Health Committee on Feb. 14th, 2008

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

Before we go on to the others, sir, on the independent agency, a lot of professions--medical professions, legal professions, maybe your profession, I don't know--are self-regulatory. Is that what's being suggested here?

You have the drug companies, the manufacturers, producing something. You have doctors prescribing it, and maybe prescribing it inappropriately. You have the pharmacists, of course, who are part of that process. And then you get back to the consumer. They have a rash or they get something funny happening to them and they don't know what to do.

There's another section, which I will, in due course, report to, where they go to the emergency room, and we have problems with our emergency rooms. They line up docs, and we've got a shortage of docs. It's something that's very serious.

My question to you is this. Is that what's being suggested by an independent agency, that there be some sort of self-regulatory body?

[Dr. Jeff Poston]

No. I think Ms. Wolfe gave a very good description of the regulatory piece that's already in place with respect to the profession of pharmacy at the provincial level that requires some level of reporting. I think what we see the agency's role being is much, if you like, less regulatory. We'll leave the regulatory piece to Health Canada. We get a lot of information in this country about drugs and their use. We have all sorts of bodies that are collecting the information. What there isn't is one place that puts it all together, analyzes it, and synthesizes it into health care policy, and then pushes that information out to health care providers and to health care practitioners. It's really doing a better job around that dissemination of information and education and training and making people aware of the issues around safety and effectiveness.

I think a model that we may need to look at is the Canadian Patient Safety Institute. They've done a lot of work in their three or four years of existence around medication errors and patient safety in hospitals, particularly in general. I think there are some pieces like this that we can look at.

And when I say independent agency, I'm thinking more from an information and education training perspective as opposed to a regulatory one.

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

Ms. Wolfe.

[The Chair, Conservative, Joy Smith]

Forty seconds left.

Mr. Villeneuve.

[Denis Villeneuve]

Obviously, there would be merit in reporting all adverse reactions, but you have to bear in mind that the feedback would come from patients and would be in their words. How would we, as professionals, manage this additional information that is already known to us?

Firstly, the adverse reaction reported by the patient may already be known to us, it may already have been recorded. Secondly, how are we going to tell patients that if they experience any adverse reactions they should make a list and inform us of them? We are already leery of informing patients of all the adverse reactions listed, for example, in the CPS. How would we manage all of this?

For example, if I meet a patient and tell him that he should inform me of any adverse reaction that I have not mentioned, he is going to want to know what I mean. I would then have to list off the 200 known ADRs and tell him that, should he experience any that I have not mentioned, he should let me know. It would be a real headache to manage. I agree with you. I have been managing information from patients for 30 years, and these are people who are worried about adverse reactions.

[The Chair, Conservative, Joy Smith]

Thank you so much.

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

Madam Chair, I think we've heard all this before. I think they should be witnesses.

[The Chair, Conservative, Joy Smith]

Thank you, Mr. Tilson.

We'll now go to Dr. Bennett.

[Carolyn Bennett, Liberal, St. Paul's, ON]

As Mr. Tilson pointed out, four years ago the committee suggested that mandatory reporting would be a good idea. I think at that time we heard the reaction from both physicians and pharmacists that they were too busy and it wouldn't really help that much, and it had better be user friendly. Four years later, we're still having 10% of adverse reactions being reported. So I don't think we've done a very good job changing the culture or doing the education or all these things that were supposed to be done in a voluntary way.

I also was a little confused last week by the testimony, on the hospital side, about incident reports, because my experience in hospitals is that the incident report is usually done only if you've been given the wrong drug. It isn't necessarily a predictable reaction. A little rash or something doesn't usually get an incident report.

So if we are going to develop a real learning culture around this, and we only have 10% of the data, what are we going to do? I don't know whether it's in the nice blue book over there or not, but I think in terms of Myrella's testimony, it's just noise if you keep hearing the same things again. And if you're not disaggregating the data.... Is this only women that the noise is about? Is it only women who had grapefruit juice for breakfast? Is it only women taking echinacea? We actually could be learning if we actually report and then find all this out.

So I guess I'm still a bit frustrated that we aren't moving on this at all, even in terms of user friendliness for patients so they are able to get online to do this, or for pharmacies so they can get online to do this. Do I have to give every doctor in the country a BlackBerry in order to do this, with a drop-down menu on which they go “same old rash”?

How are we actually going to design a system in which we have 100% of the data or even 85% of the data, instead of this pathetic 10% with which we cannot, I don't think, learn.

[Claude Gagnon]

I understand your question and your argument. As health care professionals, even we are not used to this way of working. I have been a pharmacist for 30 years. Personally, I have always thought that a known reaction should not be reported. We report unknown reactions described to us by patients. By unknown reactions, I mean those that are unexpected and not mentioned elsewhere. When such reactions occur, we make a report. Everybody knows that a certain drug might cause a skin reaction.

I have always believed that, in such a situation, my role as a professional is twofold: firstly, to stop dispensing the medication and, secondly, to find a substitute. I know that it happens, but I'm not convinced that all professionals are aware of the need to report known reactions.

Perhaps it is our training that is at fault. We are not taught to make this type of report at university. Perhaps professionals need training on this matter. I am not convinced that everybody fully understands what needs to be reported.

[Carolyn Bennett, Liberal, St. Paul's, ON]

What about the frequency with which such reactions occur? That is something which is very important.

[Manon Lambert]

We already know the frequency with which reactions to most drugs are experienced. ADRs are detected at the pre-marketing stage precisely because they occur frequently. We therefore have a good idea of the frequency at which they occur. Mandatory post-marketing reporting would not simply reproduce information available at the pre-marketing stage. It is adverse reactions that have not been detected at the pre-marketing stage that have to be reported at the post-marketing stage. These sort of reactions, although rare, are often potentially deadly.

In Quebec, we are 10% short of the number of pharmacists that we require. Some hospitals only have locum pharmacists, people who fill in for a week or so before moving on. If you ask pharmacists to report adverse reactions, or even if you require them to do so, you will be simply wasting your time, as it would do nothing to improve their scientific knowledge or change the way in which they treat their patients.

The focus should be on developing a culture whereby professionals report the more serious ADRs they are not familiar with, and where these reports are met with feedback. Feedback is important, as it allows pharmacists to treat their patients appropriately. At the moment, however, there is no feedback.

[Denis Villeneuve]

Could I please add something on frequency?

The question of frequency is an interesting one. Increasingly, we have access to data comparing the frequency of adverse reactions experienced by patients taking a given drug compared to those experienced by patients taking a placebo, a pill with no therapeutic benefit. The data shows that the instance of adverse reactions is very high amongst those taking the placebo. What should we do when faced with the fact that, often, patients who have not even taken a drug experience adverse reactions? It is a question of culture and of the individual patient. It is important to be cautious here. I understand that a 10% shortage in pharmacists is worrying, or even catastrophic, but we have to maintain perspective.

[Myrella Roy]

To come back to your example of declaring a rash, currently, as with the definition that's proposed by Health Canada in their MedEffect database, if a rash causes the patient to stay longer in the hospital, this is considered a serious adverse drug reaction and should be reported. That is the type of example I was referring to: this information will not add significant information on how to deal with this intervention, and it will not add significantly to the body of knowledge we already have.

I concur with all of my colleagues in their previous interventions that where we need to act on this—to address your question directly—is with educating health care professionals. We are not doing as much, and that's what I mentioned in my intervention previously. We support greater reporting, but we support greater reporting of quality information.

[The Chair, Conservative, Joy Smith]

I'm sorry, we've run out of time.

Mr. Brown.

[Patrick Brown, Conservative, Barrie, ON]

Thank you, Madam Chair.

The first question is for the Canadian Pharmacists Association, for Mr. Poston.

Health Canada contributed funds, from what I understand, to your organization for a web-based communications tool, e-Therapeutics. Could you comment on the outcome of that?

[Dr. Jeff Poston]

It has gone extremely well. We launched the product into the marketplace two or three years ago. It's a web portal.

As you know, we publish the big blue book, the Compendium of Pharmaceuticals and Specialties, which is a collection of Health Canada product monographs. We also publish a book called Therapeutic Choices, which is like a set of clinical guidelines to drug use in particular diseases. As for what e-Therapeutics is, we actually integrate the content from those two publications and make them available online.

So the system is working. It's working very well.

For a physician who is treating a particular disease and wants some information, it recommends drugs that could be used, but then the physician can click on that drug and go to the full monograph to get information. The important value of it as well is that we are able to incorporate advisories from Health Canada directly into that system. So in the example we had about the warning from Australia about the risks of serious hepatic adverse drug reactions associated with the non-steroidal anti-inflammatory drug, as soon as Health Canada issued that advisory, we had it on our website being delivered to those physicians, pharmacists, hospitals, and institutions that subscribe to our e-Therapeutics product.

The uptake has actually been slower than what we had anticipated. As you know, the funding was issued on the basis of it being a sustainable business model. We're close to sustainability, but one of the things that are hampering uptake a little bit is the delay that we've seen in the implementation of provincial drug information systems. But the system has been incredibly well received by practitioners.

[Patrick Brown, Conservative, Barrie, ON]

I have a question for Ms. Roy.

What are your comments on whether pharmacists be remunerated for reporting? Is that something that should be considered as we look at ways to have a greater percentage of adverse drug reactions reported?

[Myrella Roy]

Your question is whether or not pharmacists should be remunerated? I don't think I mentioned that at all in my intervention, but I don't think that hospital pharmacists--and I'm pretty sure I can speak for all of my colleagues in community pharmacy as well--consider adverse drug reaction reporting as part of our duty, and we are not expecting to be remunerated for that.

[Patrick Brown, Conservative, Barrie, ON]

I have a general question that I have asked previous witnesses before this committee. In terms of Health Canada's powers, do you have any comments on whether Health Canada should have the power to recall pharmaceutical products?

[Karen Wolfe]

My understanding of the current regulations is that they can strongly suggest to manufacturers that they take their product off the market once serious adverse reactions are reported, yet they do not have the regulatory power at this point in time to mandate it.

I think that would be a step in the right direction for the government agency that oversees the safety of the Canadian public and the use of drugs.

[Dr. Jeff Poston]

I think I would support that, but it's interesting that the practice recently has been that pharmaceutical companies have pulled their products off the market or made adjustments quite a bit before Health Canada has acted. It's been interesting.

This is, I think, one of the areas that need some studying. It's getting to be quite interesting. Companies will almost react to international reports or will react to the stock market reaction to international reports before they'll actually respond.... They often are acting earlier than Health Canada. The recent incident that comes to my mind is the issue around dosage of cough medicines for children under two, where industry acted very quickly on that.

It's a little bit of a mix, but I think it would be sensible for Health Canada to have the power.

[The Chair, Conservative, Joy Smith]

There's less than a minute, Mr. Brown.

Go ahead.

[Patrick Brown, Conservative, Barrie, ON]

Okay, I'll be quick.

What do you think the reason might be for that? Who hears about adverse reactions first? Is it nurses? Is it doctors? Is it pharmacists? Do you have any evidence that would suggest what are the best sources to hear about adverse reactions? How can Health Canada learn about them more quickly?

[Manon Lambert]

In fact, the best source of information is the person to whom the patient speaks. If a patient experiences a reaction, which he does not necessarily associate with his medication, and he tells his pharmacist, because he sees him on a regular basis, then the pharmacist would be the best source. If, on the other hand, he tells his doctor, the doctor would be the best source. That is how we found out about adverse reactions. Usually, a patient will complain of a reaction, or it will be detected in a hospital by diagnostic tests or lab tests when a functional variation shows up. In such cases, it usually tends to be the doctor who will get the information. But it really is these people—doctors, pharmacists, nurses—who are best placed to report reactions. However, it is not a matter of knowing who is the best placed. I think that the person...