Australia tightens restrictions over codeine-containing medicines

Codeine-containing medicines will no longer be available over the counter in Australia from 1 February 2018.

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Products containing codeine will no longer be available over the counter (OTC) in Australia following a review by its medicine’s regulator, the Therapeutic Goods Administration (TGA).

The medicines will lose their OTC status on 1 February 2018 when they will become available only on prescription. The TGA says its decision was influenced by similar moves in the United States, Hong Kong, Japan and the United Arab Emirates, adding that “most of Europe” has also changed the status of codeine-containing medicines to prescription only.

The move also follows evidence from the Australian Advisory Committee on Medicines Scheduling, which concluded that misuse of OTC codeine products can be fatal as well as causing liver damage, stomach ulceration and perforations, hypokalaemia and respiratory depression.

The TGA says patients were putting themselves at risk of addiction by buying the OTC products to self-medicate for long-term chronic pain relief. It also says there was little evidence that codeine-containing medicines at the doses available OTC were any more effective in tackling pain relief or cough than non-codeine containing products. However, pharmacists in Australia have expressed disappointment over the decision to reclassify codeine medicines.

Joe Demarte, president of the Pharmaceutical Society of Australia (PSA), comments: “While we are concerned with the harm and deaths arising from inappropriate use of codeine-containing medicines, the PSA does not believe the decision to make OTC codeine medicines prescription-only on its own provides for a holistic consumer-focused solution.

“The majority of documented opioid-related harm comes from prescribed medicines so simply requiring a prescription for OTC codeine products will not solve these complex issues for consumers,” he adds.

The PSA also says the decision to reclassify OTC codeine products “appears to ignore coronial reports that have repeatedly called for real-time monitoring of the prescribing and dispensing of drugs of dependence as a key part of the response to this issue”. Demarte adds that the PSA wants to see a national reporting system implemented to allow monitoring of prescribing and dispensing of specific high-risk medicines, including drugs of dependence.

“We believe this is an urgent priority issue,” he says.

In the UK, codeine is available as a prescription-only medicine at higher doses (15mg codeine phosphate per tablet) or OTC from pharmacies at lower doses (8mg codeine phosphate per tablet) combined with aspirin, ibuprofen or paracetamol.

The Medicines and Healthcare products Regulatory Agency, the UK medicines regulator, says it keeps the safety of all medicines under review “and will consider any new evidence which comes to light”.

Last updated
The Pharmaceutical Journal, PJ, January 2017, Vol 298, No 7897;298(7897):DOI:10.1211/PJ.2016.20202131

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