July 31, 2019: Educational Support for Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device IncidentsThe Protecting Canadians from Unsafe Drugs Act, also known as Vanessa’s Law, is intended to increase drug and medical device safety in Canada by strengthening Health Canada's ability to collect information and to take quick and appropriate action when a serious health risk is identified. It will be mandatory for hospitals to report serious adverse drug reactions (serious ADRs) and medical device incidents (MDIs) to Health Canada, effective December 2019.
Overview of the Reporting Requirement:
The mandatory reporting requirements for hospitals apply to therapeutic products, including pharmaceuticals (prescription and nonprescription drugs), biologic drugs, radiopharmaceutical drugs, disinfectants, and medical devices. Hospitals will be required to report a serious ADR or MDI to Health Canada within 30 calendar days of first documentation of the event within the hospital. Health Canada has specific definitions for these terms.
Health Canada, ISMP Canada, Health Standards Organization and the Canadian Patient Safety Institute worked together to develop educational materials to support the implementation of mandatory reporting. Read more …