Backgrounder: Consumer Side Effect Reporting Form

News Release: Health Canada Makes it Easier for Canadian Consumers to Report Side Effects

June 2010

Health Canada has launched a new Consumer Side Effect Reporting Form to make it even easier for consumers to report side effects to drugs and other health products to the Canada Vigilance Program. The new form is simpler, friendlier and easier to understand than the form previously available to consumers, and is now available online at the MedEffect™ Canada website.

What is a side effect?

Despite prior testing, health products - including prescription and non-prescription drugs, natural health products, biologics (including fractionated blood products, as well as therapeutic and diagnostic vaccines) and radiopharmaceuticals - can sometimes have side effects when used alone or in combination. These side effects are also known as adverse reactions. Side effects can range from minor irritations - such as a rash - to life-threatening reactions like heart attack, kidney failure or liver damage.

Some side effects may not become evident until the general population uses a new health product under "real life" circumstances. They might occur within minutes after using a health product or take years to develop.

Health Canada wants to know about allsuspected adverse reactions, especially if they are unexpected (even if not considered serious), serious, or related to a new health product (i.e., one that's been on the market less than 5 years).

Who can report side effects?

From industry to health professionals and the general public, everyone has a role to play in reporting side effects.

For their personal health and safety, consumers are encouraged to inform their health professionals about a suspected side effect and to report it to Health Canada. They may ask their health professional to review their report as he/she may want to add additional information.

How are side effects reported?

MedEffect™ Canada makes it easy for health professionals and consumers to report a side effect to the Canada Vigilance Program. This program collects adverse reaction reports related to health products.

Consumers can report side effects in one of three ways:

• By completing the Consumer Side Effect Reporting Form available at the MedEffect™ Canada Web site, which can then be mailed postage-paid or faxed toll-free to 1-866-678-6789
• By calling toll-free to 1-866-234-2345
• Online at the MedEffect™ Canada website

What happens to reports of side effects?

Information gathered through adverse reaction reports is combined with information from other sources to identify potential health product safety issues.

Once an assessment is made and a problem is identified, consumers and health professionals are informed through several means, including:

• Advisories or warnings posted on the MedEffect™ Canada website and distributed through the MedEffect™ e-Notice
• The Canadian Adverse Reaction Newsletter
• Updates to the official product monograph associated with the health product
• Other publications, guidelines and learning products

The Canada Vigilance Online Database contains information reported to Health Canada about suspected side effects and is searchable by the public.

All information related to the identity of the patient or those reporting side effects is protected under the Privacy Act and is not included in the Canada Vigilance Online Database and cannot be made public through Access to Information.

What is the importance of reporting side effects?

Each report contributes to the safe use of health products. Taken together, the reports directed to Health Canada combine to create a better picture of the effects of health products on consumers. By working with a full range of partners - the health products industry, health professionals, consumers and the general public - Health Canada can improve product safety for all Canadians.