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New federal reporting requirements for serious adverse drug reactions and medical device incidents


Oct 22, 2019

BC Patient Safety & Learning System (PSLS) has been working with Health Canada, the Ministry of Health and BC's health authorities to promote reporting and support hospitals in their compliance with upcoming regulations associated with Vanessa's Law—officially known as the Protecting Canadians from Unsafe Drugs Act.

On Dec. 16, 2019, federal regulations will come into force requiring all hospitals in Canada to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs) to Health Canada within 30 days of the incident. In B.C., PSLS will facilitate the reporting process by receiving ADR and MDI reports from the health authorities and forwarding them to Health Canada.

PSLS is available to all nurses working in a BC health authority. A webpage with downloadable resources is currently available from PSLS, and a 15-minute eLearning module has been added to LearningHub and iLearn (Interior Health only).