ACMS interim decision: OTC codeine could go S4

codeine tablets, glass of water

The Pharmacy Guild of Australia has expressed concern at the proposed re-scheduling of codeine containing analgesics to Schedule 4, Prescription Only Medicine.

The interim decision of the Advisory Committee on Medicines Scheduling released today would see all codeine products, including many well known cough and cold relief products, available on prescription only from June 2016.

The Guild says it acknowledges that codeine dependence is a real and growing concern and that side effects from taking excessive amounts of codeine containing analgesics can be very serious.

However, it says it believes the proposed re-scheduling is unlikely to address the issue of dependency and may instead create further problems, such as:

  • For the large majority of people who use these products safely and effectively, re-scheduling will make pain relief medicines more expensive and more difficult to obtain.
  • There will be an increase in the workload of doctors.
  • There will be increased Medicare and PBS costs (particularly if doctors elect to prescribe consumers higher strength codeine products or other opioids listed on the PBS).


The Guild says the alternative to re-scheduling should include:

  • a real-time recording and reporting system to identify consumers potentially at risk, to prevent medication misadventure. A prototype of such a system has already been developed, with cross industry and consumer support; and
  • a mandatory front-of-pack warning about the potential for addiction.


The Guild says it regards the implementation of a national real-time recording and reporting system to be a high priority.

Such a system would be a clinical decision support tool (as opposed to the current Project STOP system which is a law enforcement mechanism designed to prevent the diversion of pseudoephedrine as a precursor for illegal ‘ice’ manufacture).

“Real-time monitoring in community pharmacy could be implemented in a very short timeframe, and would be more effective and economical in assisting to identify at-risk consumers, facilitating access to education materials, and supporting appropriate referral when required,” says national president of the Pharmacy Guild, George Tambassis.

The Guild says the real-time decision support tool would help pharmacists determine if the supply of a medicine is appropriate.

At the same time as the supply/non-supply decision is explained to a patient, relevant clinical information can be provided, and an electronic record can be maintained to show that this has been done.

“The re-scheduling of combination analgesics containing codeine would add significant costs to the health system, and would disadvantage many thousands of consumers who use these products safely and beneficially,” says Tambassis.

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