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CPSI Share                                                  
12/20/2018 3:00 AM

The Protecting Canadians from Unsafe Drugs Act, also known as Vanessa’s Law, strengthens regulations to report Serious Adverse Drug Reactions (ADRs) and Medical Device Incidents (MDIs). The Law improves Health Canada’s ability to: 

  • Collect post-market safety information on drugs and medical devices;  
  • Take appropriate action when a serious risk to health is identified; and 
  • Promote greater confidence in the oversight of therapeutic products by increasing transparency.

The Law includes a requirement for mandatory reporting, by certain health care institutions, of serious adverse drug reactions (ADRs) and medical device incidents (MDIs) and this requirement will come into force six months following publication of final regulations in Canada Gazette, Part II which is anticipated in the Spring of 2019. Quality reporting will improve the knowledge base on product safety and contribute to a better understanding of the benefits and the risks of drugs and devices. 

The Institute for Safe Medication Practices Canada (ISMP Canada) in a Joint Venture with Health Standards Organization (HSO) and the Canadian Patient Safety Institute (CPSI), were awarded a contract to assist Health Canada with outreach, education and feedback. The contract was awarded in December 2017 following a formal request for proposal process.  

The Joint Venture Partners are working with Health Canada to develop and implement an educational approach and content that will help healthcare providers and healthcare leaders identify and report serious ADRs and MDIs. Improving the awareness of reporting requirements and providing support to certain health care institutions to report serious ADRs and MDIs to Health Canada through outreach, education and tools is expected to assist with successful implementation of this initiative and help minimize burden. Education will be designed to easily integrate into existing educational activities, courses and programs provided by stakeholders, including the general public and are anticipated to be available by July 2019.

Health Canada Announcement:
https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/medical-devices-action-plan.html

Media Contact:

Christopher Thrall, Communications Officer at CPSI who will connect you with each of the organizations (CPSI, HSO and ISMP Canada). cthrall@cpsi-icsp.ca, 780-566-8375 

The Institute for Safe Medication Practices Canada (ISMP Canada) is an independent national not-for-profit organization committed to the advancement of medication safety in all healthcare settings. ISMP Canada works collaboratively with the healthcare community, regulatory agencies and policy makers, provincial, national and international patient safety organizations, the pharmaceutical industry and the public to promote safe medication practices. ISMP Canada's mandate includes analyzing medication incidents, making recommendations for the prevention of harmful medication incidents, and facilitating quality improvement initiatives. Information about ISMP Canada's work with Canadians to prevent medication incidents is available at: www.ismp-canada.org; and also at www.SafeMedicationUse.ca, a website designed for consumers. 

Health Standards Organization (HSO) builds world-class standards and innovative assessment programs, new technologies and activation services for accreditation bodies, governments, associations and others. Our standards are designed in partnership with clinicians, policy makers, technical experts and patients to ensure they provide effective health services and overall value. HSO is the only global standards body focused on health and social services that help people in their local jurisdictions save and improve lives. We’re on a mission. Discover more at www.healthstandards.org @HSO_World 

The Canadian Patient Safety Institute (CPSI) is a not-for-profit organization that exists to raise awareness and facilitate implementation of ideas and best practices to achieve a transformation in patient safety. CPSI reflects the desire to close the gap between the healthcare we have and the healthcare we deserve. CPSI would like to acknowledge funding support from Health Canada. The views expressed here do not necessarily represent the views of Health Canada. www.patientsafetyinstitute.ca