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Wednesday, 8 February 2012
Page: 338


Mr DUTTON (Dickson) (18:22): I rise to speak on the National Health Amendment (Fifth Community Pharmacy Agreement Initiatives) Bill 2011. The Commonwealth allocates considerable taxpayer funds for community pharmacy to provide timely access to medicines. The most recent pharmacy agreement will provide $15.4 billion over a five-year period to fulfil this important role in our health system. There are 5,000 community pharmacies across the country dispensing around one-quarter of a billion scripts a year. The coalition in government provided policy certainty and stability for community pharmacy. We support in principle the fifth agreement but will continue to consider carefully all legislative changes presented to this parliament.

The bill before us enacts the Continued Dispensing Initiative and the Medication Chart Initiative as included in the Fifth Community Pharmacy Agreement between the Commonwealth and the Pharmacy Guild. It also makes amendments to conditions for authority-required medications. The continued dispensing provision will allow pharmacists to supply pharmaceuticals without a prescription, however the eligible pharmaceutical items and the conditions of supply are not specified in this bill. Proposed section 89A subsection 3 states that the minister will determine the details by legislative instrument.

The then Health Minister, Hon. Nicola Roxon, said in her second reading speech that the measure will apply to oral hormonal contraceptives and lipid modifying agents. These two groups were chosen apparently because they are well tolerated and have a good safety profile. This is also reflected in the government's consultation paper issued in 2011. Importantly, the consultation paper does provide some more specific parameters and context for this particular initiative. It states:

The Continued Dispensing initiative will apply where a patient has run out, or is about to run out, of their essential continuous therapy medicine/s and does not have a valid prescription available.

The patient must be able to demonstrate they have been prescribed the medicine for at least a six month period and have been taking the medicine immediately prior to the request for continued dispensing.

The supply of increased maximum quantities based on an 'Authority Approval' will not be permitted.

… supply under this initiative cannot be utilised on consecutive occasions.

There will be no switching of medicines within the same class.

The department's briefing notes further clarify that patients must not have received the medicine by continued dispensing within the last 12 months. The department also states that the pharmacist must provide within 24 hours written communication to the most recent prescriber advising of the supply of the medicine to the consumer. It is important that the medical practitioner remains the principal care provider and is kept fully informed of patient treatment, especially when pharmaceuticals have been supplied under section 89A subsection 1 without a prescription.

The Australian health workforce, particularly the medical profession, continues to face shortages and maldistribution. Any change in scope of practice for a particular health profession must reflect the skills of those practitioners and not be a rash attempt to provide a second-best option for Australians otherwise unable to access treatment.

On the available information, the targeting of this provision to two common, well-tolerated medications, in combination with clear conditions and protocols, assists in addressing any issues regarding patient safety. However, the coalition's concern is that this detail was not contained within the legislation. It is a common practice of this government to defer considerable detail to delegated legislation, with the risk being the final instrument does not reflect an earlier intent. In this instance, we could not be sure that the legislative instruments would reflect the conditions stipulated in Minister Roxon's second reading speech—and Minister Roxon was notorious for this practice.

Whilst it would be preferable to have a copy of the draft legislative instrument, I do welcome the information that the current minister's office has provided on the proposed legislative instruments in response to the coalition's concerns. Nevertheless, there remains some unease that eligible pharmaceuticals and conditions may be changed into the future. However, such changes would have to be by legislative instrument and therefore subject to parliamentary scrutiny and disallowance.

The coalition will carefully consider any future changes in close consultation with all stakeholders, including the medical profession. The proposed continued dispensing initiative is intended to complement existing emergency supply provisions. The existing and proposed provisions assist patients to continue their treatment when presenting to pharmacies without a valid script.

The outcome of a Pharmacy Guild survey is contained in the government's consultation paper. Conducted in January 2009 and involving 2,000 guild member pharmacies, it found: firstly, approximately 67 per cent of pharmacies are presented more than five times a week with a situation where supply of a medicine is requested to be dispensed in the absence of a prescription in order to ensure continuity of therapy; secondly, that 43 per cent of respondents indicated the main reason given for such a request was difficulty with obtaining an immediate appointment with the prescriber; and, finally, approximately 64 per cent of the respondents considered that five or more patients attending their pharmacy per week may not be compliant because of difficulties with current emergency supply arrangements.

'Owing prescription' protocols already allow a pharmacist to supply a PBS medicine after contacting the patient's doctor by telephone. The doctor is required to provide the pharmacy with a prescription within seven days. The pharmacist will be able to continue to supply under the owing prescription protocols pharmaceuticals not covered by section 89A. It is argued that for well-tolerated medicines with a good safety profile and high volume supply, the continued dispensing provision will reduce the administrative burden associated with owing prescription procedures.

In addition, pharmacists can supply under emergency provisions without a script. Under state and territory regulations, this allows a three-day emergency supply of an essential medication. The medication is dispensed as a private item and the patient has to pay the full cost as opposed to just the PBS co-payment. It is argued that 'breaking' full packs to provide just three days' supply can lead to wastage for pharmacists and risks incorrect dosage. Also, it leaves patients out of pocket as they are not eligible for subsidies under the PBS and it only provides for a very limited supply. Despite these difficulties, it will also continue to be available in addition to the proposed continued dispensing regime. I also note that Minister Roxon gave an undertaking for a review after two years. The PBS statistics that are published annually should also contain information on the continued dispensing provisions. This is not reflected in the legislation. It is something the coalition would like to ensure does occur, and I will be addressing this further during consideration in detail. The coalition's proposal is consistent with the government's stated intent and should be facilitated by recording requirements contained in guidelines for pharmacists.

Guidelines for the continued dispensing of eligible prescription medicines by pharmacists have been developed by the Pharmaceutical Society of Australia. The purpose of the guidelines is to assist pharmacists to meet their professional responsibilities, exercise professional judgment in individual circumstances and manage risks associated with the continued dispensing of eligible prescribed medicines. The guidelines require an appropriate recording mechanism. They stipulate that information recorded by pharmacists should include: the date of the request for medicine supply without a valid prescription; consumer details such as name and address; the medicine requested, including strength, form and directions for use; the reason for the request; most recent prescriber and practice details; dispensing history; consumer history and clinical notes obtained during consultation; and details of any communication with other health professionals or providers and the prescriber. Therefore, according to the guidelines, sufficient data should be recorded and available to facilitate the publication of detailed statistics and an appropriate review of the measure's implementation and use.

More broadly, it is important in the context of this bill to understand the process by which medicines are subsidised and made available through the PBS. Minister Roxon said that continued dispensing would help prevent the interruption of treatment for patients prescribed eligible medicines and ensure they do not bear the financial burden of the full cost of those medicines. This was a reasonable position for the then minister to advocate. Unfortunately, though, Labor's actions, particularly over the last 12 months, have seriously jeopardised timely access to subsidised medicines for Australian patients. In fact, Labor's actions fell well short of their rhetoric.

There has been longstanding bipartisan support for an independent process of assessing which medicines should be subsidised by government. The Pharmaceutical Benefits Advisory Committee rigorously assesses medicines according to set criteria. A recommendation is then provided to the health minister. Until recently, the minister could list medicines costing less than $10 million in a given year. Cabinet considered medicines over $10 million. Almost without exception, previous governments listed medicines according to the advice of the PBAC. In February 2011, the government indefinitely deferred the listing of seven new medicines and a vaccine recommended by the PBAC due to the Commonwealth's 'fiscal circumstances'. This occurred just months after Minister Roxon signed a memorandum of understanding with Medicines Australia to provide policy stability in return for $1.9 billion in savings to the PBS. Minister Roxon promised that the MoU would provide:

… policy predictability to the industry for the next four years, cut red tape and speed up the addition of new medicines to the PBS.

But the ink was not even dry on the paper—in fact, it was only a matter of months—when Labor dishonoured this signed agreement, sent the sector into policy chaos and denied patient access to important medicines.

The government's decision to subject all PBAC recommendations to cabinet and refuse to list medicines based on the government's fiscal situation set a very dangerous precedent. For the first time, it subjected the listing of medicines to a political decision. After a Senate inquiry and considerable public pressure, the government eventually agreed in September last year to list medicines deferred in February. However, the government's announcement did not provide any greater certainty for the PBS listing process. The Gillard government announced on 30 September last year there would be further 'deferrals into the future' for new medicines being subsidised on the PBS. The government only committed to not deferring 'drugs that cost under $10 million a year for the coming year'. At this stage, we do not know which patients are going to be denied access in the future to their medicines and on what grounds. While we are considering an initiative today that is supposed to improve continuity of access to medicines, the government's broader pharmaceutical policy is causing uncertainty that may lead companies to reconsider the costly process of listing new medicines in Australia.

The pharmaceutical sector is also important for the health and wellbeing of our economy. Medicines Australia recently highlighted that the pharmaceutical sector in Australia had exports to the value of $3.7 billion in 2011. This is compared to $2.5 billion for the car industry and $2 billion in the wine industry. The Australian medicines industry is reported to have grown 1,200 per cent since 1990 and employs over 14,000 people. Constant changes to the listing process risk patient access to medicines and jeopardise a very important sector in our economy. The coalition renew our call for the Gillard government to rule out further deferrals and to subsidise new medicines according to the independent advice of the PBAC.

The second initiative in this bill will allow for the supply and claiming of pharmaceuticals based on a standardised medical chart in residential aged-care facilities. This measure has broad support, with the claim it will reduce the administrative burden in aged-care facilities and improve patient safety. The Australian Commission on Safety and Quality in Health Care has commenced development of a standardised chart, and further consultation is due to occur during 2012. According to the commission, the National Residential Medication Chart Project will develop standardised information fields and layouts. It will enable pharmaceutical supply and PBS claiming directly from the chart. It follows the development and implementation of the National Inpatient Medication Chart by health ministers in 2004 for use in public hospitals. This is also a standardised medical chart designed to improve patient safety and specifically intended for hospital use.

It is common for residential aged-care facilities to use the inpatient chart at present, but the commission has identified a number of potential problems. Aged-care facilities have differing medication management needs to hospitals, including but not restricted to the following: they have long-stay residents with chronic conditions and comorbidities rather than short-stay, unstable, acute-care patients; they have general practitioner rather than frequent specialist prescribing; medicine administration is not always conducted by registered nurses; PBS medicines require duplicate documentation unlike in public hospitals; and many ongoing and regular prescription medicines are delivered in prepackaged dose administration aids, which are prepared off-site rather than dispensed by a co-located pharmacy.

Whilst a separate standardised medication chart for aged care may still be a way off, it is appropriate that pharmaceuticals can be supplied and claimed for from the chart. Removing the need for a separate prescription is a simple and sensible way to reduce red tape for providers, staff, pharmacists and medical practitioners.

The third schedule of the bill addresses the minister's power in relation to conditions that must be satisfied for prescribing in certain circumstances. As outlined in the explanatory memorandum, this includes specifying different conditions, including maximum quantity and repeats for medicines with different uses. The schedule clarifies that determinations made under section 85A are a legislative instrument.

In conclusion, the coalition do not oppose this bill but we intend to ensure the government's assurances are honoured. Unfortunately, we know this government does not have a good recent history on keeping to its word. The Coalition will propose amendments to ensure that a review is conducted of continued dispensing and is publicly available after two years. We will also act to ensure annual statistics are published on pharmaceutical items supplied under this initiative. I do appreciate that the continued dispensing provision may be contentious. However, on the available information the current proposal in a number of ways is more limited than existing provisions and the coalition's amendments will allow genuine scrutiny of the implementation and operation of the measure.

The proposed conditions are appropriately restrictive and will be subject to further parliamentary scrutiny as disallowable instruments. An important condition is that there will be timely feedback to the prescribing medical practitioner within 24 hours to help maintain continuity of care for the patient. Whilst we do not oppose the initiatives in this bill, we will hold the government to its word through our amendments and we will examine in detail future legislative instruments.