Australia bans over-the-counter codeine sales to target opioid abuse

By Flora Southey

- Last updated on GMT


Related tags Opioid Codeine

Australia’s Therapeutic Goods Administration will reclassify all codeine products to ‘prescription only’ from February 1, in a bid to combat opioid tolerance, dependence and poisoning.

Codeine – an opiate closely related to morphine – is an active ingredient in a number of products marketed in Australia, including Reckitt Benckiser’s Nurofen Plus, Johnson & Johnson’s Codral, and GlaxoSmithKline’s Panadeine.

The Therapeutic Goods Administration (TGA) said the use of codeine-based medicines is associated with high risks, including opioid tolerance, dependence, addiction, poisoning, and in high doses, even death.

“Research shows that current over-the-counter low-dose (<30 mg) medicines containing codeine for pain relief offer very little additional benefit from compared to similar medicines without codeine,” ​the Administration added. 

The Australian Medical Association – which represents practitioners and medical students – supports the TGA’s decision: “Codeine is not a safe treatment for long term or chronic pain,” ​said president Michael Gannon.

“Patients who have short term pain will still have access to alternative over-the-counter painkillers, which are more effective than low-dose codeine, but without codeine-associated risks,” ​he added.

According to the Federal Department of Health, state governments have also backed the decision.

“No state or territory jurisdiction has requested the decision on codeine be revisited, with all supporting the change,” ​said the department’s spokesperson.

These changes are also in-line with international practice, with at least 26 countries only allowing prescription access to codeine based products, she added.

Pharmacists’ resistance?

However, membership organisation The Pharmacy Guild of Australia – which represents pharmacists nationally – said it does not support the TGA’s decision.

“The Pharmacy Guild has opposed this change on the basis that we believe the current over-the-counter arrangements should be retained, but with strict clinical protocols to limit codeine supply to limited quantities and for acute paint only (as opposed to chronic pain),” ​spokesperson Greg Turnbull told us.

According to Turnbull, reclassifying a medicine to ‘prescription only’ will not prevent its abuse.

“We believe unfortunately some people abusing low codeine will actually receive prescriptions for higher dose codeine products if they are forced to go to the doctor.

“Unfortunately, so far in Australia we do not yet have real time recording connecting doctors to other doctors and to pharmacies…therefore the practice of ‘doctor shopping’ [the practice of visiting multiple physicians to obtain multiple prescriptions, or a specific medical opinion] for prescriptions will continue,” ​he said.

Manufacturing and demand

Turnbull told us it is difficult to predict if the reclassification will affect sales.

“It is difficult to be precise about the impact on sales of medicines, because this change will produce a change in consumer behaviour.

“Some patients will seek alternative over the counter analgesics. Some will go to their general practitioner for a prescription,” ​he told us.

Reckitt Benckiser – which makes codeine-based Nurofen Plus tablets in its UK manufacturing facility for the Australian market – said it will closely monitor sales development as a result of the up-schedule.

“Production will continue, and as per our standard procedure for all RB products, production will reflect levels of demand which we monitor closely,” ​a spokesperson told us.

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