0242 Mandatory reporting of serious ADRs and MDIs

Since December 16, 2019, Canadian hospitals have been mandated under the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) to report to Health Canada’s post-market surveillance program, Canada Vigilance Program (CVP), the occurrence of serious adverse drug reactions (ADRs) and medical device incidents (MDIs) that have resulted in serious harm (or MDIs that have the potential to result in serious harm). The purpose of mandatory reporting is to improve the safety of therapeutic products and medical devices used to treat Canadians.

This presentation will:
• outline Vanessa’s Law (Protecting Canadians from Unsafe Drugs Act)
• define serious adverse drug reactions (ADRs) and medical device incidents (MDIs)
• explain the significance of ICD-10-CA coded data to Horizon’s process to monitor and improve reporting compliance