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Burdensome Authority Prescription arrangements come under review

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The AMA has had a couple of significant wins regarding therapeutics policy.

The Pharmaceutical Benefits Advisory Committee (PBAC) has agreed there should be a systematic review of each PBS medicine currently requiring an Authority to ensure the requirement “remains appropriate”. It has requested the Department of Health to draft terms of reference for the review.

The AMA has been lobbying to remove the requirement for doctors to phone a clerk before they can prescribe a PBS medicine. Around 100 PBS medicines still fall under this regime.

However, as an interim measure, in July 2013 we submitted a detailed proposal to PBAC identifying eight medicines that should be removed from authority requirements altogether; 23 medicines that should require only an initial authority and then streamlined arrangements for the same patient in the same circumstances; and 12 medicines that should only require an authority for the initial prescription when used in palliative care circumstances.

The PBAC decision is a direct result of the time and effort devoted by Therapeutic Committee members to preparing the AMA’s submission to PBAC.

In its response, PBAC advised that the AMA’s submission had prompted its decision to initiate a systematic review, and that it would investigate our proposal that some medicines should only require an initial authority and then no or only a streamlined authority for the same patient in the same circumstances.

The AMA has also been concerned with increased threats to therapeutics supply in Australia, which have led to several serious medicine shortages over the last three years.

In 2012 and early 2013 I met with Catherine King, the-then Parliamentary Secretary responsible for the TGA, Medicines Australia and the Generics Medicine Industry, to discuss proposals for ensuring Australia had clear, consistent and coordinated systems for the timely notification and management of medicine shortages.

The TGA has now developed a protocol for Australian sponsors of medicines that will clarify the responsibilities of sponsors and the TGA.

The protocol will identify the circumstances in which sponsors should communicate potential and actual shortages to the TGA; the timing of such communications; when and how shortages should be communicated to other stakeholders such as medical practitioners; and the management strategies that may need to be implemented.

The TGA also plans to improve the transparency and timeliness of notifications, and the management strategies being implemented by publishing the information on its website.

While the medicine shortage protocol relies on voluntary sponsor compliance rather than mandated notification processes for high impact medicine shortages, as we would have liked, it is a considerable improvement on the current ad hoc and uncoordinated approach.

The TGA plans to have the medicine shortages protocol and a supporting website in place by June 2014.

The AMA will keep you up-to-date with developments in both PBS Authority medicines policy and the TGA medicines shortages protocol.