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Monday, 20 August 2018
Page: 7697


Ms McBRIDE (Dobell) (11:33): I rise to speak in support of the Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018, as it will go some way to improving continuity of supply of critical medications in Australia. I'm pleased to follow my colleague, the member for Macarthur, Dr Mike Freelander, and I echo his concerns about the critical shortage of lifesaving medications that we experience all too commonly in Australia today. This bill amends the Therapeutic Goods Act 1989 to introduce a mandatory reporting scheme for medicine shortages and decisions to permanently discontinue supply involving high-risk medicines in Australia, and for the introduction of civil penalties for noncompliance with the scheme.

I come to this legislation with some experience. I've been a pharmacist for 20 years. I was the Chief Pharmacist of Wyong Hospital, in my electorate of the New South Wales Central Coast, for many years and later sat on our local Central Coast health district's Drugs and Therapeutics Committee. I've been the person who picked up the fax alert—and, yes, in public hospitals they're still commonplace—late on Friday afternoon that a medication such as fentanyl, which is difficult to run an operating theatre without, was out of stock. Currently, 0.5 per cent plain bupivacaine is out of stock and won't be available for at least another three to six months, which means that common procedures like hip and knee surgery are affected. I've been part of drug and therapeutics committees' decisions considering individual patient use applications from specialists for patients on discontinued medications, such as antipsychotics like thioridazine, through the Special Access Scheme, or SAS, as it's the only treatment that is effective and keeps someone out of hospital.

One of the central roles of any pharmacy service in all settings is inventory control, particularly of life-saving medicines, where a shortage or discontinuation would be of critical impact. I welcome any measure that would improve certainty or continuity of supply and early notification of a discontinuation or shortage.

Early in my career, it was rare to experience shortages in commonly prescribed medications. It's now becoming increasingly common. Medicine shortages represent a growing and potentially life-threatening risk to patients in Australia whose health depends on access to those medicines. Medicine shortages may occur, and do, more frequently in a more globalised economy with consolidation of manufacturing operations and less manufacturing occurring locally, in Australia. Many people might be surprised that common medications such as insulin aren't manufactured in Australia. If there were a critical shortage, where would that leave diabetics in our community? If more production occurs in fewer sites with the consolidation of the globalised economy in manufacturing, especially overseas, there may be less redundancy and more risk of interruptions.

I spoke to a director of pharmacy yesterday, and he was lamenting that we now end up in a queue, and the Australian market or the Australasian market isn't a big market to global pharmaceutical companies. Without local capacity to manufacture, if there is a shortage, there can't be a quick upscale in manufacturing to be able to respond to a change in demand. It's a significant concern. With manufacturing or production occurring in fewer sites—especially overseas, as I pointed out—there'll be less redundancy and more risk of interruptions. Similarly, a single manufacturing plant may produce multiple brands of a particular medicine that has the same pharmaceutical ingredients. When a disruption occurs, many brands are affected at the same time.

The voluntary notification scheme where sponsors are encouraged to notify the TGA of medicine shortages hasn't worked. In fact, I was at a pharmacy training course over the weekend and thought I'd ask the pharmacists there. Many pharmacists that I spoke to weren't aware that this voluntary scheme had been introduced or hadn't seen any improvement since its introduction. Under this scheme, a significant number of shortages of medicines with a critical impact on patients haven't been reported, and therefore a mandatory scheme is considered necessary. An example—I know this example has been discussed before—is the recent shortage of EpiPens, which wasn't reported to the TGA until January 2018, despite Australia's only EpiPen supplier being aware of the issue in November the year before.

This has been such a critical issue that the Society of Hospital Pharmacists of Australia, of which I'm a member, conducted a survey last April. It really highlights the widespread nature and extent of this problem. The SHPA gathered data from 280 healthcare facilities across Australia. What it revealed was that stopgap solutions such as ordering medicines from overseas or using emergency stock have now become commonplace. The SHPA president, Professor Michael Dooley, said:

… the results of the … survey show the extent of medicines shortages across Australian hospitals is broad - and worsening -and processes for monitoring are struggling to keep up.

Information about current or impending shortages was also found to be 'highly unreliable', with shortages flagged by pharmaceutical suppliers only 15 per cent of the time, according to the survey respondents. Professor Dooley said:

When we cross-referenced the responses with warnings and alerts available that day through government websites, including TGA's Medicine Shortages Information portal, 85 per cent of reported shortages were not listed by their respective companies—

according to the survey. Further, he continued:

There are … worrying signs beyond the data - anecdotally, many pharmacists contacted SHPA saying they wanted to list additional shortages, but ran out of time.

This is commonplace when you're working in pharmacy departments in public hospitals, particularly when the alert comes through, as it commonly does, on Friday afternoon and, firstly, you have to see what stock you have within the pharmacy department, then what stock is impressed in the wards of the hospital and then whether it's something that there is isn't a substitute for or another way of accessing. I've been in the situation, which is a very uncomfortable situation, where you have to talk to the executive of the hospital about trying to get something put in a cab from Royal North Shore to get to Wyong Hospital in order for somebody to receive the treatment they need.

According to the SHPA, 70 per cent of respondents found out about medicine shortages when trying to order stock, prompting them to switch brand of drug, or to use emergency stock or to procure stock through the TGA Special Access Scheme. Typically, this increased costs in 93 per cent of cases. Just over 32 per cent of shortages were reported to have had a direct impact on patient care. This was through swapping to a less-effective medicine; changing the administration due to a different form or route of administration—perhaps by switching from IV to oral medication; or, in many cases, through a lack of suitable alternative. Hospital pharmacists reported 1,577 individual shortages across a wide range of medicine classes, with the top five being: antimicrobial medicines, with almost 40 percent of shortages; anaesthetics—and I did mention bupivacaine plain at five per cent, which is out of stock at the moment; cardiology medicines; and endocrinology medicine, which Dr Mike Freelander, the member for Macarthur, touched on earlier. He mentioned about Metformin XR, which is one of the most commonly prescribed medicines for type 2 diabetes, being out of stock for a prolonged period of time. The list finishes then with chemotherapies.

SHPA CEO, Kristin Michaels, notes that Canada has recently regulated the reporting of shortage of medicines and vaccines by manufacturers and wholesalers, providing our Australian government with a precedent to address this urgent issue. These measures have been developed in consultation with industry and are supported by the Pharmaceutical Society of Australia and The Society of Hospital Pharmacists of Australia, as I have mentioned. In commenting on the introduction of this legislation, the SHPA CEO, Kristin Michaels, said:

… a nationwide system for managing and communicating medicines shortages through the Therapeutic Goods Administration (TGA) will improve patient outcomes.

I welcome this. Further, she said:

The prioritising of medicines used to treat acutely ill patients in hospitals, through the Medicines Watch List—

Which I have been looking at today—

will reduce the will reduce the amount of time hospital pharmacists spend seeking alternative or replacement medicines.

Hospital pharmacists provide care for the more seriously ill Australians and, by prioritising the visibility of shortages of medicines that are critical to this acute care, pharmacy teams can ensure they are on the front foot managing and resolving shortages before they adversely affect patients.

The PSA, the Pharmaceutical Society of Australia, has also emphasised pharmacists' firsthand experience with confused and distressed patients, and their carers, when a medicine—especially for an emergency health situation or chronic condition—is not available. It's a very difficult conversation to have with a patient or a carer when you have to explain to them that the only medication that keeps them well, or the only medication that they can tolerate if they're a treatment refractory patient, is one that isn't available.

These measures will go some way in making sure of continuity of supply, so that patients, carers, pharmacists and prescribers aren't landed in the situation—which they are too commonly now—where there isn't the lead time to be able to make those clinical considerations or to discuss with the patient and their carer what an appropriate substitute might be, how they might be able to access it and what it might mean for their continuity of care.

I have seen this myself, especially in my role as a mental health pharmacist in acute inpatient units, when a medication has been discontinued and the patient has less than a few week's supply. They don't know whether their only option might be to risk switching to a less-effective medication or to be admitted to hospital—not something that most mental health patients want. Understandably, that is quite distressing for all patients.

To put it in a global context, the PSA, the SHPA and others understand that medicine shortages occur worldwide for a variety of reasons. They have worked closely with the TGA and other stakeholders to help improve the response to shortages, but there are still significant gaps and problems in this procurement pathway in Australia. The PSA supports mandatory reporting of medicine shortages which is based on the risk assessment of likely impact on patients. It also seeks timely and accurate information to pharmacists and prescribers so that optimum patient care can be supported—not that last-minute fax that you pick off the machine on a Friday afternoon, or only finding out that the medication you ordered hasn't arrived because there's a slip sitting on top of the stock.

The PSA and the SHPA have welcomed this legislation. Medicines Australia has also welcomed it. So this is a culmination of working together with the sector to review the issues of medicine shortages in Australia. The partnership of Medicines Australia and the broader group of stakeholders, led by the TGA, has developed a comprehensive protocol which will be implemented through this legislation. As I said at the outset, this legislation will go some way to ensuring there is timely and relevant information available on the supply of medicines, which should assist patients, their doctors and other allied health professionals to manage their treatment plans so they receive uninterrupted care.

Before I conclude, I will go back to draw on my experience as a pharmacist for 20 years and a mental health pharmacist for 15 years. It causes distress and confusion for patients and their carers when the only medication that keeps them well is discontinued. For example, I remember the discontinuation of Mellaril thioridazine. It was discontinued voluntarily because of its severe cardiac complications, but for some patients it was the only medication that kept them well. I remember conversations with individual patients and their treating psychiatrists about what we might be able to do in order for them to be able to continue accessing the only medication that kept them well. Many of you may know that medications have an onset of action. Particularly for antipsychotic medications or antidepressant medications, that onset of action may be several weeks rather than the hours or days in other therapies. Switching, washout periods and swapping is something that is clinically very complex and does require an appropriate period of time and sometimes a hospital admission. It also is something that for the person themselves can compromise their care just from them having to confront the idea that the only medication that has worked for them, often after several treatment failures and lot of switching and swapping in the past and having to manage side-effects, is being discontinued. Many of these drugs are really dirty drugs with very severe side-effects. So when they have found one that works with them and where they can manage the side-effects and stay well, having to switch medications, particularly at short notice, is something that is distressing for them, potentially risky and needs to be properly addressed.

In conclusion, we know the new scheme will principally apply to prescription medicines. Some of my former colleagues have said that they believe this watchlist should be expanded and that other medications should be considered as ones that would have a critical impact. I'm sure that will be something that will be looked at over time. I welcome the fact that this is now being made mandatory, because it's evident from my experience as a hospital pharmacist and from my experience on hospital drug and therapeutic committees and assessing IPUs that the current system is broken and does need to be urgently redressed.

On the shortage of critical impact drugs and this notification of within two working days when it's 'reasonably known', I'm sure that suppliers and manufacturers will enter into this in the spirit of it and make this notification as soon as possible, because sometimes two days is too long. With other shortages it's within 10 working days. Again, early in my career you didn't see the shortages of common antibiotics or common medications that you see now. I think there needs to be a wider look at this particular problem, but I welcome the measures that have been taken. I look forward to there being an improvement in continuity of supply and I look forward to there being more work done in this space.