The Therapeutic Goods Association (TGA) decision to reschedule over the counter (OTC) codeine-based products, announced today, will save the lives of many Australians, according to the Royal Australian College of General Practitioners (RACGP).
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.
"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 over-the counter 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.”
Dr Seidel said the Australian Medicines Handbook and other bodies agreed that the rescheduling of these products is absolutely necessary.
“The Australian Medicines Handbook is a highly authoritative source. It states that even after decades of availability there is no conclusive evidence that products containing 8–15 mg of codeine per tablet with paracetamol, aspirin or ibuprofen have any benefits over these non-opioids alone,” he said.
“Clearly the continued widespread availability of a drug product that causes so much drug dependence and harm, and provides no proven benefit, simply cannot be justified.”