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Educational Support for Mandatory Reporting of Serious ADRs and MDIs by Hospitals

The Protecting Canadians from Unsafe Drugs Act, also known as Vanessa's Law, underpins 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. As of December 16, 2019, it became mandatory for hospitals to report serious adverse drug reactions (serious ADRs) and medical device incidents (MDIs) to Health Canada. 

Learning tools to report serious ADRs and MDIs 

Four modules were developed in collaboration with Health Canada to explain, describe and promote the reporting of serious ADRs and MDIs. They are learning tools for hospitals, healthcare professionals, patients and their families, and educators, and can be read online or downloaded from the Government of Canada website.  

The four modules are:  

• Module 1: Overview of Vanessa's Law and reporting requirements 
• Module 2: Reporting processes to Health Canada
• Module 3: Strategies to promote and support mandatory reporting
• Module 4: Health Canada's review and communication of safety findings

You can use these materials (as entire modules, individual slides or selected content) for individual learning or incorporated into presentations, orientation, continuing education and other information-sharing activities, to support and raise awareness of mandatory reporting requirements. For example: 

• Hospitals can include some or all 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 healthcare 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 healthcare 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.    

If you have questions about Vanessa's Law and the mandatory reporting requirements, please contact hc.canada.vigilance.sc@canada.ca.

Acknowledgements

Health Canada, ISMP Canada, HSO, and HEC gratefully acknowledge input received from the advisory panel: 

• 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 
• Joel Lexchin, MD, 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 
• 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 

Please note that member details were valid at the time the group was convened, and may no longer be current.