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As a result of new regulatory changes, Australians can no longer purchase over-the-counter (OTC) medications containing codeine. As of 1 February 2018, all codeine-based products previously available OTC are now only obtainable by prescription. The most common analgesics containing codeine are Nurofen Plus and Panadeine.

Why the change?

These changes to regulations have arisen from an increase in fatal codeine-related overdoses in Australia. OTC codeine products were previously widely and readily available. There have been several years of government scrutiny regarding the use and abuse of OTC medications containing codeine. It is estimated that approximately 600,000 Australians misuse OTC codeine products and each year nearly 100 people die from this cause. In 2015, the Advisory Committee on Medicine Scheduling sought public submissions and consultation on the use and misuse of OTC codeine products.

In submissions to the Therapeutic Goods Association, doctors reported their patients taking between 60 and 100 pills (OTC codeine containing paracetamol or ibuprofen) daily. These patients typically began taking low doses to combat moderate to severe pain. They often had a history of trauma and depression, which, coupled with the addictive properties of codeine, lead them to abuse the medication. Submissions to the Therapeutic Goods Association also suggested that many consumers are unaware of the significant risks associated with taking OTC codeine products in large doses or for an extended period of time, which underpinned the move towards making them  prescription only medication.

Before the recent changes, consumers were limited to the purchase of five days' supply of codeine-based medications in one transaction. Addicts and professionals in the medical and addiction fields reported that "pharmacy-shopping" was widespread. Medical professionals supporting the changes have also emphasised that OTC codeine-containing analgesics often provide little additional benefits compared to similar analgesics without codeine. These products contain less than 30 mg, which some say is not enough codeine to have a significant effect on pain. This may also lead patients to increase their dose to obtain relief.

What are the legal changes?

The delegate to the Secretary of the Department of Health has amended the Standard for the Uniform Scheduling of Medicines and Poisons (also referred to as SUSMP or Poisons Standard) under the Therapeutic Goods Regulations 1990. From 1 February 2018, codeine products were removed from Schedules 2 and 3 (which cover OTC medication able to be purchased at pharmacies), leaving codeine products in Schedule 4 (by prescription only) and Schedule 8 (controlled substances).

What does this mean for doctors?

These changes effectively place an increased onus on doctors to detect and prevent codeine addiction. Codeine overdose fatalities are increasingly scrutinised by the Coroner's Court and the Australian Health Practitioner Regulation Agency. In light of these changes, doctors must ensure:

  • their practices are reviewed and compliant
  • detailed and accurate records are maintained
  • prescriptions are provided in line with clinical indications, and
  • patients at risk, or already in the throes of addiction, are alerted to the risks.

Practitioners must undertake a thorough review of patient needs and demonstrate vigilance when prescribing codeine medications. For the practitioner's own protection, this should be reflected in the clinical records.

Several professionals in the field have suggested these changes will push doctors to develop their practise of pain management and treatment. Some are hopeful doctors will look to alternate treatment and focus on the psychological aspects of pain management. It has been suggested this change of focus is already growing in the medical community.

What does this mean for pharmacists?

Some pharmacists have been critical of the scheduling changes—in the past, it was largely up to them to monitor the supply of OTC codeine products and if they believed a customer was abusing codeine, had the discretion to refuse supply and direct them to a general practitioner (GP).

The Pharmacy Guild of Australia developed MedASSIST—a real-time monitoring system that allowed pharmacists to find out if a customer had recently purchased OTC codeine products. While the system was voluntary, pharmacies that implemented it were reporting positive results. MedASSIST has now been discontinued by the Pharmacy Guild as it felt it had been rendered obsolete by the scheduling changes.

What's next?

There is consumer backlash, with chronic pain sufferers expressing concerns about not being able to treat pain at the onset. Instead, they may be required to wait hours or days to schedule an appointment with their GP. The scheduling is also likely to result in increased Medicare and Pharmaceutical Benefits Scheme costs.

The Australian Medical Association has warned that these changes alone are unlikely to address the issue of abuse and dependency. It has called for improved education for consumers and practitioners, as well as real-time monitoring of prescriptions and dispenses. Real-time monitoring can help reduce doctor and/or pharmacy "shopping" and help people struggling with addiction.

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