AMA supports TGA’s call for Codeine upscheduling

21 Oct 2015

Over-the-counter codeine may soon be banned following an announcement by the Therapeutic Goods Administration (TGA) that it is considering limiting access to codeine preparations only by prescription.

The TGA made the announcement following advice provided by its Advisory Committee on Medicines Scheduling (ACMS). It intends to move current codeine preparations available under Schedule 2 (over the counter) and Schedule 3 (pharmacist supervised) to Schedule 4 (prescription only) from 1 July 2016.

The AMA supports the decision on the basis that ACMS is an independent expert committee that has examined the latest evidence on codeine prescribing, codeine-related harms and the effectiveness of codeine alternatives. The reasons provided for the recommendation are compelling.

There is increasing evidence of harm and death from codeine misuse and potential for severe adverse effects at usual doses in ultra-rapid metabolisers. There is also considerable evidence of inappropriate use of codeine for chronic pain, which should be managed with medical practitioner advice.

Codeine is not available over the counter in 13 European countries nor in the US. All other opioids in Australia are only available on prescription.

Importantly, alternative non-opioid analgesics are now available over the counter, including ibuprofen plus paracetamol, which appears to be more effective without codeine associated risks. There is also a lack of evidence that there is any benefit of codeine in doses of 8mg-15mg per unit beyond placebo.

AMA submission – Codeine upscheduling proposal