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20 Dec 2016

The AMA has backed the medicine watchdog’s “evidence-based” decision to pull common painkiller codeine from shop shelves and make it a prescription-only medication.

AMA Vice President Dr Tony Bartone said the Therapeutic Goods Administration’s move to reclassify products containing codeine as Schedule 4 medicines was justified by mounting evidence of the harm caused by overuse and abuse of the drug.

“We respect the work that has gone into making this evidence-based decision,” Dr Bartone said. “The evidence shows a compelling case regarding the increasing harm caused by the misuse and abuse of codeine including, tragically, overdose and fatalities.”

The TGA said many patients were taking codeine without medical supervision to treat chronic pain, causing large numbers to become addicted and suffering severe health effects including liver damage, stomach ulcers, respiratory depression and death.

A Medical Journal of Australia study documented 1437 codeine-related deaths between 2000 and 2013, and showed that the incidence was rising over time, from 3.5 per million at the beginning of the century to 8.7 per million in 2009.

A review of 99 hospitalisations caused by the misuse of OTC analgesics containing codeine found they cost, on average, $10,000 per admission.

The study, presented to an Australasian Professional Society on Alcohol and Other Drugs conference in November, found patients were taking a mean 28 tablets a day for 606 days prior to admission, and some reported taking up to 90 a day.

The mean length of hospital stay was six days, and 10 per cent of patients in the study required treatment in intensive care units.

An interim TGA proposal in October last year to re-schedule codeine provoked an outcry, and the regulator responded by undertaking a further round of consultations.

But, despite the objections of the Pharmacy Guild and others, the TGA has re-affirmed its plan to end the ready availability of codeine.

“In making this decision, the TGA decision maker took into consideration compelling evidence of the harm caused by overuse and abuse of over-the-counter [OTC] codeine-containing medicines, as well as the fact that the USA, most of Europe, Hong Kong, Japan, the United Arab Emirates and several other countries have already stopped codeine-containing products from being sold without prescription,” the watchdog said.

The regulator said there was little evidence that codeine was any more effective in relieving pain or cough symptoms than other medications, such as paracetamol and ibuprofen.

Dr Bartone said the evidence was that there were alternative treatments to codeine readily available to patients, and because the pain killer was an opioid, it needed to be “treated with respect”.

 The AMA Vice President said OTC was never designed to be used for long-term pain management, and there were better pharmacological and non-pharmacological options available.

The ban on OTC codeine sales will come into force on 1 February 2018, giving users a little more than a year to adapt to the change.

According to the TGA, modelling showed that making codeine prescription-only would deliver a net benefit by reducing deaths and dependence and improving quality of life.

Adrian Rollins

Published: 20 Dec 2016