Codeine decision inconveniences consumers, rejects targeted measures

20 December 2016

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Consumer access to medicines and
choice of treatments will be restricted

Sydney, 20 December, 2016 -The Australian Self Medication Industry (ASMI) said it is extremely disappointed with the Federal Government Scheduling Delegate's final decision to up-schedule over-the-counter (OTC) codeine-containing analgesics and codeine-containing cold and flu medicines to Schedule 4 (Prescription Only).

While ASMI acknowledges the robustness of the review process, it is regrettable that more targetted measures for codeine-containing medicines currently available over-the-counter have not been given an opportunity.

The decision comes despite the promising MedsASSIST codeine monitoring program, which was taken up by over 68% of pharmacists across the nation and recorded more than 4 million requests for codeine, with a 2% no-supply rate (of which nearly 50% were referred to their doctor for more treatment, while others were referred to products more appropriate to their needs). 1

Deon Schoombie, ASMI Chief Executive Officer said: " ASMI strongly supports the appropriate and responsible use of all medicines but this decision is not proportionate to the level of risk, as the vast majority of consumers use OTC codeine containing medicines safely and responsibly.

"It is particularly disappointing that codeine-containing cold and flu medicines will be up-scheduled as there is only anecdotal evidence of misuse of these products and adverse events are rare. We acknowledge that there is a risk that needs to be addressed and we have put forward alternatives that do this.

"Pharmacists are required by law to determine whether it is appropriate to supply OTC analgesics containing codeine and this decision disregards the expertise of pharmacists and their important role in the frontline of primary care.

"This decision will have several undesirable consequences.

"Consumers will be disadvantaged as they will have to visit a GP or emergency room to get a prescription for 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 brings productivity costs to the economy. Furthermore, consumer choice will be reduced as the range of cold and flu medicines and analgesics available over-the-counter will decrease.

"ASMI and other key stakeholders had proposed and begun to implement regulatory options that reduce the risk of misuse of codeine-containing analgesics, whilst retaining pharmacy access for consumers who need these products for conditions such as headache or dental pain," said Schoombie.

"This decision goes against the ASMI position, which provided for a package of targeted measures for OTC codeine-containing analgesics, including mandatory warning statements, reducing pack sizes and a mandatory real-time monitoring system for community pharmacy.

"Label warning statements are an accepted way of mitigating risk by providing consumers with important advice that facilitates appropriate use of the medicines and addresses specific risks. Many ASMI member companies have already voluntarily applied label warning statements, but making them mandatory would harmonise the practice.

"ASMI advocates limiting packs of OTC codeine containing analgesics to three days' supply. This quantity is sufficient 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.

"ASMI also supports the introduction of a real time monitoring system for OTC codeine-containing analgesics, and the availability of educational resources for health care professionals and consumers.

"We believe real-time monitoring provides a valuable tool for pharmacists to ensure the quality use of medicines and to identify problem use."



1. Figures to November 21, 2016 according to the Pharmacy Guild of Australia. MedsASSIST- Informing Medicine Decisions,