Health Committee on Feb. 28th, 2008

[Fleur-Ange Lefebvre]

Yes, it would, so that would provide a lot of advantages.

I'm just going to comment briefly, if I may, on the alerts. One of the things we're also working on, as you know, is emergencies and disasters. One thing that's really important is that when physicians receive an alert they have to be reassured that it is in fact an alert. There's a lot of work we can do together on this, with the Public Health Agency of Canada and Health Canada, to make sure that alerts--adverse drug reactions and emergencies--can be handled in a way that is comprehensible and immediately identifiable by the physician at the receiving end. We're not there yet, unfortunately.

[The Chair, Conservative, Joy Smith]

You have a couple of more minutes.

[Susan Kadis, Liberal, Thornhill, ON]

I have another question for the Canadian Men in Nursing Group.

[The Chair, Conservative, Joy Smith]

All right. Please go ahead.

[Susan Kadis, Liberal, Thornhill, ON]

The question was, given that we don't have mandatory reporting but that it is optional, when, as health care professionals, do you feel it's necessary to voluntarily report? Are there common criteria or standards that guide that? Do the physicians discuss this issue and what the role of nurses is, and how is that taking place in terms of adverse drug reactions?

[Irfan Aslam]

My other colleagues here from CMA have also commented on that.

Right now, under the reporting system, there is no obligation on health care professionals to report. However, in my experience and according to the last literature search I've done, most of the physicians and other health care professionals would report if they found some kind of adverse effect of a medication. It's not mandatory at this time, and we don't want it to be mandatory at this time, because we do not have the rest of the pieces that are needed to support the health care professional. If you are going to make it mandatory at this time, I don't think it would be helpful in bringing more information from the professionals.

[Susan Kadis, Liberal, Thornhill, ON]

Thank you.

Has there ever been a time when you've been in a position where you've felt it should be reported and the physician did not, for some reason, report it, and you wanted to?

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

You mean that the nurse reported it because the doctor hadn't?

[Irfan Aslam]

In my own experience, I have not actually seen this happening. Usually it is done in the form of a group, so if a nurse or doctor noticed an adverse effect, they would discuss it with each other. After that, it would be reported.

If you were taking a scenario in which one person had not reported, I've seen that the other person would report. For example, if a doctor missed an adverse effect event, then the nurse would report it, or vice versa.

[Susan Kadis, Liberal, Thornhill, ON]

How often do you see adverse drug reactions?

[Irfan Aslam]

Minor adverse drug reactions are quite common. In my practice I see maybe once a week a minor reaction. But if you're talking about something that is really serious, that is very rare, Andrew was talking about 176. So you can see that in all of Canada there were only 176 events that actually resulted in that, and only 18 of them were reported because--

[Susan Kadis, Liberal, Thornhill, ON]

That goes to one of my first questions, Madam Chair, if we have just a moment.

When would you feel it necessary to report? Is there a criterion or a standard?

[Irfan Aslam]

There is no particular criterion. However, when we see that this drug is not acting in a way that it is supposed to act.... We can get the information. Right now we are getting other professionals--doctors and pharmacists--to get that information. There are side effects attached to each and every drug. If there's something outside of the side effects that have been written there or that are well known, then we do report.

[The Chair, Conservative, Joy Smith]

Thank you very much.

Dr. Haggie, I think you indicated.... You have only about 50 seconds.

[Dr. John Haggie]

I think Dr. Bennett's comments and her colleague's questions speak to communication.

One of the difficulties we have is the number and volume of communications. I can get up to about 80 communications a month on drug- and product-related issues. They're opened, but whether they're read to a large extent depends on context, because they tend to send everything to everyone. It's actually very difficult for me to sift the signal from the background noise. It's well nigh impossible.

If I have only 50 seconds, I'll stop there.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Haggie.

Madame Gagnon.

[Christiane Gagnon, Bloc, Québec, QC]

Good morning. Thank you for being with us today.

They say that 50% of adverse drug reactions can be attributed to an ineffective or inappropriate prescription. Health Canada has noted that a number of physicians are acting outside of federal regulations.

In your opinion, what could prompt a physician to prescribe a product that has not been tested for purposes other than those for which it is normally used? What responsibilities does a physician or Health Canada have in relation to that practice? For example, opiates, which are medications prescribed for chronic pain in patients with a terminal illness, are often prescribed for acute fractures, which is an off-label use.

What is the purpose of such a practice? Who authorizes it? Given that a determination has already been made as to the uses of the medication, and that it has already been tested for such uses, physicians who do this are actually operating outside the Drug Act.

[The Chair, Conservative, Joy Smith]

Ms. Lefebvre.

[Fleur-Ange Lefebvre]

Because my colleagues seem to be catching up with the translation, I'll have a go at this.

I'm assuming that you're talking about off-label use of prescription drugs.

You are essentially talking about off-label use of drugs.

Several weeks ago, at a Health Canada meeting, I was surprised to discover that, for certain drugs in certain populations, such as the pediatric population, off-label use is more extensive than on-label use. The figures are really quite astonishing. You are right to say that this is not consistent with the regulations, but the fact is that medicine is constantly evolving, and off-label use of drugs can have some fairly significant beneficial effects.

I believe this brings us back to the previous question, which has to do with communication. There has to be a means of communicating quickly with the people writing prescriptions, the people using them and Health Canada, so that we can bring all those results together and arrive at a system that offers maximum benefits to patients.

That is a little outside of parameters of your question, but it is a very difficult issue.

[Christiane Gagnon, Bloc, Québec, QC]

Some people who comply with the regulations are critical of that kind of behaviour, saying that there is tremendous pressure from the industry to promote the use of certain drugs. Do you share that concern or apprehension?

[Fleur-Ange Lefebvre]

I will let my colleagues from the Canadian Medical Association answer that question.

[Christiane Gagnon, Bloc, Québec, QC]

The reason I'm asking the question is that there can be terrible consequences. This results in deaths, is very costly for the health care system because of the number of hospitalizations, and the figures are alarming. In the United States, they result in 106,000 deaths every year, and more than two million adverse drug reactions require a patient to be hospitalized. We can compare that to what is happening in Canada and Québec.

[The Chair, Conservative, Joy Smith]

Who would like to address that?

Dr. Haggie.

[Dr. John Haggie]

I think everyone's looking at me.

I think there are a couple of very important points here. One is medication error. Medication issues have been highlighted in other jurisdictions, and in the Baker and Norton report, as a major issue.

I think I will just put that point to the side and concentrate on Madame Gagnon's initial point, which is about off-label use.

I think there are several factors that need to be recognized. One is that the label is related to the licence that's issued for that product. Often these licences are actually very narrow. For example, there currently are anti-arthritic or anti-inflammatory agents on the market that are indicated or labelled for use for arthritis in the knee only. If you write that prescription for somebody with a hip problem, you're using it off-label. From a pharmacological point of view, it's very difficult to justify scientifically why a drug will work on the knee rather than the hip. To be honest, I personally believe this is a marketing ploy, because it allows them to change the label later on, with the patent continuing to run from the date of the new label. That's one factor in terms of what's on the label in the first place.

The second thing is that there is an art to medicine as well as a science. In the negotiation on a case-by-case basis between a physician and a patient, it may be appropriate to use a drug in situation A that you wouldn't use in situation B. Technically that is outside the label. With time a lot of these things become established practice.

I think one of the reasons that pediatric practice makes bigger use of off-label indications is that when drugs are initially released on the market, they are labelled for adult use only; there are no comparable medications for children. Therefore, under those circumstances, do you treat or do you not? You have to say, well, this is technically off-label, but as an experienced pediatrician or pediatric surgeon, I have no reason to believe the pharmacology in the children in this situation is any different; therefore, this offers me an option that doesn't otherwise exist. If you look at some drugs on the market now, they were originally marketed as anti-tumour agents and are now used in children for rheumatoid arthritis, for example. That was started by experts in the field using the drugs on a case-by-case basis for off-label purposes.

So I think you have to allow the clinician a certain amount of leeway. And some of the issues with labelling may actually relate more to the label rather than the use.

[The Chair, Conservative, Joy Smith]

Would anyone else like to make a comment on that?

Dr. McCallum.