Why it’s hard to justify upscheduling codeine OTCs: Schoombie

As the final decision on OTC codeine scheduling draws near, ASMI’s Deon Schoombie ponders some of the drawbacks of upscheduling

In the lead up to the announcement of the final decision on the scheduling of OTC codeine medicines, it is timely to step back and consider the issue from a broader perspective.

There is general agreement that action is needed to reduce the risk of misuse of OTC codeine-containing analgesics, but there is disagreement about the best way to manage this risk.

Some believe that up-scheduling these medicines to Schedule 4 is the most appropriate response, while a number of stakeholders such as ASMI consider this to be a blunt instrument that will shift the problem to already overstretched GPs and emergency departments and will not fundamentally address the issue of codeine analgesic misuse.

It is important to emphasise there is no evidence of misuse of codeine-containing cold/flu medicines. It is widely acknowledged that consumers use these medicines for short periods of time for the relief of cold and flu symptoms and there is a very long history of safe use.

It would be difficult to justify regulatory intervention in this category and it would be inappropriate to apply the same regulatory measures to the cold/flu and analgesics categories. The patterns of use are not the same.

ASMI believes the current scheduling of codeine containing cold and flu products remains appropriate and there should be no changes to this category.

Instead of up-scheduling OTC codeine-containing analgesics, ASMI, The Pharmacy Guild of Australia, Pharmaceutical Society of Australia and Consumers Health Forum believe that a package of targeted measures, including a real-time monitoring system, mandatory front of pack warning labels and increased consumer awareness and education is necessary to manage the risks associated with analgesic combinations.

While there has recently been vigorous debate about this issue, certain aspects of the debate have not been fully canvassed:

  • There is little publicly available data on the magnitude of misuse of these products. To ensure decisions about risk mitigation are fully informed and based on evidence it is critical for the information to be available to all stakeholders who can then examine the data and contribute to the development of measures to ensure the safe and quality use of these products – consumers, healthcare professionals and industry.
  • Up-scheduling OTC codeine products would have immense social and public health impacts and significantly increase healthcare costs. The total estimated cost to the economy is close to a billion dollars annually1,2 due to increased Medicare and PBS costs, greater out-of-pocket costs for consumers and lost productivity. The workload of doctors in general practice and emergency departments would increase and the pain management and cold/flu treatment options for pharmacists to offer consumers would decrease.
  • The recent Review of Medicines and Medical Devices Regulation (the Review) acknowledged Australia’s Scheduling Framework has serious shortcomings. The lack of transparency compromises the legitimacy of scheduling decisions. This and other administrative shortcomings need to be addressed to maintain public confidence in the scheduling framework. The potential economic impact of scheduling decisions highlights the need to address these issues as a matter of priority. The recommendations of the Review provide an ideal opportunity for reform.

We believe it would be critical to examine the potential consequences of an up-scheduling decision through a Regulatory Impact Statement. This detailed examination must be concluded before any steps are taken towards finalisation or implementation of the interim decision.

ASMI is calling for the final decision about the scheduling of OTC codeine medicines to be deferred for 12-18 months to allow a real-time monitoring system to be implemented and sufficient data from it collected and analysed.

At the same time the identified shortcomings in the Scheduling Policy Framework should be addressed.


  1. Macquarie University. The Value of OTC medicines in Australia. March 2014.
  2. Figures calculated using Macquarie University Consumer Fact Book data (March 2015) and publically available data on unit costs.


Deon Schoombie is the chief executive officer of ASMI.

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