Evidence of meeting #21 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was drugs.
A recording is available from Parliament.
12:05 p.m.
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
There are a lot of different players that take part in the surveillance of health products, and we've heard from a lot of different areas about who should be doing the reporting and who shouldn't and the different roles that different people can play.
What areas do you think Health Canada should be focusing on, what would be the areas that other players could focus on, and who would those other players be?
12:05 p.m.
Assistant Professor, Centre for Health Services and Policy Research, University of British Columbia
I think the other players would be provinces that, at the current time, are effectively data stewards as it relates to administrative data records around pharmaceutical use and other health care services. They're going to be a key player in terms of ongoing, active post-market surveillance and what is sometimes referred to as data mining.
Key initiatives to be taken I think are an investment in personnel and infrastructure necessary to engage in this. I think it is also necessary to have a secretariat or advisory council that can actually set priorities and ensure that the research being done is in fact of value to the regulatory frame and these other partners.
12:05 p.m.
Conservative
12:05 p.m.
Liberal
Carolyn Bennett Liberal St. Paul's, ON
The first thing I'd like is just a clarification from Dr. Morgan about his idea of progressive licence, because I think mine was different. I guess I thought if we were calling for a progressive licence, it meant that what is now a final licence would only be temporary until it had real world experience. So any drug would be on some sort of real world probation.
I didn't see the progressive licence as being something that hurried things up. I thought it was a matter that we would wait and see what happened out in the real world before you get your final papers.
Maybe what I will do is ask the three questions and then you can take whatever time is left.
On the $21 billion, 2% piece--I guess dreaming in Technicolor--what do you think we could do with $500 million if we were going to invest that in addition to what is actually in the process now?
I guess certainly Dr. Laupacis' real world safety network would obviously be a dream come true of part of this, and I want to know whether you see this as part of a separate health protection agency, like the FDA, where it's very clear that its responsibility is for quality and effectiveness, not this murky thing we have right now at Health Canada. Then this network would be like what we now have with the public health network, where all the chief public health officers come together to plan and plot and deal with the safety of the public health.
I guess the third little question was, in B.C.'s PharmaNet right now--in terms of how far behind we are on electronic health records--does the fact that you've got at least the drugs there mean the pharmacists are able to call everybody on Prepulsid and tell them to go and see their doctors if there is a recall?
Those were my three little....
12:05 p.m.
Assistant Professor, Centre for Health Services and Policy Research, University of British Columbia
Very quickly, the notion of progressive licensing, which you have articulated--which is to maintain the status quo in terms of pre-market regulation but add a notion that a licence is deemed temporary--is, in my view, the ideal notion of a progressive licence.
According to the front page of today's paper, however, the progressive licensing seems to be pitched as a mechanism for Canadians to get more rapid access to “breakthrough” drugs. I haven't seen the legislation, but if that's the purpose of progressive licensing, it sounds like more rapid access is tantamount to lowering the bar.
There was a fascinating paper recently published in The New England Journal of Medicine, I believe it was, suggesting that deadlines in regulatory policy can be harmful to the public health.
12:05 p.m.
Liberal
Carolyn Bennett Liberal St. Paul's, ON
But in terms of sorting out that little piece, if a drug has been internationally approved--it's in the EU, Japan's got it, everything--is there a process by which stakeholders, patient groups, everybody, could fast-track that drug, based on international evidence, so that we could actually focus on the post-market piece in terms of real world life in Canada? I think Dr. Laupacis, or both of you, had said you want to do it in all jurisdictions.
12:10 p.m.
Assistant Professor, Centre for Health Services and Policy Research, University of British Columbia
I think maybe I'll leave this one to Andreas.
12:10 p.m.
Executive Director, Li Ka Shing Knowledge Institute, St. Michael's Hospital
First of all, around the progressive licensing, I interpreted it the same way that Steven did. So Health Canada might make a drug for cancer available to patients where, before, we might have required studies that showed a benefit in decreasing the risk of death with the cancer, and now it would be approved on the basis of showing a shrinkage of the tumour on an x-ray, for example.
If that's the case, then you can amalgamate all the data you want from around the world, but if you don't have the data that looks at the hard clinical outcome, you're not going to have the ultimate answer you want.
I'm sorry, what was the second part of that question?
12:10 p.m.
Liberal
Carolyn Bennett Liberal St. Paul's, ON
In terms of the $21 billion, the 2%, if we had $500 million to invest in the dream system, would it be an agency? How would we do that? Would it incorporate your network? How would that be?
12:10 p.m.
Executive Director, Li Ka Shing Knowledge Institute, St. Michael's Hospital
We were thinking about the network not as taking over the legislative mandate of Health Canada but as an independent and fairly nimble....
I appeared before this committee a while ago as a former chair of the Canadian Expert Drug Advisory Committee, and frankly, one of the reasons I didn't sit for another term was my frustration with getting anything moving that required all 13 provinces and territories and the federal government to agree upon something. So I think you'd need to have a group that's independent but well connected with the policy-makers.
If it were up to me, I would be funding some randomized trials of head-to-head comparisons of the like of Trasylol that I described, which I think would markedly increase the quality of information.
And I'm not sure I'd do what you suggest, which is actually mandate that there has to be post-marketing surveillance for absolutely every single drug that's applied there or that's initially funded. If it's another beta blocker or something, do we really need to do that?
In my view, we don't want to reach the situation where we're doing every study just because the study could be done, because I do worry sometimes that the amount of information we get out there might be so overwhelming that we'll throw out the baby with the bathwater because we can't detect and focus on the things we really need to focus on.
12:10 p.m.
Conservative
The Chair Conservative Joy Smith
I'm sorry, I'm going to have to interrupt. Thank you, Dr. Laupacis.
Mr. Brown.
12:10 p.m.
Conservative
Patrick Brown Conservative Barrie, ON
Thank you, Chair.
Mr. Morgan, you mentioned something that I found interesting before, about using electronics in, I think you said, New Zealand and Australia to have better real time access when prescribing drugs.
I found that interesting, because previously, when we had the CMA at this committee, one of the things they mentioned was that the real time access to information was an issue. There were some other members, some doctors, who receive updates from fax or mail, who don't get to them as quickly as they could.
Do you have any information on the type of mechanism they use in New Zealand, to have that as a hand-held device like a BlackBerry that a doctor could log onto? Do you have any idea of what the costs associated with such a step would be?
12:10 p.m.
Assistant Professor, Centre for Health Services and Policy Research, University of British Columbia
The costs I don't, but I'll give you a Canadian example of an innovative system for bringing electronic prescribing assistance devices into the hands of physicians.
It's from Montreal. Dr. Robyn Tamblyn, at McGill University, runs a project called the Medical Office of the 21st Century, otherwise nicknamed MOXXI. This is a project in which they've enlisted physicians and pharmacists into a system where, at the point of clinical encounter—that is, when the doctor is seeing the patient—they have a BlackBerry-like device, or a Palm Pilot-like device, that provides them with menu-driven information not only about the drugs they are selecting in that encounter for the patient, but also about the drugs that were prescribed by them and other doctors to that patient and whether the patient filled those prescriptions, because that can be an important part of dialogue, to say, “Well, why not fill this?”
So I would encourage this committee perhaps to invite Dr. Tamblyn to speak before you. The results from the Canadian trials of these devices are astounding. The ability with which they have been able to improve quick prescribing is quite impressive.
12:15 p.m.
Conservative
12:15 p.m.
Assistant Professor, Centre for Health Services and Policy Research, University of British Columbia
Fantastic. I would direct those questions to her. It's a particularly impressive Canadian success story.
12:15 p.m.
Conservative
Patrick Brown Conservative Barrie, ON
That will be interesting.
In terms of other international examples, do you have any other information you could share with us about where Canada could look for information?
12:15 p.m.
Assistant Professor, Centre for Health Services and Policy Research, University of British Columbia
Canada could look south of the border, for instance, to the veterans administration in the United States. The VA runs an electronic system for tracking and monitoring prescription use and for helping physicians make prescribing choices. So do many of the major managed health organizations in the United States. Group Health Cooperative in Seattle has a very well-developed system that is available both to prescribers and to patients, interestingly, so they can see more of their own prescription records.
In the United Kingdom they've invested considerably in electronic health records and electronic prescribing as well, and it is a system to look at. They, like other jurisdictions, have run into some challenges, because it's not inexpensive, and it's a process in which you have to build the trust of the professionals so that they understand that there is, if you will, something in it for them when they engage in electronic prescribing.
As these things roll out.... Group Health Cooperative in Seattle has done a study of this, and they've found that the practitioners don't want to go without it. Take the device away from them and they begin to complain.
12:15 p.m.
Conservative
Patrick Brown Conservative Barrie, ON
I have a question for Andreas.
In your response to Ms. Bennett, you were saying you don't necessarily have to have mandatory reporting in every case. I think you're touching on that a little bit. Could you expand a little bit more on where that line would be, in terms of making it effective?
12:15 p.m.
Executive Director, Li Ka Shing Knowledge Institute, St. Michael's Hospital
In terms of physicians reporting adverse events, I think you'd want to encourage physicians to do that for all drugs that they think there's an issue with.
My point was around the use of some of these administrative databases, as Steven described, which would allow us to kind of data mine to look for adverse events for every single drug that's approved. Sometimes if you look, you're going to find stuff that looks like it's there, but it may not actually be accurate.
And there's a cost, in terms of both personnel and the cost of doing all these things. So my sense is that if there's a new drug in a class, if there's anything from the initial studies that suggests there's a concern, if someone reports an adverse report, one would want to look at those drugs with the administrative data.
If it were another of a kind, a new statin, as Steven said, to lower cholesterol, and I had a limited budget and time, I'm not sure I'd spend my time looking at that drug. You have to make some kinds of reasonable decisions, it seems to me.
12:15 p.m.
Conservative
April 8th, 2008 / 12:15 p.m.
Bloc
Ève-Mary Thaï Thi Lac Bloc Saint-Hyacinthe—Bagot, QC
I want to thank the witnesses for coming here this morning.
My first question is directed to all of you. Today our population is aging. In recent years, the health care system has been under-funded, a situation that has resulted in many accessibility problems. Lack of accessibility to physicians has led people to self-diagnose and self-medicate. Furthermore, the over-the-counter drug market has been growing in the past several years.
In your opinion, is it acceptable that current drug advertising practices can impact people in terms of the treatment they require? When I must use an OTC drug, I always consult with a pharmacist before making a choice. However, not everyone does as I do. Advertising practices can have a major influence on consumers.
I would like to hear your views on this subject.
12:15 p.m.
Executive Director, Li Ka Shing Knowledge Institute, St. Michael's Hospital
I'm not sure I'm going to be able to answer the question particularly satisfactorily. The number of over-the-counter drugs that are available is relatively small, and I think there is some potential harm. With some of the drugs for arthritis, for example, for acute pain, I think some patients are self-medicating. My own personal bias as a physician is that it isn't a huge issue.
Many patients are on alternative medicines or natural therapies, and I think that's an area where we actually don't know (a) their effectiveness, (b) their safety and what ingredients are there, and (c) how they interact with conventional medicine. So I think that's an area to focus on.
But I would share your concern with the lack of accessibility to family physicians and, in people with chronic diseases like diabetes, to appropriate management. We've talked a lot here about the excess use of medications and their side effects, but I think patients are also being harmed if they don't have access to drugs that have been clearly shown to be effective.
12:20 p.m.
Assistant Professor, Centre for Health Services and Policy Research, University of British Columbia
I appreciate your bringing up the question about access because it is an important issue as we discuss prescription drugs. Canada shares the distinction with the United States of being one of the only developed countries not to have universal pharmaceutical insurance coverage. So Canadians in fact face greater financial barriers to filling prescriptions than our comparable populations in many other countries, except for the United States.
I think this is an important issue because it may in fact lead some people to use over-the-counter remedies or other mechanisms that may be less rigorously assessed, or, at least as I think you're asking, that may be below the radar, and this is an important issue. One of the things I think the federal government might do in this domain is to ensure that we are adequately conducting surveys and collecting information about the population's use of these over-the-counter medicines and about their use of natural and homeopathic treatments.
That I think could be done through expanding, for instance, the Canadian community health survey, run by Statistics Canada, or through other mechanisms. So there are possibilities for bringing that information into this research realm so we can better understand it.
12:20 p.m.
Lawyer, As an Individual
I won't be able to comment on the over-the-counter products because I have no expertise in that, but I do want to compliment you on the question itself because it shows that the whole medical system has to be treated as a system in a holistic way. So if you have people with no access to physicians, they might be trying to self-prescribe or self-treat.
I saw in the bus shelter on my walk here this morning someone sewing themselves up; the OMA had an ad about this.
If we want to solve the problem, if people are taking drugs and having adverse events and they have no physician to tell it to, how do we deal with that? Or how do we bring people into the system rather than have them do underground medicine? That's all I can say to people.