ASMI Media Releases – Support for Codeine OTC

Support for retaining codeine products over-the-counter

The Australian Self Medication Industry (ASMI) has restated its support for retaining the current status of over-the-counter codeine-containing analgesics. ASMI supports a range of targeted measures for codeine products, including mandatory warning statements, reducing pack sizes, education on benefits and risks, and the real-time recording and monitoring system for medicines containing codeine.  ASMI believes these measures will be more effective at reducing the risk of OTC codeine misuse than up-scheduling these medicines to prescription only.

Currently the decision on a change in the scheduling for codeine products rests with the Delegate of the Secretary of the Department of Health. This decision will be based on the upcoming Regulatory Impact Statement and a financial modelling report from KPMG. The delegate will decide whether codeine-containing analgesics currently scheduled S3 (only available through consultation with a pharmacist) remain S3 or move to prescription only, and whether cold and flu medications containing codeine currently  scheduled S2 (available on the shelf at pharmacies) or S3 should be upscheduled. The Therapeutic Goods Administration (TGA) has proposed separate regulatory approaches for cold/flu products and OTC codeine-containing analgesics given the lack of evidence of misuse of cold/flu medicines.

“ASMI strongly supports the appropriate and responsible use of all medicines, and a Schedule 4 entry is no guarantee against misuse,” says Deon Schoombie, ASMI Chief Executive Officer.

“Pharmacists are required by law to determine whether it is appropriate to supply OTC analgesics containing codeine. Any suggestion to make all codeine products prescription-only disregards the expertise of pharmacists and their important role in the frontline of primary care.”

The strong evidence emerging is that it is not necessary for the Government to re-schedule codeine-containing medicines to Prescription Only.

More than 3.5 million transactions involving over-the-counter medicines containing codeine have been recorded by pharmacists participating in the Pharmacy Guild of Australia’s MedsASSIST program since the rollout in March this year. MedsASSIST is a counselling tool that helps pharmacists determine the best treatment for a condition, while recording clinical information about the patient and monitoring the supply of codeine products in real time. The Guild developed MedsASSIST in response to concerns over patient safety relating to these medicines and as an effective alternative to making them Prescription Only Medicines. 

About 65 per cent of Australia’s 5500 pharmacies are using MedsASSIST. There have been more than 53,000 instances where codeine products have not been supplied because they were not considered appropriate. This shows that community pharmacists are taking time to speak to their patients about medicines containing codeine and when identifying those at risk are assisting them with referral options.

At present, MedsASSIST requires informed patient consent but to maximise its effectiveness in reducing harm and to create consistency across the country, the recording of the supply of codeine medicines must should be mandatory across all States and Territories. By contrast, there is no system in place to monitor the supply of prescription medicines.

“Should codeine-containing products that are currently available over-the-counter move to prescription-only, then consumers will be disadvantaged,” says Schoombie.

“Consumers will have to visit a GP or emergency room to get a prescription for a minor condition or acute pain that could be safely managed by a pharmacist. They may need to wait several days for a doctor’s appointment and they may have to take time off work, which all has productivity costs to the economy.

“The need to consult with a medical practitioner to access codeine analgesics will increase direct Medicare costs by at least $170 million per annum and consumers will pay an additional $70 million each year. PBS costs will also increase at the same time the Federal Government is looking for PBS savings. The indirect costs of lost productivity and delayed treatment are over $400 million annually1.

“Furthermore, consumer choice will be reduced as the range of cold and flu medicines and analgesics available over-the-counter will decrease.”

A TGA-commissioned review on the efficacy came out in favour of codeine. ASMI advocates a range of additional measures to mitigate risk to consumers, including limiting packs of OTC codeine containing analgesics to three days’ supply to meet the needs of a consumer using the product for acute pain, whilst also ensuring more frequent contact with a health care professional if further pain relief is needed.  Many ASMI member companies have already voluntarily applied label warning statements to OTC codeine products, but ASMI supports standardising this practice. 


1. Macquarie University. The Value of OTC Medicines in Australia. March 2014.

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