Health committee  Regarding mandatory reporting by physicians, the current plan is basically to consider--

Health committee  Hospitals, yes. That will help, because some of the serious adverse drug reactions will bring people to consult in an emergency, so that will enable us to identify, maybe earlier, these signals that need to be further investigated.

Health committee  Yes, there has been consultation with numerous stakeholders or representatives of the public and patient interest groups, physicians, and industry. The general consensus was that there was not necessarily a net gain in having all spontaneous adverse drug reactions reported, but more to have a strategic approach to target where it's most likely to make a difference.

Health committee  If I understand your question well, you're wondering how we're going to leverage or how we're going to collaborate more with international agencies to gather more information?

Health committee  We do have memoranda of understanding with countries such as the United States and the European medicine evaluation agencies, as well as with Australia, Singapore, and Swissmedic. So we do have these types of collaborations; whenever there are emerging safety issues, we can contact them and share information.

Health committee  Based on international references, somewhere between 1% and 10% are reported in Canada. We don't know exactly, because there is no way to exactly estimate the real occurrences. One concept that is important to understand is that a spontaneous ADR system is not necessarily there to collect all drug reactions; it's there to identify what we call early signals--that is, unpredictable or unknown occurrences of events with drugs that have been recently marketed.

Health committee  On the first point, about the definitions, there is currently a definition in the food and drug regulations of an adverse drug reaction. There is also a definition of a serious adverse drug reaction. So these definitions do currently exist in the food and drug regulations. On the question about what will come out of all this information, I think there's been a steady increase in the resources that are dedicated to post-market surveillance in Canada in the past five years.

Health committee  I think it's an area in which we're making step-by-step progress. A recent improvement is the ability to submit spontaneous adverse drug reaction information electronically. There is also now the capacity to search the spontaneous adverse drug reaction database online. Although it's very difficult to have immediate retroactivity for the person who's reporting, they can have more of a population--

Health committee  The technology to give some estimation of the numbers of adverse events that have been reported to Health Canada for a specific drug and/or a specific adverse event is in place now. There's a delay because the adverse events reports have to be processed, looked at by a specialist, and then entered into the database.

Health committee  We use the Canadian Adverse Reaction Newsletter as one way of identifying clusters of cases. It's distributed to all physicians in Canada with the Canadian Medical Association Journal. So we have different ways to go back to the physician to--

Health committee  So your question is about whether we can identify emerging safety signals in pharmaceuticals. I think tremendous progress has been accomplished in the past few years in that area, especially very recently with the creation of the Canada Vigilance online database. It is a new database that will enable more efficient collection of spontaneous adverse drug reactions.

Health committee  Good morning. All marketed health products have risks associated with their use. Prescription drugs, over-the-counter products, biological, vaccines, medical devices and natural health products all have risks. Some of these risks are known at the time of market authorization, but we also know now that additional information about risks can only become known once the product is more widely used.