February 20, 2004 (37th Parliament, 3rd Session)


John Harvard


Hon. John Harvard (Parliamentary Secretary to the Minister of International Trade, Lib.)

Madam Speaker, all Canadians want to know that the medicines they are taking are safe. They place tremendous confidence in the ability of Health Canada to effectively regulate the therapeutic product industry to enable access for them and their health care professionals to update product safety information.
To maintain and improve Canada's excellent drug safety record, Health Canada continues to be receptive to suggestions that increase our capacity to detect new problems with marketed drugs, and thereby reduce the potential for serious adverse reactions to drugs taken by Canadians.
The government welcomes the motion by the hon. member, which is something I have already said, that the government should consider making it mandatory for health care professionals to forward to Health Canada information on all serious adverse drug reactions within 48 hours of their occurrence. However, to potentially make a useful difference in drug safety, such a system should not only address the quantity of reports submitted but also the quality of the reports received.
At first glance, mandatory reporting might seem to be a useful approach to improved post-market drug safety. However, I would caution that it would be premature to draw this conclusion prior to a full and frank discussion with the provinces and territories and health profession groups on the issues that surround this matter.
Before discussing the many issues pertaining to mandatory adverse reaction reporting, let me give a background on the drug approval and post-market surveillance programs in Health Canada.
First, no drug is authorized for sale in our country before it has gone through clinical testing and a rigorous drug review process. Once a drug is on the market, Health Canada regulates the market authorization holder who is responsible to report known adverse reactions to Health Canada. Manufacturers also investigate complaints or reported problems, update conditions of drug use via changes to the product monograph, communicate new information to health professionals and consumers, and if necessary, limit the distribution of a drug or remove it from the market.
Health Canada itself also monitors adverse reactions as well as the effectiveness of the actions of manufacturers and can take regulatory action if necessary.
Patients, health professionals and manufacturers work together with the department to monitor adverse reactions. The Canadian reporting system consists of two components: mandatory reporting of serious side effects by manufacturers to Health Canada in accordance with our Food and Drug Act; and, the voluntary reporting of adverse drug reactions to Health Canada by health professionals. There are 23 countries worldwide, including the U.S.A., the United Kingdom and Australia which have similar combinations of mandatory and voluntary reporting systems.
Canada was also a founding member of the WHO drug monitoring program and continues to work with the WHO Uppsala Monitoring Centre with some 65 other member countries.
It is important to acknowledge that the effectiveness of all reporting systems are affected by reporting rates. Some international studies estimate reporting rates as low as 1% to 10%. The low rates can be attributed to barriers such as the lack of awareness about the existence and benefits of a report system, concerns about litigation and privacy, heavy workloads and confusion over when and what to report.
These barriers are a widely acknowledged international reality in the field of adverse reaction reporting. The schemes rely on a potential reporter making the connection between a symptom and a drug therapy and then taking the time to report. These are some of the challenges the department officials must face in their efforts to promote and encourage reporting.
It is also important to note that increasing the volume of reports by itself does not really lead to success. Our ability to identify potential and new safety problems also relies heavily on the contextual richness of the information in the case report describing the event and the circumstances.
Experts in pharmacovigilance responsible for post-market surveillance believe it is more effective to be making decisions based on fewer reports with high quality data than on many reports with poor quality data. An inherent challenge is to find a way to improve both reporting rates and the quality of the data submitted.
In addition to report promotional activities carried our by the network of five regional adverse reaction centres located in local drug information centres, a monthly Health Canada journal advertisement has been published in the Canadian Medical Association Journal to promote Health Canada's toll-free telephone and fax lines specifically established to facilitate adverse reaction reporting by health professionals.
Officials at Health Canada also actively participate at health professional meetings and conferences to promote the reporting program, improve its visibility and provide feedback to the health professional community as to how adverse reaction reporting contributes to the safe use of medications.
Another approach to stimulate reporting is targeting specialists. Health Canada has partnered with the Canadian Paediatric Society to launch an active surveillance initiative. The project will collect information from 2,300 pediatricians and subspecialists on a monthly basis.
The focus of reporting is on serious and life threatening adverse reactions in children and youth up to 18 years of age. In addition, the partnership will encourage pediatricians to report adverse drug reactions through regular reminders and monthly feedback to reporters.
Health Canada is also looking into ways in which mobile wireless technology, in other words palm pilots, can facilitate reporting.
We hope that this technology will enable health professionals to promptly and more completely report adverse reactions to Health Canada.
Health Canada also works with academia to encourage inclusion of education about adverse reaction reporting in curricula of health professional schools right across Canada. The department cannot, however, mandate the curriculum content of health professionals in Canada.
I would like to emphasize the importance of international information sharing. The size of the Canadian population is a key limiting factor in accumulating adverse reaction data in as short a time as in a larger population.
Rare, previously unidentified adverse reactions are only likely to be found when a drug is given to larger numbers of patients than took the drug prior to market authorization in clinical trials.
For this reason, Health Canada is collaborating with foreign regulators to use non-regulatory tools such as partnerships and information sharing, among other strategies, to counteract and overcome these limitations.
Over the past five years, Health Canada and the U.S. Food and Drug Administration, Australia's Therapeutic Goods Administration and New Zealand's MedSafe organization have worked closely in exchanging information on adverse drug reactions. In fact videoconferencing between them currently takes place on a bimonthly basis.
Drugs are used all around the world, and drug safety depends on countries working together and sharing information. It can be difficult for a relatively small country, like Canada, to accumulate sufficient domestic reports independently to evaluate signals for rare adverse reactions. That is why partnerships and cooperation are so vital.
Another improvement initiative currently in progress in the area of post-market surveillance would see Health Canada to move to the use of software developed for the U.S. FDA to manage Canadian adverse reaction reports.
All aspects of implementing mandatory reporting must be carefully weighed so that an informed decision can be taken on this issue.
If indeed mandatory reporting were to result in the generation of a higher number of quality reports, then it would certainly increase Health Canada's ability to determine drug safety problems.
It is true that reporting by health professionals is considered vital. However, at present Health Canada has no clear evidence that a mandatory reporting system would actually result in the increased submission of quality information.
Again, let me reiterate that, in principle, the government supports the motion as a means of potentially strengthening Health Canada's ability to generate drug safety signals. However, I must point out that there are still a number of aspects of this motion that require further clarification and discussion.
In closing, I know I can call on all the member of the House to support our future initiatives to improve the post-market surveillance activities of Health Canada.

Topic:   Private Members' Business
Subtopic:   Adverse Drug Reactions
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