OTTAWA, Nov. 7, 2012 /CNW/ - Today the Health Council of Canada is appearing before the Standing Senate Committee on Social Affairs, Science and Technology to make recommendations on the post-approval monitoring of prescription pharmaceuticals in Canada.
Health Council representatives include Dr. Ingrid Sketris, Councillor and pharmacist, and John G. Abbott, CEO.
"We're pleased to see the Senate Committee tackle this important issue" said Abbott. "We hope our input can contribute to a better understanding of the need for improved vigilance to protect Canadians once medications are in the marketplace."
The committee will be discussing issues such as (but not limited to) the process to approve prescription drugs, the post-approval monitoring of these drugs, and unintended consequences or adverse reactions associated with prescription drugs. In 2010, the Health Council issued a discussion paper on drug safety called, Keeping an Eye on Prescription Drugs: Keeping Canadians Safe. The paper showed that the number of people exposed to unsafe drugs has been increasing, and that Canadians are often not aware of the risks associated with certain prescription drugs.
"Because drugs are approved based on pre-marketing clinical trials with selected populations and relatively short durations, it is extremely important to continue monitoring to determine the benefit/risk balance after a drug becomes available for sale," said Sketris. "We need to develop a better, more efficient and open way to ensure better patient safety."
The Health Council's paper found that Health Canada has limited authority to deal with post market safety issues. They cannot require companies to conduct post market studies after the product has been approved unless significant new safety issues have been identified. And although they have the authority to order drugs to be withdrawn from the market, they rarely exercise this power or tend to do so slowly. Recent media reports show this to be a continuing issue.
The Health Council paper made a number of recommendations to improve post-market monitoring of drugs in Canada. These will be the subject of discussion at today's senate hearing.
About the Health Council of Canada
Created by the 2003 First Ministers' Accord on Health Care Renewal, the Health Council of Canada is an independent national agency that reports on the progress of health care renewal. The Council provides a system-wide perspective on health care reform in Canada, and disseminates information on leading practices and innovation across the country. The Councillors are appointed by the participating provincial and territorial governments and the Government of Canada.
SOURCE: Health Council of Canada