Call for more transparency and improvements to drug safety in Canada

Nov 18 2010

Commissioned paper by the Health Council of Canada calls for more transparency and vast improvements to drug safety in Canada

A commissioned discussion paper released today by the Health Council of Canada, Keeping an Eye on Prescription Drugs, Keeping Canadians Safe, underscores the many limitations to how drug safety and effectiveness is monitored and reported in Canada. The report provides clear recommendations for changes to the current system to ensure Canadians are safe from undue pharmaceutical harm.

Pharmaceuticals can offer significant health benefits to patients, but there are also many risks associated with their use. Over the past 25 years the percentage of drugs that were withdrawn from the market has not changed, however, the number of people exposed to unsafe drugs has been increasing. For instance, two of the five most heavily promoted drugs in Canada in 2000 and ones that were widely prescribed (Baycol^TM and Vioxx^TM) were withdrawn because of safety issues. Furthermore between 1999 and 2004 when Vioxx^TM was removed from the market, about 16 million prescriptions had already been written for it. To make matters worse Canadians are uninformed of the safety concerns of the drugs that are currently on the market.

"People often think that since a drug has been approved by Health Canada, it is safe," says John G. Abbott, CEO, Health Council of Canada. "What Canadians don't know about are the limitations in our current pre-market testing and the lack of surveillance once a drug has entered the market."

Pre-market testing is completed by pharmaceutical companies in a short period of time with a relatively small number of patients. Although mandatory, pre-market testing is limited in scope. Furthermore, the current random nature of post-market surveillance is due to the lack of regulatory requirements that compel drug companies to conduct additional research on product safety and effectiveness once their drug has entered the market.

"Health Canada has limited authority to deal with post market safety issues," states Joel Lexchin, a professor at York University's School of Health Policy and Management, and one of the lead authors of the paper. "Health Canada cannot require companies to conduct post market studies or change drug labels after the product has been approved unless significant new safety issues have been identified. And although it has the authority to order drugs to be withdrawn from the market, they rarely exercise this power."

The paper also explores the work of other international jurisdictions, such as New Zealand, the United States of America, the European Union, the United Kingdom and France. It examines the drug safety regimes of each of these jurisdictions and provides recommendations on how to develop a comprehensive drug safety system in Canada.

"Canada's drug safety network is in the early stages of development. In Canada the Drug Safety and Effectiveness Network was created in 2009," says Abbott. "We look to learn from our international counterparts to develop and improve our system in order to keep Canadians safe."

Recommendations within the paper that are based on learnings from international jurisdictions include:

• Post-market researchers should have access to data from all sources
• Post-market research required by Health Canada should be registered, unbiased, transparent, free from conflicts of interest and follow guidelines
• Legislative authority given to Health Canada to impose penalties for failure to complete post-market safety studies
• All required post-market studies should be made public
• All researchers and committee members should submit conflict-of-interest disclosures

Also called for are:

• Adequate and ongoing funding
• Better communications of drug safety messages (wide dissemination)
• Monitoring and evaluation of drug safety messages
• Broad stakeholder involvement in the decision making concerning publicly commissioned post-market studies

Source: HEALTH COUNCIL OF CANADA