Medicine shortages in Australia – Challenges and opportunities

The supply of medicines can be interrupted for various reasons, causing significant impact on the health and wellbeing of Australians.

At the Therapeutic Goods Administration (TGA), we have improved how medicine shortages and discontinuations are managed in many ways. But we want to do more to further reduce the impact for Australians.

We wanted to hear from people who are impacted by medicine shortages and discontinuations including individual consumers and health professionals, consumer and health professional organisations, the pharmaceutical industry and state and territory health departments.

We asked them:

• How do medicine shortages and discontinuations impact you?
• What challenges and barriers do you face when you’re planning for and responding to medicine shortages and discontinuations?
• How do you ask for, receive and communicate information about the availability of medicines? What are the challenges and barriers you face doing this?
• What do you think the TGA, you, and others could do to improve the situation? How can we collaborate to face the challenges and barriers to a reliable supply of medicines in Australia?

We are using the feedback we received to make recommendations for improvements to further reduce the impact of medicine shortages and discontinuations on Australians.

We received 221 submissions in response to the consultation. These came from:

• state and territory health departments
• health professional representative bodies
• pharmaceutical industry representatives
• consumer representative groups
• individual healthcare professionals
• individual consumers.

These submissions provided a range of experiences and views on medicine shortage impacts, challenges and improvement opportunities.

Stakeholders also raised concerns on the vulnerability of Australia’s medicine supply chain and Australia’s reliance on overseas manufacturing of medicines.

Impacts of medicine shortages and discontinuations

A significant number of respondents from all stakeholder groups outlined the considerable time and resources it took for them to monitor and address medicine shortages and discontinuations.

Although the specific activities involved were different depending on the respondent’s situation, the sustained effort required to manage shortages was reported consistently. Respondents also reported the significant impact of this effort on their health, finances and workloads, whether they were consumers, health professionals or were involved in the industry.

Another reported impact of medicine shortages and discontinuations was the increased strain on the public health system when community-based patients go to hospitals in search of their medicine.

Several respondents also highlighted that medicine shortages and discontinuations disproportionately impact certain population groups, including First Nations people and people living in rural and remote areas of Australia.

Medicine shortages most frequently mentioned 

We asked all respondents to list medicine shortages that have impacted them over the past 12 months. The medicine shortages most frequently mentioned were:

• lisdexamfetamine capsules
• semaglutide injections
• menopause hormone therapy patches
• opioid oral liquid (discontinuations)
• antibiotic medicines
• combination blood pressure and cholesterol-lowering medicines

Opportunities for improvement

Most respondents expressed a desire for improved access to and content of medicine shortages information. They wanted:

• to receive notifications about shortages and discontinuations sooner
• notifications about shortages and discontinuations to be tailored to their interests and needs
• greater transparency about the reasons for a medicine shortage
• consistent and location-specific information about stock availability
• more accurate return-to-supply dates.

There was general support for earlier coordination, engagement and collaboration between the TGA, the pharmaceutical industry and key stakeholders when a medicine shortage is predicted.

Some respondents indicated that current regulatory processes were impacting their capacity to effectively manage or respond to medicine shortages. They wanted prescribing, dispensing and manufacturing regulations to be more flexible and easier to comply with.

Other matters relating to the supply of medicines in Australia

We also received a number of submissions from individual consumers and health professionals advocating for the registration of specific COVID-19 vaccines and treatments. This issue was beyond the scope of the consultation.

The TGA analysed all submissions to the public consultation and compared the feedback with the findings from our recent market research survey, which ran from 23 February 2024 to 13 March 2024.

This market research consisted of an online survey (800 participants) and 17 one-on-one interviews. The participants were individual consumers, pharmacists and prescribers. They were asked about the clinical, economic and lifestyle impacts of medicine shortages and discontinuations. All participants were reimbursed for their time.

Market research - Understanding the impact of medicine shortages in Australia.

Summary of challenges and barriers

We summarised the public consultation and market research feedback about the challenges and barriers of medicine shortages and discontinuations, under 6 themes:

1. Information can be inconsistent, inaccurate, come too late, or be out of date

• When a health professional prescribes a medicine, they often won’t know if it is available or in short supply,  or where to find information about alternatives, especially if a medicine has been discontinued.
• Consumers and pharmacists feel they receive varied and out-of-date information about the availability of medicines during shortages.
• Pharmaceutical companies (sponsors) don't find out about a competitor's product shortage in time to manage the possible increased demand for their product.

2. Sponsors don’t have to report shortages of all important medicines

• The TGA introduced a mandatory reporting scheme for medicine shortages and permanent discontinuations of all prescription and some over-the-counter medicines in 2019. However, the requirement for sponsors to report shortages to the TGA does not cover all medicines that are important to the health of consumers in Australia.
• Non-reportable medicines mentioned in the consultation include:
  • radiopharmaceuticals
  • contrast agents (for medical imaging)
  • intravenous saline
  • paediatric analgesic medicines
  • topical scabies treatments.

3. Low confidence or uncertainty in the supply chain can lead to stockpiling behaviour by consumers and pharmacies.

• When consumers and pharmacists are not confident in the reliability of their medicine supply or do not fully understand the reason for a shortage or discontinuation, they can resort to stockpiling to ensure continuity of supply. This makes it difficult for sponsors to predict demand.
• It’s difficult for sponsors to predict how long and severe a medicine shortage will be when the reason is outside of their control, such as fluctuations caused by competitor shortages, excessive stockpiling and changes to what the medicine is being prescribed for.
• Consumers feel there is limited coordination between their healthcare professionals when responding to medicine shortages. They feel they must take on the responsibility of finding solutions which can lead to delays in accessing their medicines and reduced confidence in the medicine supply chain.

4. Consumers with limited treatment options are disproportionately impacted by medicine shortages and discontinuations

• Consumers experience significant impacts when there are few or no suitable alternatives available for a medicine in shortage or discontinued. For example, we heard from several individual healthcare professionals about the impact of the recent colestyramine powder sachet shortage for people using it as a last line therapy for severe diarrhoea following ileal resection. Many people rationed their remaining supply because there were limited alternative treatments available for this condition.
• Consumers who use medicines for rare conditions face greater impacts when those medicines are discontinued as there are often few alternatives on the Australian market. For example, the recent discontinuation of lomustine capsules sparked significant concern from the Australian oncology community because there are very few alternatives available to treat glioblastoma, a rare and aggressive brain cancer.

5. Time-consuming and manual administrative and regulatory processes for accessing alternative medicines cause delays to treatment.

• Consumers face manual and time-consuming steps when attempting to access an alternative medicine, including travelling to multiple pharmacies and making additional appointments. This disproportionally impacts consumers in rural and remote areas who have further to travel to pharmacies and prescribers.
• Sponsors report that many regulatory and administrative requirements for monitoring, reporting and responding to medicine shortages and discontinuations are manual and time-consuming. This diverts attention from actively managing the medicine shortage.
• Some of the TGA’s regulatory processes and systems are perceived to be inefficient and can hinder timely management and communication of medicine shortages and discontinuations.  For example, the process of adding new overseas medicine approvals to the Section 19A Database on the TGA website may take several days, causing delays in making this information accessible to consumers and healthcare professionals.
• Some hospitals and health organisations are investing significant time and resources developing the same guidance and alerts about how to manage individual medicine shortages and discontinuations. This duplication of effort wastes time and resources that could be used more effectively elsewhere.

6. There are inequalities in the distribution of and access to limited stock*

• Some alternative medicines can be more costly. Consumers on lower incomes have reduced access to medicines during a shortage and it can push some consumers into the public hospital setting.
• Consumers with limited health literacy are more at risk of negative clinical outcomes from delays in accessing medicines.
• Pharmacies that can afford to purchase and store extra stock experience lesser impacts of medicine shortages and potentially limit access to stock for other pharmacies.

*Please note, issues mentioned within challenge theme 6 fall outside the TGA’s regulatory jurisdiction. However, we recognise these challenges have a considerable impact on consumers and health professionals and will be directed to the relevant areas of the Department.

Recommendations for reforms 

Medicine supply chains are complex global systems involving many parties. In June 2024, we hosted a webinar to present the consultation and market research findings to stakeholders in the medicine supply chain including representatives from the pharmaceutical industry, health professional and consumer organisations and state and territory health departments.

These stakeholders also participated in a series of online focus groups to discuss and prioritise issues identified in the consultation and market research, focusing on addressing the most critical and practical issues first.

Outcomes of these discussions, including recommendations on priority areas for potential reform, were provided to the Australian Government for consideration. On 6 November 2024, the TGA announced proposed improvements to TGA’s monitoring and management of medicine shortages and discontinuations.