Caveat and Privacy Statement

Caveat

This caveat relates to information taken from adverse reaction reports that are submitted to Health Canada by health professionals and consumers, either directly to Health Canada or via market authorization holders (manufacturers and distributors). Each report represents the suspicion, opinion, or observation of the individual making the report.

The Canada Vigilance Program is a spontaneous reporting system that is designed to detect signals of potential health product safety issues during the post-market period. The data is collected primarily by a spontaneous surveillance system in which adverse reactions to health products are reported on a voluntary basis. However, Health Canada is aware that adverse reactions are often under-reported to both voluntary and mandatory spontaneous surveillance systems.

The number of adverse reports in the Canada Vigilance Adverse Reaction Online Database should not be used as a basis for determining the incidence of a reaction or for estimating risk of a particular product, as neither the total number of reactions occurring, nor the number of patients exposed to the health product, is known. Because of the multiple factors that influence reporting, quantitative comparisons of health product safety cannot be made from the data. Some of these factors include the length of time a drug is marketed, the market share, size, and sophistication of the sales force, publicity about an adverse reaction and regulatory actions. In some cases, the reported clinical data is incomplete and there is not certainty that the health products caused the reported reaction. A given reaction may be due to an underlying disease process or to another coincidental factor.

The information is provided with the understanding that the data will be appropriately referenced and used in conjunction with this caveat statement.

Privacy Statement

Information related to the identity of the patient and/or the reporter of an adverse reaction is protected as per the  Privacy Act and in the case of an access to information. Suspected health product-related adverse reaction information is submitted on a voluntary basis, and is maintained in a computerized database. Adverse reaction information is used for the monitoring of marketed health products, and may contribute to the detection of potential product-related safety issues as well as to the benefit-risk assessments of these products.

More details regarding personal information collected under this program can be found in
InfoSource's  Personal Information Bank
Health Canada;
Health Products and Food Branch;
Branch Incident Reporting System;
PIB# PPU 088.

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