Canadians are unaware of dangers that may be lurking in prescription drugs, which aren’t sufficiently tested or monitored, says a report issued today by the Health Council of Canada, and headed by two York University researchers.
Keeping an Eye on Prescription Drugs, Keeping Canadians Safe calls for sweeping improvements to drug safety in Canada, highlighting these little-known facts:
- Over the past 25 years, the percentage of drugs that were withdrawn from the market has not changed; however, the number of people exposed to unsafe drugs has been increasing.
- Many Canadians are uninformed about safety issues with drugs currently on the market.
- Pre-market testing provides information about the benefits of drugs, but does not establish a full safety profile; it is conducted by pharmaceutical companies in a short period of time with a small number of patients.
- There are no regulatory requirements for drug companies to conduct additional research on product safety once their drug has entered the market.
- Health Canada cannot require companies to conduct post-market studies and cannot order changes to drug labels after a product has been approved unless new significant safety issues are identified.
- Although Health Canada has the authority to order drugs to be withdrawn from the market, it rarely exercises this power.
The paper’s lead authors are Mary Wiktorowicz and Joel Lexchin, professors in York’s School of Health Policy & Management in the Faculty of Health; it is co-authored by Kathy Moscou of the University of Toronto’s International Pharmacy Graduate Program.
To view a copy of the report, visit the Health Council of Canada website.
Lexchin notes two drugs that were widely promoted and prescribed in 2000 – BaycolTM and VioxxTM – were withdrawn due to safety issues. "Roughly 16 million prescriptions for Vioxx had been written in Canada by the time it was taken off the market," he says.
Their comparative analysis of Canada, the United States, Britain, France, the European Union and New Zealand found an array of policy approaches being adopted internationally and emphasizes the manner in which the governance of post-market surveillance systems can be enhanced.
John Abbott, CEO of the Health Council of Canada, says the public may think a drug approved by Health Canada is always safe. "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," he says.
Among the report’s recommendations:
- Wide dissemination of drug safety messages, including monitoring and evaluation of messaging.
- Health Canada should have the authority to impose penalties for failure to complete post-market safety studies.
- Post-market research should be registered, transparent, free from conflicts of interest and the results made available to the public.
- There should be broad stakeholder involvement in decision-making concerning publicly commissioned post-market studies.