Outreach, Education and Feedback – Mandatory Reporting for Institutions

Title: Outreach, Education and Feedback – Mandatory Reporting for Institutions. Scope: Health Canada is seeking the services of a Contractor to assist in Mandatory Reporting for Institutions – Contract for Outreach, Education and Feedback. Health Canada has a requirement for the development and implementation of an educational approach and content to support healthcare professionals and healthcare institutions in the identification and reporting of serious adverse drug reactions and medical device incidents. This requirement includes an assessment of the type of outreach, education and feedback needed to motivate and support reporting. Background: Health Canada is continuously looking for ways to strengthen its knowledge base on product safety in the interest of improving patient outcomes and public health. The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) makes several amendments to the Food and Drugs Act (F&DA), including a new requirement for certain health care institutions to provide Health Canada with information on serious adverse drug reactions (serious ADRs) and medical device incidents (MDIs). The central objective of this authority is to improve the quality and increase the quantity of ADR and MDI reports, thereby ensuring that there is sufficient data to detect safety problems. Under-reporting has been a long-standing issue for Health Canada and therapeutic product regulators worldwide. As a complement to the regulations, Health Canada has recognized that improving the reporting of serious ADR/MDIs will require outreach and education as well as meaningful feedback to address reporting barriers that are perhaps beyond the reach of regulations. Educational efforts will be introduced in advance of new regulatory requirements with a focus on raising awareness of the importance of reporting ADR and MDIs and how it helps Health Canada complete their analysis to understand if the reaction/incident was caused by the drug/device or other factors. Educational efforts focussed on encouraging quality reporting can also contribute to a more informed understanding of both the benefits and risks of drugs and devices. Quality reporting improves the knowledge base on product safety and since this information is shared by Health Canada with the health care community and the public, it will empower Canadians along with their health care providers to make better, more informed decisions regarding their medical treatment and support overall patient safety. Meaningful feedback is instrumental in building motivation and buy-in with reporting programs. Healthcare professionals indicated they are looking for some form of feedback that will demonstrate that the effort they have invested in sharing information is making a difference or help them with their decision making efforts on patient safety. Health Canada will therefore require efforts to be placed on understanding the type of feedback required to motivate and support reporting.