Health Committee on Feb. 7th, 2008

[Dr. Brien Benoit]

Not that I know of.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

So what advice would you give this committee to ensure that we provide the best advice to the minister and the Canadian public? That's an open-ended question.

Those will be my questions, Madam Chair.

[Dr. Brien Benoit]

I'll take the question in my role as a physician rather than as chair of the PMPRB, because I think your objective is a very valid one and good one, and it's very current.

There are all kinds of difficulties in implementing a very good mandatory reporting system for adverse reactions. I think at the moment, in terms of physician input, you'd need to have discussions with the medical establishment, because any type of reporting is burdensome. If you have a busy family practitioner and a person comes in and says “I have a rash from taking this particular pill”, your natural instinct is just to say, well, stop taking the pill and I'll give you something else, when in fact that particular rash may be part of bigger picture. So there's no incentive really to report adverse reactions, unless they are catastrophic, surprising, or unexpected according to what the product information brochure says. If you look at any product information brochure, you're going to see every possible adverse reaction listed there. Most physicians just skim over them; you only look at the most important ones.

You'd have to have some kind of mandatory regime to oblige the reporting of adverse reactions, in my opinion. In hospitals it would easier to acquire, but out in the community it would be difficult.

[Glenda Yeates]

My sense is that it would be very important to have a clear sense of role. As we all know, there are very complex linkages in the sense of who does what. So I think we would need to have an agency or someone responsible with a very clear role to do this in order to understand what works, but data also will be huge part in doing this effectively. Speaking perhaps from our data provider perspective, it would important not to duplicate unnecessarily, but to build on and look at how we could use the data that currently exists to further this very important objective.

[The Chair, Conservative, Joy Smith]

Thank you both, Dr. Benoit and Ms. Yeates.

Now we'll go to Madame Gagnon.

[Christiane Gagnon, Bloc, Québec, QC]

Good day. I have two questions for the witnesses.

Ms. Yeates, there are two types of analyses. I would like to focus on the Canadian Medication Incident Reporting and Prevention System pursuant to which data on medical accidents and incidents is collected, analysed, exchanged and reported.

Earlier, I asked you to describe for me the role you play in monitoring the safety of pharmaceutical products. You responded that this was neither the role, nor the mandate of your organization. However, the mandate of CMIRPS includes collecting data. I am trying to understand the responsibilities the various players have when it comes to pharmacovigilance. MedEffect also gathers data, just as CMIRPS does.

Are you involved in this process? Where do you draw the line? Do you rely on information from these two databases? Would it be preferable to have only one database? Can you explain the difference to us? Do you all work together, or do you work alone?

[Glenda Yeates]

I will ask my colleague to speak to some of the other databases and the linkages, but initially I would just make the distinction.

I am not a pharmacist, so this is a distinction that was not initially obvious to me. But in regard to the language, we were asked and funded specifically to develop a database to gather information on “medication incidents”, which are distinct from, as I've learned, “adverse events”. Medication incidents are really about the processes of care.

Certainly I think we've seen a number of hospitals in this country that have had tragedies in emergency rooms, for example, where medications that looked very similar or that were stored in an emergency room were inappropriately given and they had tragic results. The concern was that one of these situations occurred in eastern Canada—I think it was in Halifax, or within Nova Scotia—one occurred in Saskatchewan when I was there, and they've occurred in Alberta, yet it seemed we had no place to actually collect those kinds of problems. So we were funded specifically and asked to develop a database to collect in-hospital medication incidents.

I think it will be a very important database. Currently we've developed the structure to find the definitions. The system is ready for piloting in September. I should be clear that at this time I can't answer what proportion or what kinds of inputs we will get to that.

We have been working with others, such as the Canadian Patient Safety Institute, because we realize it will take on-the-ground support for individual physicians and hospitals to be encouraged to actually submit data to the database. We have partnerships there to try to encourage that kind of submission so that we can build the database so we don't have to make the same mistakes in one part of the country as we've made in the other, but rather, we can learn from them.

The distinction that I've had to appreciate, since learning of this, is “medication incidents” versus “adverse events”. When we do get data, at the current time it's designed to do the one and not the other.

I'll ask my colleague to speak to some of the linkages you mentioned.

[Michael Hunt]

From the outset with the CMIRPS project, the vision was that it wasn't to be built in silos. So if you look at the organizations that have been involved in the product from the beginning, Health Canada is certainly up front, as is the Canadian Patient Safety Institute, within their mandate of safety within the country, and the Institute for Safe Medication Practices Canada, or ISMP, has also been involved in the field.

If you look at the components of the data we're managing to collect, there will certainly be incidents or errors that will occur that are essentially associated with the product. So we have naming, packaging, labelling, look-alikes, and sound-alikes. Certainly that's data that Health Canada is very interested in, in their legislative role, so we would look at making sure that data is available.

We talk of the entire environment of reporting. This is not a mandated reporting area, so this is a cultural change. This is a change from a reporting culture of naming and blaming to one of learning and sharing. The system design is really there to share the data. We want to be able to share the incidents or errors that occur back with the institutions where they occurred, do that in an aggregate way so that they can look at other institution incidents, and then use that data to put in place safety strategies.

CMIRPS, from the beginning, is a cooperative venture. We have most of the players at play. Certainly in our initial consultations we include health care practitioners—nurses, physicians, pharmacists—those involved with the delivery of medications within the institutions.

So from our perspective, it's well linked right from the outset. It's a good concept of sharing that data. We're the data gatherer and we're to make sure that the data we gather is valuable, that the data set is useful, and that we find mechanisms to share that in a privacy-sensitive way.

[The Chair, Conservative, Joy Smith]

Thank you, Mr. Hunt.

Mr. Brown.

[Patrick Brown, Conservative, Barrie, ON]

I don't have any further questions. I'm not sure if Mr. Fletcher does.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

I have no further questions.

[The Chair, Conservative, Joy Smith]

We'll now go to Mr. Temelkovski.

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

Thank you very much, Madam Smith, and thank you to the presenters.

Madam Yeates, do you feel that you have the network and contacts to undertake post-market surveillance data management?

[Glenda Yeates]

We have a very good relationship with government: the federal government, provinces, and territories. We have good relationships with practitioners, although that is a very large group, so I would characterize it as good relationships with leadership.

In many ways, what's often critical for us is that there is agreement among those parties about what is a priority to collect. I think we can facilitate the collection and the standardization, and based on our good relationships, work that out, if there's an agreement about what people want to achieve. If, fundamentally, there's a disagreement about whether we should be collecting this, we have no mechanism, and even with good relationships, it won't produce actual data if people don't have some consensus around what's to be collected.

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

How would you enhance what Health Canada already does in this field, and why would you do so if it is outside the Patent Act?

[Glenda Yeates]

Again--maybe I'll speak a little bit with my previous hat, as a provincial deputy minister--I think post-marketing surveillance is of great interest to a great many health stakeholders across the country. Health Canada certainly is interested, the provinces and territories are interested, and in my experience, practitioners are as well. I think there is a lot of interest, potentially, in doing this.

Often it is a matter that the devil's in the details. It depends on who is going to pay, what it's going to look like. Those would be things that would need a fair bit of working out.

My sense is there could well be interest. There seems to be some common interest among the parties.

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

Dr. Benoit, did you have a comment on that?

[Dr. Brien Benoit]

I think this whole initiative is great. In my opinion, it's long overdue. But you have a lot of work to do in terms of how you're going to implement it.

You have different organizations; you have CIHI that can collect the data, if it's obligatory that it be reported to them. I'm not sure what our role in this would be exactly. We do have a regulatory component to our organization, but it's driven by the Patent Act. And this is not part of the Patent Act, as far as I know.

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

Right.

In terms of competitive groups that are collecting data, such as IMS, what's your take on that? Can this go to a private company, or should we keep it close to our chest?

[Glenda Yeates]

Well, it depends on what one wants to achieve. We certainly have the kinds of governance structures.... We are governed, essentially, by the health sector as a cross-section, so governments are represented, hospitals, practitioners. Often that builds a degree of trust with the sector because of the governance model, and certainly we are very strictly regulated in a privacy sense.

In the past that has worked well. It has given people the confidence that we handle their data well. I think we have a very strong track record that we've built up in terms of being very strict and able custodians of data and being appropriate. We certainly wouldn't be the only possibility, and it would really depend on what the goals were, but we think we have a strong track record and strong basis in terms of what we do.

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

I have two short questions.

[The Chair, Conservative, Joy Smith]

How about one short question? You're just about out of time.

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

In terms of aboriginal data collection, Dr. Benoit, could you answer this question?

If there is an issue regarding the safety and efficacy of a particular product, does such a situation affect the pricing? Would you examine how its non-excessive price was calculated?

[Dr. Brien Benoit]

I'll give you a short answer. Right at the moment our price regulations apply at introduction. We are currently asking for discussions and proposals regarding a real-world efficacy after the drug has been on the market for a few years. But at the moment, we don't look at the price after introduction--

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

So it would be helpful.