Pharmacy codeine ‘virtually unmonitored or unregulated’

white capsules, that resemble OMG Slim capsules

Rescheduling of over-the-counter codeine products will save lives, the RACGP says

In welcoming the TGA’s decision RACGP President Dr Bastian Seidel said the RACGP had long supported the up-scheduling of codeine to a Schedule 4 drug as a “necessary step to improve patient safety and reduce harm”.

“Until now OTC codeine combination analgesics have been sold over the counter in pharmacies, virtually unmonitored or unregulated, while other opioids are only legally accessible through prescriptions from medical practitioners,” he said.

“Current evidence demonstrates that significant harm is caused by these medicines, with little or no therapeutic effect.

“Unfortunately, the harm caused by these medicines has not been reduced by restricting them to pharmacy-only.

“Thousands of everyday Australians are using OTC codeine non-medically to achieve a drug effect; many have needed treatment for drug dependence, hospitalisation, intensive care and surgery for serious harm such as bowel obstruction.

“Unfortunately, the non-medical use of OTC codeine products has also led to an increasing number of drug-related deaths.”

He said a study published in the Medical Journal of Australia found the rate of ­codeine-related deaths had more than doubled between 2000 and 2009.

“As GPs at the frontline, we frequently see people getting into trouble with OTC codeine. It is a major cause of harm and distress for the people who unfortunately find themselves caught in a cycle of addiction following their use.

“First and foremost, GPs have the best interests of their patients at heart. Our position on this matter is significant because it is not distorted by any commercial interests.

“I applaud the TGA for resisting pressure from other bodies who have lobbied against the rescheduling these drugs, with only their commercial interests in mind.

“Patient safety must always come before big business.”

A spokesperson for the Pharmacy Guild refuted the idea that codeine sales in pharmacy were not monitored or regulated.

“The Guild and community pharmacists take very seriously their responsibilities bestowed under our medicines scheduling system,” the spokesperson told the AJP in response to Dr Seidel’s remarks.

“Pharmacist only medicines (S3) require pharmacist involvement in a sale, and pharmacists are very mindful of their responsibilities under the schedules.

“The Guild opposes the TGA decision because it will not solve the abuse problem, it will add to national health costs, and it will inconvenience patients who have used these medicines safely for many years.

“The insinuation of a commercial motive is completely rejected, ill-founded, and frankly graceless.”

As of November 21, four million transactions relating to OTC codeine had been recorded in the Guild’s MedsASSIST monitoring and decision-making tool, with 2% of transactions denied or not supplied.

Meanwhile, NPS MedicineWise welcomed the move.

“The decision announced today by the TGA to make codeine-containing products available only on prescription will help to reduce the rates of side effects, misuse and dependence associated with codeine in the community,” says NPS MedicineWise spokesperson and pharmacist Sarah Spagnardi.

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  1. Nicholas Logan

    Did Dr Seidel mean to say “Until now codeine combination analgesics have been prescribed in surgeries, virtually unmonitored or unregulated”? And again he is quoting the MJA study that shows the majority of traceable codeine-related death is from prescribed codeine. Sorry if I sound like a broken record.

  2. David Haworth

    What guidance will the RACGP provide to GPs and how will GPs counter Dr Shopping for these previously OTC items?

  3. stephen boyle

    codeine products have been proposed to become prescription only in 2018. can the RACGP or some other decision making health body please provide a descriptive pathway for all health professionals to manage people already identified or who will be identified by pharmacists in the next 12 months,with a suspected overuse of codeine, so that we can help people who need help and treat pain appropriately when it is right to do so.
    Enough ivory tower BS. A person with a toothache or a migraine or an acute injury deserves access to pain relief until they can see a gp or lmo if required.
    Stephen Boyle Pharmacist

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