Evidence of meeting #17 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was drug.
A recording is available from Parliament.
12:05 p.m.
Conservative
March 11th, 2008 / 12:05 p.m.
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
I'd like to thank our presenters for being here this morning. We seem to be going around and around with this issue of post-market surveillance, and we hear a lot of different things.
My first question is going to be, who should be defining adverse effects? We have different definitions of what we're talking about.
Does anybody want to answer that? And what do you think that definition should be?
12:05 p.m.
Chair of the Board, Cancer Advocacy Coalition of Canada
I think any unwanted effect is an adverse effect. This is why I include failure to work as an adverse effect. Any unwanted effect from any intervention is an adverse effect. That's how I would define it.
12:05 p.m.
Past Chair, Cancer Advocacy Coalition of Canada
I think it comes in two packages, known and unknown. We've historically thought of adverse events as something down the road that was unexpected in chronic use and wasn't predicted from the initial studies. That's one category.
The major category, as far as the physician is concerned, is the untoward effect you can expect from the initial studies, which can occur if you go beyond a certain dose.
But as Jim says, the other adverse effect is failure to respond. So those are the three categories: known, unknown and unexpected, and failure to respond.
12:05 p.m.
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
Would the rest of you agree that those things should all be included?
12:05 p.m.
Vice-President, Institute for Safe Medication Practices Canada
Yes. I would just like to add that you're correct, the definition is extremely important. Different definitions are used in studies and reporting programs. The message would be that whatever reporting program it is, there needs to be a clear definition of what it is that's expected to be reported, who's expected to report, and how it's going to be analyzed.
It is true, there are different definitions, and clarity of the definition is very important to the success of reporting programs.
For example, is there a difference between the critical incident reporting program in Saskatchewan and the adverse reaction reporting program of Health Canada? And what are those nuances and those differences? How can we standardize information so that outputs from the different reporting programs can be compiled together?
12:10 p.m.
Conservative
12:10 p.m.
Vice-President, Institute for Safe Medication Practices Canada
Well, Health Canada has the MedEffect program, and it is the adverse reaction reporting program. There is a regulatory definition for an adverse reaction. There is also acceptance by the adverse reaction program for adverse event reports that might extend past the regulatory definition.
So there are options to look at that data in different ways.
12:10 p.m.
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
I would like to ask whoever would like to answer this. We've talked a lot about mandatory versus voluntary reporting and who should be doing the reporting. I think we've gone the full gamut of who does it and who doesn't do it.
In your opinion, who should be doing it, and should it be mandatory?
12:10 p.m.
Chair, Expert Advisory Committee on the Vigilance of Health Products
I'm going to comment on that.
My original reaction to mandatory reporting of adverse events by all health professionals was a negative response, primarily because I felt it was going to add more noise than quality to the reporting. Part of my concern was that we may end up with more than we need or with elements that are not necessarily bringing any value. However, one of the comments brought to us during our last meeting was the fact that when you mandate something, you show that it's important, and we feel this is important. If we look at it from that perspective, then I'm totally supportive of mandating reporting.
The concern we have is how to ensure that the reporting we get is the reporting we want.
12:10 p.m.
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
How do you ensure that it doesn't become a paperwork nightmare?
12:10 p.m.
Chair, Expert Advisory Committee on the Vigilance of Health Products
That's going to be a challenge. There is also the challenge of having to re-educate people. Health providers, people who've been out working for decades, were not taught how to report adverse events. We knew it was part of our review of the patient, whether it be lack of efficacy or an adverse event. We knew it was part of the risk of drug therapy, but taking the next step, which was to report this to a body, whatever body that may be, was not included.
I think we need to start looking at that and return to our universities and get our students to do this. Their practicums need to include this in their training. We've been remiss in that.
We have people who have been involved with clinical trials. They have that knowledge and skill. They do it regularly, because it's part and parcel of a clinical trial. But the great majority of practitioners are not involved in that. It has to become the day-to-day routine. If we had an electronic means of transmitting the information from all practitioners in the country, I think we would have an amazing array of information, which we then would have to have someone analyze, obviously, to make it useful for the practitioners.
12:10 p.m.
Conservative
12:10 p.m.
Bloc
Luc Malo Bloc Verchères—Les Patriotes, QC
Professor Moride, in terms of the different experiences internationally, is there a country out there which could be a source of inspiration? Are you aware of legislation that would be consistent with what you would like to see in place here?
12:10 p.m.
Associate Professor, Faculty of Pharmacy, Université de Montréal
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 about 10 provinces with a different culture, in the sense that the risk minimization processes probably differ from one province to the next. So, that is a challenge. However, in Europe, we are talking about 27 different countries, and they, too, face that kind of challenge. So, is there one country whose situation closely resembles that of Canada? I'd say that the concept of risk per se is not a global issue. Canada should be developing measures that will probably be different from those in place in other countries.
12:10 p.m.
Bloc
Luc Malo Bloc Verchères—Les Patriotes, QC
I am trying to make the proper connection between two pieces of information that we have been given. First of all, you said a little earlier that antidepressants often do not work because the treatment is interrupted before six months have elapsed. In fact, in the notes prepared by our researchers, Health Canada is quoted as saying that, in patients suffering from moderate depression, drugs are ineffective—that they have a placebo effect. So, I am wondering whether, when information seems contradictory at first sight, it's because there haven't been enough studies conducted in real life circumstances, or because every group of individuals is completely different. Last week, we heard from physicians. They told us that in terms of adverse drug effects, it is possible for there to be completely opposite effects—such as sleepiness and insomnia, constipation and diarrhea. Basically, we could study these things to death, but ultimately, we are talking about different individuals, and therefore different adverse effects in each case.
12:15 p.m.
Associate Professor, Faculty of Pharmacy, Université de Montréal
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 on the sole basis of the clinical research. That is precisely why it is very important to have the same volume of information from actual practice settings or based on observation. At the same time, the data you are referring to should be interpreted cautiously, in my opinion, because we have to be sure to compare apples with apples. The fact is I was not referring to exactly the same concepts.
12:15 p.m.
Bloc
Luc Malo Bloc Verchères—Les Patriotes, QC
So, an ordinary member of the public receiving this information could easily become confused.
12:15 p.m.
Associate Professor, Faculty of Pharmacy, Université de Montréal
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 information.
12:15 p.m.
Bloc
Luc Malo Bloc Verchères—Les Patriotes, QC
Who should be conducting studies on the subgroups? Who should be taking responsibility for those studies?
12:15 p.m.
Associate Professor, Faculty of Pharmacy, Université de Montréal
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 there—centres of excellence in pharmacoepidemiology, for example, which could conduct studies funded by the people who have the products—in other words, the pharmaceutical companies. That would be a good idea.
12:15 p.m.
Bloc
Luc Malo Bloc Verchères—Les Patriotes, QC
I now have some questions for the physicians. Gentlemen, have you noted completely opposite effects from one patient to the other in your own practices—as I was saying earlier, very different effects between two patients receiving the identical treatment?
12:15 p.m.
Past Chair, Cancer Advocacy Coalition of Canada
Yes. As a matter of fact, there exists an example of a drug that was given to improve the hemoglobin level so that the anemia from the chemotherapy drugs is alleviated without the need for transfusions, only to find that the drug that improves the blood also makes the cancer grow faster. So that's been the basis for the withdrawal or the black box warning on the use of these drugs.
12:15 p.m.
Conservative
