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02 Nov 2017

Federal Health Minister Greg Hunt is standing firm on the up-scheduling of codeine products, despite a push against the independent ruling of the Therapeutic Goods Administration (TGA).

Objections to the decision to ban over-the-counter codeine has come not only from the pharmacy lobby but also from some of Mr Hunt’s Cabinet colleagues as well as some State Governments.

From February next year, all codeine-based products will become prescription-only, much to the chagrin of the Pharmacy Guild of Australia, which has been lobbying hard for exemptions.

But the Guild has backed down and appears to have reversed its position.

The Minister told a recent health conference that the Guild had finally accepted the up-scheduling in full.

“So they’re not the only ones that can be strong,” he said.

“On this, they have now come around and made it absolutely clear that they will work with us and support the up-scheduling.”

In a subsequent media statement, the Minister said the Government would provide $1 million to ensure health practitioners and consumers were properly informed about the changes.

“From 1 February next year, medicines containing codeine will no longer be available over-the-counter and will instead require a prescription from a doctor,” Mr Hunt said.

“I have listened carefully to calls from State Health Ministers, consumer and medical groups for more support and this funding announced today will ensure health professionals and consumers have the information they need.

“Moving codeine to script-only was the unanimous recommendation of the Advisory Committee on Medicines Scheduling, which is made up of Chief Pharmacists and Chief Health Officers in States and Territories.

“The Advisory Committee on Medicines Scheduling made two separate recommendations to reschedule codeine in August 2015 and March 2016. The Advisory Committee on the Safety of Medicines also made the same recommendation in March 2016.

“The Therapeutic Goods Administration implemented this advice and on 20 December 2016 announced that over-the-counter medicines containing codeine will become prescription only from1 February, 2018.  

“The final implementation of this scheduling is a matter for each State and Territory as to whether they adopt the decision in their own jurisdiction. Medical authorities have, however, advised these changes will save lives and protect lives.

“Over-the-counter codeine products have been estimated to be a factor in nearly 100 deaths each year, with evidence that three in four pain-killer misusers had misused an over-the-counter codeine product in the last 12 months.”

The changes are also in-line with international practice, with at least 26 countries only allowing prescription access to codeine based products.

These include the United States, United Kingdom, Japan, Germany, France, Italy, Spain, Sweden, Austria, Belgium, Hong Kong, Iceland, India, the Maldives, Romania, Russia, and the United Arab Emirates, Croatia, the Czech Republic, Finland, Greece, Hungary, Luxembourg, Netherlands, Portugal and Slovakia.

The Guild has not confirmed it has reversed its position but has issued a media statement, along with the Pharmaceutical Society of Australia, saying the changes signal a shift in the pain management category for community pharmacy. The statement says they must plan for and manage the change and ensure pharmacy assistants are prepared for it.

AMA President Dr Michael Gannon said groups seeking to circumvent the TGA's decision were putting self-interest ahead of patient welfare.

“The health community – including pharmacy – must quickly implement the changes necessary to switch to prescription-only codeine in February next year,” Dr Gannon said.

Dr Gannon recently met again with the TGA to discuss codeine harm. They also discussed cannabis supply where clinically indicated, e-cigarettes, euthanasia drugs, and medicine shortages.


Published: 02 Nov 2017