Serious Adverse Drug Reaction and Medical Device Incident Reporting

The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) introduces the requirement for mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals.

The law improves Health Canada’s ability to:

• collect safety information;
• take appropriate action (such as a label change or a product recall) when a serious health risk is identified; and
• increase transparency (by sharing more information).

Who is required to report?

The requirement for mandatory reporting applies to all hospitals.

• The requirement also applies to outpatient clinics if they are legally part of the hospital.
• Health-care institutions that are not defined as hospitals, such as private clinics or long-term care facilities (e.g. nursing homes), continue to be encouraged to report on a voluntary basis.

WRHA SOPs

• ADR/MDI reporting general SOPs for staff
• ADR/MDI reporting SOPs for Site Representative and Quality Improvement and Patient Safety (QIPS)
• Basic reporting instructions for adverse drug reaction in RL

For more information about Vanessa’s Law, visit the Canadian Patient Safety Institute at https://www.patientsafetyinstitute.ca/en/toolsResources/Vanessas-Law/Pages/default.aspx.