July 9, 2019
The Regulations regarding mandatory reporting of serious adverse drug reactions (ADRs) and medical device incidents (MDIs) by hospitals, proposed last summer, have now been adopted and will come into effect by December 16, 2019. As per the regulatory requirements in the Food and Drug Regulations for adverse drug reactions and the Medical Devices Regulations for medical device incidents, hospitals (not the involved HCP) must report the serious ADR or MDI, in writing, within 30 days of the incident to the Canada Vigilance Program of the Marketed Health Products Directorate (MHPD) of Health Canada. These requirements apply to the following therapeutic products:
Note that cannabis, used medically or recreationally, is excluded.
This mandatory reporting only applies to facilities that are licensed, approved or designated as a hospital according to the laws of the province or territory since this is the expected site of treatment for serious ADRs and MDIs. As such, private clinics and long-term care facilities are outside of the scope of these regulations. They are encouraged, of course, to report but it is voluntary.
Health Canada encourages hospitals to report serious ADRs and MDIs to manufacturers, but they are not required under the regulations to do so. Manufacturers are expected to consult the Canada Vigilance Adverse Reaction and the Drugs and Medical Devices Online Databases to identify reports for their products and are required to report cases from these sources back to Health Canada only when new information is available from the manufacturer. For MDIs, hospitals are “strongly encouraged” to report incidents directly to the manufacturer or importer.
The Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Guidance document provides details towards the implementation of these regulations.
It is important for manufacturers to keep vigilant on reports made by institutions regarding their products. In addition to the Canada Vigilance Adverse Reaction Online Database, Health Canada has a publicly available online database for MDIs, Health Product InfoWatch to alert HCPs and the public on suspected adverse reactions and summaries of safety reviews to identify the actions taken by Health Canada.