Improvements to managing medicine shortages and discontinuations

Interruptions to the supply and availability of medicines in Australia can occur for various reasons and have a range of impacts on patients and health professionals. Medicine shortages are a global problem and unfortunately some supply disruptions can be unavoidable.

We continually seek out ways to improve the way we monitor and manage shortages and discontinuations in Australia. Recent improvements include the introduction of the Medicine shortages data-sharing framework, that allows us to share information to better manage serious shortages of hospital medicines. However, medicine shortages can still impact the health and wellbeing of people in Australia.

In 2024, we heard about the challenges and barriers people currently experience associated with medicine shortages and discontinuations. In response, we are pursuing a program of regulatory, digital and process improvements to address the following high priority issues and further reduce the impact of medicine supply disruptions:

1. Update TGA’s medicine shortages regulatory framework to better meet public information needs – this is our initial focus.
2. Critical data and digital infrastructure improvements.
3. Better access to shortages information for health professionals.
4. Better sponsor predictions on medicine demand and shortages.

Updating TGA’s medicine shortages regulatory framework to better meet public information needs

Health professionals and consumers need access to timely and accurate information about medicine shortages and discontinuations to effectively plan and manage their response to a supply disruption. We heard that there is a need for earlier notice of discontinuations to support health professionals and consumers in adapting to changes in available therapies.

We also heard that certain medicines considered essential to the health of consumers are not currently captured in the mandatory reporting framework. For these medicines, the TGA has limited powers to require the pharmaceutical companies who supply them (medicine sponsors) to provide detailed supply information when a possible shortage or supply disruption occurs.

Consequently, we are consulting on proposals to:

• Add critical non-prescription medicines to the list of reportable medicines, which would require sponsors of those medicines to report shortages and discontinuations to the TGA.
• Update the Therapeutic Goods Act 1989 to enable the TGA to require detailed supply information from sponsors of any medicines, not just reportable medicines.
• Require sponsors to provide 12 months’ notice to the TGA of a decision to permanently discontinue supply of any reportable medicine in Australia.

These proposals will enable the TGA to better access and share information about possible shortages and discontinuations to reduce the impact of supply disruptions.

Investigating other improvements

We are also investigating other possible improvement options to:

• further reduce the impact of shortages and discontinuations through uplift of data and digital infrastructure
• improve the accessibility of shortages information for health professionals to better empower their decisions and minimise consumer impact and
• assist medicine sponsors in making predictions on the demand for their medicines, leading to more accurate information on the TGA website about the length of a shortage and the dates that a medicine will return to supply.