Adverse drug reactions and medical device incidents occur in hospitals, emergency departments, and people's homes – but the events are significantly underreported.
The Protecting Canadians from Unsafe Drugs Act, also known as Vanessa's Law, honours the memory of Vanessa Young, who died at the age of 15 due to a heart problem after being prescribed cisapride.
The law increases safety in Canada by strengthening Health Canada's ability to collect information on drugs and medical devices and take quick and appropriate action when a serious health risk is identified. The law includes a requirement for mandatory reporting by hospitals of serious adverse drug reactions (ADR) and medical device incidents (MDI). This provision of the law will come into effect later this year.
The Institute for Safe Medication Practices (ISMP Canada) is working in a joint venture with the Health Standards Organization (HSO) and the Canadian Patient Safety Institute (CPSI) to assist Health Canada with outreach and education to encourage ADR and MDI reporting.
After this initial pilot and revisions based on your feedback, the educational materials will be available in July 2019 for use in any setting to support Vanessa's Law.
How the education approach will work
The educational materials will be provided in PowerPoint slides (as pdfs for the Pilot) that contain content about ADR and MDI reporting that can be used by healthcare leadership, healthcare providers, patients/ families and educators.
The PowerPoint slides are designed to be "building blocks" for you to integrate into your own learning or to incorporate into orientation, continuing education and other education activities.
- Hospitals can include some, or all, of the PowerPoint slides in their orientation programs.
- Educators can use the content in presentations or as part of a curriculum.
- Professional associations, colleges, and societies can use the content to create accredited courses or certification programs for continuing education.
- Patient and consumer organizations can use the materials to increase awareness and knowledge among their members.
One of the principles guiding this project is that the best people to communicate information about mandatory ADR and MDI reporting are those closest to their audience.
How to participate in the Pilot
Anyone, including healthcare leadership, healthcare providers, patients and families, and educators can participate in this Pilot.
We have invited healthcare leadership, healthcare providers, patients and families, and educators to participate in this Pilot and we would like to know if the content is helpful.
You can review as many of the modules as your time permits.
In English only
Overview of Vanessa’s Law and Reporting Requirements
Culture of Safety
ADR and MDI Reporting Processes
System Supports for Reporting and Learning
Health Canada’s Review and Communication of Safety Findings
After looking at the modules, we would like to know if:
- the information is helpful
- you now have a good understanding of what needs to be reported according to Vanessa's Law
- this approach will be helpful to you and others
- there is additional information that you think should be included.
The final modules, with your feedback incorporated, will be provided in July 2019 as PowerPoint slides.
If you have questions about the Pilot, please contact