From 1 February 2018, codeine and codeine containing medicines will no longer be available over-the-counter and will require a script from a GP before they are sold in pharmacies.

Doctors, pain specialists, and hospital pharmacists are overwhelmingly supportive of this move, possibly because we see first-hand the damage caused by these products being so freely available. It’s a decision that is also backed by key health consumer groups who understand the risks and harms of these medicines.

But as is the way with most regulatory reforms, not everyone is going to agree. Groups like the Pharmacy Guild, which represent community pharmacy business owners, have been lobbying state and territory health ministers, claiming restricted access to codeine will inconvenience many consumers and they have made a case for exemptions to the plan to ensure people can continue to buy and use these drugs.

So why is the regulatory environment changing for codeine medicines?

Codeine is closely linked to morphine and, like morphine, is derived from opium poppies.

It often results in opioid tolerance, addiction, poisoning and, in high doses, can contribute to both accidental and intentional death. When combined with paracetamol or ibuprofen, the addictiveness of codeine drives some people to increase the number of tablets taken as their body’s tolerance to the codeine builds, increasing the medical risks associated with paracetamol or ibuprofen.

There is a wide bank of evidence that documents the misuse, addiction, and secondary harm due to high dose exposure to the non-opioid analgesic medicines with which codeine is combined (for example gastric ulcer with complications of haemorrhage or perforation, hypokalaemia, or renal tubular acidosis).

The misuse of codeine products has resulted in a significant number of deaths in Australia. Between 2007- 2011, the latest years for which audited coronial data is available, there were 573 deaths due to codeine where morphine was not detected, 575 deaths where codeine and morphine were detected together and 769 deaths that were attributed to a possible codeine combination product. This compares to 1,127 deaths from heroin for the same five year period.

Making codeine medicines prescription-only, is not a plan the Therapeutic Goods Administration (TGA) cooked up overnight. The TGA carried out a comprehensive review of the evidence and worked closely with all stakeholders and the wider community.

Those who oppose the upscheduling of codeine, point to real-time monitoring as an alternative to tighter restrictions on access. A nationally coordinated and implemented real-time reporting and monitoring system in the form of the Electronic Recording and Reporting of Controlled Drugs has the medical community’s strong support. 

A monitoring system on its own, however, is not a solution to the problem of codeine abuse. It’s a clinical tool that will inform clinical decision making into the future.

Pharmacists are highly trained in the therapeutics and toxicology of medicines and will continue to provide carefully considered advice on a range of safer and effective analgesic medicines that will remain available over the counter. If these medicines do not provide sufficient pain relief or if concerned, pharmacists will continue to refer patients to their doctors for medical assessment and treatment.

We know that upscheduling codeine will be an adjustment for doctors, pharmacists and patients. But keeping these combination medicines available over-the-counter can’t be justified given what we know about these medicines and the harm they cause. This change will contribute to a broader strategy to prevent and reduce prescription opioid harms in the Australian community and will ultimately save lives.

Associate Professor, Adrian Reynolds
President of the Chapter of Addiction Medicine
Royal Australasian College of Physicians