Could the committee come to order?
I would like to welcome everybody and ask everyone to please be seated. We're going to have quite a rigorous morning today.
Pursuant to Standing Order 108(2), I'd like to welcome you to the third meeting of post-market surveillance of pharmaceutical products, prescription and non-prescription.
We have with us witnesses who will be taking part in today's panel on federal, provincial, and territorial issues. I'd like to welcome the witnesses who made it today.
Unfortunately, one of our witnesses, Ms. Susan Paetkau, from the Ontario Ministry of Health, will not be with us today due to the bad weather in Toronto. If any of us has ever gone through Toronto on a snowy day, we know we often have the same problem she's had.
We do have witnesses. There are representatives from the Canadian Institute for Health Information and the Patent Medicine Prices Review Board.
I would like to remind witnesses that they have ten minutes per organization to make their presentations. The committee will hear all presentations before proceeding to questions from the members of the committee.
I would like to begin with Ms. Glenda Yeates, president and CEO of the Canadian Institute for Health Information. Welcome to the committee, Ms. Yeates.
The Canadian Institute for Health Information, or CIHI, gathers data on the health care system , which it then makes available to Canadians. CIHI was set up by the federal, provincial and territorial governments as an independent, not-for-profit organization dedicated to ensuring a common vision of health information in Canada. Our goal is to provide timely, accurate and comparable information.
CIHI's data and reports focus on health policies, support the effective delivery of health care services and inform Canadians about factors that contribute to good health.
CIHI's 16-member board of directors is proportionally constituted to create a balance among health sectors and among regions of Canada. It links federal, provincial, and territorial governments with non-governmental health-related groups, such as regional health authorities.
CIHI produces reports focused on health care services, population health, health spending, and health human resources, thanks to information that's supplied to us from hospitals, regional health authorities, governments, professional associations, and other partners.
Recently CIHI has been developing two new databases in the pharmaceutical area: the National Prescription Drug Utilization Information System, or NPDUIS, and the Canadian Medication Incident Reporting and Prevention System, or CMIRPS.
The National Prescription Drug Utilization Information System was built--and I quote here from a federal-provincial-territorial Ministers of Health press release--“to provide critical analyses of price, utilization and cost trends so that Canada's health system has more comprehensive, accurate information on how prescription drugs are being used and on sources of cost increases”.
In 2002 CIHI received funding for the development and implementation of a claims level database, with data and ongoing support from the federal, provincial, and territorial governments. The project is a collaboration with the Patented Medicine Prices Review Board. Each organization will take the lead in areas in which that organization has the expertise, experience, and mandate. Overall, the NPDUIS database provides access to standardized information on prescription drug use and costs from across jurisdictions; information that will facilitate the informed management of drug plans; exploration and analysis of the interplay among plan design, formulary listings, and utilization; analysis of the impact of policy decisions on utilization; analysis of trends in utilization over time and across jurisdictions; and new knowledge through analytic studies.
Due to its complexity, the NPDUIS database has been developed in stages. The first stage was to incorporate drug product information from Health Canada's drug product database as well as formulary and plan information from public drug plans across the country. The majority of federal, provincial, and territorial jurisdictions are currently supplying this information.
The second and much larger phase is the development of the system to hold the claims data. This includes the following information: what drug was dispensed when to which person where, who prescribed the drug, how often the prescription was filled, how much of the drug was dispensed, and how much it cost. Although the patient information is de-identified--for example, there are no names or addresses--this is done in such a way as to enable tracking of drug claim patterns over time. It's important to note that claims data does not include the reason a drug was prescribed, nor does it capture adverse drug reactions.
The current primary data sources for NPDUIS drug claims are provincial drug programs. The data is submitted once policy and technical issues are resolved. these include the legislative ability to provide the data to CIHI, privacy concerns, and the circumstances under which the data can be shared and/or disclosed by CIHI. For example, the data that is accessed by the Patented Medicine Prices Review Board for their analysis is governed by legal agreements between CIHI and each jurisdiction that is submitting the data. As data custodian, CIHI ensures that the data is collected and kept safe and secure for purposes of analysis and research, consistent with our mandate. And on an annual basis, we notify the jurisdictions of how the data has been accessed.
As of February 2008, NPDUIS includes provincial public drug claims data from the plans in Alberta, Saskatchewan, Manitoba, New Brunswick, Nova Scotia, and Prince Edward Island. We are in active discussions with many of the other jurisdictions.
The NPDUIS database is used by CIHI to conduct analysis and to produce reports, is shared with PMPRB for their NPDUIS work, provides an environment in which drug plan managers can conduct analysis, and is a means by which researchers and non-government organizations--such as, for example, the Canadian Agency for Drugs and Technologies in Health, CADTH--can access data according to our privacy policies and principles.
An example of how NPDUIS data can inform the health of Canadians is reflected in the first analysis released by CIHI last September. Here the database was used to identify trends in potentially inappropriate medication use among seniors. The analysis examined claiming patterns for seniors on public drug programs in Alberta, Saskatchewan, Manitoba, and New Brunswick. Specifically, we calculated the proportion of seniors on public drug programs who were using drugs that are either internationally recognized as potentially inappropriate for seniors due to the elevated risk of adverse events or are on a list developed by gerontologist Dr. Mark Beers.
So while I believe this type of study to be a very powerful example of the types of analyses that NPDUIS can support, I should also point out that there are some limitations in the types of analyses that can be performed using the database, in some cases due to privacy concerns or in others because of the lack of availability of the data. For example, our sub-geographical data is limited, in-hospital and private sector drug use data are currently not available in the drugbase, and there are some data-sharing conditions that are stipulated by the submitting jurisdictions.
I will now turn briefly to the other initiative you kindly invited us to speak about, the Canadian Medication Incident Reporting and Prevention System, or CMIRPS. This is a hospital-based reporting system which is in its developmental stages at CIHI and will be pilot tested later this year. We are working closely with Health Canada, the Canadian Patient Safety Institute, and the Institute for Safe Medication Practices Canada to coordinate our country's ability to effectively manage information on medication errors through the development of this database.
I should point out that CMIRPS, as currently designed, does not capture adverse drug reactions. Rather, it is designed to measure system errors caused by inappropriate human actions, such as the patient being given an incorrect medication or the wrong dose of a medication in a hospital setting. Data collected by hospitals and submitted to CMIRPS will be analyzed to inform systems and process redesign, which in turn will make it possible to deliver safer patient care.
That brings me to the conclusion of my presentation. As an organization that is dedicated, and even passionate, about the power of health information to improve health and health services, we want to thank you very much for your interest in our emerging databases.
I will be happy to answer your questions.
Thank you, Madam Chair.
Good morning. Bonjour.
On behalf of the Patented Medicine Prices Review Board--and we will call ourselves the PMPRB from here on out, as it is a lot easier--I am pleased to have this opportunity to appear before this committee to discuss the work of the National Prescription Drug Utilization Information System, also called NPDUIS. These acronyms are in our jargon, and if they become part of your jargon, we'll just use those acronyms if it's okay.
With me today is Barbara Ouellet, Executive Director of the PMPRB. Following my opening remarks, I will be pleased to respond to any questions you may have.
Permit me to preface my comments today by offering a very brief overview of the PMPRB's role and mandate. We appeared before this committee last year, and many of you have probably heard these next comments, but I see there are new members sitting around.
The PMPRB was established by Parliament in 1987--we've just celebrated our 20th anniversary--under the Patent Act as an independent quasi-judicial tribunal. Although part of the health portfolio, the PMPRB carries out its mandate at arm's length from the Minister of Health.
The PMPRB has a dual role. The first part of that role focuses on the PMPRB's regulatory function, which is to ensure that prices charged by patentees for patented medicines sold in Canada are not excessive, thereby protecting consumers and contributing to overall Canadian health care. This involves the review of prices of more than 1,100 medications. So every year we have 1,100 or so medications under our jurisdiction, and each year, on average, we have 75 new medicines that come under our umbrella.
Pursuant to the Patented Medicines Regulations, 1994, patentees file information on their patented medicines sold in Canada, including on pricing information. In the event that the price of a patented medicine appears to be excessive, the Board can hold a public hearing and, if it finds that the price is indeed excessive, it may issue an order for the reduction of the price to a non-excessive level and for the offset of the excess revenues accrued by the patentee.
Our reporting role constitutes the second part of our mandate, and I believe this is mostly what you're interested in today. Under this role the PMPRB reports on pharmaceutical trends of all medicines and on research and development spending by pharmaceutical patentees, hence contributing to informed decision- and policy-making. The PMPRB reports annually to Parliament through the .
In addition to these reporting responsibilities, under section 90 of the Patent Act the has the authority to direct the PMPRB to inquire into any other matter.
In October 2002, following approval by the Federal-Provincial-Territorial Ministers of Health of a Business Case for the implementation of the National Prescription Drug Utilization Information System (NPDUIS), the Minister of Health directed the PMPRB to undertake specific areas of activity related to this new system.
NPDUIS is conducted through a partnership between the PMPRB and the Canadian Institute for Health Information--and you've just heard Ms. Yeates explain her role in all of this. CIHI is responsible for the creation and management of a database of individual public drug plan claims-level data and produces reports of broad interest to stakeholders, while the PMPRB undertakes most analyses of trends in pharmaceutical prices, expenditures, cost drivers, and key policy-relevant questions as described in the business case and endorsed by a steering committee composed of participating federal-provincial-territorial drug plan managers. All jurisdictions are currently participating except Quebec. Ultimately, NPDUIS is a tool to inform and support decisions on drug utilization, cost trends and projections, and overall policies of federal-provincial-territorial drug reimbursement programs.
The work of NPDUIS is not directly linked to Health Canada’s responsibility for post-marketing surveillance of pharmaceuticals; however, NPDUIS does involve a number of complementary activities.
NPDUIS was originally envisaged to provide a range of important and objective information on: aggregate drug cost and utilization trends as well as factors driving drug utilization, using nationally standardized indices, prescribing patterns, and potential impacts on drug plan budgets from new, or about to be launched, drug products.
Since the inception of the NPDUIS, the PMPRB has released a number of publications under its NPDUIS analytical studies series, the most recent of which include: Pharmaceutical Trends Overview for selected provinces and First Nations, published in June 2006, which examined expenditure and price trends among public drug plans; Guidelines for Conducting Pharmaceutical Budget Impact Analyses for Submission to Public Drug Plans in Canada, from May of last year, which set out best practices, tools, and methodologies for use by the pharmaceutical industry in predicting the potential financial impact of introducing a new pharmaceutical as part of its submission to a public drug plan for purposes of obtaining the plan’s agreement to list the drug on its formulary and provide reimbursement for beneficiaries; and the New Drug Pipeline Monitor, June 2007, which, on an ongoing basis, identifies and summarizes information on new drugs that are expected to be launched in Canada within the next two to five years that could potentially have a significant impact on federal, provincial, and territorial drug plan expenditures.
A list of additional NPDUIS publications and information can be found on both the CIHI and PMPRB Web sites.
NPDUIS projects currently underway include a new edition of the Pharmaceutical Trends Overview Report and a Methodology and Tool for Forecasting Drug Plan Expenditures.
With respect to the forward agenda for NPDUIS, last week the federal-provincial-territorial NPDUIS steering committee discussed potential research priorities for 2008 and 2009. These include financial implications for public drug plans of long-term demographic shifts, high-cost claimants, methodologies to identify prescribing patterns and track uptake of new drugs, indices to measure trends in drug therapy costs for major health problems, drug utilization relative to expenditure limitation arrangements, pharmacy dispensing fees, and rapid response for ad hoc requests.
The partnership between the PMPRB and CIHI and the collaboration with federal-provincial-territorial drug plans through the steering committee make NPDUIS a valuable resource that provides policy-makers with information and insights regarding Canada’s public drug reimbursement programs. For its part, the PMPRB is committed to making this partnership as successful and productive as possible, and to the best of its ability, using objective analytical expertise to analyze questions of public importance.
The PMPRB saw its reporting role further evolve in 2005 when it was directed by the Minister of Health, on behalf of himself and his provincial and territorial colleagues, to also begin monitoring and reporting on the prices of non-patented prescription drugs.
Funding for this initiative and for NPDUIS has been provided separately by Health Canada, but both activities will be merged under the umbrella of NPDUIS beginning in 2008-2009. This means that, to the extent possible and appropriate, future NPDUIS studies would analyze issues from the perspective of both patented and non-patented drugs.
Thank you. I would now be pleased to address any questions you may have.
That's all, Madam.
I can answer that question. First of all, the role of the PMPRB is to protect Canadian consumers from excessive prices. The meaning of the word “excessive” is poorly understood by the public because drug companies will tell you—as they no doubt did last time they appeared before you—that they spend a considerable amount of money on R&D. Our role, however, is to define the word “excessive” and we do that in several ways.
Firstly, our scientists analyse all of the clinical studies done on a drug. We ask them to identify therapeutic comparators, beginning with comparators in Canada, and if that is not possible, those in seven countries, for example the United States, Great Britain, France and so forth. We compare prices. A price is deemed excessive if it is much higher than the price of these comparators.
The public only looks at the excessive price. It thinks the price is high, but it may not be aware, however, that a particular drug is the only one that can treat a particular illness.
There are different categories of drugs. A drug that is the only available treatment for a particular illness would be a category 2 drug, meaning that its benefits are recognized as being much greater than those of its comparators. This fact justifies charging a much higher price for the drug.
I'm one of the new boys here, so I'm not as informed as some of the other members. But as I understand the process, we're trying to determine how we can lessen the effects from drugs, either through human error or some defect in the drug that wasn't caught in the pre-examination.
As I also understand it, from what has been said by other witnesses and what you're saying, the only people who report to the Ministry of Health are pharmaceutical companies, although it's going to be suggested that hospitals report. Doctors don't and long-term-care people don't—the others who Doctor Bennett referred to.
You, Ms. Yeates, only look at human error. I think that's what you said. So there appears to be a problem.
Monsieur Benoit, your issue is that you have a general mandate and you can get into all kinds of things.
Because of that, I look to both of you, through your experience and what you're doing, for recommendations to the Government of Canada as to how the process could be improved.
We'll start off with you, Monsieur Benoit.
When I look at the documentation provided in your presentation and past presentations, I see that on this question of data collection we have the MedEffect of Health Canada, we have NPDUIS that is shared between both your organizations, CMIRPS with CIHI, and COMPUS with the Canadian Agency for Drugs and Technologies in Health.
We have these four parallel organizations. Then we also have everything happening under Infoway, which hopefully is within these, but there might be some other silos or some other organizations. Yet at the end of the day, we hear from our witnesses, and I think it was confirmed, not statistically but in principle, by Dr. Benoit, that we know about only 10% of serious adverse effects or events, and we know very little about what we wouldn't consider serious--serious being something that requires hospitalization or further treatment that you can't necessarily solve by just discontinuing treatment--but what could be relevant.
It would seem to me that we should have 100% of those. Hopefully we'll be able to resolve that and get hospitals and clinicians to report on those.
In the case of those that are not life-threatening or that we don't consider serious--and I put this to Dr. Benoit as a practitioner--how do you know about them through your system? I know it would apply, especially in the case of off-label use of drugs, but even with regular use of pharmaceutical products for which there can be some adverse events that are not life-threatening, how do you know about events in the past or elevated risks involving them, under other practitioners?
Is there a good way out there? Is there a good exchange of information?
I will ask my colleague to speak to some of the other databases and the linkages, but initially I would just make the distinction.
I am not a pharmacist, so this is a distinction that was not initially obvious to me. But in regard to the language, we were asked and funded specifically to develop a database to gather information on “medication incidents”, which are distinct from, as I've learned, “adverse events”. Medication incidents are really about the processes of care.
Certainly I think we've seen a number of hospitals in this country that have had tragedies in emergency rooms, for example, where medications that looked very similar or that were stored in an emergency room were inappropriately given and they had tragic results. The concern was that one of these situations occurred in eastern Canada—I think it was in Halifax, or within Nova Scotia—one occurred in Saskatchewan when I was there, and they've occurred in Alberta, yet it seemed we had no place to actually collect those kinds of problems. So we were funded specifically and asked to develop a database to collect in-hospital medication incidents.
I think it will be a very important database. Currently we've developed the structure to find the definitions. The system is ready for piloting in September. I should be clear that at this time I can't answer what proportion or what kinds of inputs we will get to that.
We have been working with others, such as the Canadian Patient Safety Institute, because we realize it will take on-the-ground support for individual physicians and hospitals to be encouraged to actually submit data to the database. We have partnerships there to try to encourage that kind of submission so that we can build the database so we don't have to make the same mistakes in one part of the country as we've made in the other, but rather, we can learn from them.
The distinction that I've had to appreciate, since learning of this, is “medication incidents” versus “adverse events”. When we do get data, at the current time it's designed to do the one and not the other.
I'll ask my colleague to speak to some of the linkages you mentioned.
From the outset with the CMIRPS project, the vision was that it wasn't to be built in silos. So if you look at the organizations that have been involved in the product from the beginning, Health Canada is certainly up front, as is the Canadian Patient Safety Institute, within their mandate of safety within the country, and the Institute for Safe Medication Practices Canada, or ISMP, has also been involved in the field.
If you look at the components of the data we're managing to collect, there will certainly be incidents or errors that will occur that are essentially associated with the product. So we have naming, packaging, labelling, look-alikes, and sound-alikes. Certainly that's data that Health Canada is very interested in, in their legislative role, so we would look at making sure that data is available.
We talk of the entire environment of reporting. This is not a mandated reporting area, so this is a cultural change. This is a change from a reporting culture of naming and blaming to one of learning and sharing. The system design is really there to share the data. We want to be able to share the incidents or errors that occur back with the institutions where they occurred, do that in an aggregate way so that they can look at other institution incidents, and then use that data to put in place safety strategies.
CMIRPS, from the beginning, is a cooperative venture. We have most of the players at play. Certainly in our initial consultations we include health care practitioners—nurses, physicians, pharmacists—those involved with the delivery of medications within the institutions.
So from our perspective, it's well linked right from the outset. It's a good concept of sharing that data. We're the data gatherer and we're to make sure that the data we gather is valuable, that the data set is useful, and that we find mechanisms to share that in a privacy-sensitive way.
I want to especially thank you for coming out on such a snowy day. We're so glad that you were here in Ottawa and not caught in some airport today. Your insightful wisdom has been very helpful to every member of this committee.
As you know, we do have two more items of business. To committee members, if you want to talk with the witnesses--I would ask the witnesses to leave the room very quickly so we can complete our business--any conversations can be held outside that doorway over there.
Thank you again.
Committee members, we're now going on to a couple of other items. As I mentioned at our meeting on Tuesday, we'll be asking the committee today to adopt a budget to pay witness expenses for our study on post-market surveillance. The request at this time is for $39,950.
I would like the clerk, if she would, to speak to this. A couple of comments might answer some questions before they've been asked.