Mandatory warning sticker and handout will soon accompany all dispensed opioids
OTTAWA, May 2, 2018 /CNW/- Opioids are sometimes the only medications that can help patients manage serious pain. At the same time, they carry risks, including the potential to lead to dependence, addiction and overdose. Health Canada wants to
Today, Health Canada published 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.
"Information is one of our most important tools for keeping ourselves and our families healthy and safe. These standardized, easy-to-understand warning stickers and patient information handouts will put information in the hands of Canadians so that they can understand the risks of prescription opioids and how to safely use these powerful medications." The Honourable Ginette Petitpas TaylorMinister of Health
New measures to inform Canadians of the risks of prescription opioids out for consultation
More details about the various actions being taken by the Government of Canada to help address the opioid crisis can be found at Canada.ca/opioids
Information Update about the updating of opioid prescription labels through the class labelling initiative
Submission of targeted risk management plans and follow-up commitments for prescription opioid-containing products - Guidance for industry
Questions and Answers: Prescription Opioids – Sticker and Handout Requirements for Pharmacists and Practitioners
SOURCE Health Canada
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