Update on the proposal for the rescheduling of codeine products

Codeine containing medicines to move to prescription only

20 December 2016

After significant consideration and consultation on the effects of medicines containing codeine on people’s health and wellbeing, Australia’s medicine’s regulator, the Therapeutic Goods Administration (TGA), has decided that products containing codeine will not be able to be sold over the counter in pharmacies, making such products available on prescription only.

This change does not come into place until 1 February 2018 so there will be no change to the availability of products occurring now or in 2017.

The change in scheduling of products containing codeine from OTC (over-the counter Schedule 2/3) medicines to Schedule 4 prescription medicines will mean that people who wish to use painkiller medicines containing codeine will have to obtain a prescription from their GP or health care provider or use an alternative OTC product such as paracetamol, ibuprofen or a combination of these drugs. There are also a number of alternative OTC cough and cold medicines that do not contain codeine.

In making this decision, the TGA decision maker took into consideration compelling evidence of the harm caused by overuse and abuse of OTC codeine containing medicines, as well as the fact that the USA, most of Europe, Hong Kong, Japan, the United Arab Emirates and several other countries have already stopped codeine-containing products from being sold without prescription.

The delegate agreed with the advice provided at two meetings of the Advisory Committee on Medicines Scheduling (ACMS) that misuse of OTC codeine products contributes to severe health outcomes including liver damage, stomach ulceration and perforations, hypokalaemia (low blood potassium levels), respiratory depression and death.

Low dose codeine-containing medicines are not intended to treat long term conditions, however public consultation indicated that many consumers used these products to self-treat chronic pain. This meant that consumers frequently became addicted to codeine.

The TGA decision maker also took into consideration that there is little evidence that low-dose codeine medicines are any more effective for pain relief or cough than similar medicines without codeine.

In addition a Regulation Impact Statement, supported by an independent modelling report by KPMG, modelled the economic, social and regulatory impacts of the proposed changes to scheduling.

The key findings of the modelling was that a net financial benefit to society could only be achieved when codeine was up-scheduled to prescription only, which would result in reduced deaths from accidental or deliberate codeine overdose, improved quality of life, and reduced codeine dependence and reduced risk of dependency.

As the changes from OTC sales to prescription only will not come into effect until February 2018 consumers will have ample time to discuss any ongoing clinical treatment options with their health care providers.

More information, including a copy of the Regulation Impact Statement, is available at www.tga.gov.au.

Media inquiries: Kay McNiece, 0412 132 585