Health Canada has commenced consultations on proposed changes to the Food and Drug Regulations and Medical Devices Regulations that would require mandatory reporting of serious adverse drug reactions and medical device incidents by health care institutions. The changes are pursuant to amendments to the Food and Drugs Act contained in the Protecting Canadians from Unsafe Drugs Act, which was enacted in November 2014. Health Canada published a Notice of Intent to amend the regulations in June 2016.
The proposed changes are intended to enhance post-market surveillance of drugs and medical devices to improve identification of emerging patient safety issues.
Health Canada is seeking input on five elements of the proposed changes to the regulations:
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Topic |
Current Proposal |
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1. Which kinds of health care institutions should report? |
Hospitals that provide acute care services |
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2. What types of serious adverse drug reactions and medical device incidents should be reported? |
Serious, unexpected adverse drug reactions and all medical device incidents within the control of the health care institution |
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3. Which health products should be reported on? |
Prescription and non-prescription pharmaceuticals, non-vaccine biologics, radiopharmaceuticals, disinfectants, and medical devices |
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4. What information should be included in the report? |
Minimum required data fields, such as the name of the health care institution and the name of the drug or medical device, as well as additional data fields that would be required if the information is known, such as patient outcome |
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5. What timelines for reporting should be in place? |
30 days starting on the day on which the serious adverse drug reaction or medical device incident is first documented |
Comments on non-regulatory approaches to improve reporting of serious adverse drug reactions and medical device incidents, including outreach, education, and feedback for reporting institutions, are also being solicited.
More information on the proposed changes can be found on Health Canada’s consultation webpage and in the accompanying Consultation Paper. The online consultation period ends on August 11, 2017. Health Canada expects that the proposed changes will be implemented, at the earliest, in 2019.
