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TGA Weighs Rescheduling Codeine Following Safety Review

Posted 01 October 2015 | By Michael Mezher 

TGA Weighs Rescheduling Codeine Following Safety Review

Codeine-containing medicines may soon be available by prescription only in Australia, following a review and public consultation by the Therapeutic Goods Administration (TGA).

Background

In Australia, as in many other countries, medicines and other chemicals are classified in a schedule based on the level of regulatory control required for different substances according to their safety and use.

Drug Schedules in Australia
Schedule 1Not currently in use
Schedule 2Pharmacy Medicine
Schedule 3Pharmacist Only Medicine
Schedule 4Prescription Only Medicine
Schedule 5Caution
Schedule 6Poison
Schedule 7Dangerous Poison
Schedule 8Controlled Drug
Schedule 9Prohibited Substance

Currently, codeine is listed on Schedules 2, 3, 4 and 8 of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

In April 2015, TGA proposed several possibilities for amending codeine's scheduling for public comment ahead of its Advisory Committee on Medicines Scheduling (ACMS) July 2015 meeting.

Among the proposed changes was a provision to raise codeine from Schedule 3 (pharmacist-only medicine) to Schedule 4 (prescription-only medicine). The proposal also stated that TGA would consider rescheduling only some codeine-containing products to Schedule 4 and that the agency would consider amending the Schedule 2 listing for codeine as well.

In total, 60 comments were received, 29 of which supported rescheduling codeine to prescription-only, arguing such measures could reduce the potential for harm and abuse. The agency also received 25 comments opposing the measures, which cited increased costs and a higher burden for patients requiring codeine-containing medicines.

ACMS Recommendation

After considering the benefits and risks of codeine as well as its uses, the ACMS is advising TGA to remove codeine from Schedules 2 and 3. By doing so, all previously over-the-counter products containing codeine would be made prescription only.

The committee cites a number of reasons for its recommendations:

  • "Risks of medication misadventure through polymorphic metabolism, deliberate misuse/abuse combined with the relative lack of efficacy compared to safer products.
  • OTC intended for management of acute self-limiting pain, however, there is inappropriate use for chronic pain.
  • Purpose is questioned since benefit is low.
  • OTC sales data are incomplete.
  • Codeine shares the properties of other opioid analgesics and is potentially capable of producing dependence and, in overdose, respiratory depression and reduced level of consciousness.
  • Changing the labelling and decreasing the pack size will not adequately address the problem of misuse and dependence.
  • Increasing amount of evidence for harm from abuse.
  • Misuse of OTC codeine products including deaths resulting from hepatic injury, gastrointestinal perforations, hypokalaemia and respiratory depression.
  • Genetic influence on codeine's action complicates risk and benefit decisions, and leads to questions regarding the role of codeine in clinical practice.
  • To adequately determine the clinical needs an appropriately qualified practitioner to assess risk."

TGA says it will make a decision whether to implement an interim decision supporting the ACMS's recommendations in late November 2015. Interested parties have until 15 October 2015 to submit their comments on the proposal.

TGA, Delegate's Interim Decision and Public Consultation


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