1. What is MedEffect?

MedEffect is one initiative that's part of Health Canada's Therapeutic Access Strategy (TAS), a five-year strategy to improve the safety, effectiveness and access to therapeutic products available to Canadians. MedEffect's goal is to provide centralized access to new safety information about marketed health products in an easy to find, easy to remember location, on the new Health Canada Internet.

The MedEffect Web site provides access to the latest advisories, warnings and recalls, issued by Health Canada concerning therapeutic drugs as well as other marketed health products including natural health products and medical devices.

MedEffect is also concerned with raising awareness about the importance of reporting adverse drug reactions to Health Canada, by health professionals and consumers alike. Reporting forms and information about how to report are available in easy to complete and submit formats.

A MedEffect partnership network is being established to help promote this Web site and to further raise awareness about adverse reaction reporting. Through partnering with health professional associations and patient groups, 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.

2. Is there a difference between a side effect and an adverse reaction (AR)?

A "side effect" is a term commonly used in everyday language to describe what is referred to by health care professionals, such as doctors and pharmacists, as an adverse reaction.

All marketed health products have benefits and risks. Although health products are carefully tested for safety and efficacy before they are licensed, some adverse reactions may not become evident until the general population uses a health product under "real life" circumstances. By submitting a suspected adverse reaction report, you are contributing to the ongoing collection of safety and effectiveness information that occurs once health products are marketed.

Adverse reactions (ARs) are undesirable effects to health products. Health products include drugs, medical devices and natural health products. Drugs include both prescription and nonprescription pharmaceuticals; biologically-derived products such as vaccines, serums, and blood derived products; cells, tissues and organs; and radiopharmaceuticals.

Reactions may occur under normal use conditions of the product. Reactions may be evident within minutes or years after exposure to the product and may range from minor reactions like a skin rash to serious and life-threatening events such as a heart attack or liver damage.

3. How can I report an adverse reaction?

If you think you or someone in your family has experienced a serious adverse reaction to a health product, you are encouraged to report the experience to your health care professional (eg, physician, pharmacist). Your health care provider can provide additional clinical information that may help Health Canada to evaluate the event.

To report a suspected adverse reaction for health products including pharmaceuticals, biologics, natural health products or radiopharmaceuticals marketed in Canada, health professionals or consumers (preferably in conjunction with their health professional, so that information about medical history can be included in order to make the reports more complete and scientifically valid) should complete a copy of the adverse reaction reporting form.

We want to know about all suspected adverse reactions, but especially if they are:

• unexpected adverse reactions, regardless of their severity (not consistent with product information or labelling);
• serious adverse reactions**, whether expected or not;
• adverse reactions related to recently marketed health products (on the market for less than 5 years).

** A serious adverse reaction is one which requires inpatient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Adverse reactions that require significant medical intervention to prevent one of these outcomes are also considered to be serious.

4. What information should I report?

Adverse Reaction reports should contain relevant information about the patient characteristics and details about the reaction(s) suspected to be associated with the health product(s), the general finding(s), the treatment and final outcome(s).

You do not have to be certain that a health product caused the reaction in order to report it. Adverse reaction reports are, for the most part, only suspected associations.

All applicable sections of the adverse reaction reporting form should be filled in as completely as possible.

5. How are adverse reaction reports used?

Adverse reaction reports are analyzed to discover potential health product safety signals. A signal is considered to be the preliminary indication of a product-related issue. The identification of a signal is not by itself the proof of the association of an adverse reaction to a health product, but it triggers the need to further investigate a potential association. Signals must be carefully evaluated in order to confirm or to disprove the potential association between the product and the adverse reaction.

Patients, health professionals, manufacturers and health product regulatory authorities work together to monitor adverse reactions. Voluntary reporting by health professionals and consumers of suspected reactions is the most common way to monitor the safety and effectiveness of marketed health products to obtain information regarding adverse reactions. These individual reports may be the only source of information concerning previously undetected adverse reactions or changes in product safety and effectiveness profiles to marketed health products.

Some important reactions may take an extremely long time to develop or occur infrequently. In addition, the controlled conditions under which patients use health products in clinical trials (e.g., under direct medical supervision without necessarily significant exposure to other products and or underlying diseases), do not necessarily reflect the way the product will be used in real life conditions once it is marketed.

Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products made available to Canadians.

Information about the identity of the patient and the health care provider is kept confidential. Disclosure of data is only done in accordance with the provisions of the Access to Information Act.

6. What information is in the Adverse Reaction Database?

The current CADRMP adverse reaction (AR) database, the Canadian Adverse Drug Reaction Information System (CADRIS), is the computerized database that houses Canadian suspected adverse reactions which have been reported to Health Canada's CADRMP. The CADRMP adverse reaction database only contains reports of reactions that have occurred in Canada with Canadian marketed health products. The CADRMP adverse reaction database is used as a tool to store and retrieve essential information from adverse reaction reports and cannot be used on its own for the evaluation of a health product's safety profile. Health Canada receives adverse reaction reports daily, including new reports and additional information for reports previously submitted. As such, the information contained within the CADRMP adverse reaction database is constantly changing and being updated. The information comprised within the CADRMP adverse reaction database is intended solely to provide health product information collected by Health Canada. It is not a substitution for medical advice. Should you have an issue of medical concern, consult a qualified health care professional.

7. What is the Canadian Adverse Reaction Newsletter (CARN)?

The Canadian Adverse Reaction Newsletter (CARN) is a reputable source of adverse reaction information, published and distributed quarterly by Health Canada's Marketed Health Products Directorate. This publication serves to alert health professionals to potential signals detected through the review case reports, some provide information about suspected adverse reactions to health products occurring in humans, before comprehensive risk-benefit evaluations and regulatory decisions are undertaken.