From 1 February 2018, all formerly over-the-counter (non-prescription) codeine-containing medicines for pain relief, cough and colds are available by prescription only.
Why has this change occurred?
The change is the result of a comprehensive review of research and evidence and extensive consultation through the cooperative national medicines scheduling process.
- The formerly over-the-counter medicines containing low doses of codeine provide little or no additional pain relief compared with similar medicines without codeine
- they are not suitable for long-term use and can cause dependence
- they are subject to misuse and abuse
- there are significant health risks to the people who use them, and these risks are increasing despite recent strategies to reduce the risks
- there are other suitable alternative medicines available without prescription that do not contain codeine that are safer and more effective.
More information about codeine and reasons for the decision can be found at the codeine information hub
published by the Therapeutic Goods Administration (TGA).
If you have been using non-prescription codeine-containing medicines, discuss your pain relief needs with your pharmacist and/or your doctor. For most people, a suitable alternative medicine (without the need for a prescription) or other treatment is available.
If you have regular or continual pain, or have been taking these medicines regularly and feel that you need to continue using them, your doctor can help you with a comprehensive plan to manage your pain. If needed he/she can refer you for appropriate specialist care.
More information about codeine is available:
Helpful information about managing pain can be found at the ACI Pain Management Network website.
Patients using non-prescription codeine-containing medicines will have questions about the changes in access and will need advice on alternative treatment options.
Care should be taken to ensure that quantities of codeine-containing medicines supplied or prescribed to a patient, like all opiates, are therapeutically appropriate.
The usual requirements for supplying and prescribing Schedule 4 medicines apply to codeine-containing medicines that became prescription only on 1 February 2018, including old non-prescription stock labelled as Schedule 2 or 3 (S2/3).
Some formerly S2/S3 codeine products are no longer available and stocks have been exhausted.
The TGA has published a list of formerly S2/S3 codeine products which are now registered as Schedule 4 medicines. However some stocks may remain at wholesalers and pharmacies of some other formerly S2/S3 product lines or formulations which may be no longer registered on the Australian Register of Therapeutic Goods (ARTG). Supply of a medicine product which is not on the ARTG (or otherwise exempted or approved under the Commonwealth Therapeutic Goods Act 1989) is generally prohibited by Section 36A of the NSW Poisons and Therapeutic Goods Act 1966. So before supplying a formerly S2/S3 codeine product on prescription, pharmacists should check the ARTG or with the product sponsor, to confirm that the product is still registered.
There are a range of materials on codeine to assist health professionals:
General practitioners with patients who may be opioid dependent can access support/advice from Drug and Alcohol Services at their Local Health District. Contact details and other information are available through ADIS
Wholesalers and product sponsors
Until 31 October 2018, wholesale licence holders may supply (as Schedule 4 prescription only medicines) old stocks of non-prescription codeine-containing medicines which are labelled as Schedule 2 or 3 medicines. The Secretary of NSW Health has issued an exemption from the relevant labelling requirements of the Poisons and Therapeutic Goods Regulation 2008 to allow this.
From 1 November 2018, any remaining wholesale stock of codeine products labelled as Schedule 2 or 3 must be destroyed or returned to the sponsor.
NSW Codeine Rescheduling Implementation Group
NSW Health formed the Codeine Rescheduling Implementation Group to manage the transition in NSW. The group has developed strategies to help fully inform all stakeholders and to help practitioners address the expected increased demand for opioid dependence treatment and pain services.