Veterans Affairs Committee on Nov. 3rd, 2016

[BGen Hugh MacKay]

Just as with any medication that has adverse effects, we have seen some patients take mefloquine who didn't like the side effects. Often it is about the dreaming. Sometimes it's about nausea and dizziness. We always give them the option of being able to change their medication to make sure that we are still able to protect them from malarial infection.

In our experience patients have had adverse effects that cause them to ask to change.

[Bob Bratina, Liberal, Hamilton East—Stoney Creek, ON]

At our committee, of course, we're now dealing with the veteran, someone who was released from service or who retired from the service and who may have been dealing with the effects that are possibly directly related to mefloquine. Post-traumatic stress disorder is a different and difficult and complicated issue.

Perhaps I could ask Dr. Raymond if there's any way of approaching the post-traumatic stress disorder problems, or the subsequent issues related to medicines, in terms of therapies or treatments that might be available to these veterans. Is that a fair question?

[Dr. Barbara Raymond]

It really wouldn't necessarily be a question within the purview of the Public Health Agency of Canada. I could speak to it in terms of the committee looking at evidence for this being associated with mefloquine, and there has been no evidence sufficient to support that.

As well, post-traumatic stress disorder is considered as a very separate entity from toxicity that might be associated with medication, so the two aren't well aligned.

[Bob Bratina, Liberal, Hamilton East—Stoney Creek, ON]

All right. Thank you.

With regard to the active personnel, the percentages are striking. At 5% of our current antimalarial prescriptions, mefloquine is now our least-selected medication, but in the overall evaluation of the medicine, would it be fair to say that it was a very low percentage of unanticipated extreme effects for the personnel who used it? Is that what the numbers tell us? That it is a low percentage of extreme effects?

I'm trying to extrapolate that from the material you've given us. How hard is this—

Go ahead.

[BGen Hugh MacKay]

On the number of 5%, on the fact that we've gone from a high percentage of people using mefloquine down to 5%, it's difficult for me to speculate as to why that has happened.

I think it is really about making sure that we're educating patients about the risks of malaria and the benefits and the potential adverse effects of the medications. I believe that all of the publicity around mefloquine is impacting people's decisions. The concern, just as we saw with people making statements about vaccines and anti-vaccine campaigns, is that there's always a risk of people interpreting information too severely, such that we cause people to make choices that aren't necessarily based on really sound science, but based more on what's going on in the discussion publicly.

[Bob Bratina, Liberal, Hamilton East—Stoney Creek, ON]

Thanks very much.

[The Chair, Liberal, Neil Ellis]

Thank you.

Ms. Mathyssen.

[Irene Mathyssen, NDP, London—Fanshawe, ON]

Thank you, Mr. Chair.

Thank you very much for all of this information. It's important to have the best information available, so I appreciate it.

I have a number of questions.

First, at the time mefloquine was given, what information was given to military personnel? What were they told at that time in regard to possible side effects? What are people told today in that regard? In the past, and I guess in the present, too, have they been given other options in regard to anti-malaria drugs?

[BGen Hugh MacKay]

Is that question for me?

[Irene Mathyssen, NDP, London—Fanshawe, ON]

Whoever feels most comfortable in answering is fine.

[BGen Hugh MacKay]

I can only speak to the military context. I can't speak to what was told to people back when we initiated mefloquine in I guess 1992.

I can tell you that today what we use is the information that comes from the monograms for all of the medications. As I said before, we talk about the risks, benefits, and side effects that are listed in trying to give them information as to what percentage of people may experience some of those side effects. We also discuss with them the real risk of malaria in the region they're going to. In some cases, the risk is much higher than in others. It's really standard practice to advise somebody on a medication choice in this regard.

[Irene Mathyssen, NDP, London—Fanshawe, ON]

There was some discussion of records, so I take it that records going back to 1992 are not helpful in regard to what people were told. Is that what you think?

[BGen Hugh MacKay]

I can't comment on what was put in the records.

Often a physician, when counselling a patient, will make annotations about the nature of the discussion. They may not annotate all of the specific details of each of the adverse effects they may have discussed. Oftentimes, that's what a physician will put in a clinical note after a patient encounter. The paper record system that we had at that time was different from the electronic health record that we have today, and I think that today we are able to produce far better records because of our electronic health record. It's much easier to recall information from our electronic health record than from what we had in the past.

[Irene Mathyssen, NDP, London—Fanshawe, ON]

Thank you.

What happens if a member of the Canadian Forces is supposed to go on a specific mission to a place that has a high level of malaria—they are informed of the risks in terms of taking the drugs that, I take it, they need to take in order to embark—and they say that they are not prepared to take those risks?

[BGen Hugh MacKay]

If the risk of malarial infection is high enough.... Malaria has significant morbidity and mortality risks associated with it, so we would probably make a decision not to permit the individual to deploy unprotected into a situation where there is a risk of malarial infection.

[Irene Mathyssen, NDP, London—Fanshawe, ON]

Is there any negative impact on that individual's record because they said that they did not wish to take the drugs and therefore couldn't be deployed?

[BGen Hugh MacKay]

A decision would have to be made, either at the personnel or the chain of command level, as to whether or not it was considered to be reasonable to take that decision, given their current personal situation. There may, in fact, be some action with respect to whether or not they continue to meet universality of service, if they are not prepared to accept the proper protective measures to go into a deployment scenario.

[Irene Mathyssen, NDP, London—Fanshawe, ON]

So they could lose their career if they felt very strongly about not taking these drugs.

[BGen Hugh MacKay]

I don't make decisions about whether or not somebody would lose a career—it's our personnel area that does that—so I would be cautious about making a comment there. There would be an evaluation of the individual's continued satisfaction of the universality of service requirement. If you don't meet the universality of service requirement, there are potential career implications.

[Irene Mathyssen, NDP, London—Fanshawe, ON]

Thank you.

Dr. Raymond, you said that health care providers are advised about concerns or issues with a drug.

What is the process? How are doctors informed about any concerns or changes to recommendations regarding these quite significant drugs that have a potential negative impact?

[Dr. Barbara Raymond]

Health care providers have access to product monographs, which are overseen by Health Canada. In terms of the CATMAT guidelines, these are published online and made available to physicians, and there is a communication strategy for those guidelines to ensure that practitioners who see travellers and who practice travel medicine and so forth are aware. It's a very basic, commonly known resource for health care practitioners who are counselling travellers.

[Irene Mathyssen, NDP, London—Fanshawe, ON]

Would anyone know what instructions were given by Health Canada to DND in regard to tracking and recording the outcomes of the medication, and what kind of follow-up was done in order to see exactly what impact it had?

[The Chair, Liberal, Neil Ellis]

You'll have to make it a very quick answer on that one, please.

[Dr. John Patrick Stewart]

The requirements and regulations under the Food and Drugs Act are that the manufacturer of a drug has a mandatory obligation to report on serious and unexpected adverse drug reactions.

There is a way to voluntarily report. Users of products—physicians, hospitals, pharmacists—can submit adverse drug reaction reports to Health Canada directly, but the obligation is on the manufacturer to report on the use of the product after it's authorized.

[The Chair, Liberal, Neil Ellis]

Mr. Fraser.