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Management and communication of medicine shortages and discontinuations in Australia

Guidance for sponsors and other stakeholder bodies

1 May 2019

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The Therapeutic Goods Administration (TGA) has implemented reforms to improve management of medicine shortages in Australia, including improving communication and increasing transparency.

Medicine shortages significantly impact the health of many Australians and have become more frequent and serious in recent years. This is due to a number of reasons, including the decrease in local manufacture of prescription medicines and the increasingly globalised nature of the medicines supply chains. Australia has only 2% of the world's medicine usage and over 90% of prescription medicines are imported.

In response to this issue, we launched the Medicines Shortage Information Initiative and associated website in 2014. This response included a voluntary notification scheme for sponsors experiencing shortages.

Since then, there has been increasing frustration expressed by many stakeholders that the information available on the Medicines Shortage Information Initiative webpage is neither complete nor current, and it is no longer seen as a credible source of information by health professionals or those involved in stock management in health facilities. The information is also not being published in a timeframe to allow alternative supplies, where available, to be accessed and/or to otherwise mitigate serious effects on patients when no alternative supply is available.

In response to this issue, the Australian Parliament amended the Therapeutic Goods Act 1989 (the Act) to establish a more transparent and responsive approach to the management of medicines shortages, including those arising from discontinuation of a medicine. Through these reforms, the roles and responsibilities of relevant parties have been clarified.

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