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Health Canada Requiring Mandatory Warning Stickers For All Opioid Prescriptions

Ottawa – Health Canada published it’s final regulations in Canada Gazette, Part II that will make warning stickers and patient information handouts mandatory with all opioids dispensed to Canadians at pharmacies or in doctor’s offices across Canada.

The warning sticker will state that the opioid medication can cause dependence, addiction and overdose, and will be applied to the container being dispensed to the patient. The patient handout will include important information about the signs of opioid overdose, and warnings such as not to share the medication, and to always store the medication safely out of reach of children. It will also advise of other serious warnings and potential side effects.

The mandatory warning sticker and the patient handout will begin to be distributed in October 2018.

The new regulations also require pharmaceutical companies to develop and implement mandatory risk management plans to help characterize, monitor, prevent and manage risks associated with the use of their opioid products. The risk management plans will include additional activities aimed at reducing the potential harms associated with the use of these products, such as including educational materials in packaging for health care providers.

These new measures are part of actions that the Government of Canada is taking to help address the opioid crisis.

Health Canada will update Canadians through social media and the Government of Canada website as these new measures are implemented and come into effect.

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