Mike Freelander (Macarthur, Australian Labor Party) Share this | Link to this | Hansard source

The Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018 is, at first sight, uncontroversial and has support from both sides, but, to me, it does not go far enough. As a medical professional, I have seen the great risks and dangers that a shortage in certain medicines poses for patients across many countries. I have worked and seen in South-East Asia and in other parts of Asia the difficulties that medication shortages can cause communities.

I'm very concerned that, in Australia, we are seeing an increasing number of medications have shortages, often with very little explanation as to the reasons why. We're often quoted manufacturing difficulties, supply chain difficulties or import difficulties for some very common medications. These include broad-spectrum antibiotics which people would be familiar with, such as minocycline and ampicillin, which are used to treat simple respiratory infections; and fentanyl, which is pain relief medication used for severe pain. It also includes some vaccines. In particular, in the recent influenza season, we've had shortages of the particularly high-dose influenza vaccine. More recently, we've been faced with shortages and lack of supply of EpiPens used to treat acute life-threatening anaphylaxis. To me, this is an issue that is not going to go away.

This bill will go a little way towards encouraging pharmaceutical companies to maintain supplies of certain medications. Maintaining supplies of many different medications is something that we will find increasingly difficult in the modern world, with the disappearance of manufacturing in Australia and the lack of reserve supplies kept in Australia for many common medications. Sadly, the manufacturing base in Australia continues to shrink. With this shrink will come an increase in the likelihood of medication shortages. Whilst this legislation is about being prepared for such instances, and, hopefully, about ensuring we're able to have a timely response to prevent such instances arising in the first place, I do have my doubts that there is sufficient incentive for the remaining large pharmaceutical companies to maintain supplies of off-patent medications.

From my medical career as a paediatrician, I can certainly attest to the impact a lack of proper medication has upon my patients, both in hospital and in ambulatory-care practice, and their families. Time and time again, I've witnessed the rapid increase in quality of life for the patient and their families when a child's been given a medical treatment that they require and that previously has not been available. Take epilepsy, for example. It's a common and mostly permanent condition affecting around three per cent of the population. This is a condition which, without appropriate treatment and medication, can control the life of a child and their family. About 70 per cent of all epilepsy sufferers have their condition treated with medication and remain well because of it. It's vitally important that sufferers of epilepsy take their medication regularly and on schedule. Failure to do so can cause seizures, which can sometimes be life threatening. It's therefore critical that supply of these medications is closely monitored.

Asthma is another common condition which impacts upon daily life of many members of our community and, indeed, a significant number of the members of this House. I recently had the pleasure of relaunching the Parliamentary Friends of Asthma group, alongside the member for Barker. Those present at the launch had the opportunity to hear from guest speakers and representatives from Asthma Australia, who were able to effectively convey the need for medications to be taken seriously and to make sure we maintain adequate supplies of these medications. During the recent thunderstorm asthma epidemic in Victoria, many pharmacies actually ran out of medications for asthma—again, illustrating the fragile nature of our supply chain for these vital medications.

I have already mentioned the shortage of EpiPens. My experience is quite a personal one, as some members of my family do have anaphylaxis and require their EpiPens to be kept with them at all times. To go to a pharmacy and be told, 'There are no EpiPens available, and we don't know when we're going to get them,' is shocking.

Complacency in our ability to provide medications is widespread, even amongst medical practitioners and pharmacists. We need to be very careful in this space. We are already seeing regular shortages of a number of medications, and my fear is that this will increase as there is very little incentive for manufacturing companies to manufacture in Australia and for importing companies to import significant quantities of off-patent medications—often very important medications—unless we have a better system of making sure we maintain supplies. EpiPens are one example; broad spectrum antibiotics are another. Even some of the other countries around the world, such as the United States, have recently had shortages of injectable hospital medications—particularly antibiotics, which have reached a critical situation. Australia is only a very small proportion of the pharmaceutical market, compared to the United States.

We are increasingly seeing vaccines becoming available for many previously fatal illnesses, such as meningococcal disease and haemophilus influenzae type B, which can cause meningitis and epiglottitis in children. My fear is that, unless we have better supply chain practices, some manufacturing in Australia and reserve supplies of these medications, we will be in serious trouble. We need to make sure that these medications are available in sufficient quantities to meet with demand.

Recently we've had shortages of the medication Metformin XR, which is the most commonly used medication for type 2 diabetes. The fact that we could have a shortage of such a widely-used, relatively cheap and well-known medication is a sign, to me, that the system is impaired. Whilst this medication will go a little way to improving the situation, it is by no means sufficient. I encourage the government to look further with the regulation of the pharmaceutical industry in making sure that Australia maintains supplies of these vital medications—particularly things such as vaccines, broad spectrum antibiotics, anti-epileptics and medications for diabetes—so that we can look forward to a future when these drugs will be readily available to all.

Emma McBride (Dobell, Australian Labor Party) Share this | Link to this | Hansard source

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.

Greg Hunt (Flinders, Liberal Party, Minister for Health) Share this | Link to this | Hansard source

I'd like to thank all members for their contribution to the debate on the Therapeutic Goods Amendment (2018 Measures No. 1) Bill of 2018. I want to acknowledge the contributions, amongst others, of the opposition in general but particularly the member for Macarthur and the member for Dobell, who bring considerable personal experience and expertise in this space. I remain—and I would say this in the most constructive spirit to the member for Dobell—open to any meetings, discussions or suggestions she may have at a further time on further measures. I think as a former hospital pharmacist hers is unique knowledge in this building. She's probably still registered, I assume.

This bill will support Australian patients by introducing a scheme for the mandatory reporting of medicine shortages and decisions to permanently discontinue the supply of medicines in Australia for higher risk, mostly prescription medicines. Medicine shortages have become an increasing problem in recent years, and a shortage of critical medicines places patient safety at risk. The recent shortage of EpiPen autoinjectors, which are critical in the response to severe allergic reactions in many people, including children, whose lives can depend on having rapid access to this life-saving medicine is a case in point. The current voluntary scheme for reporting medicine shortages by sponsors has, unfortunately, proven to be ineffective and a significant number of shortages of critical patient impact not been reported to the TGA. This means the TGA is not always able to alert the Australian public or their health practitioners to such shortages or for steps to be taken to alleviate the effects of a shortage for patients.

The purpose of this bill is, therefore, to amend the act to require the reporting of all medicine shortages and decisions to permanently discontinue reportable medicines within specified time frames supported by appropriate civil penalties for noncompliance. In particular, a shortage that is of critical impact for patients must be notified to the Secretary of the Department of Health as soon as possible but no later than two working days after the sponsor knew, or ought reasonably to have known, of the shortage. This will enable complete and current information to be available to patients, healthcare professionals and those involved in stock management in healthcare facilities. Shortages cannot always be avoided. But, when they do occur, this mandatory reporting scheme will help Australian consumers to be more aware in advance and better enable measures to be put in place to minimise the risk to patients such as redirecting of supply to where it is most needed or considering alternative treatments for patients while the medicine is an shortage.

I would like to acknowledge in particular Professor John Skerritt, the head of the TGA, and other officials of the TGA for their work in developing this important new scheme. I also want to acknowledge both Alex Best and Sam Bevlin, my previous and current medicines and pharmaceuticals advisers, for their work and their contribution. This work, and this bill, adds to the broader improvements to medicines regulation resulting from the expert review of medicines and medical devices regulation which are being implemented by the government.

I would also like to recognise and thank state and territory health departments and the key industry and clinical representative groups for their support in developing this important scheme. In particular, the AMA has been extraordinarily constructive as have the Society of Hospital Pharmacists of Australia and members of the Medicines Partnership of Australia, including the Pharmacy Guild of Australia, Medicines Australia, the Australian Self Medication Industry, the National Pharmaceutical Services Association, the Pharmaceutical Society of Australia and the Generic and Biosimilar Medicines Association.

This has been an example of all sides of parliament, Commonwealth and state governments, the experts in the sector and community representatives working to achieve an outcome that will improve access to medicines with certainty and predictability and, therefore, improve patient outcomes. I thank all of those involved and commend the bill to the House.

Question agreed to.

Bill read a second time.