Notice to Stakeholders: Updates to the Opioid Patient Information Handout

Date: March 15, 2019
Our reference number: 19-105242-212

The purpose of this Notice is to notify stakeholders that Health Canada has made changes to the opioid patient information handout entitled “Opioid Medicines – Information for Patients and Families”. Canada's Food and Drug Regulations were recently amended to require that a warning sticker and patient information handout be provided to patients, at the time of sale, with all prescription opioids that appear in Part A of the “List of Opioids”.

The handout, which originally included a statement that advised patients or their families to call 911 in the case of an opioid-related emergency, has been modified to read “call 911 or your local emergency response provider” to encompass Canadian jurisdictions where the 911 emergency service is currently unavailable.

The handout has also been modified to replace the term “doctor” with the expression “health professional who prescribed your opioid” to reflect the full spectrum of health professionals that may prescribe opioids.

Pharmacists and practitioners practicing in jurisdictions where the 911 emergency service is available may continue to provide patients with the previous version of the handout until their current stock of pre-printed handouts is depleted.

For more information on Health Canada's opioid warning sticker and patient information handout initiative, please visit the Government of Canada website.

For any questions regarding this Notice, please contact:

Bureau of Cardiology, Allergy and Neurological Sciences (BCANS)
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
1600 Scott Street
Holland Cross, Tower B, 2nd Floor
Ottawa, Ontario
K1A 0K9

Email: HC.bcans.enquiries.SC@canada.ca

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