New Vanessa’s Law reporting regulations: Information for physicians

Vanessa’s Law comes into effect on December 16, 2019 and requires all Canadian hospitals that have serious adverse drug reactions (ADRs) or medical device incidents (MDIs) to report them to Health Canada within 30 days of the incident being documented. Examples of ADRs and MDIs include: kidney damage following ingestion of a diuretic resulting in dialysis or a malfunctioning medical infusion pump.

The reporting process in BC is facilitated by the BC Patient Safety & Learning System (PSLS), which forwards hospital reports to Health Canada on behalf of the relevant Health Authority. You can report in PSLS on any health authority computer, or by calling: 1 877 789 PSLS (7757). For full instructions, please see the BC Emergency Medicine Network’s resource. 

Physicians can take a short e-learning module facilitated by the BCPSLS that covers compliance with Vanessa’s Law regulations, identifying reportable ADRs and MDIs, and locating information about unsafe products. Please follow this link for more information, and to access the e-learning course.
 
Receiving royal assent in 2014, Vanessa’s Law also allows Health Canada to order recalls, impose tougher penalties for unsafe products, and compel drug companies to review labels or do further testing on products. 

Filing these reports will help Health Canada identify unsafe drugs and devices across the country. Healthcare providers who report may receive feedback and information from Health Canada about the safety of therapeutic products they prescribe or administer.