Health Committee on Jan. 31st, 2008

[Meena Ballantyne]

We're doing a lot more of it, at a variety of levels.

[Patrick Brown, Conservative, Barrie, ON]

Just more actively?

[Meena Ballantyne]

Yes, we are much more proactive in trying to seek opportunities to share work with them and to share reports of post-market surveillance. If they're picking up any signals in those countries, then we would have this rapid sharing of information.

[Patrick Brown, Conservative, Barrie, ON]

Was that not done before?

[Meena Ballantyne]

It was done before, but we've recognized that it needs to be done much, much more proactively than ever before.

[Dr. Chris Turner]

I would add that one of the interesting aspects of the developing science around post-market surveillance is that it is evolving. You asked whether some of this work done before. It wasn't, because the tool to do it was not there.

I have a three-page report, which we could leave with the committee, that talks about what our regulatory partners are able to do in their jurisdictions. We in Canada, as Dr. Bennett mentioned, have an opportunity to lead, using tools like the National Prescription Drug Utilization Information Service, NPDUIS, and COMPUS, the Canadian Optimal Medication Prescribing and Utilization Service. These are resources that we can bring to the table.

With others--for example, in New Zealand, France, and Norway--there are pharmacovigilance centres connected to health care facilities. In the U.K., there's the general practice research database, which resources a group of physicians to keep track of their patients and enables that information to be mined. Data mining, which wasn't as available before, is a tool we use in some partnerships with the U.K. and HRA, our equivalent. We leverage the general practice research database.

But on our side, we also have these opportunities we can bring to the table. We have discussions, as Ms. Ballantyne said, with our foreign regulatory partners so we're able to leverage the worldwide surveillance experience.

The reality is that rare adverse reactions, especially if they are in a subpopulation, are less likely to be identified in Canada than they are when you can data-mine the worldwide experience. If we want to address the needs of a subpopulation, we may have to go to that part of the world to get it. For example, with some of the products, like traditional Chinese medicines and ayurvedic medicines from India, it's much more likely that Canadians are going to be able to mine that information from those parts of the world where there is a larger population.

Those are some examples of our foreign partnerships. We recognize that we don't have to do it all ourselves, but we have to be integrated with our foreign regulatory partners to be able to leverage the expertise.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Turner.

Ms. Kadis.

[Susan Kadis, Liberal, Thornhill, ON]

Thank you for coming today to help us study such a critical area, to ensure that Canadians can be confident that the drugs they are taking are safe.

That's what I would like to ask you. Can Canadians feel a sense of security regarding our current post-market surveillance, particularly in relation to adverse drug reactions?

I know about some fairly recent experiences where there were very serious and potentially serious adverse reactions. I know from the literature we have received that it is not mandatory for health professionals to report. I'm sure many do, but based on what I'm seeing, perhaps many don't. I find it surprising and perhaps somewhat shocking that it is on a voluntary basis. I understand that industry does it on a mandatory basis, but for health professionals it seems to be optional. Perhaps you could illuminate us as to how many physicians in hospitals and in private practice are now routinely providing that information.

On this whole notion of voluntary, you mentioned rare adverse reactions, but how do we know they're rare? Someone could have a serious reaction and may be led to think it is very rare. In fact, if it hasn't been reported adequately, for whatever reason, maybe it isn't so rare. I think this is a critical area in terms of ensuring that confidence.

It sounds as if there is a need to improve. Are we going to make changes that will significantly improve that confidence level, or are we going to leave out this piece regarding information? It's the information that is going to lead us to the best possible decisions for Canadians' health and safety regarding pharmaceuticals.

[Meena Ballantyne]

You're absolutely right that it is mandatory for manufacturers to report adverse events, but not so for health care professionals or, obviously, Canadians.

In the reporting of adverse events, there is a lot of underreporting, for a variety of reasons, going on in terms of barriers to reporting and communications channels. We've been looking at this issue actively, because that's a fundamental part of any kind of post-market surveillance activity. There's no question that, using a multi-pronged approach, we need to try to increase the reporting on these, because that's going to add to our information base in this progressive licensing or life cycle approach.

I'll let my colleagues who've been working on these issues much longer than I have speak to this, but in all our consultations in terms of looking at the international practices, looking across this country and talking to a variety of people, what was felt was that at this point in time there are many folks who are starting to work on putting systems in place to report these incidents. For example, a couple of the provinces—I think Manitoba and Saskatchewan—are putting into their hospitals or regional health authorities critical reporting systems. We have the Canadian Patient Safety Institute, as we know, trying to encourage that, so that it's not an individual who's held responsible and it's a system issue that we can all learn from.

During our consultations with all these folks, what came up was that at this point in time maybe the best place to start could be focusing on mandatory reporting by hospitals of serious drug adverse reactions to their regulated products, because we know that at some stage people will have to be, unfortunately, hospitalized if they've suffered a serious adverse event. What we're saying is that maybe as a first step we will try to have mandatory reporting within health care institutions. We're actively working with our colleagues in the provinces and territories, and there are a number of issues to be worked out, but I think the mood worldwide is to go in that direction, because we know we have to increase the reporting of these things using a variety of means.

[Susan Kadis, Liberal, Thornhill, ON]

Thank you.

Along those lines, internationally, are other countries having health professionals provide that information currently on a mandatory basis? How do we compare, in general, with post-market surveillance?

[Dr. Chris Turner]

As part of the workup for this issue—and this again is something that was discussed with the previous Standing Committee on Health—we have done an international survey of foreign regulatory action, and what we've found is that there are a certain number of countries that do have mandatory reporting requirements for health professionals, but what we've also been told by them and what the evidence shows is that those requirements for mandatory reporting by individual health professionals have increased neither the quality nor quantity of adverse reaction reports. As a result, we have, again, through consultations with our provincial and territorial partners, and as well, by looking at some of their critical incident reporting systems, found that groups and teams of individuals provide more and better-quality reports.

In addition to the numerous other initiatives we've put in place since the creation of the marketed health products directorate in 2002, in the last year there was a 17% increase in the number of domestic adverse reaction reports. That's significant. We have seen a continual increase in those reports since 2002, as another element.

So there isn't just one solution. We recognize that the best place to get...I don't want to call it the best bang for the buck, but the most likely place to get the serious adverse reactions, which are the ones we're most concerned about, is from health care institutions. As a result, working with our provincial and territorial partners, hopefully they will be able to leverage the information, because we know that hospitalizations from adverse reactions are a significant drain on the health care system, in addition to individuals.

[Susan Kadis, Liberal, Thornhill, ON]

Thank you, Dr. Turner.

[The Chair, Conservative, Joy Smith]

Madam Kadis, I'm sorry, you have just 30 seconds.

[Susan Kadis, Liberal, Thornhill, ON]

Thank you, Madam Chair.

I wholeheartedly agree with going in that direction, but of course you have to consider the fact that at that point, when they go to the hospital, it may be fatal, whereas if we can get the information earlier we may avert that fatality.

I would encourage also that you table the study that you referenced before regarding MedEffect. We know that with the Canada Health Network there were three million viewers, so it far exceeded the MedEffect and was another important tool for information.

[The Chair, Conservative, Joy Smith]

Thank you, Ms. Kadis.

Dr. Turner, when you were answering questions from Mr. Brown, you referred to a three-page document on international partnerships. I was wondering if you would be so kind as to table that with the clerk so that members of the committee could have that information.

[Dr. Chris Turner]

Sure.

[The Chair, Conservative, Joy Smith]

Thank you so much.

Ms. Davidson.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Thank you, Madam Chair.

I'd like to thank each of the presenters who are here today to answer our questions.

I just want to carry on a little bit along the same line as Ms. Kadis did.

On page 2 of your presentation, Ms. Ballantyne, you talk about Health Canada encouraging reporting from health care professionals, and you say that it's only the manufacturer that is responsible for reporting serious adverse reactions. I have a few questions along this same line.

First of all, what is the definition of “adverse reaction” versus “serious adverse reaction”? Is anything mandatory at all right now for health care professionals?

When I go back to page 5 of your presentation, you talk about the legislative amendments to the Food and Drugs Act and about the authority to make it mandatory for hospitals to report. We're again back to the definition of adverse reaction and serious adverse reaction. Your definition will probably answer this question, but are serious adverse reactions the ones that require hospitalization? How would we know that if health care professionals don't have to report anything? How do we know whether or not there are adverse reactions out there? If it is only the manufacturers that have to do this, isn't there a huge gap? How would the manufacturer even know if there had been a reaction? Isn't it the doctor or the patient who would know whether or not there had been a reaction? If I had one, I wouldn't be contacting the manufacturer of the drug; I'd be contacting my doctor—

[David Tilson, Conservative, Dufferin—Caledon, ON]

Or your lawyer.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

I'd start with my doctor.

If you start making it a mandatory requirement for physicians and health care professionals to report everything, how are you going to balance the increased red tape and bureaucracy, and everything else that's required, with the fact that our physicians and health care professionals are overloaded today with that type of requirement from governments? We hear every day that government requires too many reports to be filled out; this has to be done, and that has to be done, and we don't have time to do our nursing care or doctoring care.

Could you answer those questions, please?

[The Chair, Conservative, Joy Smith]

Dr. Turner, go ahead.

[Dr. Chris Turner]

The definitions of adverse reaction and serious adverse reaction are in the regulations. A serious adverse reaction does involve hospitalization, but it involves several other things as well: if there is a life-threatening reaction; a death, obviously; a disability; or a congenital anomaly. Those are internationally harmonized definitions of serious adverse reactions. They're not Canadian only.

As was discussed previously, we are attempting wherever possible to harmonize this internationally, because we need to be able to merge the data. If someone has coded something in their database as serious, based on a different definition, and we're not using the same definition, it makes it impossible to come up with a summary to know what its significance is and to use numeric comparators—what we call proportional representation index numbers—to be able to say that one report makes any difference in the context of all the other reports in that class of drugs, or all of the drugs reported.

I hope that addresses your issue about what is serious.

As for how we would know there were other things going on, in addition to working with our foreign partners to be able to identify trends.... That is what adverse reaction reports are; they are not individual. They're not like CSI or a coroner's report—and some of them may be coroners' reports—but are used for trending, which is studied more intensively and may involve a study—

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

But the trending must come from individual reports.

[Dr. Chris Turner]

By accumulating them.

We have other approaches. For example, we're working with groups such as the Canadian Medical Association and the Canadian Institute for Health Information in terms of hopefully, in the nearer future, being able to leverage reports without relying on, or waiting for there to be, a voluntary report.

In terms of your point about manufacturers' reports, although 66% of the reports that we get actually come from manufacturers, they get them from health professionals or consumers. So, for example, if there's a 1-800 number on a label and a consumer calls the manufacturer, then the manufacturer has to report it. In other words, the mandatory component is that anything the manufacturer is aware of they have to tell us, no matter where they get it. If they hear about it themselves, or if a physician, a nurse, a dentist, a naturopath or a consumer tells them, they have to make a report.

The problem is that the level of quality may be extensively different, depending on how close they were to the situation. If one were a salesperson in a doctor's office who got a full case report from that physician and then sent it to us, obviously that may be more useful than if we just know that somebody had a rash, but didn't give you a dose, and there's no temporal relationship to when the drug was taken. That's less useful. We would get the full range of that in the approximately 17,000 domestic reports we get per year and 350,000 foreign reports per year. So it becomes a trending exercise.

Then once we've identified what we call a signal, and they're potential signals, then those are further investigated. That may involve actually doing a post-market study. That may involve talking to foreign regulatory bodies. That may involve including academia or provinces and territories looking at utilization information. That may involve purchasing utilization data from groups like IMS, or Brogan Inc., and others who have that kind of information, to be able to put the full picture together.

[Meena Ballantyne]

I would just add that the beauty of the new approach we're proposing is that you could attach the studies that Chris is talking about to the licence, so that you would be saying that based on the science and the sound science in the best interests of Canadians, we will issue a licence for a drug. But we want to make sure that we monitor it closely, for whatever reason. If there's something in the science that's telling us that we don't have all the information at this point, but we've made this assessment--and it's always going to be based on science--that the benefits outweigh the risks at this time, but we want to monitor it very closely as it moves forward, right now we can't do that. We would just give it a licence, wait for an adverse event to happen, and then just pull the licence, which is a very blunt instrument.

With this progressive licensing, we could say to the company that they have to carry out this post-market surveillance, they have to submit the studies, they have to reassess the product, and we will be monitoring it very closely. So we would be able to use something that isn't taking the drug off the market, because it does benefit. As long as the profile always remains that the benefit outweighs the risk, then you would continue to have it out in the market.