Health Committee on Feb. 7th, 2008

[The Chair, Conservative, Joy Smith]

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.

[Glenda Yeates, President and Chief Executive Officer, Canadian Institute for Health Information]

Thank you very much.

On behalf of the Canadian Institute for Health Information, I want to thank you for inviting us to be part of your study on post-market surveillance.

[Glenda 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.

[The Chair, Conservative, Joy Smith]

Thank very much, Ms. Yeates.

Let us now hear from Dr. Brien Benoit, chairperson of the Patented Medicine Prices Review Board. Sir, could you give your presentation?

[Dr. Brien Benoit, Chairperson, Patented Medicine Prices Review Board]

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 Minister of Health.

In addition to these reporting responsibilities, under section 90 of the Patent Act the Minister of Health 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.

[The Chair, Conservative, Joy Smith]

Thank you so very much.

Members of the committee, the first round is seven minutes, and we'll address the questions to the witnesses.

We'll start with Dr. Bennett, please.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Thank you very much.

I need clarification from the chair. In terms of the federal-provincial-territorial working group or conference, are these witnesses prepared to answer questions on what they're up to, or will Susan Paetkau be re-booked?

[The Chair, Conservative, Joy Smith]

Yes, we will try to get her back here at another time. Thank you, Dr. Bennett.

[Carolyn Bennett, Liberal, St. Paul's, ON]

I thank the witnesses for the presentation. It's very helpful to the committee to hear what you're up to now, but I would love to know what you think should happen.

Dreaming in technicolor, if you had the best possible data in order to do post-market surveillance in a real-world way, what would that system look like? I understand that we haven't yet asked Infoway to come, but I believe that post-market surveillance can be Canada's present to the world, and that we could figure out a way to do things better because of our single-payer system.

At the moment, what I'm hearing is that CIHI is still getting only billing data and provincial drug program data. You're not getting data from long-term care institutions. Is that right? You're not getting hospital data, and you're not getting diagnoses. So you don't know why it was prescribed, and you don't get a notice if someone changes from this medication to that medication. Can you track that or not?

[Glenda Yeates]

Yes, we can.

[Carolyn Bennett, Liberal, St. Paul's, ON]

But in a real data set, if there were another field there that said why they'd changed, you would have a much better handle on what was going on. Is that right?

[Glenda Yeates]

We have a claims system, so it's all of the information that one would typically submit to a provincial government to make a claim: who did the prescribing; who got the prescription; what they prescribed; what they filled in terms of the prescription. But you're absolutely correct; it does not include diagnoses.

[Carolyn Bennett, Liberal, St. Paul's, ON]

It sounds as though you're trying to make patterns out of incomplete data sets. In terms of your being able to write a report, as the Canadian Institute of Health Information, you can't really give us a report on what's happening on drugs in Canada.

[Glenda Yeates]

Certainly NPDUIS, we believe, is a huge step forward. It will be a massive database, much better and bigger than everything we've ever had. We think it will allow us to track patterns that we've never been able to track before, because in some cases we may be able to link those to hospitalization, for example. We have other data sets. I've been asked to speak about the pharmaceutical ones, but we do have other data sets as well.

But you're absolutely right: there are some limitations to what you can do, even with these very large data sets.

[Carolyn Bennett, Liberal, St. Paul's, ON]

So if we're getting only 10% reporting on adverse reactions, and it sounds as though we're getting none from hospitals, the regulations don't seem to be there.

So tell me, in the best possible world, what would CIHI want to have in order to do your job properly, to be able to do an annual report? Would that include e-prescribing, where, with the identifiers off, the data came directly to you?

[Glenda Yeates]

I'll speak to both of those questions.

In terms of the adverse event reporting, first of all, currently no one submits that information to us, and there are no plans for that at the current time. We certainly believe that efficiency in data information is our strength. We think we're very good at standardizing databases. We have good relationships with data providers and in general we think we're a very good place to standardize data. Just as we are able to do that, develop NPDUIS, and then we have agreements with the submitting jurisdictions that we can give access to that data to PMPRB with their regulatory mandate, it's certainly possible that we could, if it were desired by all involved, perform that function as well.

I do think there is some efficiency to be gained by having the data collected as few times as possible, rather than in numerous ways.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Would you recommend that on the prescription pad or the BlackBerry prescribing, the diagnosis should be there?

[Glenda Yeates]

In terms of the electronic health record, we certainly see the future of what we sometimes call health system use or secondary use like this, drawn from an electronic health record, as being a tremendous efficiency. I think there's a tremendous possibility there.

I understand, for example, that in some jurisdictions diagnosis is not something that is permitted to be shared. I think that's the case in at least one province that I'm aware of. Certainly the limitations of public acceptability and what's available to be shared would need to be worked out. Certainly we think we are a good repositing place for that secondary use of data or the health system use. If we can simplify that and have it come directly from an electronic health record, we think that offers great efficiency in the future.

[Carolyn Bennett, Liberal, St. Paul's, ON]

There were two reports. One was the consultant's report on medicines that work for Canadians, the business plan. It was commissioned, I believe, by Health Canada. The other is the blueprint. Can you just tell us how involved you were in both those reports and whether you agreed with the recommendations and whether you see anything changing?

[Glenda Yeates]

If I'm understanding the reports you're referring to, we were not involved in those reports.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Were you involved, in PMPRB?

[Barbara Ouellet, Executive Director, Patented Medicine Prices Review Board]

No.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Maybe we could figure out what consultation means. I'm not sure they can do this without you two. That's a bit shocking, actually.

I think I'll stop there.

[The Chair, Conservative, Joy Smith]

Thanks, Dr. Bennett.

Madame Gagnon.

[Christiane Gagnon, Bloc, Québec, QC]

Thank you, Madam Chair.

Thank you for joining us today. I would like to begin by sharing some general impressions with you. Many players are closely monitoring the whole issue of pharmacovigilance, or the science of assessing the safety and effectiveness of pharmaceutical products, including your organization. What the committee needs is an organization chart showing all of the players, along with their different responsibilities.

Does Health Canada have this kind of organization chart that shows what responsibilities different organizations have and who reports to whom? Today, we are hearing from two of the main players, the Canadian Institute for Health Information and the Patented Medicine Prices Review Board. It is rather difficult for us to see how your respective responsibilities are connected, even though you claim to work with each other. Is an organization chart like this available from Health Canada?