MedEffect is one of the deliverables of the Therapeutic Access Strategy (TAS), a five-year strategy to improve the safety, effectiveness and access to therapeutic products available to Canadians. The MedEffect program will be comprised of a website, and a partnership initiative involving, for example, professional health care associations and consumer/patient groups. Partnering with outside associations and groups will help to expand and maintain the community of networks knowledgeable about MedEffect. Through these networks, it is hoped new opportunities will arise to share information more effectively by creating links between MedEffect and the websites or publications of the participating partners.
The MedEffect program has been developed by Health Canada's Marketed Health Products Directorate (MHPD), with the following goals in mind:
MedEffect is being developed and designed in consultation with Canadian health professionals, consumers/patients and the general public.
Health products, ranging from pharmaceutical drugs to natural health products and medical devices, play an important role in the lives of Canadians, and in Canada's health care system. There are over 22,000 human drug products and 40,000 medical devices available on the Canadian market. Millions of people trust that the products available have passed Health Canada's rigorous safety standards and will help to deliver desired health outcomes
Health Canada continues to monitor the safety, effectiveness and quality of health products after they reach the marketplace. The department routinely evaluates Canadian adverse reaction reports and selected foreign reports, from manufacturers, health professionals and consumers. These evaluations may include a comprehensive reassessment of the benefit-risk profile of a product. If a safety issue is identified, appropriate action is taken. Such actions range from distributing new product safety information to the public and/or the health care community, to recommending changes to the product's labelling or requesting the removal of the product from the market.
All health products carry risks and benefits. Many of these risks are identified in pre-market testing and can be managed as "expected" or "tolerable" side effects that are outweighed by the product's benefits. However, once a product is made available on the Canadian market, new "unexpected" or undesirable side effects, referred to as adverse reactions, are sometimes discovered when the product is used in "real world" conditions.
Having the ability to track such adverse reactions is therefore critical to assessing and communicating the evolving pattern of risks associated with various health products. The only way to achieve this is if Canadians - health professionals and patients/consumers alike -report adverse reactions to Health Canada.
By reporting an adverse reaction to Health Canada, Canadians will help the department to: