Reaching out - Programs, Resources and Tools

2008
ISBN: 978-0-662-48764-7 (PDF Version)
Cat.: H164-85/2008E (PDF Version)

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

MedEffect™ Canada

MHPD's MedEffect™ Canada Initiative is an essential component of the post-market surveillance system for building awareness of adverse reactions, facilitating the reporting process and disseminating of new health risk information.

Through its Web site and other communications, MedEffect™ Canada offers a single point of service that gives consumers, general public, and health professionals access to health product safety information and provides a mechanism for reporting adverse reactions to the Canada Vigilance Program.

MedEffect™ Canada Web site

The MedEffect™ Canada Web site provides new health risk information such as advisories, warnings, recalls and offers direct access for reporting adverse reactions from health products to the Canada Vigilance Program. It also provides access to issues of the Canadian Adverse Reaction Newsletter, guidelines, learning materials, and publications.

Risk Communications

Advisories and Warnings
MHPD disseminates new health risk information about marketed health products through advisories, warnings, and other risk communication documents. These communications are sent to the media, posted on the MedEffect™ Canada Web site, and distributed through MedEffect e-Notices and through the Canada Newswire.

These risk communications enable consumers, patients, and health professionals to make informed decisions about the continued use of marketed health products.

Health Professional Communications
Safety-related information delivered directly to health professionals are known as Dear Health Professional Letters and Notice to Hospitals.

Dear Health Professional Letters are used to inform health professionals about time-sensitive issues regarding the safety or effectiveness (or both) of marketed health products. These letters can either be issued by the Market Authorization Holder, containing content approved by Health Canada, or by Health Canada.

Notice to Hospitals are a type of health professional communications used to communicate risk where products are primarily used, if not exclusively in hospitals. These letters can either be issued by the Market Authorization Holder, containing content approved by Health Canada, or by Health Canada.

MedEffect™ e-Notice

To maximize timeliness of information, MHPD issues risk communications electronically to consumers, health professionals, and other interested parties directly through the MedEffect™ e-Notice, an e-mail-based notification system. Subscribers also receive the quarterly publication of the Canadian Adverse Reaction Newsletter (CARN).

Canadian Adverse Reaction Newsletter

The Canadian Adverse Reaction Newsletter (CARN) informs health professionals and the public to potential signals detected through the review of case reports submitted to Health Canada. It is a useful mechanism for disseminating information on suspected adverse reactions before comprehensive benefit/risk evaluations and regulatory decisions can be undertaken. The CARN is published quarterly in January, April, July, and October and is intended to stimulate adverse reaction reporting.

Canada Vigilance Program

The Canada Vigilance Program is MHPD's post-market surveillance program that collects and assesses reports of suspected adverse reactions. Adverse reaction reports are accepted online, by telephone, fax, or mail.

Canada Vigilance Regional Offices
MHPD coordinates adverse reaction reporting activities at the national level through the participation of seven Canada Vigilance Regional Offices. These offices are located in Vancouver, Edmonton, Winnipeg, Saskatoon, Toronto, Montreal, and Halifax, and perform the following functions:

• increase health professional and consumer awareness of adverse reaction reporting, and
• provide guidance on adverse reaction reporting to maximize the quality of reports.

Canada Vigilance Online Database
The Canada Vigilance Online Database contains information reported to Health Canada about suspected adverse reactions to drugs and health products, such as prescription and non-prescription medication, natural health products, cells, tissues and organs, and radiopharmaceuticals. The database, accessible via the MedEffect™ Canada Web site, is updated quarterly, and as of 2007, contains over 200,000 adverse reaction reports submitted since 1965.

Post-Market Surveillance Tools

MHPD publishes guidance documents, learning tools, and information booklets to make it easier for consumers and health professionals to report adverse reactions. These tools allow industry, health professionals, and consumers alike to learn which adverse reactions should be reported and how to report them. Regulatory information such as policies, acts, and regulations are also readily available for consultation by health product manufacturers and distributors.

Expert Advisory Committee of Vigilance of Health Products

To ensure greater stakeholder involvement, MHPD has established the Expert Advisory Committee on the Vigilance of Health Products as a means of receiving advice on broad strategic policy and program issues involving marketed health products.