New standard for hospitals on reporting adverse drug reactions released today

Standard will be supported by marketing activities to boost reporting by health professionals

OTTAWA, January 30, 2013 /Canada NewsWire/ - The Honourable Leona Aglukkaq, Minister of Health, today congratulated Accreditation Canada on including, for the first time, guidance on the reporting of adverse drug reactions in its latest Medication Management Standards for health care facilities, including hospitals.

"Our Government is committed to protecting the health and safety of Canadians," said Minister Aglukkaq. "This initiative supports Health Canada's ongoing efforts to increase the quality and quantity of adverse reaction reports, an important part of our drug safety monitoring system."

As part of a certification process, Accreditation Canada evaluates the performance of its clients against national standards of excellence. These standards examine all aspects of health care, from patient safety and ethics, to staff training and partnering with the community. The new adverse reaction reporting component of the new standards was commissioned by Health Canada.

Accreditation Canada's Medication Management Standards are now available to more than 700 client organizations, including 143 hospitals and other acute care facilities, and other facilities including long-term care, home care and aboriginal health services.

The adverse reaction reporting component provides guidance on issues such as how to report patients' adverse reactions to drugs, and who is responsible for reporting them. The standards will encourage consistency in reporting practices and will strengthen and complement any reporting systems already in place.

This new standard will also complement Health Canada's ongoing efforts to promote adverse reaction reporting, including marketing activities aimed at health professionals in Canada. These activities provide information on how to report adverse reactions to drugs and other health products, why it's important to do so, and how to stay up to date on new safety information.

Starting next month, Health Canada will place notices in selected health professional journals and will distribute adverse reaction reporting forms with instructions to selected health associations, physicians and pharmacists, and facilities.

Adverse reaction reporting is an important source of data Health Canada uses to identify potential safety problems with marketed health products. Other sources include peer-reviewed scientific studies and information from drug manufacturers and international regulatory agencies.

The new reporting standard stems from Health Canada's consultations with provinces and territories, health professionals, industry, and the Canadian public regarding ways to address the under-reporting of adverse drug reactions in Canada. Much feedback, particularly from provinces and health professional associations, supported the development of a hospital-based adverse reaction reporting standard as an alternative to a legislative requirement.

Health care professionals and organizations can contact Accreditation Canada for more information on the new standards.