Caveat, Privacy Statement and Interpretation of Data - Data Extract from the Canada Vigilance Adverse Reaction Online Database

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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.

Interpretation of Suspected Adverse Reaction Data

The following limitations should be taken into account when interpreting the suspected adverse reaction report data:

1. The data has been collected primarily by a spontaneous surveillance system in which suspected adverse reactions to health products are reported to market authorization holders (manufacturers) and Health Canada on a voluntary basis.
2. There is under reporting of adverse reactions with both voluntary and mandatory surveillance systems.
3. Adverse reaction reports are suspected associations which reflect the opinion or observation of the individual reporter. The data presented reflects, as much as possible, the reporter's observations and opinions, and does not reflect any Health Canada assessment of association between the health product and the reaction(s).
4. Inclusion of a particular reaction does not necessarily mean that it was caused by the suspected health product(s). Certain reported reactions may occur spontaneously. They provide a background rate in the general population and may have a temporal, but not necessarily a causal, relationship with the health product. The purpose of the Canada Vigilance Program is to detect possible signals of adverse reactions associated with health products. Additional scientific investigations are required to validate signals from the Canada Vigilance Program and to establish a cause and effect relationship between a health product and adverse reaction. Assessment of causality must include other factors such as temporal associations, the possible contribution of concomitant medication or therapies, the underlying disease, and the previous medical history.
5. This database contains only a small proportion of adverse reactions reported following receipt of vaccines, and is reflective of serious reactions reported to market authorization holders as required under the Food and Drugs Act. The majority of reports of these reactions are submitted to the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS).
6. The number of reports received should not be used as a basis for determining the incidence of a reaction as neither the total number of reactions occurring, nor the number of patients exposed to the health product is known.
7. Numerical comparisons should not be made between reactions associated with different health products on the basis of the data in these line-listings.
8. Where a health product has multiple ingredients, it may not be possible to determine which, if any, of the substances in the combination product were responsible for a particular reaction.
9. In order to be entered into the database, information from adverse reaction report is coded using key words (reaction terms) which represent the reaction(s) described in the case report. The coding of adverse reaction reports is subject to limitations of coding terminology dictionaries. Each report relates to a single patient, however, more than one reaction may have been described and therefore coded per case report.
10. The data provided do not represent all known safety information concerning the suspected health product(s) and should not be used in isolation to make decisions regarding an individual's treatment regimen; other sources of information, including the prescribing information for the product, should be consulted.
11. The assistance of a health care professional should be sought to aid in the interpretation of the information contained herein.
12. The database is routinely checked for duplicate reports. Duplicate reports are reports related to the same patient and event received from more than one source (e.g., pharmacist and consumer). It is not always possible to detect duplicate reports, often because the documentation in the original report may be variable or incomplete. Each duplicate report received will appear separately on the summary and will be identified as duplicate in the Link/Duplicate Report Information field.
13. When follow-up reports of a single case or event are received, only the latest version of the report is included in the output.

Information from the Canada Vigilance Adverse Reaction Online Database is provided with the understanding that it will be appropriately referenced and used in conjunction with the Caveat.

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