Canada Vigilance Program (formerly called Canadian Adverse Drug Reaction Monitoring Program)

Privacy Impact Assessment:
Canadian Adverse Drug Reaction Monitoring Program

Date:
March 30, 2004

Contact:
Heather Sutcliffe
Manager, Marketed Health Products
Safety and Information Division

Program/Service Web Site:

• Marketed Health Products Directorate
• Adverse Reaction Information

Brief Program/Service Description:

The Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of the Marketed Health Products Directorate (MHPD) of Health Canada collects reports of suspected adverse events to health products (including pharmaceuticals, biologics, natural health products, and radiopharmaceuticals) marketed in Canada. Adverse events include adverse reactions and medication incidents. Adverse reactions are noxious and unintended responses and include any undesirable patient effects suspected to be associated with the use of health products. Medication incidents are preventable events that may cause or lead to inappropriate use or patient harm, and are the most common (known) single preventable cause of patient injury.

Reporting by health professions and consumers is on a voluntary basis. There are approximately 10,000 domestic adverse event reports submitted annually. All information on domestic adverse events is maintained in a computerized database.

Scope of the PIA:

The scope of the PIA does not include the authority of the sources that report an adverse event to a marketed health product to collect personal information or to disclose personal information to MHPD.

The PIA should be considered in conjunction with the report on the US AERS database and the Threat and Risk Assessments (TRA) for the management of the CADRMP paper collection process and the Canadian AERS database.

The information in the PIA reflects the status of the CADRMP and the Canadian AERS database project as it existed on November 27, 2003.

Privacy Risks and Mitigation Strategies:

The privacy impact assessment uncovered a number of privacy risks. Mitigation strategies for all of the risks were recommended and accepted by the project manager. The implementation of these mitigation strategies are ongoing.