About Health Product Surveillance

While Health Canada conducts a thorough evaluation of the health product before it is approved, some safety risks only emerge after a health product is used more broadly by Canadians. Some of the information that Health Canada looks for once a product is on the market includes: serious side effects that are occurring more often than expected; new side effects that were not expected; side effects in vulnerable groups like children, pregnant women or the elderly and interactions with other health products. Health professionals and patients can report adverse reactions to Health Canada.

Health Canada makes sure that the known serious risks are written on the product label or product monograph, as well as provides information on how to manage these risks, so that patients and/or health professionals can make informed choices.

Additional information on health products approvals, reviews and surveillance:

• How Drugs are Reviewed in Canada

Surveillance

After a product is approved, Health Canada actively monitors safety information from a wide variety of sources including: manufacturer reports, adverse reaction reports from health professionals/patients/consumers, academic studies and information from other regulators. If a potential safety issue is identified through surveillance, Health Canada assesses all available information by conducting a safety review.

Safety Reviews

A safety review involves assessing in detail all the information that is available on the potential safety issue. This includes determining the severity of the risk, and how often it occurs. The findings are balanced against other information such as the seriousness of the conditions treated using the product, the availability of other products that can treat the same condition, the patient population that typically uses the product, and whether there are steps that can be taken to reduce or avoid the health risk.

Health Canada prepares a detailed safety review report that outlines the findings and recommendations. The report includes an analysis of whether or not sufficient information was available to decide if there is a new health risk. It also includes recommendations for how the health risk can be addressed.

On occasion a safety review will cover only a single product. On other occasions Health Canada may review an entire class of drugs. A drug class is a group of medications that may work in the same way, have a similar chemical structure, or are used to treat the same health condition. It is important to note that the safety review of a single product does not imply that other drugs in the same class are more or less safe. The other products in that class may be reviewed by Health Canada at a later date and have similar or different risks associated with their use.

Outcomes of a Safety Review

Most of the time the safety review confirms the benefits and risks associated with the use of the product based on Health Canada's original approval. In these cases, Health Canada makes a decision to continue its ongoing monitoring of information related to the health product, in order to identify and assess potential harms.

There are other times when the safety review identifies a new (or increased) health risk. In these cases, Health Canada may take a number of actions including:

• Notifying consumers, patients or health professionals by issuing a risk communication.
• Requesting changes to the product labeling or product monograph,
• Requesting additional information, studies or more monitoring by the manufacturer, and
• If necessary, and in rare cases, withdrawing the product from the Canadian market if the benefits no longer outweigh the risks of the product.

Summary Safety Reviews

A summary safety review is a short, plain language document that provides the reader with an overview of the safety issue that was reviewed by Health Canada, and the outcome of the review. Rather than publishing the entire safety review, which can be lengthy and technical, Health Canada prepares summaries so that Canadians have access to information that allows them to make informed decisions about their health. Further information on safety reviews can be obtained by contacting the Marketed Health Products Directorate.

Health Canada publishes summary safety reviews for:

• prescription drugs (pharmaceutical and biologic)
• non-prescription drugs
• vaccines and,
• natural health products

Health Canada will be expanding the scope of health products that require a summary safety review to include medical devices in the near future.

Additional Resources

• Comprehensive information on drugs is available in the Drug Product Database (DPD).
• Comprehensive information on natural health products in the Natural Health Products Ingredients Database.