Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents

The Protecting Canadians from Unsafe Drugs Act, also known as Vanessa's Law, is intended to increase drug and medical device safety in Canada by strengthening Health Canada's ability to collect information and to take quick and appropriate action when a serious health risk is identified. It will be mandatory for hospitals to report serious adverse drug reactions (serious ADRs) and medical device incidents (MDIs) to Health Canada, effective December 16, 2019.

Downloadable from this webpage are 4 modules that contain core content intended for use by hospitals, health care professionals, patients and their families, and educators, to explain, describe, or promote the reporting of serious ADRs and MDIs.

• Module 1 - Overview of Vanessa's Law and Reporting Requirements
  English: PowerPoint | PDF | Webpage
  French: PowerPoint | PDF | Webpage

• Module 2 - Reporting Processes to Health Canada
  English: PowerPoint | PDF | Webpage
  French: PowerPoint | PDF | Webpage

• Module 3 - Strategies to Promote and Support Mandatory Reporting
  English: PowerPoint | PDF | Webpage
  French: PowerPoint | PDF | Webpage

• Module 4 - Health Canada's Review and Communication of Safety Findings
  English: PowerPoint | PDF | Webpage
  French: PowerPoint | PDF | Webpage

These materials (as entire modules or as individual slides or selected content) can be used for individual learning or incorporated into presentations, orientation, continuing education, and other information-sharing activities. The materials can be used in the following ways to support and raise awareness of mandatory reporting requirements:

• Hospitals can include some or all of the content in their local, regional, and/or provincial information-sharing activities (e.g., "Lunch and Learn" sessions, presentations, orientation programs for new staff).
• Educators in the health care sector can use the content in presentations or as part of a curriculum.
• Professional associations, societies, and regulatory colleges, as well as other training institutions for health care workers, may incorporate the content of the modules into accredited courses or continuing education certification programs.
• Patient and consumer organizations can help disseminate some or all of the information in the modules to increase awareness and knowledge among their members.

This conceptual model of serious ADR and MDI reporting by hospitals depicts the information provided in the 4 PowerPoint modules: mandatory reporting requirements, reporting processes to Health Canada, strategies to promote and support reporting, and Health Canada's review and communication of safety findings.

Health Canada, ISMP Canada, HSO, and CPSI gratefully acknowledge input received from the Advisory Panel (listed in alphabetical order): Glenn Cox, Senior Director Pharmacy Services NSHA, Director Pharmacy Services, Cape Breton/Antigonish/Guysborough, Cape Breton Regional Hospital, Sydney, NS; Michael Gaucher, Director Pharmaceuticals & Health Workforce Information Services, Canadian Institute for Health Information, Ottawa, ON; Andrew Ibey - Clinical Engineer, Children's Hospital of Eastern Ontario, Ottawa, ON; Denis Lebel - Pharmacien, adjoint aux soins, enseignement et recherche, Département de pharmacie, CHU Sainte-Justine, QC; Dr. Joel Lexchin, Professor Emeritus, School of Health Policy & Management, York University, Toronto, ON; Faith Louis, Regional Manager, Quality Improvement & Support Services, Pharmacy Services, Horizon Health Network, NB; Holly Meyer, Provincial Director, Product Quality & Safety, Alberta Health Services, AB; Maryann V. Murray, Patients for Patient Safety Canada; Tolu Oyebode, Government of Saskatchewan, Senior Project Manager, Patient Safety Unit, Strategic Priorities Branch, Ministry of Health, SK; Sheryl Peterson, Associate Director, Lecturer, Faculty of Pharmaceutical Sciences, The University of British Columbia (Vancouver Campus); Michelle Rossi, Director, Policy and Strategy, Health Quality Ontario, Toronto, ON; Myrella Roy, Executive Director, and Cathy Lyder, Director Professional Practice, Canadian Society of Hospital Pharmacists, Ottawa, ON; Christelle Sessua, Quality Assurance-Risk Management Coordinator, Iqaluit Health Services, Department of Health, Government of Nunavut; Robyn Tamblyn, James McGill Chair, Professor, Department of Medicine, Department of Epidemiology & Biostatistics, McGill University, Scientific Director, Institute of Health Services and Policy Research, Canadian Institutes of Health Research, Montreal, QC; Annemarie Taylor, Executive Director, Patient Safety & Learning System, Vancouver, British Columbia; Terence Young, Chair of Drug Safety Canada and father of Vanessa Young.