New regulations to provide better information for patients on the safe use of opioid medications

Mandatory warning sticker and handout will soon accompany all dispensed opioids

May 2, 2018 - Ottawa, ON - Health Canada

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 ensure that Canadian patients receive consistent, relevant information about the safe use of prescription opioids and their potential risks.

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.

Quotes

"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 Taylor
Minister of Health

Quick Facts

• Health Canada consulted extensively on the proposed warning stickers and patient handouts. Canadians were invited to provide comments via the Canada Gazette in June 2017. The stickers were also tested with patients.
• This is the first time the federal government is requiring a warning sticker and patient handout with a medicine dispensed by a pharmacy.
• This is also the first use of the terms and conditions authority granted by Vanessa’s Law, under which the Government will require risk management plans as part of the requirements for authorization of opioids.

Related Products

New measures to inform Canadians of the risks of prescription opioids out for consultation

Associated Links

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