seek and receive permission from the C ommonwealth Department of Health to continue to prescribe that drug without interruption. No new patient should be eligible for the prescribing of barbiturates unless special circumstances such as epilepsy warrant it. The Committee feels there is an added benelit to such an approach: the doctor w ill be forced to reconsider his decision to maintain a patient on a substance that may well be better substituted by one of the benzodiazepines. The Commonwealth Department of Health has included the 3 principal barbiturates subject to inappropriate use. quinalbarbitone (scconal), sodium amylobar- bitone (amytal) and Tuinal (a combination of equal proportions of the above drugs), in its Drugs of Dependence Monitoring Scheme.86 However, at the time of w riting this report, no monitoring of these drugs had commenced. The Committee is aware of staff shortages in this area, and is concerned that, as a result, effective monitoring of the barbiturates may not take place for a substantial period of time. In view of the Committee's decision to recommend rescheduling, it further RECOMMENDS that all necessary staff be made available to the Drugs of Dependence Monitoring Scheme to enable it to monitor the specified barbiturates. Whilst the Committee believes illicit diversion of barbiturates in transit and from sources of supply is not a problem at present, this may well prove to be the case once supplies become scarce.

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Finally, as previously stated in Chapter 5, the Committee stresses the need for medical and pharmacy boards to take swift and consistent action against members who deviate from their ethical manner of practice. In the case of barbiturates the Committee sees the need for such boards to deal firmly with reported practices of indiscriminate prescribing and dispensing of these potentially lethal drugs.

The Committee was told that the New South Wales Medical Board deregistered a doctor in March 1981 after he was found guilty of unprofessional conduct relating to indiscriminate and inappropriate prescribing of barbiturates. The Committee also understands that a further 5 doctors are likely to face similar charges in the near future.Q 0 Although the lengthy procedures have not been changed, the Committee commends the

Medical Board and the New South Wales Health Commission for taking firm and definite action. In Tasmania, the Department of Health Services took action against a doctor in relation to the prescribing of barbiturates. The doctor was charged and convicted under the Poisons Act for not issuing adequate directions for use of a restricted substance.1 ' 1

Conclusions and recommendations The drug problem affects the whole community. This chapter has tried to show that each of us at some time is probably a part of it. The so-called drug subculture is only one very small aspect of the dilemma, and there are many more sides to the drug problem than

those discussed in this chapter. Yet we have already seen an alarming cost to the community in terms of money, human suffering and our general state of health. Drugs are being adopted by the community as a panacea for all ills. The Australian public needs to develop a more healthy respect towards medication and a better perspective of the role

that medication should play in our society. The Committee has made several recommendations which it believes w ill help lessen the likelihood of inappropriate use in a number of areas. First, with respect to the problem of non-compliance, the Committee recommends that the manufacturers, medical associations and pharmacy guilds meet together to draw up standard instruction sheets

for various courses of medication (see page 128). Secondly, the Committee's recom­ mendations directed at lessening society’s dependence on drugs have been dealt with in Chapter 11 (see Chapter 11, pages 146-147). Finally, the Committee has made 3 specific recommendations relating to the distribution and use ot barbiturates:

— that barbiturates be rescheduled to Schedule 8 (see page 138); that doctors who wish to continue prescribing barbiturates for patients who use the drug appropriately should seek and receive permission from the C om- monwealth Department of Health to avoid any disruption to the treatment ol

those patients (see page 138); and that necessary staff be made available immediately to the Drugs ol Dependence Monitoring Scheme to enable it to monitor the specified barbiturates (see page 138). References

1. Evidence, p. 2139. 2. Evidence, p. 2984. 3. Commonwealth Department of Health. Annual Report ot the Director-General ot Health 1979 RO, p. 183. 4. L. R. H. Drew. 'Drug Deaths in Sydney'. Australian Journal ot Alcoholism and Drug

Dependence August 1979, p. 90. 5. "Non-compliance "the major problem" of drug therapy' The Australian Journal of Pltarmaiy July 1977. p. 380. 6. D. L. Smith, "Patient compliance with Medication Regimens'. Drug Intelligent e and ( limcal

Pharmacology 10. July 1976. p. 388: B. David et al.. Some Results of a Campaign for the Collection of Unused Medicines in Perth', The Australian Journal of Pharmacy May 1979. p. 353. 139

7. M. Andrews. Million Dollar Drug Drain', the Australian. 7 May 1980. 8. J. Abrahams, "Patient Compliance in General Practice’, Australian Family Physician 6. September 1977, pp. 1200-01. 9. David et al.. p. 350. 10. David et al., p. 351. 11. David et al.. p. 351. 12. "Non-compliance "the major problem" of drug therapy', p. 381. 13. Γ. N. Halloran et al.. 'An Evaluation of the Cost of Drug Wastage in a South Australian

Community A Pilot Study’, Australian Journal of Hospital Pharmacy 8. 3, 1978, pp. 84 6. 14. M. Andrews, the Australian. 7 May 1980. 15. Submission to the Committee from Organon (Australia) Pty Limited, p. 44. 16. "Non-compliance "the major problem’’ of drug therapy", pp. 380- 1. 17. "Non-compliance "the major problem" of drug therapy", p. 381. 18. M. Andrews, the Australian. 7 May 1980. 19. F. Shaw and M. Hemming, "Communication Difficulty a factor contributing to poor

compliance’, Australian Prescriber 2, 4, 1978, p. 74. 20. Shaw and Hemming, p. 74 21. Shaw and Hemming, p. 74. 22. "Non-compliance "the major problem” of drug therapy’, p. 381. 23. P. Ley, "Patient Compliance: a psychologist’s viewpoint’, Australian Prescriber 2, 4. 1978. p.

86.

24. Cited in Ley. p. 86.

25. Ley, pp. 86 7.

26. B. Miller, "Patient Compliance", Australian Journal of Hospital Pharmacy 8. 1, 1978, p. 29. 27. Ley, p. 86. '

28. Ley, p. 86. 29. Abrahams, p. 1202. 30. Evidence, p. I 193. 31. Miller, p. 30. 32. "Non-compliance "the major problem" of drug therapy", pp. 381 2. 33. Abrahams, p. 1202. 34. Australian Council of Social Service Inc. "Bex is Better . . . than reality?’ Australian Social

Welfare December 1977, pp. 22-3. 35. Australian Council of Social Service Inc. p. 23; R. Coopcrstock and H Lennard, Some Social Meanings of Tranquilizer Use, Addiction Research Foundation. Toronto. Canada, pp. 1 3: Evidence, p. 325; D. Wyndham, My Doctor Gives Me Pills to Put Him out of My Misery:

Women and Psychotropic Drugs (paper presented at the First Pan-Pacific Conference on Drugs and Alcohol, Canberra, 3 March 1980), p. 3. 36. Wyndham, p. 1. 37. Evidence, pp. 2846 7. 38. R. Cooperstock, "Psychotropic Drug Use Among Women’, Canadian M edical Association Journal 23 October 1976, p. 760. 39. The Working Women's Centre, "Drug Abuse. Its Impact on Occupational Safety and Health’, reprinted in The Communication Worker. March 1978, p. 22. 40. Cited in Australian Council of Social Service Inc., p. 22. 41. Cooperstock and Lennard. p. 7. 42. Cooperstock and Lennard. p. 9. 43. Cited in Cooperstock and Lennard. p. 10. 44. Cooperstock and Lennard. pp. 7 8. 45. Australian Council of Social Service Inc., p. 24. 46. Australian Council of Social Service Inc., p. 25. 47. "Misuse of Drugs for Old People Attacked’, the Sydney Morning Herald. 14 March 1980. 48. "Misuse of Drugs for Old People Attacked’, the Sydney Morning Herald. 14 March 1980. 49. "Misuse of Drugs for Old People Attacked’, the Sydney Morning Herald. 14 March 1980. 50. "Elderly "Victims" of Medical System’, the Canberra Times. 27 February 1980. 51. D. de Souza, "Some aspects of clinical therapeutics as applied to geriatric medicine’. The Journal of Geriatrics 1973. pp. 22 3.

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52. O u r Sedated Society: Legal Drug Abuse’, 'Four Corners'. 22 March 1980. 53. de Souza, p. 38. 54. D. Hailstone, ‘Elderly taking too many tablets doctor', the Advertiser, 9 May 1980. 55. "Elderly “victims'" of medical system", the Canberra Times 27 February 1980. 56. "Four Corners’, 22 March 1980; B. Learoyd, "Psychosocial disadvantages of psychotropic

drugs’, Australian Family Physician 4, August 1975, p. 761. 57. Dr A. Schlebaum, From Zygotes to Zombies? A Critical Look at our Children's Brave New World of Chemical Abuse (presented to the First Pan-Pacific Conference on Drugs and Alcohol in Canberra, 1980) p. 1. 58. E. Hvizdala et al., "Intentional Poisoning of Two Siblings by Prescription Drugs: An

Unusual Form of Child Abuse’, Clinical Pediatrics 14. 6. June 1978; Dr A. Schlebaum. pp. 11 1 2 . 59. Aust ral i an Bureau o f Statistics, Australian Health Survey 1977-78, Catalogue No. 4311.0. 60. "Babies Get too Many Drugs Doctors’, the Advertiser. 27 October 1977, p. 3. 61. Wyndham, p. 1. 62. Evidence, p. 335. 63. Evidence, p. 325. 64. Australian Council of Social Service Inc., p. 26. 65. A. Mant, "Determinants of Prescribing of Psychoactive Drugs by General Practitioners'. The

M edical Journal of Australia 14 June 1975. p. 743. 66. Wyndham, p. 2. 67. Wyndham, p. 2. 68. (a) Evidence, p. 330.

(b) Submission from the Faculty of Medicine. Monash University, Submission No. 16. (c) Submission from the Department of Medicine, University of Queensland. Submission No. 25.

(d) Evidence, p. 1221. 69. Evidence, p. 328. 70. Evidence, p. 1193. 71. C. Joyce, "Quantitative estimates of dependence on the symbolic function of drugs'. Scientific

Basis o f Drug Dependence London, Churchill, 1969, cited in I). Wyndham. pp. 5 6. 72. G. Stimson and B. Webb, Going to see the Doctor: The Consultation Process in General Practice. London, Routledge and Kegan Paul, 1975; see evidence, p. 329. 73. Wyndham, p. 6. 74. Australian Council of Social Service Inc., p. 25. 75. Australian Council of Social Service Inc., p. 25. 76. Australian Council of Social Service Inc., p. 25. 77. Evidence, p. 335. 78. Wyndham, p. 7. 79. Evidence, p. 3235. 80. South Australian Royal Commission into the Non-Medical Use of Drugs. "Three Studies in

Drug Use’, Research Papers 3, 4 and 5, Adelaide. 1979. p. 27. 8 1. Commonwealth Department of Health, unpublished statistics. 82. Evidence, pp. 3298-9; Gresham Williams. "Barbiturate deaths rising', the Sydney Morning Herald. 1 March 1980. 83. New South Wales Health Commission, personal communication. 84. Evidence, p. 3261. 85. Unpublished material presented to the Committee by We Help Ourselves Fellowship (W IIOs).

86. Evidence, p. 3194. 87. Evidence, p. 3090. 88. J. F. Kramer and D. C. Cameron (eds). .1 Manual of Drug Dependence. World Health Organisation, Geneva, 1975. p. 33.

89. Commonwealth Department of Health, personal communication. 90. New- South Wales Medical Board and the New South Wales Health Commission, personal communication. 91. Department of Health Services, Tasmania, supplementary evidence.

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CHAPTER 11

M e d i c a t i o n a n d t h e m a i n t e n a n c e o f

h e a l t h

Introduction in this report the Committee has looked at many aspects of drug use in our society. It has examined the conceptual and philosophical framework behind society’s almost unquestioned faith in medication, and has discussed the evaluation, production and distribution systems.

The Committee has concluded that the medical use of drugs in our society has played an important role in the past and will continue to play a significant role in the future. That is not to deny that there are a number of problems with respect to the use of medication. In this report the Committee has drawn attention to a number of areas of concern and has made recommendations which would significantly improve the handling and use of drugs in the community. Greater uniformity between the States, the establishment of minimum standards, the establishment of a more effective and comprehensive information system, a greater community awareness, further evaluation of a wider range of drugs, continued

research and development into the bio-technology and molecular sciences and improved community and medical teaching are just some of the measures the Committee believes would improve the-distribution and use of medication in our society. The Committee believes, however, that the present and future use of drugs should be assessed against the broader aspects of health and not simply in the context of curative (and palliative) medicine. The ultimate objective of medical care, of which drugs are an

integral part, is the attainment of a better level of community health and well-being. Curative medicine concentrates mainly on the negative aspects of health (that is. ill health). Valuable as this is. we need to look as well at other aspects of health. We also need to consider whether or not the use of medication alone is the most appropriate strategy for coping with or preventing particular problems. That is, even if drug treatment is effective, we still need to satisfy ourselves that its use is the most appropriate course of action.

It is with these matters in mind that the Committee believes there is a need for the Australian community to declare for itself a long-term strategy which takes better account of all aspects of health, both curative and preventive, and which ensures that each determinant of health is given appropriate weighting and support. In addition, we need to look critically at whether we have handed far too many problems in our society over to the medical profession. These matters are examined in the remainder of this chapter.

Medicine equals health? Possibly one of the major contemporary misunderstandings concerns the belief that more medical care (which includes not only drugs but doctors, hospitals, health centres etc.)

leads to better or improved health. Aaron Wildavsky. former Professor of Political Science at Berkeley, believes that the medical system based on these indices for measuring health can only account for around 10 per cent of factors determining health.1 The remaining 90 per cent, he claims, arc determined by factors outside the medical sy stem, and are largely uninfluenced by it. Such factors include individual lifestyle, social conditions, physical environment and working conditions.2 The Committee believes that most Western nations hav e poured vast amounts of money, manpower and time into the medical system, not just for the benefits which it confers, but also in the belief that such emphasis can lead to a happier, healthier and more productive society, from the

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individual’s point of view, this belief is undisputed. However, it is not at all clear from a societal point of view that this ever increasing health care expenditure has achieved the desired result. In Australia we have a department of health at Commonwealth level, a health

department or commission at State level, and numerous health centres, clinics and hospitals. By world standards we are more than adequately catered for by doctors and pharmacists; in fact, we could say we are very well catered for in the medical sense. Again

by world standards our housing, water, sewerage and other facilities are excellent overall (even though they may be appalling for particular individuals or subgroups). However, it does not automatically follow that our total health care program is all that it could be. A close examination of the role and functions of the Commonwealth Department of

Health reveals that it is almost exclusively concerned w ith the medical aspect of health (with the exception of certain sections or branches within the Policy and Planning Division and the Public Health Division). Similar conclusions can be drawn from an analysis of the activities of State health departments or commissions. The continued primacy of curative functions within these departments continues to reinforce the arguable proposition that medical care is the prime determinant of health.

The amount of money spent on preventive medical research and health promotion accounts for only a very small percentage of total health care expenditure In the report. Health Promotion in Australia 197

medical services. ’ However we must take into account the large sums of money that are spent annually on such things as water, sewerage, pollution control, hygiene and many other services. The provision of these services provides a valuable and significant contribution to preventive medicine.

Total expenditure in Australia on health and medical care (doctors, hospitals, drugs, health centres etc.) is likely to reach $10 billion4 (approximately 8 per cent of the gross domestic product) in 1980 81. With more and more money being spent one could reasonably ask whether we receive value for money spent in this area. In economic terms it

might be suggested that not only the production or provision of health services has reached the stage of diminishing returns but we have now reached the stage of negative returns (that is. health services have grown to such an extent that lor every additional dollar spent on health services we are deriving a negative benefit).

While the costs of medical care can be easily identified and quantified, the resulting benefits in most cases arc difficult to identify and measure. I he Committee has already discussed in its Report, Through a Glass. Darkly', the need to evaluate both the benefits and costs arising from any health care program. In the absence ol adequate technology lor measuring outcomes in the health area, one’s perception of the benefit depends very much on value judgments, m particular the way in which individuals perceive the role and

availability of medical care.

M ediealisation o f society The concentration on medical care in the health area is sy mptomatic of society s tendency to medicalise as many problems as possible. It would appear that we have reached a stage where medicine has become so refined that we have specialists and chemical substances to

treat just about every disease group. Modern medications are powerful, specific anil .ire effective in many of their uses. More and more of the problems we encounter today are being dealt with almost exclusively by the medical profession, lor example bereavement, loss ol appetite, lack ol energy, tiredness, stiff hack, isolation, obesity, old age. common cold, overwork,

tension . . . and the list goes on and on. By doing this without first looking at our lilestylc. we have come to depend and expect that drugs will be an integral part of the treatment

Carlson, while acknowledging the flood of technological development (huge investment in bio-medical research and development, advances in the basic sciences as well as refinements in electronic instrumentation and computerisation) that has advanced the cause of medicine in recent years, sees a paradox:

Medicine aspires to perfection, even miniaturization reduction of the patient’s problems to manageable and manipulable sets. But as it does so, it erodes its capacity to deal with [the] health of the people . . ,6 Last century, and as recently as 20 to 30 years ago, society held the view that certain behaviour or attitudes were sinful or criminal. Illich claims that:

In a morbid society the belief prevails that defined and diagnosed ill health is infinitely preferable to any other form of negative label. It is better than criminal or political deviance, better than laziness, better than self-chosen absence from work. More and more people subconsciously know that they are sick and tired of their jobs and of their passivities, but they want to be lied to and told that physical illness relieves them of social and political

responsibilities. They want their doctor to act as lawyer and priest.7 Today, many of these problems have been reclassified as a sickness or an illness. The battered child syndrome, the hyperactive child, alcoholism, compulsive eating, com­ pulsive gambling, drug addiction, child molesting and many more conditions are being treated more and more as illnesses and less as problems of behaviour or of society itself. Even our legal system asserts that if the accused was drunk or under the influence of drugs at the time of the commission of a crime (so that he could not form a criminal intent), then

he may not be held totally responsible for his actions.* It would appear that we arc handing more and more problems to the medical profession in the hope that it can use both chemotherapy and psychotherapy to help contain, control or 'cure' people that society regards as deviants from accepted social norms.

This approach has led us to spend more and more money on medical care. It has reinforced society’s belief that individuals cannot adequately look after themselves without the assistance of the medical profession. This has placed more pressure and responsibility on the doctor and has made him a scapegoat when he fails to achieve the impossible. To maintain that position the doctor has relied very heavily on the availability of a great battery of therapeutic substances.

Future o f medicine We are dealing with a very complex problem. There would be difficulties and resistance to any attempt to demedicalise or reclassify particular illnesses or dysfunctions. Neverthe­ less, the Committee believes that many problems have been wrongly or simplistically diagnosed as medical matters when in actual fact such problems would be best dealt w ith in a broader societal and community context. For some problems it is only a societal approach which can hope to be effective in the long term. To a certain extent the system has already become locked in and it would be difficult in the short term to try to change the way in which we treat some problems. A long-term strategy will need to place less reliance on medication, valuable as medication is, and give greater attention and value to other determinants of health in today’s society. Indeed, Carlson states our problem thus:

We have the medicine we deserve. We freely choose to live the way we do. We choose to live recklessly, to abuse our bodies with what we consume, to expose ourselves to environmental insults, to rush frantically from place to place, and to sit on our spreading bottoms and watch paid professionals exercise for us . . . To-day few patients have the confidence to care for themselves. The inexorable professionalisation of medicine, together with reverence for the scientific method, have invested practitioners with sacrosanct powers, and correspondingly vitiated the

* High Court of Australia, Full Court. 20 June 1980. R v O'Connor.

144

responsibility of the rest of us for health . . . What is tragic is not what has happened to the revered professions, but what has happened to us as a result of professional dominance.

In times of inordinate complexity and stress we have been made a profoundly dependent people. The public has been convinced that human suffering is a disease that medicine can cure . . . Most of us have lost the ability to care for ourselves . . . We have not understood what health is . . . The pursuit of health and of well-being will be possible only if our environment is made

safe for us to live in and our social order is transformed to foster health, rather than to suppress joy. If not, we shall remain a sick and dependent people . . . The end of medicine is not the end of health but the beginning . . ,8 Sir MacFarlane Burnet in his book Genes, Dreams and Realities suggests that medicine, in particular drugs, may have made a large contribution in the past, but it cannot be expected to do so in the future.9 He believes that many of the modern diseases and disabilities (cancer, old age, road accidents, alcoholism, drug addiction etc.) cannot

be solved by laboratory medicine (though it can help comfort us), but will be best dealt with by social scientists, environmentalists, ecologists and ethologists.10 Burnet. Carlson and others11 are suggesting that because medicine may have been successful in combatting or controlling diseases and problems of the past, one should not

automatically expect that medicine will overcome or help solve problems and diseases associated with wealth and affluence that presently exist in most Western societies.

Determinants of health It has been suggested that our modern diseases have arisen primarily as a result of society's departure from the conditions of life under which man has evolved. If this is so. one could reasonably ask whether it would be feasible to return to such conditions of life in order to eradicate or modify the diseases that are presently afflicting mankind. McKeown says that society may very well return to some of our ancestral practices, such as increasing exercise, reducing fat consumption and replacing refined flour by wholemeal.12 However, he suggests that we would find it much more difficult to accept all

preventive strategies, for example early and frequent pregnancies, should it be shown that these are the changes needed to reduce the frequency of cancer of the breast.13 It would appear that if we are to make progress in the improvement of society’s health and well-being, not only will we have to place relatively less reliance on medicine, we will also have to be prepared to modify our life-styles (perhaps in ways already practised by

several minorities, such as the Seventh Day Adventists and the Mormons).14 In terms of modern day values, the achievement of good health is not without its costs and sacrifices. Principally these require the denial of present pleasure for future benefit. Are we prepared to incur those costs and make the necessary sacrifices?

If we asked every member of the community whether he or she would like to enjoy good health, the response would have to be a unanimous ‘yes'. However, if it meant giving up certain activities and pleasures the response would not be as positive. There is a dilemma in pursuing a course to bring about improved health within the community.

Society has known for quite some time that health and quality of life are improved by taking exercise, avoiding tobacco, alcohol and other drugs and limiting our consumption of food. If these are the main determinants of health in today's society , w hy is it that governments or local community groups have not openly and actively pursued or tried to create conditions under which such practices are encouraged? The dilemma is that to

promote activities which will encourage better health is also to put at risk the long-term viability of many industries and thereafter some employment opportunities in our community. That is. we have come to depend very heavily on a tobacco industry. a drug

industry, an alcohol industry and a refined food industry as well as other activities which act either directly or indirectly in some degree against the attainment of good health. Garry Egger sees this dilemma and goes so far as to conclude that the root cause of ill

145

health is directly related to our pursuit of maintaining growth-oriented economies. In fact, he claims that it is even a ‘cop-out’ to advocate changes in life-style because he believes this approach, along with curative medicine, only deals with the symptoms.15 Aaron Wildavsky is very pessimistic about the outcome of any actions to promote health. He believes

health policy is pathological because we are neurotic and insist on making our government psychotic. Our neurosis consists in knowing what is required for good health (Mother was right: Eat a good breakfast! Sleep eight hours a day! Don't drink! Don't smoke! Keep clean! And don't worry!) but not being willing to do it. Governments’ ambivalence consists in paying, coming and going: once for telling people how to be healthy and once for paying their bills when they disregard this advice.16 The Committee is not as pessimistic. Realistically, society cannot expect to bring about

radical changes overnight. But society is becoming more aware. More citizens are showing more interest for health-promoting activities, and dietary habits are under closer scrutiny. The declaration of a long-term strategy might help advance further these desir.able activities. Because of the way our health care system is presently structured, it can do little more than serve as a catchment net for the victims that fall prey to environmental and behavioural threats to health. It subsidises the care of illness, but not

those activities which preserve health. Not only do we need to broaden our health care system, we need a change in emphasis as well. The emphasis should be on the promotion of health, not just on the treatment of disease and the pursuit of more and more chemical cures. Today, when people talk about health, they are talking about ill health! Let us

instead be positive!

What can be done? Health is about many things. Medication has played its part well and will continue to play a significant role in the maintenance of health. However, medication alone cannot promote or guarantee a healthy society. All aspects of health must be equally desired and cherished. Commonwealth and State governments, through their respective health departments-(or commissions), must ensure that all citizens have access to both curative and preventive medicine. Beneficial effects of medication will not be enhanced if society continues to rely heavily on the availability of "pills and cures' to put them back on the

road to good health. Medication cannot do what individuals are unwilling to do! What must be made clear is that the Committee is not advocating alternatives to drugs but rather the need to place less reliance on drugs. If alternatives were being considered, the Committee would be campaigning strongly to have them fully evaluated and costed. Similarly, the Committee does not suggest that many of the socio-medical problems presently being treated by the medical profession should be handed over to other groups within the community without the effectiveness of these other professions hav ing been assessed thoroughly.

One may well ask what a government can do to achieve this end. Governments can provide the necessary framework or incentives to enable individuals to make health promotion decisions based on relevant and meaningful information. However, the Committee sees the maintenance of health as being very much the responsibility of the individual. What governments must do is to ensure that individuals have access to the best information possible to improve the decision-making processes regarding health matters.

This Committee sees the following list of possibilities (by no means exhaustive) as measures which governments should adopt as part of a long-term strategy which will lead to a healthier and less drug-dependent society: 1. Total elimination of inappropriate use is unlikely, but action should be taken to try

to minimise the problems. As a first step, the Committee RECOMMENDS that all governments in Australia reaffirm their support (both to the concept and

146

implementation) of the declared strategy outlined in our previous report, Drug problems in Australia— an intoxicated society? In addition, the Committee RECOM M ENDS that all governments take into account the reappraisal of that strategy as outlined in this report. Such a com m itm ent, in the Com m ittee's view,

will help establish the necessary fram ew ork from which all aspects of the drug problem can be considered and feasible policy options developed.

2. To date the em phasis has been on the treatm ent o f disease, not on the prom otion of health. In particular, w hat is needed is a better balance to be struck between the am ount o f m oney spent on medical care and the am ount spent on all other factors which have some relationship to health. The Committee RECOMMENDS that the Commonwealth Department of Health undertake a study to obtain more

information about the relative importance of all determinants of health. An evaluation study o f this nature would provide a valuable insight into the relative merits o f medical care (including drugs) com pared with all other determ inants of

health. This study could then be used to reassess the allocation of public funding in the area o f health.

3. Awareness- - governm ents can m ake effective use of the mass media to get across positive messages on health to the general public. This has been proved by the 'Life. Be in it' cam paign. This cam paign has achieved an almost total com m unity awareness (an evaluation of the cam paign has shown that 88 per cent of

A ustralians know ab o u t N orm and Life. Be in it). While this campaign has achieved great com m unity awareness, it has yet to dem onstrate that the

com m unity has become actively involved in more leisure and recreational activities. It is up to the individual to decide whether he or she wants to heed this advice and participate in some form o f recreation or leisure activity. The Committee RECOM M ENDS that the Commonwealth Department of

Health undertake a pilot study to examine the feasibility of using the mass media to get across to the public effective messages concerning determinants of health other than drugs. These messages could cover such things as diet, exercise, road safety, relaxation and hygiene. The Com m ittee believes that the government can play a

very useful role in providing inform ation to enable individuals to make better inform ed decisions. Such activities could start in the schools w here children could learn the simple basics o f good health and taking care ot their bodies.

4. There has been a great deal o f discussion in recent years about the decline in A ustralia's sporting and athletic prowess. The C om m ittee believes strongly that active com m unity participation in all forms of sport would make a positive contribution to the state of health and well-being within this country. 1 he Com m ittee acknowledges that both the Com m onw ealth and some State governm ents have already taken positive steps in this direction. The C om mittee w holeheartedly supports these governm ent actions and encourages other governm ents to provide or upgrade recreation and sporting lacilities.

The C om m ittee believes that sporting activities have been dow ngraded in. and in m any cases elim inated from, school curricula. The Com m ittee believes that such activities do have an im portant role to play in the physical, mental and educational developm ent of students and as such should not be taken out of school curricula. The Committee RECOM M ENDS that all education departments or their equivalent

reassess the place of sport and physical education within school curricula.

5. The Com m ittee has previously stated in an earlier report. D n n · p ro b lem s in

Australia an in to x ic a te d s o c ic tv7. that governm ents can take the initiative to discourage activities which are deemed harm tul to the individual s health. I he report refers to the banning ol advertising ol such products as alcohol and

1 4 7

tobacco. The Committee urges both Commonwealth and State governments to act upon the recommendations made in this earlier report regarding promotion, advertising and sponsorship by alcohol and tobacco companies. Though there are significant revenue considerations involved in the discouraging of activities which, are detrimental to health, the Committee believes very strongly that governments must face up to this dilemma and not leave it in the "too hard basket".

Conclusions and recommendations The Committee recognises only too well that there are many problems associated with governments actively supporting and promoting a better state of health and well-being in a community. It also acknowledges that such changes cannot be expected to come about overnight. The Committee believes that governments should make a long-term declaration regarding the desirable state of health and well-being in the community. Such a declaration would provide a positive impetus to those activities which promote health and at the same time would give adequate warning to other activities which are detrimental to health. If we do not make moves in this direction, our health, or to be more specific, our ill health, will come to depend more and more on the medical profession and the vast battery of drugs that it has at its disposal.

In particular, the Committee has recommended: that all governments in Australia reaffirm their support (both to the concept and implementation) of the declared strategy outlined in our previous report. Drug problems in Australia an intoxicated society'.', and that all governments take into

account the reappraisal of that strategy as outlined in this report (see page 146): that the Commonwealth Department of Health undertake a study to obtain more information about the relative importance of all determinants of health (see pace 147); that the Commonwealth Department of Health undertake a pilot study to examine the feasibility of using the mass media to get across to the public effective messages concerning determinants of health (see page 147); and

that all education departments or their equivalent reassess the place of sport and physical education w ithin school curricula (see page 147). References 1. Aaron Wildavsky. Doing Better and f eeling Worse: The Political Pathology of Health Policy". Daedalus 1(16. 1. 1977. p. 105. 2. Wildavsky, p. 105. 3. Commonwealth Department of Health. Health Promotion in Australia 197S 79. Canberra. 1979. p. 192. 4. Stall"estimate based on Commonwealth Department of Health projections. 5. Senate Standing Committee on Social Welfare, Through a Glass. Darkly. Evaluation in Australian Health and Welfare Services. Volume One. Canberra. 1979. 6. R. .1. Carlson. The kind of Medicine. John Wiley and Sons. New York. 1975. p. 37. 7. 1. lllich. Medical Xcmcsis The /expropriation of Health. London. 1975. p. 59 8. Carlson, pp. 37. 44. 141.230 31. 9. Sir MacFarlane Burnet. Genes. Dreams and Realities. Pelican. 1973. 10. Burnet, p. 237. 1 I. Burnet. Carlson. T. McKeovvn. The Role of Medicine. Oxford. 1979. p. 184. 12. McKeovvn. p. 183. 13. McKeovvn. p. 183. 14. B. Davidson. 'What Can We Learn About Health from the Mormons?', fa m ily ('in /<· Magazine January 1976. 15. (i. J. F.gger. "Medical Nemesis and Economic Health, or Economic Nemesis and Medical Health: The Modern Dilemma". Journal of Social Issues 13 4. 1978. pp. 287 301. 16. Wildavsky. pp. 122 3.

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SECTION FIVE

B a c k g r o u n d

CHAPTER 12

H i s t o r y o f m e d i c a t i o n

The development o f therapeutic drugs Before the 19th century the only remedies which could have any possible therapeutic efleet were laudanum (which contained opium), ipecacuanha (an emetic agent), mercury, cinchona, digitalis, iron and alcohol.1 Because of the way in which laudanum and

ipecacuanha were used, they could not be regarded as life-saving remedies. Mercury may have cured some cases of syphilis but also probably had disastrous side-effects. Because of the problems with dosage, digitalis, used in the treatment of heart disease, probably killed as many people as it cured. Iron was used as a tonic and occasionally must have had some therapeutic effect. There was also available an incredible array of ineffective and often noxious remedies.

A description of the contents of a doctor's portable medicine chest in the 1770s was given in a recent article in the Medical World News'. T here were . . . 16 bottles containing such medicines as whiskey. brandy, paregoric*, laudanum , calo m elt. j a l a p f and such o th er prep aratio n s as tartar emetic, Dover's pow der (10 per cent

ipecac, 10 per cent opium, 80 per cent potassium sulphate), extract o f lead, friar's balsam, mercurial o intm ent, yellow basilicon . . . (and) . . . an oval box o f D r Fothergill's pills, round and black, m ad e up o f calomel, squill an d digitalis.2

In the 19th century pharmacology began emerging as a science seeking to isolate the active principles in the crude drugs then in use and to define their actions in the body. Sir Derrick Dunlop has listed the drugs that were available at that time: A tropine, callcine, codeine, digitalis, emetine, iodine, m orphine, pilocarpine, physostigmine.

quinine an d strychnine were all isolated; and nitrous oxide, ether, chloroform , chloral, salicyclie acid an d aspirin were synthesized. ’

Alcohol was still regarded as a therapeutic agent and in Worcester Royal Infirmary in 1861,6436 gallons of beer were consumed in 12 months. For financial reasons (not for medical reasons) the Board became alarmed and directions were issued that children under 14 years should be rationed to half a pint a day while patients under 8 years should get none at all.4

At the beginning of the 20th century there was a considerable number of drugs available but still only very few were of any real value. Of these, the only ones in use today arc the belladonna alkaloids, the opiates, cardiac glycosides (digitalis etc.), vaccines lor smallpox and for rabies, diphtheria antitoxin and aspirin.5 The picture remained static with only minor modifications until shortly before World War II.

The drug revolution began in 1935 with the discovery of the first sulphonamidc. This discovery made effective treatment of bacterial infections possible for the first time and set in motion mass discoveries of the modern chemotherapeutic and antibiotic agents. The next discovery was of sulphapyridine and occurred during World War II. Antibiotics were

then discovered the first of these was penicillin. Although penicillin was pioneered by Florey and studed later by Fleming in 1929. enormous difficulties had been encountered in producing it in quantity. By 1941. United States pharmaceutical companies had

* Paragoric is a camphorated opium tincture, t Calomel is a mercurous chloride, t Jalap was used as a purgative.

151

developed it into a practicable economic proposition on a small scale, and, in 1944, on a bulk scale. Adding to the list of antibiotics, streptomycin was discovered in 1945 and after the war neomycin (1949) and oxytetracycline (1950) were developed. Antihistamines were also developed during this time.

In the 1950s anticholinergics, antithyroids, cortisone and vaccines against polio and measles were developed. In the 1960s antirheumatics, oral contraceptives and effective antidepressants came into being. During the 1970s anti-Parkinson agents and anti­ asthmatics were developed. By 1976 there were over 200 drug discoveries. The following graph illustrates this drug revolution:

220 200

180 160 140

120 100 80 60

40 20

Source: Australian Pharmaceutical Manufacturers Association. 'Fact Book: The Prescription Medicine Indlistrv in Australia'. Sydney. 1977. p. 60.

In spite of the dramatic increase in the number of therapeutic drugs available over the last 50 years, there is still a long way to go. There is a need for remedies for heart disease, cancer, stroke, schizophrenia, arthritis, kidney failure, cirrhosis and the degenerative diseases associated with ageing. In the United States there are about 25 major afflictions, and many more in the less developed countries (viral, parasite and nutritional diseases), which require a remedy.6

The following table outlines the effect of these drugs on airborne diseases by show ing the decline in mortality from each disease since the introduction of a specific therapy. Table 12.1 shows that about a quarter of the fall in mortality from all airborne diseases occurred after the introduction of therapeutic measures (second last column). It also

shows that the fall in deaths which occurred from airborne diseases after the introduction of therapy is about one-tenth of the fall in deaths from all causes.

The development o f the drug industry

Pharmacies In the 1850s one Melbourne pharmacy dispensed only 6 prescriptions daily. It is estimated that this pharmacy serviced 10 000 people.7 Today, the picture has changed dramatically. It is estimated that each pharmacy dispenses an average of 60 prescriptions8 per day and that there is 1 pharmacy per 2700 people.6

The work of the pharmacist has changed over this time, also. On the gold fields in the 1850s, a pharmacist weighed gold for prospectors, preserved fish paste for housewives, and removed lice from humans and worms from animals. Because doctors' services could be afforded by only the wealthy, the pharmacist dispensed few doctors' prescriptions. His

Figure 12.1 Cumulative Major Drug Discoveries: 1910 1976

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152

Table 12.1: Airborne diseases: fall of mortality since introduction of specific measures of prophylaxis or treatment: England and W ales

Year when specific F allbv 1971 Proportion o f Fall a fter introduction

Fall in standardized Fall as percentage measures after introduction total fa ll after oj spec if ice measures as

death-rate between o f fa ll fro m became o f specific introduction o f percentage o f total fa ll

Cause 1848-54 and 1971 all causes available measures specific measures fro m all causes

( a) ( b) (<·) (c/a) { b e / a )

Tuberculosis (respiratory) Bronchitis,

2 888 17.5 1947 409 0.14 2.5

pneumonia, influenza 1 636 9.9 1938 531 0.32 3.2

Whooping cough 422 2.6 1938 43 0.10 0.3

Measles 342 2.1 1935* 50 0.15 0.3

Scarlet fever 1

1 016 6.2

f 1935 15 1

0.30 1.9

Diphtheria j | 1894 292 /

Smallpox infections of

263 1.6 Before 1848 263 1.00 1.6

ear, pharynx, larynx 73 0.4 1935 65 0.89 U.4

6 640 40.3 1 668 0.25 10.1

* treatment of secondary infections was available in 1935, but measles vaccines were not available until 1955. Source: T. McKeown,‘The Role of Medicine Dream, Mirage or Nemesis', Oxford, 1979, p. 51.

own personal medicine-prescribing business constituted up to 80 per cent of his total dispensing, and about 50 per cent of his total sales.10 In the 19th century the pharmacist's shop featured a street-front window, which was

usually decorated with ornate jars and bottles lilted with coloured liquid. Inside, there were many jars, bottles and drawers filled with commonly used medicines. Compound medicines were made in the dispensary, which was hidden from the public by a screen. In a third room, quantities of infusions, tinctures, oils and ointment boxes were manufac­ tured, usually by an apprentice, from raw ingredients. The development of local wholesalers who were able to supply galenicals in ready-made form gradually made this

third room unnecessary. With the advent of factory-made medicines at the beginning of the 20th century, most of the medicines in jars and bottles on display in the shop were relegated to the dispensary to make room for distinctively packaged patent medicines, cosmetics and photographic requisites.11

Today, the pharmacist still relies on the sale of products other than drugs to earn income. The latest retail census conducted in 1973 74 reveals that 53.2 per cent of total sales in pharmacies represented professional business or medicinal sales in that thev were related to drugs, medicines and therapeutic appliances.12 The rest related to cosmetics,

perfumes, toiletries, toys etc. Nearly all prescription medicines are now read} -prepared bv the pharmaceutical manufacturing companies and the pharmacist is only required on a few occasions to compound his own medicine.

The medical profession It is difficult to estimate the number of medical practitioners in existence in the earlv dav s of Australia because before the 1850s there was no law to prevent anv person from setting up practice.13

In Victoria in July 1857, after an Act to regulate the practice of medicine was passed in 1854. there were 487 registered medical practitioners14 or 1 doctor per 930 people.1 In 1972 there were estimated to be 17 900 to 18 000 doctors in the Australian work force1 or 1 doctor per 700 people.17

153

In the 19th century the mortality and morbidity rate was high. Serious illness, pain and disfigurement were common, slight wounds became infected and minor irritations like toothache and headache became major preoccupations. As mentioned above, the drugs available at the time were mostly ineffective and there was therefore very little a doctor could do to remedy the ailment. Dr Douglas Gordon, Professor of Social and Preventive

Medicine at the University of Queensland, comments:

It is a puzzle why midst this chronic and recurring human slaughter doctors not only retained their reputations but were in fact more highly revered and paid comparatively more than they are today.18 He concludes that the reason for this is that most patients on average will recover irrespective of the illness. Therefore, if the doctor managed to practise between great epidemics, he would have appeared highly successful.19 Today, armed with greater

knowledge, more effective drugs and more sophisticated methods of surgery, the doctor is far more successful in treating illness.

The pharmaceutical manufacturing industry There were several drug manufacturers established in Australia in the 19th century. The English firm of Burroughs and Wellcome, for example, set up its overseas agency in Australia in 1886.20 In fact, the development of the local industry is typified by foreign firms establishing overseas agencies in Australia. The local industry has been centred on

the importation, from parent or subsidiary companies, of active ingredients which are then formulated and packaged to suit Australian conditions and requirements. Very little published statistical data are available which traces the development of the industry over the past 70 80 years. One can only assume that the pattern and rate of growth was similar to that experienced overseas, but on a far smaller scale. For example, in the United States

the most rapid development, accompanied by the greatest number of changing circumstances, has taken place in the last few years. Ely Lilly & Co., for example, is 94 years old; yet in terms of growth, it took 75 years to reach the first $ 100 million sales level, 14 years to reach $200 million. 4 years to attain $300 million, and only 2 years for $400 million and a little more than 1 year for $500 million.21

The Australian Bureau of Statistics has published Australian Standard Industrial Classification data for the Pharmaceutical and Toilet Preparations Industry from 1960-61 to 1967 68. From 1968-69 to date, pharmaceutical products were reclassified into the Australian Standard Industrial Classification group, "Pharmaceutical and Veterinary Products'. The following table and Table 5.1 above provide, at best, only a

Table 12.2: Pharmaceutical and toilet preparations industry: summary of statistics: 1960-61 to 1967-68

Year Factories

Persons employed Salaries and wages paid

Value of materials Value of used production Value of

output

(S'OOO) ($’000) ($'(>00/ ($■000)

1960 61 .................................. 212 7 805 14 896 47 260 64 310 113 254

1961 62 .................................. 211 7910 15 728 51 171 66 258 119 024

1962 63 .................................. 209 8 058 16 940 55 176 63 996 121 022

1963 64 ................................. 213 8 173 16 904 56 454 73418 130 943

1964 65 ................................. 230 8 818 19 492 67 061 84 588 149 877

1965 66 .................................. 236 9 342 21 667 68 577 88 243 158 231

1966 67 ................................. 227 9 782 24 251 75 843 103 568 180 997

1967 68 ................................. 228 10010 26 148 80 631 112 942 195 230

Source: Australian Bureau of Statistics; taken from Pharmaceutical Manufacturers Association, 'The Prescription Medicine Industry in Australia, Fact Book', Sydney, 1973, p. 6.

154

very broad picture of the development of the industry because pharmaceutical products cannot be separated from the other goods which are not under reference to this inquiry.

The history of the Pharmaceutical Benefits Scheme In 1944 the Pharmaceutical Benefits Act was passed. This Act provided free medicines but only if prescribed from a government formulary. The Victorian Branch of the British Medical Association (forerunner to the Australian Medical Association) appealed to the

High Court against the Act on the grounds that it was coercive in nature and interfered with professional freedom. It won its case and the Act was declared ultra vires. A second attempt was made in 1947 to introduce a Pharmaceutical Benefits Act. This Act listed certain free medicines but also bound the medical profession to use government

prescription forms and a Commonwealth formulary. In 1949 the British Medical Association again appealed to the High Court, which again declared the Act ultra vires. After a change of government in 1949, Sir Earle Page, the new Minister for Health, introduced the Pharmaceutical Benefits Act in 1950. This provided a range of drugs without cost to the patients. These products were listed in a formulary; however, the prescriptions could be written on the doctors' ow n forms. In 1951 a wider range of drugs was made available free of charge to pensioners.

During the 1950s the list of drugs available through general and pensioner pharmaceutical benefits expanded with advances in medical knowledge. In 1960 a major recasting and expansion of the Scheme took place. The general and pensioner schemes were amalgamated and almost the entire range of medicines in both Schemes was made available to the general public. Persons other than pensioners were required to pay a fee ol 50 cents for each prescription. Since then there have been 5 further adjustments to the patient contribution: in November 1971 it was raised to S1.00. in September 1975 it was raised to $1.50, in March 1976 it rose to $2.00. in July 1978 to S2.50 and in September 1979 to $2.75.22

The development of the Pharmaceutical Benefits Scheme in terms of size is illustrated in Table 12.3. During the 1960s and 70s the range of medicines in the Scheme also increased markedly. In June 1961 there were 436 individual medicines listed as benefits. In June 1976

this had grown to 644 an increase of 48 per cent.23 It is estimated that the Pharmaceutical Benefits Scheme accounts for about 66 per cent24 of the total prescription medicine market including hospital use.

Conclusions The development of therapeutic drugs has meant a marked improvement in the availability of effective remedies. Before the "drug revolution" many substances were used as panaceas but very few had any real therapeutic effect. Today, a more scientific approach has been taken to medication and most active substances must be thoroughly tested and proved for a particular illness before they can be marketed. There is very little- reliance now on panaceas.

The drug distribution system has also changed markedly over this century. A pharmacist now must have recognised qualifications. However, because most drugs arc- prepackaged, he may be losing some of the skills of mixing ingredients possessed by former chemists. The number of pharmacists in business has increased and therefore access to drugs has been made easier. This ready access is added to by the availability of some medication in supermarkets and health food stores.

The number of drugs subsidised by the Government under the Pharmaceutical Benefits Scheme has increased greatly over the last 40 years. This means that for the consumer most medication is now very cheap.

155

Table 12.3: Number and Cost of Pharmaceutical Benefits Prescriptions 1948-1979

Year Total cost

Number

o f prescriptions*

$'000 ‘000

1948 49 ........................... 298 281

1949 50 ........................... 609 484

1950-51 ........................... 5 860 3 759

1951-52 ........................... 15 370 8 171

1952-53 ........................... 14 431 9 620

1953-54 ........................... 18 459 10 498

1954-55 ........................... 21 479 13 620

1955-56 ........................... 23 775 14 206

195657 ........................... 23 434 14 626

1957 58 ........................... 30 068 16 623

1958-59 ........................... 41 946 20 075

1959-60 ........................... 50 562 24 653

I960 61 ........................... 66 087 31 217

1961 62 ........................... 83 388 37 714

196263 ........................... 91 653 42 192

1963-64 ........................... 94412 44 357

1964 65 ........................... 99 044 47 556

196566 ........................... 109 265 49 993

1966 67 ........................... 1 19 628 53 687

1967 68 ........................... 123 639 55 423

1968 69 ........................... 138 503 60 408

1969 70 ........................... 158 660 65 575

1970 71 ........................... 184 659 71 487

1971 72 ........................... 208 735 72 442

1972 73 ........................... 226 273 74 676

1973 74 ........................... 277 311 87 288

1974 75 ........................... 329 125 97 674

1975 76 ........................... 379 086 101 117

1976 77 ........................... 346 579 89 705

1977 78 ........................... 371 073 93 167

1978 79 ........................... 400 860 92 781

1979 80 .......................... 398 053 89 819

* General and pensioner prescriptions combined.

Source: Commonwealth Department of Health, Submission to the Com­ mittee, Appendix 6A; Annual Reports of the Director-General of Health, 1977 78, 1978 79 and 1979 80.

Overall, the development of therapeutic drugs and the allied distribution system has brought improvements in the making and marketing of medicines.

References

1. G. A. Broe, Changing Aspects of Medical Care (an address given at the Royal North Shore Hospital. Sydney, 1969). p. 2. 2. Quoted in Organon Pty Ltd. submission to the Committee, pp. 2 3. 3. Sir Derrick Dunlop. 'The Innovation, Benefits, Drawbacks and Control of Drugs", Journal of

the Royal Society o f Medicine 71. May 1978. p. 324. 4. Broe. p. 3. 5. G. B. Chesher and R. C. Winkler. Pharmacological Progress and Problems in Health Care". Search 5. 10. October 1974. p. 460. 6. L. Thomas, "Medical Science: Where Has It Been? Where Is It Going'.'" Horizons L'.S.A. 26.

1978, p. 46.

156

7. The Victorian College of Pharmacy Ltd, supplementary submission to the Committee, p. 4. 8. The Victorian College of Pharmacy Ltd. p. 5. 9. See Chapter 5. 10. N. C. Manning and Η. V. Feehan, 'The Gold-field Druggist'. The 1V dorian Historical Journal

48, 4, p. 321. 11. G. Haines, 'The Grains and Threepenn’orths of Pharmacy: Pharmacy in New South Wales 1788 -1976’. Kilmore, 1976, pp. 116-117. 12. Η. V. Feehan and A.C. Manning,'The Market for Medicines Pharmacy's Share. 1968 69 to

1975-76', The Australian Journal o f Pharmacy May 1977. p. 297. 13. E. A. Mackay, 'Medical Practice During the Goldfields Fra in Victoria'. Medical Journal of Australia 26 September 1936. p. 422. 14. Mackay. p. 428. 15. Population of Victoria in 1857 was 456 500 (Australian Bureau of Statistics figures). 16. D. Gordon, Health, Sickness and Society. St Lucia. Queensland. 1976. p. 766. 17. Population of Australia in 1971 was 12.755 million (Australian Bureau of Statistics. Australian

Life Tables 1970-1972). 18. Gordon, p. 4. 19. Gordon, p. 165. 20. Haines, p. 71. 21. C. W. Pettinga. "Drug Discovery. Science and Development in a Changing Society'. Gould. R.

F. (ed.), Advances in Chemistry Series 108, Washington. D. C. American Chemical Society. 1971, quoted in M. Diesendorf, 'The Magic Bullet’, Canberra. 1976. p. 34. 22. Australian Pharmaceutical Manufacturers Association, Fact Book: The Prescription Medicine Industry in Australia, Sydney, 1977, pp. 46 -7. 23. Australian Pharmaceutical Manufacturers Association. 1977. p. 49.

24. See Table 2.9.

157

C H A P T E R 1 3

B a c k g r o u n d a n d c o n d u c t o f the inquiry

The Senate Standing Committee on Social Welfare was established by resolution of the Senate on 2 March 1976 and replaced the former Senate Standing Committee on Health and Welfare. Under the terms of this resolution, the present Committee was empowered to inquire into and report on such matters in its area of responsibility as had been referred to the Legislative and General Purpose Standing Committees appointed during previous sessions and not been disposed of by those Committees.

One of the references not fully disposed of by the Health and Welfare Committee was the 'continuing oversight of relevant aspects of the Report of the Senate Select Committee on Drug Trafficking and Drug Abuse.' However, the Health and Welfare Committee did investigate and present a report in February 1975 on the recommendations of the Select Committee’s report and identified areas which the Health and Welfare Committee

believed warranted further investigation. On 26 May 1976, Senator Baume, on behalf of the present Committee, presented a report on outstanding references from the former Standing Committee on Health and Welfare and advised that the Standing Committee on Social Welfare had resolved to 'continue the oversight and from time to time investigate selected aspects raised in earlier reports’. He advised that initially the Committee intended to examine further the extent and nature of the inappropriate use of alcohol, tobacco, narcotics and other drugs. The report of this inquiry. Drug problems in Australia an intoxicated society7, was subsequently presented to the Parliament on 25 October 1977.

On 24 May 1978, Senator Baume announced that under its charter to maintain an oversight of relevant aspects of the 1971 Senate Select Committee's Report on Drug Trafficking and Drag Abuse, the Senate Standing Committee on Social Welfare had decided to examine 'the use and abuse of medication available over the counter or on

prescription".

C ollection of evidence In order to gain the latest information from the widest number of sources, the Committee advertised its terms of reference in the national press on 17 June 1978, inviting written submissions. A press release announcing this inquiry was sent on 26 May 1978 to 35 metropolitan and country newspapers and a further press release, this time inviting submissions, was sent on 12 June 1978. In addition, letters inviting submissions were sent to 75 individuals and organisations, of whom 48 responded. Seventy-two submissions were eventually received (sec Appendix 5).

The Committee also took evidence from 84 witnesses (see Appendix 4). Of these, 24 were from government departments, 53 from organisations and 2 from business companies, while 5 appeared in their own right. Altogether, 16 public hearings were held in Canberra, Sydney, Melbourne and Adelaide.

In order to gain further information, the Secretariat collected and indexed over 500 published and unpublished papers which related to medication, and referred to information supplied in other reports dealing with drugs. These reports included the South Australian Royal Commission into the Non-Medical Use of Drugs (Sackvillc

Report); the Progress Report from the Joint Committee of the Legislative Council and Legislative Assembly upon Drugs: the Australian Royal Commission of Inquiry into

158

Drugs; the Report of the Interdepartmental Working Party on the Drug Problem in Victoria, and the Pharmaceutical Manufacturing Industry Inquiry.

Expert adviser In order to gain a practical view of the situation with regard to medication, the Committee wished to employ an adviser who was working in the field. The Committee was fortunate to obtain the services of Professor William Louis, M.B., B.S.. M.D., F.R.A.C.P . who is Professor of Clinical Pharmacology and Therapeutics at the University of Melbourne and is engaged in work at the Austin Hospital. The Committee sought formal approval from the President of the Senate to secure his services on 21 May 1980 and was granted this approval on 27 May 1980. The Committee would like to thank Professor Louis for devoting much of his valuable time to providing expert adv ice on many matters raised in this report.

Commissioned data During the inquiry it became obvious to the Committee that the data which are currently being used to estimate the level of consumption of medication in the community were grossly inadequate. The Committee therefore commissioned data on pharmaceutical sales by chemists from Intercontinental Medical Statistics (Australasia) Pty Ltd to help rectify this situation. The Committee is grateful to Mr Norman Taylor. Joint Managing Director of Intercontinental Medical Statistics (Australasia) Pty Ltd, who not only supplied the data originally requested but willingly answered many subsequent queries which the Committee posed.

The Committee is also grateful to the Australian Pharmaceutical Manufacturers Association who supplied data on the sales of medication to hospitals. Until now . public- data on total hospital consumption of drugs have been completely lacking.

Acknowledgments The Committee would like to thank the witnesses who appeared before it to give oral evidence. The Committee also expresses its gratitude to those who presented submissions

but who were not called to give evidence. Much of the information in these submissions was used in drafting the final report. The Committee was pleased with the response ot some State Premiers and their departments and for the co-operation that they gave. It also

wishes to thank the staff of the Parliamentary Library w ho have obtained innumerable reports and research papers for the Committee. The technical nature of the report has meant that additional demands were made on the Secretariat staff. They were required to familiarise themselves with the correct use of innumerable medical terms and the Committee is deeply appreciative of their dedication to the task. The Committee thanks the former Secretaries. Bob Thomson and Paul

Barsdell. and the present Secretary. Peter Keele. w ho joined the Secretariat in the middle of a very difficult reference which he most ably completed. The Committee also thanks Patricia Mayberry and Pamela Gulloni. research officers, and Eleanor Gilmour. steno- secretary. for their support.

An outstanding debt of gratitude is owed to Senator Peter Baunie. the former Chairman of this Committee. Although he was unable to preside over the final drafting of this report, his ideas and influence did have a great bearing on the Committees deliberations.

159

Survey of sales of therapeutic drugs from manufacturers to hospitals 1974-1979

A P P E N D I X 1

$’000

Category 1974 1975 1976 1977 1978 1979

Antibiotics 8 968.4 9 321.0(a) 10 401.5 10 811.9 11 037.0 12 576.2

Cardiovascular drugs Psychotropics

1 800.5(a) 2 132.0(a) 2 949.7(a) 3 798.4(a) 4 043.3 4 847.1

Total 2 854.0 3 044.7 3 206.5 3 510.7 3 011.2 3 624.8

Neuroleptics 1 161.8 1 307.5 1 507.7 1 841.7 1 789.9 2 152.0

Other tranquillisers 969.2 954.9 802.1 766.6 445.8 530.9

Antidepressants 363.0 334.5 346.5 392.1 356.3 514.7

Psychostimulants (b ) (b) (b) (b) 7.3 9.8

Barbiturates Non-barbiturate sedatives 28.9 29.8 40.8 39.1 35.7 40.2

and hypnotics 331.1 418.0 509.4 471.2 383.5 387.0

Anti-asthmatics 1 382.7 1 410.8 2 109.8 2 608.6 2 913.1 3 117.5

Antineoplastics 862.2 1 148.0 1 848.4 2 789.0 2 844.1 2 784.7

Antispasmodics 528.0 524.1 684.8 1 283.4 2 286.3 2 506.7

Hormones 1 471.0 1 524.1 1 806.5 2 108.8 2 437.6 2 478.6

Dermatologicals 2 051.5(a) 2 337.6(a) 2 715.5(a) 2 472.0(a) 2 605.2 2 198.8

Analgesics 1 011.0 1 270.1 1 609.3 1 738.8 1 826.6 1 887.9

Anticoagulants Anti-arthritics (including 574.0 1 296.3 2 063.1 2 461.0 2 205.8 1 747.7

topical) Anaesthetics

789.4(a) 867.3(a) 1 001.1 1 279.4 1 391.4 1 438.6

Local and topical 417.7 719.4 939.8 1 176.6 1 175.3 1 424.9

Other (.b) (b) (b) (b) 849.2 65.3

Diuretics 1 538.5 1 610.3 1 883.2 1 786.1 1 588.5 1 417.9

Anticonvulsants Inorganic elements (includes 436.3 434.6 542.6 807.8 1 109.9 1 338.8

Calcium) 377.8 503.8 669.1 882.0 1 170.6 1 324.4

Muscle relaxants 239.6 326.0 489.2 646.2 838.6 991.5

Dietetics 273.5 353.6 313.3 541.9 709.6 782.2

Diabetic therapy 553.4 733.1 977.4 737.8 706.9 760.0

Opthalmic preparations Gynaecological (Anti-387.1 475.6 659.8 626.6 547.3 734.4

infective) Cough and cold preparations 103.8 1 12.1 159.6 178.5 222.0 719.4

General 124.1(a) 162.0(a) 228.4(a) 253.3(a) 445.2 555.4

Containing antihistamines (b) (b) (b) (/>) 5.1 6.9

Hematinics 155.6 143.6(a) 233.3(a) 220.8(a) 342.5 536.5

Tuberculosis preps 639.4 550.5 (b) (b) 390.2 467.3

Enzymes 81.0(a) 140.3(a) 185.9(a) (b) 448.6 451.8

Hemostatics 228.1(a) 341.9(a) 360.3(a) 454.2(a) 424.2 440.1

Vitamins Antidiarrheals (includes intestinal anti-infectives and

177.3(a) 200.2(a) 246.0(a) 279.7(a) 320.4 413.3

anti-monilials) 214.2 197.7 217.6 289.5 366.2 362.7

Oxytocics 156.9 153.0 175.7 188.3 215.3 249.8

160

$'000

Category 1974 1975 1976 1977 1978 1979

Antihistamines 251.5 377.7 467.7 216.7 189.9 232.1

Laxatives 95.8(a) 129.7 (b) I/O 182.4 221.1

Parasympathetic agents 95.6 180.8 186.9 164.4 199.9 214.9

Antimalarials 41.2 43.9 58.4 100.0 106.0 204.9

Haemorrhoidal preps 94.7 120.5 113.2 99.3 179.6 170.5

Urinary antiseptics 137.7 1 15.2 121.5 135.2 1 18.1 142.6

Cholesterol reducers (b) (b ) (b ) (b) 116.3 125.2

Otic preparations 51.8 89.4 100.6 107.5 97.9 124.6

Biologicals 113.8 323.0 544.1 562.4 559.9 108.9

Antiobesity 125.3 1 17.5 121.8(a) 100.4 87.4 76.0

Thyroid therapy (b) (b) (■ b ) (b) 34.7 42.5

Diagnostic aids 198.9 272.5 509.3 437.0 218.3 32.0

Tonics 12.5 12.2 25.7 I/O 25.8 29.4

Sulfonamides 18.6 13.5 2.1 11.1 14.7 16.2

Hepatic therapy 11.9 (6) 17.5 0.7 0.3 0.6

Miscellaneous 752.3(a) 1 060.8(a) 943.2 982.4(a) 1 663.3 2 039.2

Other 2 224.0 1 394.3 2 325.8 3 260.8 1 079.9 1 580.5

Total 33 096.7(a) 36 925.2(a) 44 984.9(a) 51 015.5 54 324.7 58 740.3

(a) Approximate. (b) Cannot be estimated from available information.

161

A P P E N D I X 2

U s e o f m e d i c a l l y p r e s c r i b e d p s y c h o t r o p i c d r u g s ( s e d a t i v e s , a n t i d e p r e s s a n t s a n d t r a n q u i l l i s e r s ) : a c o m p i l a t i o n o f s u r v e y i n f o r m a t i o n 1 9 7 1 — 1 9 7 7 ( f i g u r e s g i v e n a s p e r c e n t a g e o f t o t a l s a m p l e u n l e s s s t a t e d o t h e r w i s e )

Date o f Sam ple population d

% o f sam ple ever using

A uthors survey terminology used M F T

% currently using M F T

% using daily ( a) or several times per week M F T

l. George Winter I97l Sydney. Northern beach suburb. 639 persons

(279 households) aged 14 + years Sedatives and tranquillisers:14— 2 1 years 22-29 years 30 39 years

4(M9 years 50-59 years 60-65 years

8.1 11.6

2.6 13.9 5.4 14.9 11.8 27.9 15.9 45.3 30.8 41.4

Total sample 33 10.0 23.6 7.0(5.1)

2. Hennessy Bruen Late 1971 Canberra, 1422 persons (525 households) & Cullen Sleeping tablets:

Adult population (over 18 years) Adolescent population (13-18 years) Tranquillisers: Adult population (over 18 years) Adolescent population (13-18 years)

Antidepressants: Adult population (over 18 years) Adolescent population (13 18 years)

11.6 16.2 14.0 3.8(2.4) 7.1(5.1) 3.8 3.0 — — Nil

7.7 14.4 11.2 2.4(1.7) 6.0(4.7) 3.2 1.5 — — Nil

2.9 4.9 3.9 1.4(1.4) 2.6(2.4) 2.0

Not asked Not asked

3. Krupinski & Stoller 1972 Melbourne. 3950 persons aged 13 -23 years Sleeping tablets: Secondary students Tertiary students Working youth

Total sample

Tablets for Secondary students nerves: Tertiary students

Working youth

Total sample

4. George 1973 Sydney western suburb. 1011 persons aged

14 65 years Sedatives & tranquillisers: Age 14- 21 years Age 22 29 years Age 30-39 years

Age 40 49 years Age 50 59 years Age 60 65 years

9.8 2.0(0.4)

13.0 1.9(0.3)

10.5 1.7(0)

11.1 1.9(0.3)

8.0 2.7(0.9)

11.2 2.1(1.2)

11.8 5.2(1.3)

9.6 2.7(1.1)

2.9 6.1

6.0 7.1

9.2 18.5 14.4 32.7 11.1 18.6 21.4 45.5

Total sample 32 8 16 13 3.1(2.2) 8.6(6.6) 6.1(4.6)

1.7 6.9

2.7 13.1 9.9 19.4 17.0 28.2 15.6 27.7

8.8 18.7

0 0.8

0 2.4

4.4 4.3

4.3 9.9

Date of Sam ple population &

% o f sample ever using

Authors survey terminology used M F 7

% currently using M l · T

% using daily (a) or several times per week M F τ

60 + years

Total adults

6. Bell, Champion & 1971 & 1972 NSW. Sample of high school, technical college Rowe students and nurses (sedatives)

1971: High school Form 4 Form 6 Technical college students Nurses 1972: High school Form 4

Form 6

Tech Technical college students Nurses 1973: High school Form 4 Form 6

Technical college students Nurses

7. Irwin 1973 & 1974 Canberra. High school students aged 11 19

yrs (Sedatives) 1973 (N =5464) 1974 (N =5138)

8. Graves August 1974 Ballarat. 1157 secondary and tertiary students and apprentices Sleeping tablets: Secondary students Fm 3 Fm 5

Tertiary students

Tablets Secondary students Fm 3

for nerves: Fm 5

13.9 21.9

5.1 8.9 7.1

27.4 14.5 3.6

19.0

14.3 16.8

30.6 14.4 19.4 16.1 2.9(1.2) 4.5(1.8) 3.6(1.4) 12.6 15.7 13.7 2.2(0.7) 3.3(2.2) 2.6(1.3) 17.7 27.2 19.3 2.9(1.1) 5.8(2.2) 3.5(1.3) 19.6 18.6 18.8 2.9(0) 3.7(1.2) 3.6(1.1)

13.8 5.7 4.8 4.9 - 1.1(6)

4.2 — - 1.4

10.4 2.2(0.3)

11.6 3.8(0.8)

7.5 0.6( Nil)

4.1 1.6(0.5)

9.1 2.1(0.8)

9.5 1.7(0.3) Tertiary students

9. Turner & McClure November Queensland. 3362 school students (Grades 1974 6-12) from 132 schools (depressants) 5.1 4.2 4.7 3.2 2.9 3.1

10. Carrington- 1974 Hobart. 500 women aged 18-60 years. Sed-

Smith atives — 55.0 — — 17.6

11. Gwynne, Shiraev & October 1498 households (3898 persons) in Gosford Armstrong December area and 1619 households (5236 persons) in 1975 Illawarra area of NSW. Total of 3117 house­ holds (9134 persons; only 15+ years figures

given—under 15 years figures excluded due to high error rate)—tranquillisers, sedatives etc. sleeping pills & medicines Gosford-Wyong: Tranquillisers, sedatives etc.

15^14 years 45-64 years 65+ years

Total Sleeping pills 15^44 years 45-64 years 65+ years

Total

Illawarra: Tranquillisers, sedatives etc. 15 44 years 45-64 years 65 + years

Total Sleeping pills 15 44 years 45 64 years

65 + years

Total

2.3 5.2 3.8

12.4 17.4 15.2 14.2 17.1 15.7

8.1 11.9 10.1

2.8 1.7

8.1 8.1 8.1

15.5 21.1 18.4

6.3 8.7 7.6

0.9 5.3 3.1

7.9 13.5 10.7 14.5 9.8

3.1 8.3 5.7

0.7 1.8 1.2

5.8 5.5 5.6

5.8 17.3 11.9

2.4 4.2 3.3

0.7(0.3)

(7.8)

Authors

Date of Sam ple population < $ ■

survey terminology used

% o f sam ple ever using M F T

% currently using M F T

% using daily ( a) or several times per week M F T

12. Reynolds et al. 1975 & 1976 Sydney. 23 032 adults who had been through a Medicheck screening (sedatives, tranquillisers, or antidepressants) 1975 sample 1976 sample

13. Gibson et al. 1975 & 1976 Sydney. 9829 adult (17 + ) members of the Australian Workers Union (tranquillisers or sedatives)

14. Magro 1976 Sydney. Canterbury Municipality. 206 Aus­

tralian born women aged 21 + years (tranquil­ lisers & hypnosedatives) 21- 30 years 31-40 years

41-50 years 51-60 years 60+ years Unknown

(7.4) (18.6) 6.7 16.1

6.1 12.7

2.3 2.3 20.5 27.2 45.4

2.3

Total

15. Egger & Champion 1977 NSW. 2298 Form 4 high school students in 30 schools

21.3 11.7

18.2 9.6 10.9 10.2 2.7(0) 34(2.1) 3.0(1.0)

(

A P P E N D I X 3

C o d e R e l a t i n g t o Et hi c al A d v e r t i s i n g

Advertisements for publication which promote pharmaceutical preparations should only include data which satisfy the following criteria except where provided for under the conditions set out in paragraph M.

A The ‘approved’ names of the active ingredients and the strengths, concentrations or proportions thereof are clearly and legibly stated in the body of the advertisement.

B There is a clear statement of indications for use of the preparation based on acceptable evidence of clinical experience.

C The dosage regimen to be observed in the use of the preparation is stated.

D There is a statement of the precautions to be observed in the prudent use of the preparation having regard to the reported experience of clinicians as appearing in the literature or as published by the Adverse Reactions Committee of the Australian Drug Evaluation Committee.

E The known toxic effects of or undesired reactions to or degree of dependence potential of the preparation in a significant proportion of instances shall be enumerated. F The likelihood of the preparation’s producing potentiating or negating effects in

relation to other substances or being potentiated or negated in its effect by the presence of other substances including therapeutic substances, foods or other environmental influences shall be made known.

G There shall be no statement bearing on the efficacy of the preparation w hich rests on the citation of a report in such a way as to mislead the reader by omitting relevant parts of such reports or by quoting from such reports in such a way as to imply a meaning other than the report intended.

H There shall be no unfaif or unsubstantiated comparisons drawn against other preparations so as unreasonably to impute to the preparation advertised a superiority of effect or advantage to the patient or the prescriber. I The name of the manufacturer of the preparation shall appear in all advertisements

or, in the case of preparations manufactured outside Australia, the name and address of the local distributors. J Should the availability of the product under the N HS be indicated, then the status of its availability must be included, e.g. "NHS unrestricted" or "NHS (SP)' etc.

K Advertisements must be clearly distinguishable from editorial matter; where there could be doubt, the word ‘advertisement’ will be required. L Statements of opinion must not be presented in such a way that they could be read as statements of fact. M The definition o f ‘reminder’ advertisements previously published no longer applies.

Guidelines for the preparation of ‘reminder’ advertisements are appended to this Code. ( T h e basic co n cep t is th a t a 're m in d er' a d v e rtise m e n t is one w hich serves to re m in d

p r a c titio n e r s th a t a p a rtic u la r p rep a ra tio n is a vailable, o r to k e e p a p a rtic u la r b ra n d n a m e in th eir m inds.

167

The amount oj written material in such an advertisement will therefore always he minimal. The amount of'promotional' material will be absolutely minimal.) N The information required by paragraphs A M shall appear in each publication in a

type face of not less than 6 point.

Guidelines for the preparation of reminder advertisements (As described under paragraph 'M' of the Code Relating to Ethical Advertising)

1 Essential requirements

1.1 The ‘approved’ name of the preparation must be stated. Sometimes, but certainly not always, depending on the particular drug, it may be necessary to indicate the particular chemical form of the preparation (e.g. Fluphenazine enanthate or decanoate etc.).

1.2 The name of the company which either manufactures of distributes the drug must be stated.

2 Optional inclusions

2.1 Major indications. A statement on ‘indications’ is no longer mandatory, but it is acceptable to include a brief statement of indications, e.g. ‘for the treatment of upper respiratory and urinary infections due to susceptible gram-positive and gram-negative organisms’. Acceptable statements on indications would rarely be

much longer than this example. Not all the indications of a preparation need to be included should the advertiser care to mention indications at all.

2.2 It is no longer necessary to state the strengths, concentrations or proportions of active ingredients, although this may be done if desired.

2.3 Dosage forms. If a variety of dosage forms exist (e.g. tablet and injection), and the advertiser wishes to mention tablet size or injection strength etc., it is not necessary to mention this for each dosage form in existence.

2.4 The company address is not required but may be included if desired.

2.5 A Arzc/statement on NHS availability may be included but is not necessary. For example, 'available NHS 100, 2 repeats’ or ‘available NHS (SP)' or ‘NHS unrestricted’ would be acceptable.

2.6 A statement to the effect that ‘further information is available on request' may be included. It would be satisfactory to say ‘for information contact “A" Laboratories’.

3 L nacceptable inclusions

3.1 Dosage must not be mentioned. Promotional material such as ‘a once a day antihistamine’ would not be regarded as infringing this requirement.

3.2 Statements on precautions, toxic effects, drug interactions etc. are unacceptable in reminder advertisements.

3.3 Comparisons, overt or covert, with other preparations are unacceptable. For example, 'the antibiotic of choice for . . .’ would rarely be acceptable as there is an implied comparison.

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3.4 Reference should rarely be necessary in reminder advertisements. They will only be accepted under special circumstances.

4 Promotional material

4.1 The amount o f ‘promotional' material will be minimal. It is not possible to be more precise in this area without unnecessarily restricting the freedom of advertisers to promote. The limits can therefore only presently be defined by precedent.

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A P P E N D I X 4

List of witnesses Aldred, Dr J. E., Acting Assistant Director, Public Health (Food and Drugs), Health Commission of Victoria Arnold, Dr P. C., Honorary Secretary, General Practitioners’ Society in Australia,

Parramatta, New South Wales Baker, Detective Chief Inspector G. D., Officer-in-Charge, Criminal Investigation Branch Drug Bureau, Victoria Police Department Barnes, Mr F. I. L., Immediate Past Chairman, National Medical Media Council,

Artarmon, New South Wales Berbatis, Mr C. G., Clinical Pharmacist, Pharmacy Department, Fremantle Hospital, Western Australia Bond, Lieutenant J. H., Manager, Salvation Army Crisis Centre, St Kilda, Victoria Brooks, Dr G. E., Director, Pharmaceutical Services, Department of Veterans’ Aifairs,

Canberra Brown, Mr E. R., President, Pharmaceutical Society of Australia, Canberra Butt, Mr E. J., Federal Secretary, Australian Pharmaceutical Manufacturers Association, Sydney, New South Wales Chant, Ms N. S., Executive Assistant, Australian Council of Social Service Inc., Sydney,

New South Wales Chapman, Mr S. F.. Senior Research Officer, School of Public Health and Tropical Medicine, University of Sydney Clarke, Dr Μ. V., Chairman, Pharmaceutical Benefits Advisory Committee, Department

of Health, Canberra Conomy, Dr A. B., Consultant in Medicine, Department of Veterans' Affairs, Canberra Cook, Mr J. C., Vice-President, Proprietary Association of Australia, Sydney, New South Wales Crews, Mr W. D., Crisis Centre Director, Wayside Chapel, Potts Point, New South Wales

Darby, Mr N. D., appearing as private citizen, Greenwich, New South Wales Darvall, Dr L., Lecturer in Legal Studies, La Trobe University, Melbourne, Victoria Davies, Mr R. P., Director, Health Research Division, Pharmacy Guild of Australia, Canberra Davis, Mr I. N„ Pharmaceutical chemist and manager of pharmacy in Elsternwick, East

Bentleigh, Victoria Davis, Mr J. L., Acting Principal Pharmacist, South Australian Health Commission. Adelaide De Souza, Dr D., First Assistant Director-General, Therapeutics Division, Department

of Health, Canberra Engel, Dr G. B., Consultant, Proprietary Association of Australia, Sydney, New South Wales Firkin, Professor B. G., Professor of Medicine, Department of Medicine. Monash

University, Prahran, Victoria Flemming, Dr K J. A., Chief Director. Medical Services, Department of Veterans' Affairs, Canberra Frew, Dr J. L., Member, Australian Drug Evaluation Committee Gammon, Dr D. A., Medical Director, Deer Park Community Health Centre. Deer Park.

Victoria

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Gentile, Mr A. J., Executive Officer, Australian Retailers Association, Food Division. Sydney, New South Wales Gianoutsos, Royal Australasian College of Physicians representative. Medical Board of New South Wales, Sydney, New South Wales Goldstein, Dr G., Member, New South Wales Branch, Doctors Reform Society, Sydney,

New South Wales Goulston, Dr S. J. M., Chairman, Australian Drug Evaluation Committee Grassby, The Honourable Albert Jaime, Commissioner for Community Relations, Canberra Griffin, Mr B. C., Chief Pharmacist, Health Commission of New South Wales Griffiths, Mr W, M., Principal Pharmacist, Department of Public Health. Western

Australia Guthrie, Mrs Μ. B., Secretary and Patient Interviewer, Patients Complaints Council, Mount Waverley, Victoria Guthrie, Mr W. J., President, Proprietary Association of Australia, Sydney, New South

Wales

Hall, Dr M. C., Acting Director, Scientific Research Directorate, Australian Federal Police, Canberra Hannaford, Mr J. P., Vice-President, We Help Ourselves Fellowship, Crows Nest, New South Wales Hausfeld, Dr J. F., President, Medical Consumers' Association of New South Wales,

Sydney Haydock-Wilson, Mr O. G., Principal Research Officer, Australian Federal Police. Canberra Hellyer, Dr R. O., Chairman, Technical Committee. Proprietary Association of

Australia, Sydney, New South Wales Hyde, Miss T., Regional Director Canberra-Goulburn, We Help Ourselves Fellowship. Crows Nest, New South Wales Irwin, Dr R. P., appearing as private citizen, Canberra Johnson, Dr G. F. S., Convenor, Psychotropic Drug Committee, Royal Australian and

New Zealand College of Psychiatrists, Carlton, Victoria Jones, Mrs Μ. M., Convenor for Proposed National Frail and Aged Protection Society. Noble Park, Victoria Kelly, Mr N. R., Executive Director, Australian Pharmaceutical Manufacturers

Association, Sydney, New South Wales Kessell, Dr A., Acting Inspector and Director, Alcohol and Drug Services, Mental Health Division, Health Commission of Victoria Fees, Mr A. J., President, Association of Retail Pharmacy Employees, New South Wales,

Longueville, New South Wales Fevy, Mr L. LL. Proprietor, Fen Fevy Chemist. St Kilda, Victoria Lim, Mr Y„ Consultant, Slimax Laboratories, Wantirna South. Victoria Lord, Mr R. J., Honorary Secretary, National Medical Media Council, Glebe, New

South Wales Lord, Mr R. T., Committee member, Weston Creek Community Health Centre. Canberra Louis, Professor W. J., Member, Pharmaceutical Benefits Advisory Committee.

Department of Health, Canberra Manning, Mr R., Director, Public Relations, Pharmacy Guild of Australia. Canberra Matthews, Mr J. P., President, Pharmacy Guild of Australia (New South Wales Branch). St Leonards, New South Wales McClintock, Ms J., Program Co-ordinator, Australian Council of Social Service Inc..

Sydney, New South Wales McLean, DrS. R., Senior Lecturer, School of Pharmacy, University of Tasmania. Hobart 171

Mewes, Mr B. R., Chief Pharmacist, Health Commission of New South Wales, Sydney, New South Wales Miller, Mr B. R., Federal Secretary, Society of Hospital Pharmacists of Australia, Heidelberg, Victoria Montgomery, Dr R. B., Member, State Executive and Convenor, Political Issues

Committee, Australian Psychological Society, Parkville, Victoria Muir, Mr J. W., First Assistant Commissioner, Treatment Services, Department of Veterans’ Affairs, Canberra Pollnow, Mr P. G., Assistant Office Manager, We Help Ourselves Fellowship, Crows

Nest, New South Wales Potts, Mr F. D., Chief Inspecting Pharmacist, Tasmanian Department of Health Services, Hobart Purches, Mr j. A., Acting President, Australian Pharmaceutical Manufacturers

Association, Sydney, New South Wales Rankin, Professor J. G. D., Director, Division of Drug and Alcohol Services, Health Commission of New South Wales Repin, Dr G. D., Secretary-General, Australian Medical Association, Glebe, New South

Wales

Richardson, Mrs E. N., Secretary, Australian Association of Dietitians, Canberra Robinson, Mr C. N., Representative of Market Research and Strategy Planning, Hospital Benefits Association Ltd. Melbourne, Victoria Ross, Dr J., Senior Poisons Control Officer, Poisons Control Services, Health

Commission of Victoria Russell, Mr A. A., National President, Pharmacy Guild of Australia, Canberra Ryan, Mr P., Executive Director, Pharmaceutical Society of Australia, Canberra Shields, Mr A. E., Assistant Director-General, Pharmaceutical Benefits Branch,

Therapeutics Division, Department of Health, Canberra Somogyi, Mr L., Economist, Australian Pharmaceutical Manufacturers Association, Sydney, New South Wales Stock, Dr B. IT, Vice-President, Pharmaceutical Society of Australia, Canberra Straton, Dr J. A. Y., Lecturer in Social and Preventive Medicine, Department of

Medicine, University of Western Australia, Nedlands Taylor, Mr N. F. A., Managing Director, Intercontinental Medical Statistics (Austra­ lasia) Pty Ltd, Crows Nest, New South Wales Thompson, Dr H. L., Vice-President, Australian Medical Association, Glebe, New

South Wales Turnbull, Miss M. A., Director of Admission and Crisis Services, We Help Ourselves Fellowship, Crows Nest, New South Wales Vernon, Mr M. 1, Chairman, Consumer Affairs Council of the Australian Capital

Territory, Canberra Wade, Professor D. N., Director, Department of Clinical Pharmacology, St Vincent’s Hospital, Sydney, New South Wales Wardell, Mr A. J., Executive Director, Proprietary Association of Australia, Sydney,

New South Wales Wilkinson, Mr W, J., President and Chairman, Pharmacy Board of New South Wales, Sydney Wilson, Mr R. E. MacDonald, Assistant Director-General, Therapeutic Goods Branch,

Therapeutics Division, Department of Health, Canberra Winton, Dr R. R., Former Deputy Chairman, National Medical Media Council. Artarmon, New South Wales Yates, Mr I. G., Secretary-General, Australian Council of Social Service Inc., Sydney,

New South Wales

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A P P E N D I X 5

List o f s u b m i s s i o n s

1 Ms Kath Mattschoss 2 Dr Trevor Sauer 3 Australian Greek Welfare Society 4 Ms Jill Hellyer

5 The Victorian College of Pharmacy Ltd 6 R. D. Goldney, University of Adelaide 7 Pharmaceutical Society of Victoria

8 S. Chapman, University of Sydney 9 Professor R. Winkler, University of Western Australia 10 Dr P. G. Penington, University of Melbourne 11 Ms J. Straton, University of Western Australia 12 Dr J. Najman, University of Queensland 13 Professor I. C. Lewis, University of Tasmania 14 Yoland Lim 15 Australian Federation of Business and Professional Women 16 Monash University Faculty of Medicine 17 Tertiary Education Commission 18 D. N. Darby, University of New South Wales 19 B. Wood & K. J. Breen, St Vincent's Hospital 20 Dr Leanna Darvall, La Trobe University, Melbourne 21 Professor Richard Gye, University of Sydney 22 National Medical Media Council 23 Commonwealth Department of Health 24 Dr W. T. Frieson, the University of Tasmania 25 Professor B. T. Emmerson, University of Queensland 26 Professor J. G. Ryan, University of Queensland 27 Doctors Reform Society 28 Dr R. A. Anderson, the University of Sydney 29 The General Practitioners Society of Australia 30 Australian Council of Social Service Inc. 31 C. G. Berbatis, Fremantle Hospital, Western Australia 32 Dr J. N. Santamaria, St Vincents Hospital, Victoria 33 Commonwealth Department of Veterans’ Affairs 34 Advertising Federation of Australia 35 Victorian Government 36 Western Australian Government 37 Roussel Pharmaceuticals Pty Ltd 38 Ciba-Geigy Australia Ltd 39 The Australian Drug Evaluation Committee 40 Dr G. D. Champion, St Vincent’s Medical Centre, Sydney 41 Organon (Australia) Pty Ltd 42 Australian Pharmaceutical Manufacturers Association 43 Joint Committee- -Voluntary Proprietary Medicine Advertising Code 44 Australian Medical Association

45 Upjohn Pty Ltd 46 Capital Territory Health Commission 47 NSW Government 48 Consumer Affairs Council of the Australian Capital Territory 49 Dr R. P. Irwin, Canberra College of Advanced Education 50 Professor J. A. Hersey, Director of the Institute of Drug Technology Ltd, Victoria 51 The Australian Psychological Society 52 Lilly Industries Pty Ltd 53 Dr K. D. Rainsford, the University of Tasmania 54 Hospital Benefits Association Ltd 55 The Society of Hospital Pharmacists of Australia 56 Australian Retailers Association 57 Dr T. Gavranic, Evatt, Australian Capital Territory 58 Dr R. S. Nanra, the Royal Newcastle Hospital 59 The Australian Association of Dietitians 60 Dr R. J. Phipps, Kiama, New South Wales 61 The Proprietary Association of Australia 62 Commissioner for Community Relations 63 Department of the Capital Territory 64 The Pharmacy Guild of Australia 65 The Royal Australian and New Zealand College of Psychiatrists 66 South Australian Government 67 Mr R. J. Monson, Rabaul, Papua New Guinea 68 Professor P. Kincaid-Smith, Royal Melbourne Hospital 69 Pharmaceutical Benefits Advisory Committee 70 Association of Retail Pharmacy Employees New South Wales

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