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Massive increase in reports of medicine shortages following introduction of mandatory reporting

The number of notifications of medicines shortages has jumped massively following the introduction of mandatory reporting in January 2019.

An analysis of the first 12 months of the mandatory notification scheme has revealed a 290% increase in shortage notifications received by the Therapeutic Goods Administration in 2019 compared with the previous 12 months.

The number of new shortages notified to the TGA increased from an average of 50 per month during 2018 to an average of 150 per month during 2019.

From 1 January to 31 December 2019 there were 1797 new shortages reported, compared with 572 shortages reported in 2018. Shortages reported in 2019 were associated with 1415 different products.

There were 382 products subject to repeated periods of shortage between periods of supply.

In 2019 the total number of notifications submitted (both new shortages and updates to previously notified cases) was 5862 compared to 1493 in 2018. This was an increase from an average of 120 per month during 2018 to an average of 490 per month during 2019.

Of the 1800 new shortages reported during the last 12 months, 176 (9%) were judged as being of ‘critical impact’.

According to the TGA, shortages are considered to have a critical patient impact if:

  • at the time of the shortage there are no products on the ARTG that could be used as a substitute, or if an appropriate substitute product is unlikely to be available in sufficient quantities to meet demand, and
  • the shortage has the potential to have a life‑threatening or serious impact on the health of people who take, or who may need to take, the medicine.

However, it was also shown that the number of approvals granted by the TGA under section 19A of the Act (for short-term supply of a product registered in a comparable overseas country to address a particular shortage) increased by 40% during 2019 compared with the previous 12 months.

The TGA said stakeholder meetings held by its Medicine Shortages Working Party had identified the need to improve shortage reporting, communications, mitigation and arrangements for supply of alternative products.

As well as publishing the report, it also aimed to:

  • Improve the TGA’s ability to anticipate shortages through exploring opportunities to use sponsor supply and manufacturing data and identifying supply chain issues that lead to medicine shortages and delays in reporting
  • Improve public access to information about shortages by increasing the proportion of shortage notifications that are published on the TGA website and implementing communications activities for healthcare professionals
  • Support rapid mitigation of shortages by clarifying guidance for sponsors about Section 19A application requirements and ensure good coordination between relevant areas of the Department of Health.
  • Improve transparency by increasing the proportion of shortage notifications that are published by the TGA
  • Increase health professionals’ awareness and use of the MSII website through communications activities and website enhancements
  • Better forecast shortages using more detailed information from sponsors and wholesalers
  • More rapidly mitigate some shortages by improving information for sponsors about section 19A requirements.

 

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