Health Committee on Feb. 28th, 2008

[Dr. Andrew McCallum]

It might, Madam Chair, but if I could, I'll quickly turn this over to the other members.

The reason I say that it might is that there's a bias introduced by the method of reporting. In other words, if the difficulty of reporting leads to under-reporting, it might introduce a bias that skews the result—we don't know. When you talk about polling, you're using a scientific method of enrolling a certain proportion of the population and you can statistically predict the likelihood and generalize to the rest of the population. We're doing this retrospectively, and I don't think we can say that.

[The Chair, Conservative, Joy Smith]

Would anybody else like to make comment on this?

Dr. Haggie.

[Dr. John Haggie]

I think Dr. McCallum's points are well made. I think the reporting bias would work in favour perhaps of over-reporting of severe problems, but at the other end, you'd get very much an under-reporting of minor side effects.

One of the issues for a practising physician is how to find out what a side effect is. Again, you go to this massive tome; but it's not incredibly useful, which leads me to another point. I have a printout here on a very common stomach drug given for indigestion. It says here that the side effects may include abdominal pain, nausea, vomiting and flatulence, diarrhea or constipation. It can cause somnolence or insomnia. It can cause agitation and aggression or depression and hallucinations.

[Robert Thibault, Liberal, West Nova, NS]

It sounds like one of my speeches.

[Some hon. members]

Oh, oh!

[Dr. John Haggie]

I wouldn't dream of saying such a thing, sir.

But you see what I mean about context and utility? It's practically a waste of the 20 minutes to look it up. If you have someone who's ill, then you will use any source you can.

Quite honestly, as a little bit of an older physician, I would say my practice has changed dramatically in the last five years; I've stopped using this book. Our website under the aegis of CMA has a very active online resource for things like this, and I use it instead. But the traditional sources of information are useless. But again, it's not something I can use when I write the prescription; it's something I have to go looking for afterwards, and that's my problem.

[The Chair, Conservative, Joy Smith]

You have a minute and a half, Mr. Thibault.

[Robert Thibault, Liberal, West Nova, NS]

I don't know who would best answer this question. Perhaps it's Madame Lefebvre. It's a question about off-label use.

I don't want to discourage off-label use. I think Dr. Haggie gave a perfect example of how it evolves and why in some instances it's good. But then we see extreme cases where there may be very good off-label use, but you wonder how fast that information can be made available or the research be done so that it can become a regular treatment.

I read the piece in Maclean's magazine a short time ago about a cancer drug that had been used for macular degeneration, and was quite successful, but that thing is gone. The clinical research hadn't been done for wide distribution or wide use.

Will the changes at Health Canada to progressive licensing have a positive effect on being able to integrate different uses for drugs that are labelled for one reason now?

[The Chair, Conservative, Joy Smith]

Madame Lefebvre, did you want to make comment on that?

[Fleur-Ange Lefebvre]

Yes, I think that's exactly it. We're quite excited about this progressive licensing, and we think it should be accompanied by progressive reporting. That's what we're talking about.

Report what you have to report. Then somebody at the other end will say, okay, this is the point where the flag goes up; we have to do something. So link that to progressive licensing, especially for use in children. You have to remember, children are in our system from age zero to 18. Well, the six-month-old doesn't need the same thing as the 13-year-old; and regarding the 17-and-a-half-year-old, where are you? So you have to be careful with that.

For off-label use for certain populations that have not been tested, or for certain uses that were never envisaged to begin with, physicians are smart; they will try something if they think it might have a beneficial effect for their patient. If they can feed that in quickly and usefully to a system that is monitoring all of that, we're quite in support of the progressive licensing.

[The Chair, Conservative, Joy Smith]

Thank you very much, madame.

Mr. Brown.

[Patrick Brown, Conservative, Barrie, ON]

Thank you.

I want to talk a little bit about electronic measures, and I have a question for both the Canadian Medical Association and the male nurses group.

What types of electronic measures are utilized right now in terms of electronic access for physicians to a patient's current prescriptions, and what measures might be suggested to enhance that? Would a portable device be something that could help avoid post-market medical errors by having timely access to a patient's current prescriptions?

In terms of the nurses group, is there any form of electronic access that you currently have?

But I'd start off with the Canadian Medical Association first.

[Dr. John Haggie]

Thank you.

My electronic access to a patient's drug record is the telephone and the fax machine, if I cannot find what I need from the patient, and sometimes you can't because the patient will be in a condition that renders them not able to give a good account of themselves and there may not be any caregiver who's aware of their current situation.

The most reliable source of what they have is a phone call to the local pharmacy. I practise in a fairly rural area, and I only have to make, potentially, seven phone calls to access the one that may have dispensed it. The catch is that if they've used more than one pharmacy then I still don't know, but their pharmacy is usually linked with the other ones.

That's a slightly facetious answer, but basically I have no online rapid way of doing that at all.

[Patrick Brown, Conservative, Barrie, ON]

How beneficial would it be if you had access to something like that?

[Dr. John Haggie]

It would be a huge quantum leap in safety for the patient—there is absolutely no doubt about it—once you have that mechanism in place simply to tell me what they're on and what they're taking. They don't always take their medication, but if I know that they've not had a refill on one particular medication for six months, I can probably assume they may not have been taking it.

Again, it would be a huge leap and it would be a skeleton, a backbone, onto which you could plug decision support tools, as I've alluded to before, about age-sensitive prescriptions or drug interactions, as Fleur-Ange has mentioned. It would be the backbone, but I don't have that at the moment.

[Patrick Brown, Conservative, Barrie, ON]

Do you know of any evidence that there are rates of medical errors caused by not having this information in a timely way? Is there anything the committee could look at further that might speak to where this deficiency exists?

[Dr. John Haggie]

If you look at primary care in the United Kingdom, you'll find that a vast majority of family practitioners, certainly in urban areas, have e-prescribing and electronic medical records. In some jurisdictions they don't actually give a written prescription. The patient has their pharmacy on record, the button's pressed, and the prescription goes directly there, so it's being filled while they're still leaving the surgery or making their way out.

I think there is data in publications from the U.K. that show very clearly that you can reduce the number of drug interactions, particularly in the elderly, with a mechanism like this. Certainly in hospitals—a lot of my practice is hospital based—we have medication error reduction protocols, and we also have checklists for prescriptions, to try to reduce the chances of writing the wrong drug up.

With medication errors, there are lots of holes in the cheese to line up. So you can get the diagnosis wrong and prescribe the right drug for the wrong diagnosis or vice versa. Then you can get the right drug but the wrong dose. Then you can have interactions with others. In hospitals there are already a lot of fail-safe mechanisms that will reduce that happening, but they're not necessarily electronic.

[Patrick Brown, Conservative, Barrie, ON]

How long does it take for a government alert on drug safety to actually get out to a physician? If there were an electronic mechanism or you had a handheld portable device, maybe there'd be a way to speed that up. What are the current timelines if there's a government alert issued?

[Dr. John Haggie]

Mostly, I get them by fax or snail mail, as my daughter calls it. Occasionally our college will promulgate an alert it has received, but it's very variable.

The other problem I have is that when the alert arrives it doesn't mean anything to me, necessarily. Take, for example, the tragic case of that young lady, Vanessa, who had cisapride. That's a drug I used quite a lot. I can vividly remember getting a report from Health Canada that said it was associated with EKG abnormalities. That's all it said. What that meant to me is that if you had a girl of her age who had EKG abnormalities like that, you'd go look to see if she was on the medication, not that if you leave this girl on medication like that she's going to die, or if you have a girl of this age on this medication, make sure they have an EKG. That never happened.

I'm sorry, I went on a bit.

[The Chair, Conservative, Joy Smith]

Thank you.

Mr. Malo.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you, Madam Chair.

I want to thank all of you for being with us today.

Having heard the comments that were made this morning, I am realizing that health care professionals may not have all the information they need in order to correctly use the pharmacology available to them. I also note that this is not only a problem in Canada; many other Western countries are struggling with that issue. Would you care to comment?

As a solution, you are advocating that the legislation be beefed up, in order to give it more teeth and force the industry to carry out more post-market studies and disclose all available information, whether it is positive or negative. However, the industry could object, saying that this might result in trade secrets being disclosed. What is your response to that concern?

[The Chair, Conservative, Joy Smith]

Who would like to answer that?

Mr. Anderson, would you like to make a comment on that?

[Douglas Anderson]

Not having any direct access to the pharmaceutical industry, I think this is mainly directed towards their bailiwick. I don't mean to be evasive on this, but I think this would be better directed towards the pharmaceutical industry per se, sir.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Perhaps Dr. Haggie, from the Canadian Medical Association, could respond, since he addressed that in his presentation.

[Dr. John Haggie]

I think it's a balance, as with most things. If you look at the pharmaceutical industry and the licensing requirements for Health Canada, that negotiation could take place with protections for trade secrets and these sorts of things, provided the experts at that level were fully informed.

The catch comes later when it's released on the market and you have some concerns over the safety of a product. There was an issue with a drug used in open heart surgery, where it transpired that there may have been a body of research that the pharmaceutical company had omitted to give, certainly to the public domain, even though Health Canada may have seen it. It's a balance you need to strike somehow between protecting the individual and the practitioners who use these drugs in good faith, and yet balancing the commercial interests of the pharmaceutical industry.

As a physician and a patient advocate, I would have to say you need to tip that balance in favour of the patient.