Opioid Warning Sticker and Patient Information Handout, and Risk Management Plans

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Health Canada has identified the need for patients to receive clear information about the safe use of opioids and the risks associated with their use. As such, requirements have been added, under the Food and Drug Regulations, for a warning sticker and patient information handout to be provided with all prescription opioids that appear in Part A of the “List of Opioids”, at the time of dispensing. Guidance to help pharmacists and practitioners comply with the opioid sticker and handout regulatory requirement is posted on our website.

Stickers and handouts are usually distributed to patients at the discretion of the pharmacist, and can vary from pharmacy to pharmacy. Requiring the distribution of a specific opioid warning sticker and patient information handout will ensure that all Canadians receive consistent information about the risks and safe use of opioids.

List of Class A Opioids

The List of Opioids is divided into two parts:

Both lists apply to human use drugs only and include the names of the active ingredients, their derivatives and any qualifying factors that may apply to specific ingredients. Active ingredients on the List of Opioids may be added or removed at the Minister’s discretion.

Information for patients concerning opioids

Part A: Opioid Warning Sticker

Practitioners and/or pharmacists dispensing an opioid from Part A of the List, must affix the following Opioid Warning sticker on the opioid bottle, container or package.

Part B: Opioid Patient Information Handout

Practitioners and/or pharmacists dispensing an opioid from Part A of the List, must provide the following handout directly to the patient. The handout is entitled “Opioid Medicines – Information for Patients and Families”.

Note: Opioids dispensed under the supervision of a healthcare professional, such as in a hospital setting, are not required to have a warning sticker and patient information handout.

Risk Management Plans

Health Canada will add terms and conditions to the market authorizations of specific opioids that would impose a requirement for the market authorization holder (MAH) to submit a Canadian-specific opioid targeted risk management plan (RMP) to Health Canada. This RMP would aim to improve the characterization, monitoring and mitigation of opioid-related harms and to manage uncertainties related to those harms. The process would include sending the MAH advanced notice of these terms and conditions and an opportunity for discussion 90 days prior to issuance of a terms and conditions letter. An additional 90 day consultation period would follow the issuance of the terms and conditions letter. Guidance explaining this process and recommending the content of the RMP is posted on our website.

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