November 2019

Nurses’ reports are key for preventing patient harm

New regulations requiring hospitals to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs) to Health Canada will come into effect on Monday, Dec. 16, 2019.

Although hospital administrators will have to submit the report to Health Canada, all nurses in all practice settings play a crucial role in identifying serious ADRs and MDIs.

Nurses have a duty to report any error, behaviour, conduct or system issue affecting patient safety. This accountability is found in section 6.5 of the Code of Conduct.

Medications and devices prescribed to patients can cause unforeseen and serious complications. When nurses report ADRs and MDIs, it contributes to patient safety in multiple ways. The reports help other health care professionals to identify serious health risks and take quick action, including making new safety information available or recalling a product.

These requirements are part of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), a new law amending the Food and Drugs Act. To support these new regulations, Health Canada has launched a website for report submission, information and inquiries, as well as a Guidance document to ensure clarity and ease of reporting.  

For more information about mandatory reporting of serious adverse drug reactions and medical device incidents, email

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