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Mandatory reporting of adverse drug reactions and medical device incidents in hospitals coming soon

August 7, 2019
Vanessa’s Law aims to increase drug and medical device safety.

Effective December 16, 2019, it will be mandatory for hospitals to report serious adverse drug reactions and medical device incidents to Health Canada. It’s a requirement of the Protecting Canadians from Unsafe Drugs Act, or Vanessa’s Law, which is intended to increase drug and medical device safety by strengthening Health Canada’s ability to collect information and take appropriate action when a serious health risk is identified. The law was introduced following the death of 15-year-old Vanessa Young from an adverse drug reaction in 2000.

The mandatory reporting requirements for hospitals include pharmaceuticals (prescription and non-prescription), biologic drugs, radiopharmaceutical drugs, disinfectants, and medical devices.

All pharmacists are reminded about Standard 5.3(g) of the Standards of Practice for Pharmacists and Pharmacy Technicians which identifies one of the appropriate responses to drug therapy problems as “reporting an adverse reaction to the Canadian Adverse Drug Reaction Monitoring Program.”

For more information, refer to the July 31, 2019, Institute for Safe Medication Practices Canada (ISMP) Safety Bulletin.