Opioid warning sticker and patient information handout requirements come into force on October 20, 2018.
On October 20th, 2018 recent amendments to Canada’s Food and Drug Regulations come into force. These amendments 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.”
Both the warning sticker and the patient information handout must meet the specifications of the source document entitled “Information for Patients Concerning Opioids,” which is published on the Government of Canada’s website. Pharmacists and practitioners are responsible for obtaining or producing copies of the sticker and handout in order to meet these new requirements.
Opioids dispensed under the supervision of a practitioner, such as in a hospital setting, are not required to have a warning sticker and patient information handout. Opioids which are authorized and used for the treatment of an opioid use disorder are also exempt from this requirement, as specified on Part A of the List of Opioids.
Health Canada has published a guidance document to assist impacted stakeholders. Please refer to this document for answers to questions related to these requirements.
Pharmacists’ Responsibility to Provide Counselling
The College would like to remind BC pharmacists of their existing responsibilities to always act in the best interests of their patients.
Under the Health Professions Act (HPA) Bylaws, pharmacists are required to provide counselling to engage in direct consultation with the patient or his/her representative. This means that in providing quality care, pharmacists’ responsibilities extend beyond simply providing the right patient with the right drug. Pharmacists must ensure that the patient knows about the medication they are taking, and understands how to take the medication appropriately, as well as any potential adverse effects.
Pharmacists’ Responsibilities under the Code of Ethics.
Pharmacists are also reminded of their responsibility to their patients as outlined in the College’s Code of Ethics.
Code of Ethics
Standard 1: Registrants Protect and Promote the Health and Well-Being of Patients
(a) Registrants are committed first and foremost to protecting and promoting the health and well-being of their patients.
Standard 2: Registrants Act in the Best Interests of their Patients in Achieving their Chosen Health Outcome
(a) Registrants utilize their professional judgment to act in the best interests of their patients in achieving their chosen health outcome.
For additional information, please contact:
Bureau of Cardiology, Allergy and Neurological Sciences (BCANS)
Therapeutic Products Directorate
Health Products and Food Branch
1600 Scott Street
Holland Cross, Tower B, 2nd Floor
- Notice to Stakeholders – Opioid warning sticker and patient information handout requirements come into force on October 20, 2018 (Government of Canada)
- Regulations Amending the Food and Drug Regulations (Opioids)
- Opioids List (Government of Canada)
- Information for patients concerning opioids (Government of Canada)
- Questions and Answers: Prescription Opioids – Sticker and Handout Requirements for Pharmacists and Practitioners (Government of Canada)
- College of Pharmacists of BC Code of Ethics
- Health Professions Act (HPA) Bylaws
- Practice Review Program Support Tool: Counselling (CPBC)