Thank you very much.
Good morning, ladies and gentlemen. On behalf of the Canadian Medical Association and our more than 67,000 physician members across Canada, I welcome the opportunity to participate in your committee's study on post-market surveillance of prescription drugs.
In addition to being the chair of the CMA board's committee on pharmaceutical issues, I'm also a practising physician from Appleton, Newfoundland, so I can also speak to the clinical aspects of this issue.
To effectively monitor the safety and effectiveness of the country's drug supply, the CMA believes a strong post-market surveillance system should include an effective process for gathering drug safety data coupled with a simple, comprehensive, and user-friendly reporting system; a rigorous process for analyzing this data to identify significant threats to drug safety; and a communications system that produces useful information distributed to health care providers and the public in a timely and easily understood manner.
Canada's current post-market surveillance system requires considerable development if this is to be accomplished. In our more detailed submission before you, the Canadian Medical Association presents recommendations that will support optimal patient health and safety and meet the information needs of health professionals and the public.
The CMA recommends Health Canada be given the tools, including regulatory authority, to require post-market studies of newly approved drugs if clinical trials identify possible safety risks that require manufacturers to disclose information if Health Canada deems it germane to making a decision in the interest of patients' safety, and to take action if post-market research uncovers new safety concerns. This could mean ordering changes to product labels, or even pulling a product off the market.
However, this enhanced authority will be useless unless Health Canada is given more resources to analyze and evaluate the information it receives. Without additional resources, merely increasing the number of ADR reports will only add to the backlog in the in-boxes of analysts.
In 2007, a coalition of Canadian research centres prepared a document, a business plan, for a drug effectiveness and safety network that proposed an integrated and comprehensive network of centres of excellence to support evaluation of drug safety and effectiveness in Canada. The committee should consider this concept and recommend moving forward.
On the reporting of adverse drug reactions, it's important to emphasize that this is only one possible way of gathering drug safety information. More structured post-market studies should also be considered as a way of augmenting spontaneous reports. The CMA acknowledges that ADRs are under-reported both in Canada and worldwide. We support measures that would strengthen Canadians' capacity to report these reactions.
Such measures could include a user-friendly reporting system, improved follow-up capacity, linkages to international post-approval surveillance systems, active solicitation of ADR reports from all health providers, and limits on what should be reported. There's no reason to require reports of side effects that are already known to be associated with given drugs. The reactions Health Canada most needs to know about are those that are unexpected or occur in newly approved drugs. There should also be incorporation of the ADR reporting process directly into the electronic medical records.
Our list does not include mandatory reporting of adverse drug reactions. If you build a comprehensive, efficient, and effective post-market surveillance system, physicians will participate actively in it. Forcing them to participate before the system has been built will result in failure and alienation. Moreover, we strongly remind the committee that provider reporting by itself does not constitute a rigorous system of surveillance.
Post-marketing surveillance doesn't exist in a vacuum. We believe that government should take other measures as well to promote the safety and effectiveness of prescription drugs. Real-time information is essential for effective surveillance. CMA strongly recommends that governments invest in supportive information technologies that will greatly increase physicians' capacity to report adverse drug reactions.
New prescription drugs, especially those that represent a therapeutic breakthrough, must be made available as quickly as possible to those who could benefit from them. However, improvements to post-market surveillance should not be used as a justification to lower the standards for a pre-approval review.
The CMA supports a risk-based approach to product safety assessment, with regulatory requirements that are greater for products with greater risk and lower for those with less risk. Health professionals and the public must have access to all information, both positive and negative, about new products. Health Canada should make the results of all clinical trials available to health professionals and the public. However, physicians believe that direct-to-consumer advertising, or DTCA, of prescription drugs inflates the market for potentially risky drugs and does not provide the public with enough information to make appropriate choices. We recommend that brand-specific DTCA not be permitted in Canada and that the loopholes permitting a limited amount of brand-name promotion be closed.
Canadians do have the right to accurate, unbiased information on prescription drugs and other therapies to help them make informed health decisions. The federal government should develop and fund a comprehensive program to provide accurate, unbiased, and independent prescription drug information for use both by patients and health professionals. The CMA is prepared to work with other stakeholders through a comprehensive program to promote optimal prescribing and drug therapy monitoring by health professionals. Such a program should be founded not on sanctions but on education, including objective academic detailing to ensure that information is accurate and impartial; the use of information technology and practice tools; be organized and implemented with the participation of professional and patient organizations; and include strategies to improve patients' knowledge of, and adherence to, drug regimens.
The Canadian Medical Association will develop a vision for an optimal prescribing program and implement portions of it over the coming year. The CMA commends both the standing committee and Health Canada for their intent to reform Canada's post-market surveillance system. Canada's physicians are prepared to work with governments, health professionals, and the public in strengthening this system to ensure that the prescription drugs Canadians receive are safe and effective.
Thank you.