Medicine shortages reforms guidance and resources

From the beginning of next year, sponsors of prescription and some over-the-counter (OTC) medicines will be required to report all medicine shortages (including those arising from discontinuations or recall actions) within specified timeframes. The Therapeutic Goods Administration (TGA) will then automatically and prominently publish information about all current and anticipated shortages of critical patient impact through its Medicines Shortages Information Initiative webpage. Sponsors will also be strongly encouraged to publish information about current shortages with low or medium patient impact.

Guidance and legislative instruments

To assist stakeholders to prepare for these changes and ensure that medicine sponsors are able to easily and effectively comply with the new reporting requirements, the TGA is now releasing Management and communication of medicine shortages and discontinuations in Australia – Guidance for sponsors and other stakeholder bodies.

Products on the Medicines Watch List (medicines for which shortages have been predetermined as having critical patient impact) and on the list of reportable OTC medicines (OTC medicines that are considered critical for public health) will be included in two legislative instruments and are listed in Appendix 1 and Appendix 2 of Management and communication of medicine shortages and discontinuations in Australia – Guidance for sponsors and other stakeholder bodies. The above guidance document and lists have been developed in close consultation with stakeholders, including industry and health professional organisations.

TGA, 23 November 2018 ; http://www.tga.gov.au/