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04 Jul 2016

The medicines watchdog has held off on making a final determination on its controversial proposal to axe over-the-counter sales of the common painkiller codeine.

Therapeutic Goods Administration has revealed that at its March scheduling meeting it deferred finalising its position on the re-classification of codeine following an interim decision late last year to make the painkiller a prescription-only medicine.

The delay follows an outpouring of concern by patients and consumer groups worried that taking codeine off the shelves would make it much harder for people to manage chronic pain and force some to pursue unsafe alternatives.

Following an interim proposal in October last year to end over-the-counter (OTC) access to the drug and reclassify it as a schedule 4 poison, the TGA received 127 submissions, including 113 opposing the move and just 14 in support.

In response, the watchdog said it would hold off on making a final determination until at least March, and any implementation would not occur before 2017.

In a submission to the TGA during its first round of consultations, the AMA did not come to a definitive position on the proposal.

While accepting that codeine dependence was “a real concern” and acknowledging the serious side effects caused by excessive consumption, the AMA voiced reservations that re-scheduling the drug would necessarily solve these problems.

It said there could be an argument to restrict access to higher dose and compound codeine preparations, and noted inconsistencies in current regulations that allowed over-the-counter sales of Panadeine Extra, while Panadeine Forte (one tablet of which is equivalent to two Panadeine Extra pills) was only available by prescription.

“Up-scheduling in isolation is unlikely to address the problems of misuse,” the AMA said, arguing that any such move needed to be accompanied by better education about safe and effective pain management options.

But in its interim decision, the TGA indicated it was persuaded by concerns about the potential harm caused by inappropriate use of codeine and the availability of effective alternatives, paracetamol and ibuprofen.

The TGA said OTC codeine was intended to help manage acute, self-limiting pain, but instead people were using it to help treat chronic pain, potentially creating dependence and toxicity.

In addition, it said, at least 10 per cent of the population were “ultra-rapid metabolisers” of the drug, making codeine potentially deadly at even normal doses.

Its concerns have been echoed by Professor Stephan Schug, Director of Pain Medicine at Royal Perth Hospital, who said codeine was a poor painkiller, had become a drug of dependence for many who were taking it at dangerous levels, and was not as effective as other, safer, alternatives.

Professor Schug said he had seen patients who were taking up to 80 tablets of codeine combined with paracetamol or ibuprofen a day, raising the risk of fatal paracetamol and ibuprofen toxicity.

“Dependence on opioid analgesics is a significant concern in Australia, and OTC codeine contributes to this by providing unmonitored access to a drug which in the body is metabolised to morphine,” Professor Schug said.

He said the number of overdose deaths related to codeine had jumped from 3.5 to 8.7 per million between 2000 and 2009.

Professor Schug said scheduling codeine would not reduce access to effective pain relief. He said adding low doses of codeine to paracetamol and ibuprofen did little to enhance their effectiveness, while combining paracetamol and ibuprofen instead provided significantly better and safer pain relief.

“As a practising clinician, I can tell you that under the current arrangements, the easy and widespread availability of these codeine-containing medicines is not limited or monitored at all well,” he said.

The AMA has repeated its call for a national Electronic Recording and Reporting of Controlled Drugs system to provide doctors and pharmacist with real-time information on the prescription of medicines prone to misuse and harm.

The peak medical association has also suggested that pharmacies be required to record codeine sales in the same way as they do for pseudoephedrine.

The AMA warned that making codeine prescription only would also likely increase Medicare and PBS costs for the Government.

Adrian Rollins

Published: 04 Jul 2016