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CPSI Share                                                  
9/12/2019 9:00 AM

The Protecting Canadians from Unsafe Drugs Act, also known as Vanessa's Law, introduces regulations that require mandatory reporting of serious adverse drug reactions (ADR) and medical device incidents (MDI) by hospitals, effective December 16, 2019.

A serious ADR is a harmful and unintended response to a drug that requires hospitalization or prolongs hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening, or results in death. A MDI refers to an incident related to a failure of a medical device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its directions for use that has led to the death or a serious deterioration in the state of health of a patient, user, or other person, or could do so were it to recur.

Three organizations – Institute for Safe Medication Practices Canada (ISMP Canada)Health Standards Organization (HSO), and the Canadian Patient Safety Institute – are working in a joint venture to assist Health Canada with outreach, education, and feedback to encourage serious ADR and MDI reporting. After extensive consultation, these partners have created educational materials that can be used to support and raise awareness of mandatory reporting requirements.

Four modules provide an overview of Vanessa's Law and Reporting Requirements, Reporting Processes to Health Canada, Strategies to Promote and Support Mandatory Reporting, and Health Canada's Review and Communication of Safety Findings. PowerPoint slides designed as "building blocks" have been created for integration into learning programs and other educational activities. To access these modules, visit www.patientsafetyinstitute.ca

To raise awareness of mandatory reporting and to support reporting and learning, it is recommended that:

  • hospitals include some, or all, of the educational slides in their orientation programs;
  • educators use the content in presentations or as part of a curriculum; and,
  • professional associations, colleges, and societies use the content to create accredited courses or certification programs for continuing education; and patient and consumer organizations use the materials to increase awareness and knowledge among their members. 
Under-reporting and the poor quality of reporting of ADRs and MDIs is an issue in Canada and internationally. ADRs can worsen a patient's medical problems, place patients in life-threatening situations and extend the patients' length of stay in hospital (thus leading to increased healthcare costs)1. To help address these concerns, Canada's Food and Drug Regulations have been amended to mandate hospitals to report serious ADRs and MDIs to Health Canada within 30 days of the first documentation of the reaction or incident within the hospital.

Mandatory reporting by hospitals of serious ADRS and MDIs will improve knowledge and contribute to safer products. It also strengthens Health Canada's ability to collect information and to take quick and appropriate action when a serious health risk is identified, such as ordering a product recall or requiring a label change/package modification to make new safety information available to patients and consumers. Together, we can all ensure that mandatory reporting contributes to safer care.

For more information on the Protecting Canadians from Unsafe Drugs Act, visit the Health Canada website.

1Wu, Chen, Chaim M. Bell, and Walter P. Wodchis. "Incidence and Economic Burden of Adverse Drug Reactions among Elderly Patients in Ontario Emergency Departments: A Retrospective Study." PubMed Central® (PMC). December 13, 2012. Accessed June 24, 2019. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3714138/.