New Health Canada Consultation on Low-Dose Codeine Products

New Health Canada Consultation on Low-Dose Codeine Products

Posted: Monday September 25th, 2017

Author: Pinky Mazumder

On September 9th 2017, Health Canada released a notice in Canada Gazette Part I concerning the non-prescription availability of low-dose codeine products (1). Codeine is an opioid drug that is indicated for mild to moderate pain as well as cough. Like other opioids, codeine can cause psychoactive side effects and result in dependence and addiction. As a result, many codeine-containing products require a prescription. However, in a situation somewhat unique to Canada, some lower-dose codeine products have been traditionally available to patients without a prescription.

One of the issues with non-prescription low-dose codeine products is the possibility of overuse, leading to an increased risk of dependence and addiction. In fact, codeine was found to be one of the most common substances used by patients entering substance abuse treatment. Outside of Canada, countries such as France, Greece, India, and Italy mandate that all codeine containing products be available by prescription only. In early 2018, Australia will follow the trend and apply restrictions on low-dose codeine products. As many of these products also contain acetaminophen, overuse poses the risk of acetaminophen-related problems such as liver toxicity.

Health Canada proposes to amend the Narcotic Control Regulations to require all codeine products to be available by prescription only (1). It is thought that by requiring the intervention of a physician, patient outcomes will be enhanced by determining whether codeine is an appropriate treatment option in the first place, and if so, by ensuring that the patient’s treatment is adequately monitored.

The proposed amendments to the Regulations are available for consultation from September 9, 2017 to November 8, 2017. Canadians, healthcare practitioners, and those in the pharmaceutical industry have been invited to participate and provide their comments. For complete and detailed information, please refer to the sources provided in the reference section below.

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1.       Health Canada Consultation

2.       Canada Gazette Part I