Codeine rescheduling and its impact on consumer access to medication


woman taking pill - vector

Dr Angel Gonzalez takes a look at the implications of the codeine decision

Community pharmacies have been facing a growing concern with the problematic use of drugs containing substances with psychoactive properties prescribed for self-medication.

The most relevant medicines are opioids, antihistamines with sedative properties, and sympathomimetics.

The use of prescription opioid pain relievers has been increasing since the 1990s, due in part to changes in recommendations for the treatment of chronic pain, but also to abuse and diversion.

Non-medical uses of these drugs is most prevalent in rural or suburban areas with limited access to cheap illicit drugs, and they also constitute the second-most abused substance, after marijuana.

Codeine used for analgesia is combined with paracetamol and can be purchased at community pharmacies without a medical prescription in doses up to 20mg of codeine per pill.

Several analgesic formulations containing codeine can be requested without a limit of duration of use in Australia.

These drugs are placed behind the dispensing counter in the pharmacies, and patients must request them from a member of the pharmacy staff. Codeine is used to treat pain and suppress coughing, and can currently be purchased without a prescription; low doses are found in some painkillers, cough syrups, and cold and flu tablets.

In Australia, the TGA took the decision to reschedule the Over-The-Counter codeine medications as prescription only,  in an effort to halt the rise in codeine-related deaths, which have more than doubled between 2000 and 2013, according to the results obtained by Roxburgh and cols.

The new regulation will come into effect on the 1st of February 2018. The US, Germany and Japan have already banned OTC sales of the codeine-combined medications.

The Pharmacy Guild of Australia argues that making codeine prescription-only will unfairly affect people who genuinely need it and use it safely. 

According to the PGA, the issue of misuse would be better managed by a real-time monitoring system that identified people at risk of misusing codeine at the point of sale.

In the US, where the OTC codeine-combined products have been banned for more than ten years, healthcare providers have identified the practice of “doctor shopping,” which is loosely defined as the process of visiting multiple consultations with the explicit purpose of obtaining controlled substances.

This seems to be the primary cause of drug diversion but also highlights concerns about the consumers’ easy access to codeine-related products from online retailers.

When used as prescribed, opioid analgesics are safe and effective for their intended use, and are an important weapon in treating patients suffering from chronic pain.

As policymakers continue to consider options to combat opioid abuse, it will be important for them to ensure patient access, including the approval of new innovations that might help limit potential abuse.

We will have to wait for the outcome of the TGA decision and its impact into both the use and misuse of this substance.

Dr. Angel Gonzalez is a Senior Associate with XPotential™ and Director of SymptoMapp. A qualified medical practitioner and anaesthetist in his home country, he is the owner of his own medical consulting business in Latin America. Angel’s deep medical knowledge, commitment to improving consumer health literacy and creativity provides unique insight into opportunities to improve healthcare in Australia.

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