About MedEffect Canada

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
• About Health Products In Canada
• Adverse Reactions to Health Products
• Adverse Reaction Reporting And Health Product Safety Information

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The MedEffect Program

The MedEffect program has been developed by Health Canada's Marketed Health Products Directorate (MHPD), with the following goals in mind:

• To provide centralized access to relevant and reliable health product safety information as it becomes available, in an easy to find, easy to remember location. This includes access to Health Canada's advisories, warnings and recalls; the Canadian Adverse Reaction Newsletter (CARN); and the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) Online Query and Data Extract.

• To make it as simple and efficient as possible for health professionals and consumers to complete and file adverse reaction reports via web, phone, fax or mail.

• To build awareness about the importance of reporting adverse reaction reports to Health Canada, and how this information is used to identify and communicate potential risks.

MedEffect is being developed and designed in consultation with Canadian health professionals, consumers/patients and the general public.

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About Health Products In Canada

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.

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Adverse Reactions to Health Products

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.

• Adverse reactions may occur even when a product is being used as directed. A reaction may occur within minutes after exposure or it can take years to develop. Reactions can range from minor irritations, like a skin rash, to serious and life threatening reactions, such as a heart attack or liver damage.

• Most often, adverse reactions are unexpected and are not necessarily indicated on the product label or on any other information provided with the product.

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Adverse Reaction Reporting And Health Product Safety Information

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:

• Identify rare or serious adverse reactions that were previously unknown
• Make changes in product safety information or remove an unsafe product from the Canadian market
• Contribute to international data on the benefits, risks or effectiveness of health products
• Develop and disseminate new and better information to enhance Canadians' knowledge about the safety of health products