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Over-the-counter medicines

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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Codeine-containing medicines currently available over the counter in Australia will become prescription-only from 1 February 2018

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”.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20202131

Readers' comments (1)

  • https://www.mja.com.au/journal/2020/212/7/changes-sales-analgesics-pharmacies-after-codeine-was-rescheduled-prescription

    What they don't want you to know:

    - About 7.3 million packet sales increase in other analgesics (paracetamol, asprin, ibuprofen) to pharmacies in the year following the ban. Does not include super market sales.

    - All the research the TGA cites indicates that paracetamol, asprin and ibuprofen were causing all the health problems.

    - Codeine not actually that harmful on the body in large doses unless you combine it with more toxic drugs (paracetamol, asprin, ibuprofen) or if you are in a very very small percentage of people who are ultra metabolisers (which there is a test for), for which the TGA has no Australian statistics for.

    - TGA has pushed the message that paracetamol, ibuprofen and asprin are more effective than codeine for pain, so it's not surprising the huge jump in their sales in the year post the ban. Wait to see more health problems arise.

    - Almost all codeine deaths are actually in cases where there are multiple drugs in the person's system.

    - The TGA had not released statistics regarding death where paracetamol, ibuprofen and asprin were implicated.

    You decide how successful and appropriate the band had really been. Read their cited research and look for the holes. You'll find it hard to not fall through them all.

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