Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 4 - Evidence - January 30, 2014
OTTAWA, Thursday, January 30, 2014
The Standing Senate Committee on Social Affairs, Science and Technology met this day at 10:31 a.m. to carry out a study on prescription pharmaceuticals in Canada.
Senator Kelvin Kenneth Ogilvie (Chair) in the chair.
[Translation]
The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
[English]
My name is Kelvin Ogilvie, and I am a senator from Nova Scotia and chair of the committee. I'm going to invite my colleagues to introduce themselves, starting today on my right.
Senator Buth: Senator JoAnne Buth, Manitoba.
Senator Eaton: Nicole Eaton, Ontario.
Senator Stewart Olsen: Carolyn Stewart Olsen, New Brunswick.
Senator Seidman: Judith Seidman from Montreal, Quebec.
Senator Enverga: Tobias Enverga from Ontario.
Senator Seth: Asha Seth, Ontario.
Senator Dyck: Senator Lillian Dyck from Saskatchewan.
Senator Eggleton: Art Eggleton, senator from Toronto, still deputy chair of the committee.
The Chair: No further comment.
I remind us that we are dealing with prescription pharmaceuticals in Canada, and this is part four of a four-phase study that we've been carrying out. In this case, we are dealing with the nature of unintended consequences. We have two organizations represented this morning. I will introduce them as I call them to make their presentations. Following their presentations, we will open the floor up for questions from the senators.
We are going to start as they are listed on the agenda, with the Canadian Institute for Health Information and John Wright, President and CEO, who will also introduce his colleague who is available here to answer questions in the event that that is required.
John Wright, President and CEO, Canadian Institute for Health Information: Thank you very much, Mr. Chair. I'm John Wright, the CEO of CIHI. With me today is a very handsome, charming and intelligent individual, Mike Gaucher. Mr. Gaucher is the director of our pharmaceutical and health human resources group at CIHI.
I have a brief statement, if I may read that, Mr. Chair. Good morning everybody, and on behalf of the Canadian Institute for Health Information, I would like to thank you for the opportunity to appear before the Standing Senate Committee on Social Affairs, Science and Technology.
For the last 20 years, CIHI has played a unique role in Canada's health sector. As an independent, not-for-profit organization, it provides essential information on our health system and the health of Canadians. Our vision is simple — better data, better decisions and healthier Canadians. Of interest to this committee today are CIHI's data holdings related to a number of areas, such as prescription drugs, addictions, the loss of effectiveness of antibiotics, and counterfeit drugs, a few items for your consideration.
At CIHI, we hold prescription drug use data in the National Prescription Drug Utilization Information System Database, the NPDUIS Database. This database captures high-level trends in drug use over time and allows an individual's drug use to be analyzed by measuring the number and types of drugs they are taking, how consistently they are taking these drugs and when they switch the drugs they are using.
Our Continuing Care Reporting System, another of our databases, collects clinical data, including information on prescription drug use for seniors in over 1,100 long-term care facilities across the country.
We have produced a number of reports and quality indicators on the safety of prescription drug use, primarily in seniors. Topics covered include potentially inappropriate drug use, polypharmacy, and hospitalizations related to adverse drug reactions. Some of the key findings from these reports include the following: About 70 per cent of seniors are taking five or more drugs, with nearly 10 per cent taking 15 drugs or more. Seniors were five times more likely to be hospitalized because of an adverse drug reaction than other Canadians. Roughly one in ten seniors outside of long- term care was taking a drug considered to be potentially dangerous.
About one in three long-term care residents was taking anti-psychotic medication without actually having a diagnosis of psychosis. We also collect information on medication errors in hospitals and long-term care facilities. This facilitates sharing and learning from medication errors at local, regional and national levels. The information is used to better understand the factors that lead to medication errors and to identify potential system improvement strategies.
Examples of the impact of this at the national level include sharing data with Health Canada to support their work related to the naming, packaging and labelling of pharmaceuticals and sharing data with the Institute for Safe Medication Practices Canada to support their work in creating awareness and identifying system improvement strategies.
Regarding addictions, we collect information on prescriptions and the listed drug-related disorders through our Hospital Mental Health Database if drugs were a contributing factor in the hospitalization. We also collect clinical information on drug abuse among people in designated adult mental health beds. We have examined the impact of combined mental illness and substance-related disorders on hospitalization patterns across the country. The results highlight the higher use of hospitalization services when individuals with a mental illness also have issues with substance abuse. Other findings have included the fact that Canadians hospitalized with concurrent mental illness and substance-use disorders made up close to one third of all psychiatric patients in 2010-11. When compared with individuals hospitalized for psychotic disorders, only those with co-morbid substance-use disorders were about 25 per cent more likely to be readmitted within a year of being discharged.
Looking ahead, our current data holdings provide some information on the unintended consequences of prescription drugs. There is the opportunity, of course, to do more. Although we do not hold detailed clinical information required to assess the effectiveness of antibiotics, we capture data that could be used to track trends in the use of antibiotics to identify changes in the medications being used, the length of antibiotic courses or other signals that the effectiveness of antibiotics may be changing. In some provinces, it is possible to monitor instances of infection- related hospitalizations among those taking antibiotics.
CIHI data could be used to track how many people may be affected by a drug shortage as well. This data could also be used to study the effect of drug shortages on patient treatment, such as how many patients switch to another drug and how many stop treatment altogether.
In the area of counterfeit drugs, our data could be used to track trends in the use of drugs with counterfeiting issues, such as identifying regions where there may be a particular concern.
Our work on pharmaceuticals hinges on one factor — better data. There are gaps in our current drug data that, if filled, could allow us to provide even more insight on the availability, use, safety and cost of drugs and their impacts on Canadians.
Examples of some of the gaps we are working to address at CIHI include the fact that our drug plan database holds limited data for younger Canadians due to the design and structure of public drug plans. There is also a data gap in the area of hospital drugs. We recently added data from British Columbia on drugs paid out of pocket by residents or by private insurers, and we have also done some preliminary work on the feasibility of collecting this data from other provinces.
We have done some preliminary work, as well, on investigating the availability of chemotherapy drug data across Canada. There are also gaps, such as radiation oncology incidence and adverse drug reactions.
A lot more information is needed on alcohol and elicit and prescription drug-related disorders and services. Currently, the Canadian Centre on Substance Abuse collects limited data on addiction treatment services in Canada. Enhancing this information would allow us to examine clinical aspects and outcomes.
So what's next? We will continue to produce analysis on prescription drug use data. We are currently working on a comprehensive review of drug use among seniors in public drug programs, and a study is expected to be released this spring and will include drug claims data for about 70 per cent of seniors.
Thank you very much, chair, for the opportunity to present this information to you. My colleague Mike Gaucher and I would be pleased to answer any and all questions you may have.
The Chair: I will now turn to the Canadian Agency for Drugs and Technologies in Health, CADTH, and invite Brian O'Rourke, President and CEO, to present to us.
[Translation]
Brian O'Rourke, President and CEO, Canadian Agency for Drugs and Technologies in Health: Mr. Chair, thank you for the opportunity to appear before the committee.
[English]
I want to commend the committee on your work to date on prescription pharmaceuticals in Canada. This is an important topic, and your first two reports made some excellent recommendations that will undoubtedly improve Canada's clinical trial infrastructure and the post-approval monitoring of safety and effectiveness in Canada.
I look forward to your third report and hope that, when I was here as a witness, I helped to contribute to your study on the off-label use of prescription pharmaceuticals.
[Translation]
I will begin by telling you a bit about the Canadian Agency for Drugs and Technologies in Health and about how the work we do may be of value when it comes to the nature of unintended consequences in the use of prescription pharmaceuticals.
The agency is an independent, not-for-profit organization that was established in 1989. We refer to ourselves as a health technology assessment organization — meaning that we provide evidence-based assessments of the clinical cost- effectiveness of pharmaceuticals, diagnostics, and medical, dental and surgical devices and procedures.
[English]
In essence, we have two broad areas of work — our drug portfolio and our non-drug or technology portfolio, which covers devices, diagnostics and procedures. Most of my comments today will be on our drug portfolio.
Our operating budget is approximately $22 million annually, with the majority of the funding coming from Health Canada and all of the provinces and territories, with the exception of Quebec. The members, or owners, of CADTH are the federal, provincial and territorial deputy ministers of health, who fund the agency, and we are governed by a board of directors that reports to the deputy ministers.
CADTH provides a range of services to support the effective management of pharmaceuticals and other health technologies in Canada. One of our flagship programs is the Common Drug Review, a federal-provincial-territorial process used to review the clinical effectiveness and cost-effectiveness of new drugs and existing drugs with new indications. The Common Drug Review supports coverage decisions by 18 of the 19 publicly funded drug plans in Canada. Quebec has its own system.
We also do therapeutic class reviews on pharmaceuticals and conduct optimal-use projects, producing reports, recommendations and tools that are the result of expert deliberative processes. Our work in this regard provides the evidentiary foundation for health care decision makers to promote the appropriate prescription and utilization of prescription pharmaceuticals.
Some recent examples of therapeutic class reviews we have completed include drug therapies for relapsing-remitting multiple sclerosis and anti-thrombotic therapy for patients with atrial fibrillation.
[Translation]
I will now talk about our value report and our rapid response service — quick summaries of the large and complex medical literature. That service is extremely helpful in that it addresses urgent needs for evidence that informs policy and practice decisions about drug and non-drug technologies. Our mandate is to support the effective management of health technologies throughout their life cycle — from innovation to obsolescence.
We do not make the final decisions on what technologies will be funded by the Department of Health or used by patients and clinicians, but our work informs technology-related decisions at both the policy level and the practice level.
[English]
As an organization involved in promoting the optimal use of health technologies, we recognize that advances in medical devices, drugs and procedures help to improve health care delivery and patient outcomes.
We also recognize that ``new'' does not necessarily mean ``better'' and that some new pharmaceuticals offer no improvement or marginal improvements at best but often at a much higher cost. We recognize the considerable uncertainty present with new drugs following their approval by Health Canada, especially the uncertainty surrounding adverse events or unintended consequences.
We see our role, and the role of health technology assessment generally, as providing the evidence to ensure that health technologies add value to the system, that they contribute to improved patient outcomes without adding significantly to the risks of treatment and that they are, in fact, innovations and not simply cost drivers.
Let me give you an example: Approximately 350,000 Canadians suffer from a heart condition referred to as atrial fibrillation, an irregular heartbeat that can lead to serious medical complications such as stroke. Most patients need lifelong therapy with anticoagulants, drugs that prevent the formation of blood clots. A drug by the name of warfarin has been the mainstay of therapy for about 60 years, but new oral anticoagulants are now available that are being touted as ``breakthrough'' drugs. A rigorous review by CADTH showed only a small potential benefit over warfarin, no long-term safety data and highly uncertain cost-effectiveness if these new drugs were to be used broadly as a replacement for warfarin. This confirmed warfarin's continued place as a first-line therapy, and our committee of experts recommended that the new oral anticoagulants be funded only when warfarin should not or cannot be used. The committee noted that the paucity of long-term safety data was a significant concern.
[Translation]
Our agency was created 25 years ago by Canada's federal, provincial and territorial health ministers to help decision makers manage the uncertainty surrounding the cost-effective use of health technologies.
[English]
Let me be very clear, uncertainty is pervasive in health care, particularly with respect to the harms and clinical benefits associated with the use of pharmaceuticals. This uncertainty includes the unintended consequences in the use of prescription pharmaceuticals, the focus of your study.
I see the unintended consequences associated with the use of prescription pharmaceuticals as being classified into three broad categories. First are unintended consequences that arise even when the drug is prescribed and used in accordance with the Health Canada-approved monograph. All drugs have the potential to cause unintended consequences. Even something as common as a decongestant tablet can cause light-headedness, wakefulness, nervousness, restlessness, increased blood pressure or an irregular heartbeat.
Second are unintended consequences when the drug is prescribed, administered or taken inappropriately. This could be related to off-label use, medication errors or any number of factors, such as using the wrong dose or not recognizing the potential for an interaction with another drug.
Third are unintended consequences when a drug is misused, such as using medication prescribed for someone else, or when it is obtained and used illegally.
With respect to those first two categories, I believe a number of initiatives are under way that will help identify, prevent and manage unintended consequences of prescription pharmaceuticals throughout their life cycle. The amendments to the Food and Drugs Act enacted under Vanessa's Law and announced by the health minister in December 2013 will provide better protection of patient health and safety, particularly in the post-marketing space.
In addition, Health Canada is in discussion with regulators from around the world regarding a novel approach to approving drugs for human use that is referred to as adaptive licensing.
Health technology assessment helps to reduce uncertainty by providing relevant, timely and credible evidence-based information. HTA agencies, such as CADTH, go beyond the risk-benefit assessments completed by regulatory bodies by looking at the clinical effectiveness and cost-effectiveness in comparison to current therapeutic alternatives. In other words, we look at the comparative effectiveness, comparative harms and comparative cost-effectiveness of new and existing pharmaceuticals. We look at available evidence generated post-market, the so-called real-world evidence, particularly looking for reports of serious adverse events that did not arise during the controlled clinical trial phase. In some cases, we provide additional guidance, tools and educational sessions to practitioners and patients. In cases where there is significant uncertainty related to safety issues, our expert committee will usually recommend that a drug be listed with criteria that limit the use of the drug until more is known about the unintended consequences.
I would also like to mention the great work being done by the Drug Safety and Effectiveness Network, DSEN, an organization that is working to increase the availability of high-quality, post-market research on drug safety and effectiveness.
You heard from their executive director, Dr. Bob Peterson, during previous sessions on your study on prescription pharmaceuticals. I am a strong advocate for DSEN and consider them a valued partner and a real asset to the Canadian health care system. DSEN contributed evidence to CADTH's work on the new oral anticoagulants that I mentioned, and they have many new projects under way in the area of real-world evidence.
With the initiatives and collaborative approaches between Health Canada, CADTH and DSEN, we have a three- part system to continually reduce the uncertainty about harms and clinical benefits of drugs in Canada, through regulatory approval, health technology assessment and post-market evidence development.
[Translation]
We can be proud of our made-in-Canada approach to developing evidence on harms and clinical benefits throughout the life cycle of prescription pharmaceuticals, but, of course, there is still much work to be done.
[English]
The third category of unintended consequences, those related to misuse or illegal use, is very complex and challenging to address. Although this area is not specifically within our mandate, we have done some work in conjunction with the federal, provincial and territorial drug plans on narcotics and other drugs of abuse, and I would be pleased to try to answer any questions that may arise should this be an area of discussion for the committee.
[Translation]
Thank you for the opportunity to make this presentation today. It will be my pleasure to answer any questions you may have.
[English]
The Chair: Thank you very much, Mr. O'Rourke. Before I open up the floor for questions, I will mention the status of our third report on off-label use. We completed the study in the spring, but, due to the nature of the parliamentary sessions and timing and so on, I will be tabling it in the Senate this afternoon. That follows up on that.
I will now open up the session for questions.
Senator Eggleton: Let me start with you, Mr. O'Rourke. I didn't hear you mention drug shortage, which is another item on our agenda, but I understand that you have been doing some work in that area in terms of alternate therapeutic approaches in case of drug shortages. Can you talk a bit about that, and have you been advising the federal and provincial governments about these alternatives? What can you do further on this issue of drug shortage?
Mr. O'Rourke: Actually, that is not within our mandate. We haven't done much. We have been a passive observer with the provinces and with some of the other organizations, like the Canadian Pharmacists Association, which does have the lead on it. We have offered our services if necessary, primarily in helping them to identify alternative therapies when there is a shortage. No requests have come our way in this regard. It is a difficult thing to do because most of those decisions have to be made at that direct patient-physician-clinician interface.
Senator Eggleton: You say you are offering alternatives. How are you doing that?
Mr. O'Rourke: We haven't offered alternatives, but we could look at the evidence and provide some guidance on what alternatives there could be in a particular area. If there was a shortage of a particular antibiotic, we could produce a report that would show other typical antibiotics that might be used in that clinical situation.
Senator Eggleton: Wouldn't that be helpful?
Mr. O'Rourke: It could be helpful.
Senator Eggleton: How could that be facilitated, or how could we help?
Mr. O'Rourke: Most of that work is being done at the local hospital level. Hospitals that have drug information centres, for example, would look at that information. It is a difficult thing to do from a central agency perspective because of the fact that most of those decisions have to be made with so many other factors taken into consideration — the individual patient considerations. We really haven't been approached to take an active role at this point.
Senator Eggleton: Mr. Wright, you've noted, in your presentation, quite a number of data gaps. How can this committee, when determining its recommendations, help you in narrowing some of these information gaps?
Mr. Wright: In many ways, we are making great progress at CIHI. We work closely with the provinces and the territories. Things take time. We've just gotten all of B.C.'s data, which is not only their public drug plan data but also their private data. We're working with Newfoundland to get their data, and then, with the exception of Quebec, we will have, for the public drug programs, comprehensive coverage across the country.
What we really are interested in getting hold of is private use data. Again, we've got B.C.'s, and we're working with several provinces on trying to access that. We appreciate the efforts of the committee; you're volunteering to do so. However, I think it's really something that we need to work through with the provinces and territories.
Senator Eggleton: You are in the process of getting these gaps resolved.
Mr. Wright: Yes.
Senator Eggleton: It's just a matter of time. As for the private aspect of this, you said you got it from B.C. but not from the other areas. Is this just, again, a matter of time and working this out with the different provinces?
Mr. Wright: Yes. We're doing some preliminary work with the other provinces on trying to access that form of data. As the electronic health record becomes more widespread and e-prescribing is more widespread, we will be able to tap into that data as well.
Senator Eaton: Thank you for coming, gentlemen. I would like to talk to you about polypharmacy. Should pharmacists and pharmacies be encouraged, and should doctors encourage their patients, to get their drugs from one pharmacist or one pharmacy so that the pharmacist could look at the range of drugs they're taking and see that they're not fighting each other or having bad effects on the patient?
Mr. O'Rourke: As a pharmacist by training, not in my role at CADTH, I certainly would support that. Having all of the available information, including information that might come from a hospital if the patient was admitted, is crucial to really understanding all of the needs of that patient. As I mentioned, every drug has the potential to have an adverse effect on the other medications that that patient is taking, so it would be very helpful to have a situation like that.
Senator Eaton: We all know that people go to specialists and to their family doctor, but there never seems to be one doctor that has all of their medication.
Mr. O'Rourke: Absolutely.
Senator Eaton: So this might be a recommendation that we could make?
Mr. O'Rourke: Certainly.
Senator Eaton: Education in that direction?
Mr. O'Rourke: Absolutely.
Senator Eaton: Does CADTH make regular assessments of approved drugs for suspected significant benefits not associated with Health Canada's approval?
Mr. O'Rourke: No, the drugs that we look at have already been approved by Health Canada, and we look at them for their approved indications. Typically, when the drug comes to us the first time, it will have maybe one or two indications. Through its life cycle, it may submit an application for an additional indication. We wouldn't look at that until Health Canada has actually approved the drug.
Senator Eaton: I see. I was given a drug for a herniated disk that has nothing to do with herniated disks, and I could walk again. So it's interesting, yet I see it advertised on television for diabetic people with bad feet. I guess I was lucky. A friend recommended it to me. But you don't undertake those kinds of steps?
Mr. O'Rourke: No, only the approved indications for the drug.
Senator Eaton: What can we do about antibiotics becoming less and less effective, Mr. Wright?
Mr. Wright: I'm not a pharmacist. I'm an economist by training. I'm surrounded by two pharmacists here. Maybe Mr. Gaucher can answer?
Senator Eaton: Would Mr. Gaucher like to comment?
Michael Gaucher, Director, Pharmaceuticals and Health Workforce Information Services, Canadian Institute for Health Information: There is some surveillance and recognition of the problems that do exist and which antibiotics and classes are potentially problematic. We don't do that work at CIHI, but the Public Health Agency of Canada does some surveillance using that data and recognizing where the problems exist.
Senator Eaton: Do we have enough education on not taking antibiotics for viruses or colds? Does enough of that go on in doctor's offices and schools, that it's not a prescription for everything?
Mr. Gaucher: Certainly you are seeing more of it now than you used to. There is a heightened awareness among care providers and the public, but there's room for more education.
Senator Eaton: Just to finish up, the U.S. is undertaking looking at antibiotics in food-producing animals. They're doing other things, such as looking at antibacterial soaps. Are we doing anything like that in this country?
Mr. O'Rourke: Not to my knowledge. Perhaps Health Canada might be doing some work in that area. To respond to your previous question, I think we need to do a better job educating patients on the use of antibiotics. When a lot of patients come in to see physicians with an infection like a cold or flu, they almost have an expectation that they should be taking an antibiotic. I have seen so many physicians get frustrated and just give up and write the prescription. Good patient education would help.
Another challenge we face is that we do need new antibiotics. We face the challenge of increasing antibiotic resistance. Pharmaceutical manufacturers should be encouraged to develop new antibiotics. However, the way we introduce new antibiotics is putting them third line, fourth line, fifth line, so the benefits to a pharmaceutical manufacturer to invest significantly in developing new antibiotics, based on the amount of money they would accrue from the sale of those antibiotics, is a challenge. It's a bit of a Catch-22 from a pharmaceutical manufacturer's perspective.
Senator Stewart Olsen: I have several questions, perhaps for both Mr. Wright and Mr. O'Rourke, on the collection of all this data. How exactly do you collect it? I know you work with the provinces. Do they just give it to you?
Mr. Wright: In essence, yes. It's provided to us with data feeds, and we have a repository for all this data. Fairly soon we'll have approximately 1.5 billion records of multi-year drug data available to us, and each record has a variety of indicators on it.
Senator Stewart Olsen: Forgive me for interrupting. You would get data for how many times a drug was prescribed or a specific drug? Exactly what kind of data are you looking at?
Mr. Gaucher: It's at the patient level, so you basically get it at the prescription level. You would know the drug, how much was prescribed, the name, the strength, the form and various fields. There are about 30 fields in total of different types of information related to that prescription: how much was dispensed, the cost of it, et cetera.
Senator Stewart Olsen: Do you also get the adverse reaction reports with that data?
Mr. Gaucher: No. There are no adverse reaction reports with the data itself. There's the potential to look at the entire profile of the patient, but, again, you wouldn't recognize an adverse reaction with that. You could recognize, for example, if there were two drugs that might interact with each other.
Senator Stewart Olsen: Wouldn't it be informative if you had some kind of method to compare the two? You're getting the patient data, the actual patient name and the drugs they were prescribed?
Mr. Gaucher: Yes.
Senator Stewart Olsen: Then you don't get any follow-up. You know they got this drug, but you don't know whether they had a reaction to that drug?
Mr. Gaucher: No, that data isn't provided. The only way we have done a little bit of that work is the study around looking at hospitalizations related to adverse drug reactions. We had to link our drug data to our Discharge Abstract Database to get the diagnostic information around the fact that it was related to an adverse drug reaction. We could potentially do that with our emergency department data as well, but it's not inherent in the drug data itself.
Mr. O'Rourke: We go well beyond that hard, objective data. CIHI is a wonderful source for us as we do our analysis. We also receive a complete dossier from the manufacturer. That's never enough, of course. We have a very strong team of librarians and medical information specialists who search the world literature. We are constantly looking for the adverse reactions, the harms. If we see a clinical study where a significant number of patients have dropped out or disappeared, we will go back to the manufacturer to seek information on what happened to those patients, so we do track whether it was a serious adverse event or a death associated with the drug. We also purchase information from some commercial manufacturers that might have data sources in addition to what we could get from CIHI.
Senator Stewart Olsen: Going on with that, how broadly is the information disseminated?
Mr. Gaucher: Our reports using our drug data are publicly available on our website, and we try to share them more broadly through other means as well. We take them to conferences and share them with different groups we think will be interested. We engage experts. There are various ways of getting information out there, but it is all available on our website.
Mr. O'Rourke: We take passive means in that everything we do is publicly available on our website, and we are very active in the social media space as well. We also take a lot of active roles in trying to disseminate our information. We have a team of knowledge mobilization specialists who try and translate complex scientific information to easily understandable and digestible forms. We get out to medical, nursing, pharmacy conferences. We have a liaison officer — a CADTH staff member —situated in each and every province in Canada who gets information for us and markets our information into the community. Everything we do is publicly available.
Senator Stewart Olsen: Do you make a point of working with medical and nursing schools so they know your organization exists and they can access your data?
Mr. O'Rourke: Absolutely. We do it through this active role. In fact, today I brought a Doctor of Pharmacy student with me from the University of Toronto who is doing a one-month rotation at our organization. We try to get out to the schools, the universities, the colleges. I'm doing a presentation next month in Nova Scotia at the annual refresher course of the physicians in Nova Scotia, talking to them about the work we do. We try to take an active role in the dissemination of our information.
Senator Stewart Olsen: Commendations on your rapid response service; is that readily available to people as well?
Mr. O'Rourke: Absolutely. It's a well-received product. We can only do so many, but any person in the public health care system, whether they're in a policy role or a clinical role, can pose a question to us and we'll provide them with whatever information they require to close the uncertainty gap, to help them make a policy decision or a practical patient level decision.
Senator Stewart Olsen: I found your information on the warfarin and anticoagulant study interesting. You recommend that warfarin is still a first-line drug because you don't have the long-term studies of the others.
Would you reassess when long-term studies are available because one of those drugs may prove better than warfarin? There are a lot of problems with warfarin, as you probably know. Would there be rolling information or a rolling evergreen look at these new drugs?
Mr. O'Rourke: Yes, we do. For every drug we review, our information specialists have the means of tracking any new study or report that would come out on that particular drug. In most cases we usually don't have to do that re- review because the manufacturer will come back to us with that information saying, ``It's time for you to do a new review of this drug.'' We have a resubmission process when new clinical information comes out. The drug plans can come to us and ask us to look at the evidence again.
The way we're trying to do it now is when one company comes out with a new drug, two or three other companies are looking in that same field. Multiple sclerosis is an example where new drugs are about to come to the market. We will do our assessment and recommendation on the individual drugs, and at the same time, we will do a therapeutic class review of all of the agents involved. Some of that requires a re-review of the evidence.
Senator Enverga: Thank you for all the presentations. My question is about seniors, who are particularly vulnerable to several of the unintended consequences of prescription drugs. CIHI has reported that people over 65 years of age are five times more likely to be hospitalized for serious adverse effects than other Canadians. Can you please explain CIHI's analysis of hospitalizations for seniors resulting from adverse drug reactions?
Mr. Gaucher: Yes. We looked at using CIHI's Discharge Abstract Database, which has diagnostic information related to adverse drug reactions, and identified seniors who had a hospitalization related to an adverse drug reaction.
We used the diagnostic information to determine that, and we looked at how often these were occurring, what types of drugs and what types of reactions they were. We found, for example, that anticoagulants, blood thinners, were the class most common in hospitalizations — related to bleeding from the drugs.
Using the drug data, we then looked at the risk factors associated with these hospitalizations by linking the patient who had hospitalization and looking at their drug profile. That's how we found that, for example, those who were on more drugs were at higher risk. We looked at various factors beyond that in terms of assessing what put the patient at highest risk. If they were older, they were at higher risk as well. That study looked at both our diagnostic information and our Discharge Abstract Database and linked it with the drug data to get a better assessment of which seniors were at risk of having these hospitalizations.
Senator Enverga: Does the data indicate that overmedication or interaction with other drugs causes the problems?
Mr. Gaucher: It's difficult to assess. We didn't go that far with the study. We noted that it could be studied further in terms of looking at those who were on a greater number of drugs and were hospitalized, the details of their drug profile and seeing if there were problems. This study stopped at looking at risk factors in general and identified that the more drugs they were on, the higher risk they were at. It identified the types of drugs most often associated with hospitalizations.
Senator Enverga: Would antibiotics be a big part of this overmedication? Are we giving too many antibiotics, especially to our seniors?
Mr. Gaucher: We looked at the drugs most often associated, and antibiotics didn't really show up there. It doesn't mean there weren't some hospitalizations that occurred. As far as just looking at the drug data goes, we tend to focus more on the types of drugs that are being used more frequently. Antibiotics generally don't show up but certainly could be looked at using the drug data. We could potentially do more focused studies on antibiotics utilization. The challenge is that we don't have a lot of data other than seniors. As Mr. Wright mentioned, we have gaps to fill on the private side, so right now most of our antibiotics data would be for seniors. We wouldn't have a lot for other groups.
Senator Enverga: During this study of drug reactions, have any of you ever sent any alerts saying this data is too much, this is affecting this particular group? Have you ever sent alerts to practitioners? Is this one of the roads you're thinking about taking in the future?
Mr. O'Rourke: Not in a direct sense of an alert to every physician across the country. I think Health Canada does have that role when they notice a serious adverse event with a particular drug. What we do is a lot of the knowledge mobilization that I talked about. If we identify specific harms or safety issues in the study or class of drugs we are looking at, we will try to promote that information in an easily digestible form. A lot of our reports can end up being 200 to 300 pages; we're trying to collapse that so that a busy physician, nurse or practitioner can read it. It is also for patients as well.
On the previous question you had about seniors, if I may, the concern with antibiotics is the resistance issue. The polypharmacy issue that Senator Eaton referred to is of major concern, particularly in the nursing home community. We've done a fair bit of work with the provinces, British Columbia in particular, on falls in seniors. We know that a lot of the falls are related to drug interactions or polypharmacy, or even if they are on one drug that has the potential to increase their risk for falls. We've made some recommendations on the use of hip protectors in nursing homes that prevent them from fracturing their pelvis, et cetera, if they do fall. It is a significant concern and issue in nursing homes in the senior community.
Senator Enverga: When you interact with Health Canada and make recommendations, what are your thoughts about their reaction? Do they do it instantaneously? How does it work for you? Do you think they need a better response time?
Mr. O'Rourke: From my perspective, we have an excellent working relationship with Health Canada, the Health Products and Food Branch in particular. We have instituted a program where we start looking at the reviews, the new drugs that come to market about three to four months prior to the drug's being marketed by Health Canada or approved. We do need to share and use some of their information. We have participated in a lot of the discussions they have with manufacturers, pre-submission. We have a very good working relationship with Health Canada.
Mr. Wright: We have an excellent working relationship with Health Canada as well, but we are not in the business of making recommendations. We prefer to have the data speak for themselves.
Senator Dyck: Thank you for your presentations this morning. I want to start off with the line of questioning regarding antibiotics. One of the unintended side effects of the overuse of antibiotics is the rise of infections with methicillin-resistant Staphylococcus aureus. In the data collection, I'm wondering whether the incidence of these types of infections is tracked and whether you track the use of the specific antibiotics that can be used to treat the MRSA and, depending on the kind of data that you see, if you would make a decision as to whether those antibiotics should be covered by a drug formulary. For example, in a specific case of a family faced with that sort of situation, they end up having to pay enormously high prescription fees in order to get the drug.
Mr. O'Rourke: Right. With respect to some of those really serious resistance patterns — MRSA and vancomycin resistance — as well and some of the serious things that happen within the hospitals, from nosocomial infections to people who get ill when they go into the hospital, we have done a fair bit of work with the hospital community in helping them identify ways to prevent those things from happening, such as usage guidelines. We did an electronic tool for MRSA, as an example, which helps hospitals prevent it from happening.
When it does happen, there are well-recognized guidelines from infectious disease societies on how to treat the patients that have these serious infections and what to use when the particular antibiotic is no longer effective in a group of patients. A lot of it has to do with techniques they have to do in the hospital.
Linking that to the funding issues, it's a difficult question to answer without knowing the specific drugs that they may have been paying for. If it was a drug that was recently approved or has a new indication that has come to us for recommendation, we would put it through our expert committee like we do for all drugs and recommend to the provinces whether it should be funded or not. For drugs used only in a hospital, we don't review those. The pharmacy hospital and therapeutic committees typically do the purchasing and funding of the drugs used in hospitals.
Senator Dyck: As a quick follow-up, would that list of approved drugs be available at a public website so that if a person had a child that was in this situation, could they look to see what drugs were approved by Health Canada?
Mr. O'Rourke: By Health Canada, yes, of course. On their website they have a list of every drug that has been approved by Health Canada. Every province also has their own drug benefit list available through their ministry of health on their website. Usually we identify if there are restrictions on who can get it. That covers those on social welfare and seniors in most provinces, depending on the scope of their benefit program.
Mr. Gaucher: As for information on treatments, there could be drug data that we have some information for. I also suspect that in some of our other data holdings — for those patients who are hospitalized or have emergency department visits — we may have some information available as well. Nothing is specifically targeted in that area, but we may hold some information that would inform some work related to it.
Senator Dyck: Continuing along the same line, do you collect data with regard to prescription drug use within prisons? Is that part of your normal collection procedure? Within prisons, of course, we know there are high levels of addictions and mental disorders.
Mr. Gaucher: We don't currently hold that information. We get some of it at an aggregate level in terms of what's spent through another data holding, but as for detailed data in our prescription drug database, we don't hold that information.
Senator Dyck: It might lead to some interesting data. I was thinking of drug use, and this leads me to a third question. Within the data that you collect, is it possible for you to interpret the data to see trends of misuse of a particular drug? OxyContin is one that has been talked about, and I made a note for myself that I don't see it very quickly here. There are other drugs for children that are prescribed, like Ritalin. There is the potential for misuse, where instead of the child using the Ritalin, it's somehow given to another person. Can you see trends of misuse by keeping track of prescription usage?
Mr. Gaucher: There are different ways to potentially pick up patterns. You can follow patients' therapy over time. Within the database, we have data for some provinces going back to 2000 and for most provinces back five years. You can look at any patient in there and follow them.
I think the challenge is determining whether there is a real problem because you may see what you feel is an unusual pattern of several different narcotic prescriptions from different prescribers, potential problems of quantities that are being refilled on a regular basis or doses continually going up. You can pick up some of that. You can't really conclude there's a problem, but for looking at potential trends and patterns, that might indicate it. Going back to the limitations, we have data for younger populations only for British Columbia and part for two other provinces. We have a lot of seniors' data, but unfortunately not for the large gap of younger Canadian residents, which we need to fill.
Senator Dyck: That was going to be my next question: What data collection do you have for children? We've talked about overmedication for seniors, but perhaps there is a perception that we're also overmedicating children. Without the data, we wouldn't be able to assess that. I wonder whether you have plans to increase the amount of data that you collect on children.
Mr. Gaucher: We're certainly working hard to continue addressing the gaps that we have on the private side. With three provinces now, we have a fairly reasonable amount of non-senior data. We're starting to look at what we can potentially do with that data. It goes hand in hand with trying hard to fill those gaps and getting more data on younger Canadians in other provinces, while at the same time looking at how we can use the data we have to help inform and address some of these issues.
[Translation]
Senator Chaput: The national anti-drug strategy will be expanded to include prescription drug abuse. Health Canada has committed to working with various organizations. Have you been consulted so far? If not, you will be consulted at some point. What position will your organization adopt on how to prevent this abuse? In addition, what measures will you recommend to identify cases and reduce repercussions?
[English]
Mr. Gaucher: Sorry, I missed the question. I apologize.
Mr. O'Rourke: We have not been consulted directly at this point. We passively received the report from the organization and looked at it to see if there was anything we could offer as well. I think it's a fantastic report that has a lot of good recommendations to move forward.
We do work closely with each of the provincial, territorial and federal drug plans, and most of them have policies and practices in place throughout their provinces. We are currently doing an environmental scan across all the provinces on drugs of abuse, the opioids, oxycodones. We are even expanding that into other classes. We hope to have that information available in April or May to see whether there are things we can or should be doing differently from each provincial level or lessons that one province can learn from another in that regard.
We've also done a fair bit of work for the drug plans on therapies used to help patients who have addiction problems with opioids, et cetera, comparing some of the drugs available, identifying the hazards with those drugs and how they can be appropriately used.
[Translation]
Senator Chaput: If I have understood correctly, certain measures could be proposed in terms of specialized therapies, to help patients overcome their addiction?
[English]
Mr. O'Rourke: Yes. Typically a patient who has a problem with an illicit or prescription drug requires two things. One is a stabilization phase where we help them break the addiction, the mental and physical side of it. There's a detoxification phase where we give them drugs like methadone or Suboxone to help them get off of the illicit drugs. Then there are the supportive phase and the ongoing maintenance phase. We have been helping them with the second phase — the detoxification phase — and the different drugs available that are used to help patients.
Mr. Wright: In the case of CIHI, we've had high-level discussions around this and explorations of what our prescription drug use database can contribute to this effort. We hope to have further conversations with Health Canada. We are here to help.
Senator Cordy: Thank you for being here today with your testimony. Senator Dyck raised a very interesting point about the collection of data in prisons. I was on a committee that dealt with aging, and the population in prisons is aging. When we look at the statistics on overmedication or misuse of medication in seniors, it is interesting. We also know that the number of people who are mentally ill is significantly higher, or seems to be quite high in prisons, so that would be an interesting area to look at.
CIHI spoke about the collection of data in hospitals, of medication errors in hospitals and long-term care facilities in the National System for Incident Reporting. Some of the reading that I have been doing is saying that the data that we are receiving, not just about medication errors but other medical errors that are taking place in hospitals and long- term care facilities, is not necessarily as accurate as one would like. Are you finding that you are getting accurate data on medication errors from hospitals and long-term care facilities? What I have been reading is that they are not all reporting when there are problems within the facilities.
Mr. Gaucher: First, to answer the accuracy of the data, there is difference in the quality we receive. For the most part, the data is codified or coded. There are some pretext fields, and we see some variability in how much information is put in by the submitter of that medication incident. It's difficult to know exactly how accurate it is and to assess that. From our perspective, we see some fairly good-quality data coming through, but it does vary, depending on probably the facility or the submitter.
Senator Cordy: I guess the thing is it's not necessarily the quality, but are you receiving all the data? I guess you don't know unless you receive it.
Mr. Gaucher: That's very difficult to actually determine. No matter where I think you read, you tend to read that just a small proportion of errors that actually occur are reported. Right now, we have data from just under 300 facilities, so obviously we are not collecting it from all facilities. It's more comprehensive from some facilities than from others. We provide the opportunity to submit the full scope, from near misses to serious incidents that cause death and harm. Some facilities submit everything; some submit only more serious events. A partial picture, I guess, is what we hold.
Mr. O'Rourke: I wanted to comment based on some of my experience in clinical practice working in hospitals. We still have a bit of a culture of not collecting or reporting particularly the incidents where the medication actually hasn't gotten to the patient, but there still has been an error associated with that. Those are the ones I think we can learn so much from and try to prevent that from ever happening again. We do report on the sentinel events, those that result in serious harm to a patient, and we do report a lot of the medication errors, but it is those medication incidents where we need to do a much better job.
If I could just respond to the Corrections Canada piece as well, it is a very good point. Part of our role is to support the federal drug programs as well, and Corrections Canada is one of our customers. One of our liaison officers does work for all the federal programs, likes Veterans Affairs and DND and Corrections. We are not in the business of collecting data, but we are in the business of analyzing the data, and we have done some work with Corrections as well.
Senator Cordy: You are right. That is a federal jurisdiction, which would be of particular interest to the committee.
Are provinces moving in the direction of forcing hospitals, as much as they can, to release these kinds of situations that are happening in hospitals? Three hundred facilities giving data is pretty low when you are talking about the country.
Mr. Gaucher: Right now the only province that legislated mandatory reporting was Ontario, for critical types of medication, IV fluid incidents. We are receiving that data. They chose the facilities to submit that data to. That's all I'm aware of. I know there are some other possibilities of other provinces with things being talked about or perhaps just recently being implemented.
Senator Cordy: I am interested in CIHI. You also spoke about looking ahead, and you talked about counterfeit drugs. How much work have you done on that? How much data do you have on counterfeit drugs? How common are counterfeit drugs in Canada? Could you give us a little bit of information? I would guess it's becoming easier to have counterfeit drugs when you can go online and order. You don't have to go to a pharmacy; you can do it in relative obscurity.
Mr. Gaucher: We haven't done anything specific yet. With regard to potential, within the database, if it becomes public knowledge that certain drugs are being counterfeited, we could potentially try to track those types of drugs within our data to see whether we can pick up any of that. It's difficult to know really. It depends on the types of drugs.
Senator Cordy: We don't know how common it is.
Mr. Gaucher: No, we don't, at this point in time. It's just something we could potentially help inform if it became a problem and we were aware of the types of drugs.
Senator Cordy: Mr. O'Rourke, are you doing anything in that line?
Mr. O'Rourke: No.
Senator Cordy: Concerning legal drugs and legal drug companies, do we, in Canada, look at where drugs are being manufactured? Many of them are being manufactured outside of Canada's boundaries.
Mr. O'Rourke: That really is the responsibility of Health Canada. They look at three things: the efficacy, the safety and the quality. Through their inspectorate, they have that responsibility.
Senator Cordy: You just collect the data. Thank you very much.
Senator Seidman: We have had a lot of questions about data and the specifics of data, so most of my questions about that have been covered. If I might, and if you'll forgive me if I ask something that seems repetitive, I would like to clarify a few things about the data.
CIHI has a National Prescription Drug Utilization Information System Database. You say that you collect clinical data for seniors. These are seniors living in long-term care facilities, not living in the community; is that correct?
Mr. Gaucher: It's both seniors in the community and in long-term care.
Senator Seidman: Okay.
Mr. Gaucher: Sorry, clinical data. No.
Mr. Wright: We collect clinical data in 1,100 long-term care facilities in the country.
Senator Seidman: Right, and prescription drug use for seniors in the community?
Mr. Wright: Through the prescription drug plans in each of the provinces, yes.
Senator Seidman: That would be person-specific, as you said. It is person-specific, with all the drugs prescribed.
Mr. Wright: Yes.
Senator Seidman: However, you don't link it to adverse events. Is that correct? It's not linked to adverse events?
Mr. Gaucher: We did the one study that I mentioned where we looked at hospitalizations related to adverse drugs reactions; we linked it for that particular study.
Senator Seidman: But then you would have to purposely link it.
Mr. Gaucher: Yes.
Senator Seidman: So it's not automatically patient-specific or person-specific and then linked in with the adverse events.
How often do you update? Is the information that is patient-specific current? When a new medication is added to a particular patient in your system, how long does it take before that's added into your system?
Mr. Gaucher: In the NPDUIS Database, it depends on the province, but generally they range from monthly to quarterly feeds of data. It's fairly timely in terms of its availability in our system for analysis in the NPDUIS.
Mr. Wright: In the case of the long-term care facilities, it's quarterly. We do get some feeds monthly as well, but generally it's quarterly.
Senator Seidman: If a medication is withdrawn from a patient, would you get that information?
Mr. Wright: Yes.
Senator Seidman: That leads me to a question, and I know you are involved in a study that you say is going to be published on seniors. That's going to be published next year, is it?
Mr. Wright: This coming spring.
Senator Seidman: This spring, excellent. I would like to ask you about a piece published in Family Practice in 2012 titled ``The Impact of Polypharmacy on the Health of Canadian Seniors.'' Population survey data were used in this study, and there were 3,032 respondents over 65 years of age, so it was a decent-sized study. Your conclusions were that there are interventions that can potentially reduce polypharmacy and adverse events, including routine medication reviews. I think that's a very interesting conclusion. We have heard that it is not often that we get medication reviews on patients.
How do you communicate conclusions such as this? It is CIHI behind this study. Does it result in some kind of action taken, perhaps a study by Mr. O'Rourke's enterprise, for example?
Mr. Wright: Let me try to take this very broadly. With all of our products and services, we use a variety of channels to get the information out. One is the media, who are very interested across the country, but also back to the ministries of health across the country. In the case of this particular study, the material would have gone to the various prescription drug plans to the attention of the executive directors or directors there. We have ongoing groups that meet, advisory committees that help advise us on this sort of thing. We bring it to their attention. It is fairly widespread, but it is up to the jurisdictions as to whether or not they choose to take action or not, and we leave it with them.
Senator Seidman: For example, what about the Royal College and the Canadian Medical Association? The Royal College oversees physicians, to some extent. We are talking about routine medication reviews, and a physician undertakes the medication review, generally. It's quite an important finding. You would somehow leave it to what, chance, that the Royal College would receive the results, or would it be obvious that they would receive the results of a study like this?
Mr. Wright: It depends on the study. In this case, I'm not sure that it actually was sent to the Royal College. Certainly the analysts within the college would be aware of this. Most researchers across the country are familiar with CIHI's products and services. Be it the Canadian Medical Association or the Saskatchewan Medical Association, they would be aware of these reports coming out.
Senator Seidman: Mr. O'Rourke, I'd like to ask you about a study and actually about a piece that was in the CMAJ at the end of last year where they talk about introducing de-prescribing into a culture of medication. There is an initiative coming from an Ontario pharmacist, and basically the hope is that we can change the way people think about pharmacy among the elderly and that certain guidelines would prompt routine re-evaluation of drugs or sets of drugs and provoke thought about how long a patient needs a drug, duration of medication use and the dosage that might change with age.
In fact, there is very little talk about de-prescribing in the elderly population, about taking patients off certain medications and changing medication regimes as opposed to just adding to them. I am putting this out there only because I'm trying to understand how you select topics for the studies you do, and you do fairly in-depth studies, and whether this is something that has ever been considered.
Mr. O'Rourke: Yes, it has, actually. A very good study has just started under the leadership of pharmacists at Élisabeth Bruyère Hospital here in Ottawa on de-prescribing. I think the first drug class they are looking at is proton pump inhibitors, drugs used for ulcers and a few other areas. They have approached us to see if we would like to either endorse the work they are doing or become involved in the work, so we are still assessing it. We have done a significant amount of work in the area of proton pump inhibitors. It is a very good study.
Some work is also being done at the Capital District Health Authority in Halifax under a physician by the name of Dr. Laurie Mallery. She is looking at developing really good guidelines for the use of medications in the frail elderly. Many seniors are put on medications even though they don't want to be on that medication. She is trying to get that information out to family practitioners and the nursing homes. I think there is some good interest in that area.
We hold an annual conference every year. Last year, we held a session on big ideas for health technology assessment, and the number two idea that came out of that was related to the de-listing of pharmaceutical agents.
Senator Seth: Most of the topics have been discussed, and many of my questions have been answered, but one question I would like to ask is whether you have considered environmental effects on the prescription drug. What happens to the chemical compound of the drugs once it is handed over to the patient? What do we do with that? Do we take any precautions? What do we do in that area?
Mr. O'Rourke: We have not done much work in this area. I think we may have done a few rapid responses based on reactions from hospitals on very specific chemical compounds, on safe disposal and handling of them, but I'm not sure we have done much work in that area.
Senator Seth: Are patients not given written instructions with some medications? Is there not advice on the bottle or somewhere about what temperature the medication should be kept at so as not to destroy the chemical of the drugs? Is it not there?
Mr. O'Rourke: That is not part of the work we do. Of course we are not involved with prescribing or dispensing medications to the patient, but certainly I believe most monographs and information in medications packages have storage information, if your eyes are good enough to read what is on the packages of some of these products.
Senator Seth: Yes.
Mr. O'Rourke: And mine aren't.
Senator Seth: We have been talking about the data that has been collected through the NPDUIS, and the most vulnerable group for unintended consequences of prescription drug is the seniors.
Mr. O'Rourke: Right.
Senator Seth: How about patients with a mental illness or children? That's one thing.
You mentioned anti-thrombotic drugs, saying that warfarin was being used commonly, but what about some of the newer drugs coming in and long-term effects that have not been seen, and yet we do prescribe? Who does that? Do we have a special committee for that, or do we leave it in the hands of the physicians to make the decision? How do we manage that, especially in elderly patients?
Mr. O'Rourke: That's a tough one to deal with. Once a drug is marketed and approved to prescribe in Canada, the manufacturer makes a decision whether they want to sell it in the country, and any physician can then prescribe it. If you are a patient, you would like to have that medication paid for. If it goes through the public drug system, we would get involved and make the recommendation on whether it is listed or not. For about 50 percent of the drugs that we assess, we do not recommend that they are funded or paid for because of safety issues or cost-effectiveness issues or they just don't add any new value to the system. However, patients can also get them through a private drug plan or pay cash for them.
A lot of the trials in those new anticoagulants and some of the key research for them were based in Canadian hospitals, so there is some promotion of the use of these new oral anticoagulants from Canadian physicians, and the drug companies themselves and their big marketing teams are going like crazy. Although we don't have directed consumer advertising in Canada, anyone who has satellite television or cable television sees these ads for the anticoagulants from the United States. To me, it is a significant issue on how we control the distribution, use and prescribing of some of these new drugs that have some dangerous unintended consequences.
Senator Seth: NPDUIS does not get involved. That's what you are trying to say. The drug companies that come into —
Mr. O'Rourke: Sorry, I missed the first part.
Senator Seth: The Canadian health institute managing the national prescription drug, they do not come into the picture?
Mr. Wright: No.
Senator Seth: They don't.
Mr. O'Rourke: In the recommendations, when we make a recommendation to the drug plans, our expert committee usually will put criteria on it. Even if we say yes to it, they will say only in specific patient populations, or only certain physicians are allowed to prescribe it. The electronic drug plan systems in the provinces will have those things, and the pharmacies, as they are looking at dispensing it, ensure that it meets those criteria before it goes to the patient.
Senator Seth: It is well-regulated then.
Mr. O'Rourke: Yes, from a provincial perspective.
The Chair: I would like to follow up on some of the issues we have covered today.
First of all, Mr. O'Rourke, I found your use of the atrial fibrillation issue interesting because we know recent reports show that the most dangerous time for a heart or stroke patient being prescribed that is the first 24 hours on the new drug, and then within the first 30 days. There is significant review in that area, which is another issue of an unintended consequence. That is designed to protect against an outcome actually heightening the possibility in a certain period of time.
I want to touch briefly on the adverse reaction issue, adverse event issue, adverse event reporting, because it has been a major concern of this committee through its first three phases, and it has come up today in terms of asking you whether you keep that data. There is a reason you don't have that data, of course. There is no systematic way of reporting that. I'm not going to delve into it with you at the moment, but I want to ask you the following question: If an opportunity were provided through the prescribing of a pharmaceutical that provided a patient with an easy way, an electronic way, perhaps, to provide their experience with the drug to Health Canada, is it within your mandate to have that automatically copied to you, or would you have to seek that data through Health Canada? Let's suppose it were to come about. It's a hypothetical question.
Mr. Wright: We would enter into a data sharing agreement with Health Canada. We currently have agreements whereby we provide Health Canada with certain information, so it would be reciprocal.
The Chair: The issue then comes back to the difficulty of getting the data reported in the first place, but, once it would be reported, say through Health Canada, then those of you who do these analyses and provide advice would have a means of getting access to that?
Mr. Wright: Yes. The other alternative is to actually have the data come to us, and then we would give it to Health Canada. We are the experts in the country on storage of health care data.
The Chair: I understand, but the law would require Health Canada to do it.
Mr. Wright: Fair enough.
The Chair: That's the reason I phrased it that way.
Mr. Wright, I want to come to your submission. I think you have clarified one of the questions I wanted to ask. I was struck by the fact that on page 4 of your document, with regard to drug shortages and counterfeit drugs, you used the phrase CIHI's data ``could be'' used to track. That implies to me that it is not being used, and you answered that with regard to counterfeit drugs, which is the next category where you mention that. My understanding is that you have the mandate to actually investigate issues, to take on projects and to look at certain areas. In the case of drug shortage and the issue of counterfeiting issues, are those issues on your agenda at some point, or are they now just issues of interest that you are following to see how they unfold?
Mr. Wright: We have a rolling two-year analytical plan that we work with people across the country. Health Canada is involved in it, and others. It is not on our plan at this point in time. If there is an expression by the jurisdictions or researchers or other advisers to CIHI, we would certainly entertain putting this on the analytical plan.
The Chair: I suppose that in terms of the people you are mandated to provide reports to, a request in these two areas would be more likely to come from the federal direction, would it not?
Mr. Wright: Yes, it would. It could come from some of the jurisdictions or the CEOs of regional health authorities.
The Chair: All it would take is an enquiry from one of those?
Mr. Wright: Absolutely, and a reasonable one, yes.
The Chair: I was also struck by your note that the database is limited for younger Canadians due to the design of public drug plans. That implies that they are not identified in the same way that those beyond youth are identified. Is that the right interpretation there?
Mr. Wright: Not quite. It is more that many of the drug plans in Canada are designed to provide assistance to senior citizens. Some provinces, such as Saskatchewan, for example, have more broadly based drug plans, and we get that data for the younger individuals. It is really the structure of the drug plan in a specific province.
The Chair: Most of them are structured so that they just give you bulk data. Other than for seniors, they give you bulk data, or they don't give you the data that involve youth?
Mr. Wright: I'll take another kick at this. It depends upon the design and the intentions of a particular provincial drug plan. We get that data. Okay? Whoever the beneficiaries are, we have excellent data on that, on the individual and so on. If an individual is not covered by a provincial drug plan — their income may be higher, they may not be a senior, they may be a middle-income family and work with their employer and private insurance — we don't get that data, except for B.C., where we do get it now, and we are working with other jurisdictions to get that private data.
The Chair: I understand now. In those cases where younger Canadians fall within some category that is covered by the province, you would get that data, but it would be limited to that?
Mr. Wright: That's correct.
The Chair: All right. That clarifies that. Thank you very much.
The final question for clarification I want to ask you is that where you indicate that Canadians hospitalized with concurrent mental illnesses and substance-use disorders make up close to a third of all psychiatric in-patients, et cetera. The way your document flows to this point, you are not implying that substance-use disorders arise purely from prescription, are you, or from perhaps the broader source of illicit drugs?
Mr. Wright: The broader source, most definitely.
The Chair: That's an important clarification. I thought that likely, but it's the way your document is structured.
Mr. Wright: My apologies.
The Chair: That's quite fine.
The final question will go to Senator Stewart Olsen.
Senator Stewart Olsen: This is going back to the provincial approvals of drugs that they fund. It's just a question raised in my mind. When you suggest to provinces that they should fund this or shouldn't fund that, do you find that they accept your suggestion? Do they base all of their approvals on what your recommendations are, or how do they go about that? There is a broad discrepancy in what provinces fund.
Mr. O'Rourke: Since our Common Drug Review program has been in place, and we celebrated our tenth anniversary last year for the Common Drug Review, the consistency of the provincial drug plans has improved immeasurably; 92 per cent of the time the decision they make is consistent with the recommendation that we make. They do a budget impact assessment, and sometimes there is a bit of a time delay if it's a listing of a product, but typically, when we make a recommendation that they shouldn't list a product, that recommendation is followed.
Senator Stewart Olsen: On the experimental drugs that some people are demanding in provinces, and I don't even know if they are experimental or if it is the fact that Health Canada has not reviewed them thoroughly, where do you stand on that? Would you have to take the years of Canadian research or Canadian studies on the efficacy and safety, or would you go to the American ones before you could say something is approved or was okay?
Mr. O'Rourke: I'm just trying to understand the question.
Senator Stewart Olsen: It's about drugs that people want approved in a particular province, but Health Canada hasn't yet done comprehensive studies on them, although there have been years of research, say, in the United States or France or England. Do you rely strictly on the Canadian studies, or do you go to studies from other well-respected countries?
Mr. O'Rourke: A couple of points: As a caveat, we typically are not reviewing drugs at that investigational stage. We review them once Health Canada has received a submission and make a recommendation going forward. We may get a rapid review, though, on a particular drug to help a province in supporting a decision. We look globally for the studies. Wherever the evidence is, that's the evidence we will look at.
Senator Stewart Olsen: Thank you.
The Chair: Just to be clear on that, Health Canada is the authority with regard to making decisions on the approval of drugs, and you're dealing with the issues you have described in terms of use efficacy once that has occurred.
With regard to adverse drug reactions, would your organizations be in favour of a much more effective means and method of collecting adverse drug reports so that the real experience in the general population is more easily accessible for advising Canadians?
Mr. Wright: Yes.
Mr. O'Rourke: Yes.
The Chair: Thank you very much. I want to thank you for being here today and for the thoroughness and depth of the responses you brought to the questions, and I thank my colleagues again for the clarity and importance of the questions they asked. With that, I declare the meeting adjourned.
(The committee adjourned.)