Evidence of meeting #26 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was information.
A recording is available from Parliament.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Right. But what will you require health institutions to report on a mandatory basis? You just say it's adverse reactions. Well, how will they know what that is? Is there a definition?
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
There again, we can leave it to the committee at the appropriate time. The thought, however, is that this discussion--to define--is an important one. There's room to define that in the regulations, so that's a detailed discussion--
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Let's hope there's some parliamentary oversight of the regulations, though, because it does not appear to be the case at present.
Director General, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
If I may, I believe “adverse reactions” is in fact a defined term in the regulations as they currently exist. Also, there already is a mandatory requirement on industry to submit adverse reaction reports to Health Canada. That already does exist.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
It's interesting, because I'm hearing from the Canadian Medical Association that they have tried to get this information and have been told that the word is “serious” adverse reactions. And that hasn't been defined, so they're in a quandary.
On that same issue, then, the biggest question of all on this issue is what are you going to do with all this information? Where are the extra staff and resources? There's nothing in the bill. It just says you're going to collect it. Where is it going to go? What's going to happen to it? Is it all going to go to Mr. Carleton? Or is it going to go to what's his name, the fellow at our committee last week who has a private company?
So to whom is this going?
Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health
On the first point, about the definitions, there is currently a definition in the food and drug regulations of an adverse drug reaction. There is also a definition of a serious adverse drug reaction. So these definitions do currently exist in the food and drug regulations.
On the question about what will come out of all this information, I think there's been a steady increase in the resources that are dedicated to post-market surveillance in Canada in the past five years. There's a commitment to continue to support that.
If you take, for example, the budget of MHPD, it has increased steadily in the past five years. Our scientific and clinical capacity to process this information has almost tripled in the past five years. There is that capacity now to absorb, process, and evaluate more information related to post-market safety issues at Health Canada.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
As to how we bring information back out, there are a number of venues. We'll be exploring that in our discussions as we go forward. But there are changes--obvious things like making changes to labels, but also communicating with the right sector at the right time. Again, this is appropriate to a very detailed discussion, but we believe we're laying in the architecture for that.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
We've had quite a negative reaction around this table from people who are part of health care institutions, doctors and other health care professionals, talking about the huge burden that this will mean and how it may not be that helpful because there is no evidence of a coordinated strategy to use this information in a meaningful way and on a timely basis.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
Yes, and yet you do hear from the same people the same goal that we're trying to advance, which is to make sure you have good continuous oversight; then you're picking up the really important safety points. It means not overdoing it in therapies that don't require heightened surveillance, but moving it to models where we really do need good, strong surveillance, very active surveillance.
I'm sure Dr. Carleton could talk about that further.
Conservative
The Chair Conservative Joy Smith
Your time is up, Ms. Wasylycia-Leis.
I want to thank you, Mr. Lee.
Now we're going to go to the second round, five minutes each, starting with Dr. Bennett.
Oh, I'm sorry, Mr. Brown, it's your turn. I was going to leave you out.
Conservative
Patrick Brown Conservative Barrie, ON
Thank you, Madam Chair. I appreciate the opposition raising the fact that we didn't get our turn.
I have a question for Health Canada. In the presentation you prepared for us, a reference was made to integrating new international information. I want to know which countries were examined or where we looked for international advice.
I know that in some of the previous presentations, we heard some interesting information from different jurisdictions--New Zealand, for instance, and some states in the U.S. where they've used mobile devices as a means of having more timely access to physicians. I'm wondering if you could shed some information on what jurisdictions you looked at.
Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health
If I understand your question well, you're wondering how we're going to leverage or how we're going to collaborate more with international agencies to gather more information?
Conservative
Patrick Brown Conservative Barrie, ON
It's not about how you're going to. The strategy includes “key objectives, such as integrating new sources of international...information” and “developing international and national partnerships to facilitate work-sharing”. Are there any countries that have already been contacted or designated to work with you on this?
Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health
We do have memoranda of understanding with countries such as the United States and the European medicine evaluation agencies, as well as with Australia, Singapore, and Swissmedic. So we do have these types of collaborations; whenever there are emerging safety issues, we can contact them and share information. That's already in place.
It's also interesting to know that the whole life cycle approach, or post-market surveillance, is moving towards what we call risk management planning and pharmacovigilance planning, which is basically a way to gather information in a systematic manner once the drug is on the market. That gathering of information might occur in Canada or it might occur in other jurisdictions, but it will be reported to us by the manufacturers, so we will have access with the life cycle approach to more than what we usually and mostly relied on in the past, which was spontaneous adverse drug reaction, and we will have access to post-market safety studies that the manufacturers with a life cycle approach will now commit to in order to better monitor their products once they are on the market.
This approach is being developed internationally. The FDA and the European agencies are moving to basically develop tools that can support or complement the spontaneous adverse drug reaction systems currently in place in most countries.
Conservative
Patrick Brown Conservative Barrie, ON
This is more of a general question for everyone here today. One figure we've heard frequently, and one I've heard numerous times as we've looked at this topic, is the 10% figure--only 10% of adverse reactions are reported. What are your opinions on that figure? Do you think it's accurate?
I have a follow-up question to that.
Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health
Based on international references, somewhere between 1% and 10% are reported in Canada. We don't know exactly, because there is no way to exactly estimate the real occurrences.
One concept that is important to understand is that a spontaneous ADR system is not necessarily there to collect all drug reactions; it's there to identify what we call early signals--that is, unpredictable or unknown occurrences of events with drugs that have been recently marketed. Usually people will identify them, especially if they are close to the time the drug was administered and especially if they are serious. Either they are life-threatening or they bring people to a hospital, so these will tend to be reported.
A spontaneous ADR system generates signals that help us identify areas that we need to further investigate. It's not a way to monitor drugs, but a way to identify safety issues that need to be further investigated. Once we identify it and an adverse drug reaction reports an area of concern, then we seek information from other sources, such as medical literature and other regulatory agencies. The manufacturer potentially might have completed some studies that would help us assess the issue. Then we do what we call a single assessment, which is basically a more comprehensive evaluation of the safety issue.
Conservative
Patrick Brown Conservative Barrie, ON
How would mandatory reporting by physicians...? Do you have any estimates on how that would improve the situation?
Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health
Regarding mandatory reporting by physicians, the current plan is basically to consider--
Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health
Hospitals, yes. That will help, because some of the serious adverse drug reactions will bring people to consult in an emergency, so that will enable us to identify, maybe earlier, these signals that need to be further investigated.
Conservative
Patrick Brown Conservative Barrie, ON
There are so many family physicians out there who deal with patients all the time who wouldn't fall under that blanket. Has Health Canada ever given any thought to mandatory reporting for physicians, period, and if they haven't, is it because there hasn't been a positive response to that notion? Has there been any reaction to making it universal?
Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health
Yes, there has been consultation with numerous stakeholders or representatives of the public and patient interest groups, physicians, and industry. The general consensus was that there was not necessarily a net gain in having all spontaneous adverse drug reactions reported, but more to have a strategic approach to target where it's most likely to make a difference.
There was general agreement that hospitals are where physicians, pharmacists, or other health care professionals are observing these adverse events and are able to report them. As you're aware, hospitals are very structured environments where there are already some mechanisms to basically collect that information. So having hospital-based mandatory reporting by a health care professional is thought to be a very efficient way to identify serious adverse events reports that may make a difference in identifying safety signals earlier on.
Conservative
The Chair Conservative Joy Smith
Thank you so much, Dr. Berthiaume; and thank you, Mr. Brown, for your patience.
We will now go into the second round, starting with Dr. Bennett. It will be five minutes for the question and answer.
Liberal
Carolyn Bennett Liberal St. Paul's, ON
Thanks very much.
I want to focus on the national pharmaceutical strategy and how all these issues are obviously both federal and provincial. So I want to know how the NPS is working in terms of the co-chairs' meeting, and working groups and all those things.
I understand that you are co-chair of the working group on real-world safety. Obviously there was a conference in September 2005. There was the invitational workshop on research projects. There was the consultant's report in 2007. Are you ending up in a two-way communication with the federal government in terms of responding to these kinds of things? What recommendations would your working group be making on this issue? Did you comment on progressive licensing? Have you commented on how you would recall a drug?
Some of the people have heard this before, but I used to do a lot of obstetrics and was sometimes up delivering a baby during the nightly news and I would receive a letter from Health Canada three days later to find that a drug had been recalled, but my patients were lined up the next morning worried about it. We seem to have a very old-fashioned way of communicating with physicians about risk.
Also, I want to know if your working group is dealing with any of the stuff around counterfeit medicine. If there has been an adverse drug reaction, how do you know it really was the medicine and not a counterfeit, as we look at the issues around heparin and the real problems coming from the States right now?
So, first of all, how is it going on the NPS? I understand there has not even been a federal co-chair appointed.
Director, Drug Program Services Branch, Ontario Ministry of Health and Long-Term Care
With respect to the national pharmaceutical strategy, there are some discussions and some recommendations that are still being considered by ministers, so we are still seeking some direction from them with respect to the next steps. But in the interim, there has been a fair bit of dialogue between the provinces and the federal government. All the working groups represent a number of individual provinces, in addition to representation from the federal government.