Health committee  In Quebec there has been a very strong movement toward what we call integrated care or chronic disease management, where the patient not only navigates through a fragmented health care system but through a team. In order for that team to be functional, everything needs to be elec

Health committee  In my opinion, adverse drug reaction is a real public health issue. We're talking populations. Even though a drug may have a small risk, if you have 10% of the population exposed, it's going to result in a very large absolute number of cases. Eventually the serious effects will

Health committee  That's the daily job of the provincial reimbursement agencies; that's exactly what they do. They weigh the benefits and the risk of a drug. Part of the benefit, of course, is that if a drug doesn't work and is extremely expensive or very risky, they won't pay for it—or they will

Health committee  The problem is, when you assess the benefit-risk at the time of drug approval, the process is not transparent. What usually happens is you have a group of experts who weigh the benefits against the harms and make a decision. There's no magic formula. They don't come up with a mag

Health committee  I just want to come back with some supplementary information. To involve pharmacists also would be a very efficient way of providing up-to-date information. For example, if they dispense a drug, it could come up on their screen that there's a new warning and they could see thei

Health committee  That is precisely the problem. With clinical trial data, we are talking about very limited patient groups. In the actual practice setting, we are dealing with subgroups of patients who will not all react the same way. Yet we are unable to get at the subtleties and small details o

Health committee  Yes, of course. We need better systems of communication. We should not be waiting until the newspapers pick it up or the information becomes sensationalized. That is one of the major perverse effects of risk surveillance. People have to be very well informed and be given adequate

Health committee  We were talking about that earlier. It's important to distinguish between who should be paying for the studies and who should be conducting them, because the primary goal is to conduct studies that are valid using the best possible expertise. There are a number of models out ther

Health committee  We are still in the early stages, even in countries where the concept of risk management has been introduced. In the United States, this only began in 2005, and in 2007, the latest definitive guidelines were adopted in Europe. Of course, we can say that in Canada, we are talking

Health committee  My recommendation would be to recognize that Canadians deserve more and that you should start thinking about introducing guidelines. Start with the guidelines and follow up with the legislation to effectively monitor drug safety in the post-marketing setting.

Health committee  There's a difference between who should do it and who should pay for it. Actually, what we've seen things evolving into is that regulatory authorities set up departments of risk management where they negotiate the plan with the companies very early on and then they agree that suc

Health committee  Actually, no. That's the thing. Now the model is such that in the U.S. they're thinking about a user fee to evaluate the plans just to administer departments of risk management within regulatory authorities, but the individual studies are paid for by the industry as part of their

Health committee  But this is the current system—the passive pharmaco-vigilance. What we're evolving into is not to rely only on the passive, spontaneous reporting, but to introduce new tools, like registries, epidemiologic studies, database studies, active surveillance, prescription event monito

Health committee  There were several issues raised, and I don't think I can discuss each of them, but the first one you brought up was the question of a new indication. You felt that maybe the system would allow the new indications to be evaluated too fast. I think what we've seen so far—and I'm

Health committee  That is also the principle behind active pharmacovigilance. For example, we can use sentinel physician networks for new products coming on the market. We can also consult specialists who are likely to be caring for this type of patient, and solicit active reporting, rather than r