New measures to inform Canadians of the risks of prescription opioids out for consultation
June 16, 2017 - Ottawa, ON - Health Canada
Canada is facing an opioid crisis. Overdoses related to opioids are claiming the lives of thousands of Canadians of all ages, and from all walks of life. Some who have become dependent on prescription drugs were not even aware that the drugs they had taken contained opioids. Patients receiving prescription opioids need a clear understanding of the risks associated with these drugs, so they can make informed decisions about how to use them as safely as possible or whether to use them at all.
As part of the Government of Canada’s work to reduce problematic opioid use and its related harms, Health Canada is proposing regulations that would make a warning sticker and patient information handout mandatory with all prescription opioids at the time of sale. This means that no matter where patients and families across Canada fill their prescriptions, the same handout and sticker would be provided to them.
The sticker would be applied by the pharmacist to the prescription opioid container to warn patients about the potential risks associated with opioid use, including dependence, addiction and overdose. The handout would contain broader information on the safe use of opioids, and on the risks associated with these drugs.
Mandatory risk management plans for opioids are also part of the Government of Canada’s commitment to addressing the opioid crisis. Through the proposed regulations, the Minister of Health would be able to require that pharmaceutical companies develop and implement risk management plans for all opioids to identify, mitigate and monitor risks associated with opioid use.
Companies would be required to keep their risk management plans evergreen by monitoring how their products are being used and develop activities should harms associated with use of these products emerge.
To finalize these regulations, Health Canada is asking Canadians to provide their comments via the Canada Gazette website. These consultations will be open for a period of 75 days, ending August 31, 2017.
- Final publication of the regulations would mark the first time the federal government requires a warning sticker and patient handout with a dispensed medicine.
- When finalized, this will be the first time that the Government of Canada will use the power granted by Vanessa’s Law to apply terms and conditions. Health Canada will use this power to require that pharmaceutical companies develop and implement risk management plans for all opioids that Health Canada authorizes.
- More details about the various actions being taken by Health Canada to help combat the opioid crisis can be found here: Joint Statement of Action to Address the Opioid Crisis.
“This will be the first time the Government of Canada requires that warnings and information on health products be provided directly to Canadians to help them understand the potential risks associated with problematic opioid use. This is just one of many urgent actions we are taking to address the growing opioid crisis in Canada. Input from Canadians is always welcome on our proposed regulations. In this case, it is particularly important.”
Minister of Health
- Government to make a warning sticker and patient information handout mandatory for all prescription opioids dispensed in Canada
- Government of Canada Information on Opioids
Office of Jane Philpott
Minister of Health
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