Australia’s TGA publishes protocol to address drug shortages

Home/Policies & Legislation | Posted 08/06/2018 post-comment0 Post your comment

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), announced in March 2018 the publication of a new protocol addressing drug shortages in Australia.

Drug Shortages FDA V13K15

Drug shortages have been highlighted as a problem in Australia due to its reliance on foreign manufacturers. The country has only 2% of the world’s medicine usage and over 90% of prescription medicines are imported. Although a National Medicine Shortages Information Initiative (MSII) and website was launched in 2014 there has been frustration that the information available on the website is neither complete nor current.

The document, ‘Management and Communication of Medicine Shortages in Australia – A new protocol’, is aimed at Australian product sponsors and supply chain stakeholders. It intends to improve the management and communication of medicine shortages in Australia by making the reporting of all medicines shortages to the TGA mandatory. However, mandatory publication on the MSII website will only be for medicine shortages assessed to be of ‘extreme’ or ‘high’ patient impact.

The protocol defines what a drug shortage is, as well as defining different types of shortages. It also outlines principles for identification and management of potential shortages.

In addition, the Therapeutic Goods Act 1989 has also been amended to enable alternatives to medicines in short supply to be sourced from a wider range of countries.

The protocol was developed through a joint initiative of the Medicines Partnership of Australia (comprising the National Pharmaceutical Services Association, Medicines Australia, Generic and Biosimilar Medicines Association, The Pharmacy Guild and the Pharmaceutical Society of Australia and Australian Self Medication Industry), the Australian Government Department of Health including the TGA, the Society of Hospital Pharmacists of Australia (SHPA) and the Australian Medical Association.

It has been ‘strongly backed’ by the SHPA, who said that the protocol ‘puts Australian patients first’ by adopting ‘a patient-oriented definition of medicine shortages’ and providing ‘important protections for Australian patients’.

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Source: SHPA, TGA

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