Good morning, ladies and gentlemen. It's very good to see everybody here this morning.
Today we are going to be listening to witnesses from the area of pharmaceutical products, prescription and non-prescription, on the post-market surveillance.
We have two orders of business to deal with at the end of the meeting. The first is the motion by Ms. Judy Wasylycia-Leis, and we will deal with that at 12:45. We have another piece of business as well. But seeing as our witnesses are here this morning, we want to make very good use of their expertise and time, and very good use of the time the committee has to ask them questions.
Pursuant to Standing Order 108(2), I'd like to welcome you to the fourth meeting on post-market surveillance of pharmaceutical products, prescription and non-prescription. We have pharmacy professionals who will be taking part in today's panel. We have representatives from the Canadian Society of Hospital Pharmacists, the Canadian Pharmacists Association, Ordre des pharmaciens du Québec, and the National Association of Pharmacy Regulatory Authorities.
I would like to remind the witnesses that you have ten minutes per organization to make your presentations. The committee will hear your presentations first before proceeding to the questions.
Let us begin with Ms. Myrella Roy, executive director of the Canadian Society of Hospital Pharmacists. Welcome.
Madam Chair, honourable members, ladies and gentlemen, thank you for the opportunity to present to you today. Merci pour l'occasion de présenter à votre comité aujourd'hui.
My name is Myrella Roy, and I am the executive director of the Canadian Society of Hospital Pharmacists. Before accepting this position, I spent 17 years as a hospital pharmacist and clinical manager with the Ottawa Hospital. The society is the national voice of hospital pharmacists in Canada. We are a not-for-profit organization committed to the advancement of safe, effective medication use and patient care in hospitals and related health care settings.
Today I wish to bring to the committee the perspective of our 3,000 members across the country on the issue of post-market surveillance of pharmaceutical products in Canada, both prescription and non-prescription. In particular, I want to comment on the proposal within Canada's food and consumer safety action plan to introduce hospital-based mandatory reporting of serious adverse reactions to federally regulated health products.
The action plan, as you know, proposes a new approach that helps prevent problems in the first place, targets the highest risks, and responds rapidly to protect the public.These are noble goals indeed, but we are concerned that the move to mandatory reporting of all adverse reactions could make it harder, not easier, to identify the highest risks and respond rapidly to protect the public.
l also want to share with you a proposal for how these goals could be achieved in relation to medication and patient care. Let me begin by making it clear that the Canadian Society of Hospital Pharmacists strongly supports measures to improve patient safety in Canada, and we do recognize the need to increase the percentage of adverse reactions to medications that are reported. We applaud the recent efforts by Health Canada to make online reporting possible, and we welcome the additional local and regional offices that will make it easier for health practitioners and consumers to report.
We are, however, quite concerned that the move to mandatory reporting of all serious adverse reactions will create an avalanche of data, and that searching for and finding the critical information within that data will be more difficult and more time-consuming. The additional time and effort, in the end, may contribute little to the overall body of knowledge on medications and adverse reactions. That's because much of the new data will come from adverse reactions to medication that are in fact well known and anticipated. Pharmacists and physicians know about these serious effects and anticipate them as an extension of the drug's therapeutic effect. We know, for example, that patients who receive warfarin, a commonly used blood thinner, may experience an increased risk of serious bleeding, or that patients undergoing chemotherapy may experience low blood cell counts.
Traditionally, these anticipated adverse reactions and the resulting hospital admissions are not reported, which helps explain why less than 2% of adverse reactions leading to hospital admission are reported to Health Canada. Making it mandatory to report all of these anticipated adverse reactions will not only create an avalanche of new data, it will also place considerable strain on the pharmacists, physicians, nurses, and other health professionals who work in Canada' s hospitals and related care settings. Given the shortage of these professionals and their already high workloads, it comes as no surprise that the workload required to report adverse reactions has been identified as a barrier to reporting in previous surveys. Any requirement to report all serious adverse reactions must consider the reality of shortages and growing workloads among Canadian health care professionals.
The greatest risk in creating so much new data from adverse reactions that we know of and anticipate is that the most valuable information will be lost or diluted by excessive amounts of information we already know. Instead, the society believes the reporting program should specifically target new adverse reactions for existing products and serious adverse reactions for new products. Focusing on these two types of new adverse reactions will provide health care professionals and consumers with quality information they can use and allow us to identify and respond to emerging risks more quickly.
Instead of moving to a new mandatory reporting program, we support enhancing the programs already in place to include reports of new serious adverse reactions. Diagnosing these adverse reactions and their causes will likely be very challenging, since there may be a number of active conditions being treated with a number of medications. It can also be difficult to detect whether symptoms are related to the medication or to the disease being treated. That's why we recommend a multi-disciplinary team approach to assess each case, including pharmacists, physicians, and nurses.
We also strongly support an expanded education and awareness program targeting health care professionals and students, designed to reduce or eliminate many of the motivational barriers to reporting that will not necessarily be addressed by the new action plan. Mandatory reporting does not address the motivational barriers that currently prevent health care professionals from reporting adverse reactions, such as the fear of negative feedback, questioning the purpose and usefulness of reporting, or the desire to publish findings independently. We are confident that an education campaign focused on reporting new serious adverse reactions will prove more effective in the long run than mandatory reporting.
Finally, there's a need to enhance information retrieval from the existing Health Canada adverse reactions database, called the MedEffect database. Consumers and health care professionals need greater access to the information contained in the database. They need this information in a format that allows them to make informed decisions. Currently the database can be searched by drug, but the details of each of the reports can only be accessed by looking at each one individually. This makes it much more difficult to assess any drug reactions.
In short, the Canadian Society of Hospital Pharmacists strongly supports the goals of Canada's food and consumer safety action plan. In many important ways those goals are aligned with the society's own mission and vision. We are concerned, however, that the move to mandatory reporting of all serious adverse drug reactions in Canadian hospitals will make it harder, not easier, to achieve those goals. Instead we call for a more focused approach that concentrates on information we can use: new adverse reactions to existing medications and adverse reactions to new medications. This focused approach will make better use of existing reporting programs and databases, make better use of the valuable time of Canada's hospital pharmacists, and when combined with a multi-disciplinary team approach to assessment, will generate higher-quality information with which we can protect Canadians.
Thank you for the opportunity to present our concerns and solutions. I would be pleased to answer any questions you might have.
I invite you to ask your questions in the official language of your choice.
Thank you, Madam Chair.
Good morning to everyone.
I'm the executive director of the Canadian Pharmacists Association, and I'm joined this morning by Denis Villeneuve. Denis is our board member from Quebec, and he's a community pharmacist practising in Quebec City.
I'd like to thank you for this opportunity to present to the standing committee today.
The Canadian Pharmacists Association was established in 1907. We celebrated our centennial last year. We're a voluntary membership association that represents the interests of Canada's 30,000 pharmacists. We do not represent pharmacies or the pharmaceutical industry.
As we know, pharmaceuticals play an increasingly important role in our health care system. For more than 10 years drugs have made up the second largest share of health spending, reaching $26.9 billion last year. But as more and more Canadians benefit from drug therapy, the number of concerns about safety and adverse drug reactions is increasing.
I'm going to hand this over now to my colleague Monsieur Villeneuve.
First of all, thank you for having invited us and for allowing me, as a community pharmacist who has worked in my field for 30 years, to come and share my thoughts with you.
The Canadian Pharmacy Association strongly supports measures to increase patient safety, including increasing capacity for monitoring, surveillance and research; and the reporting of adverse drug reactions. For professionals, for pharmacists and for myself as a community pharmacist, patient safety is a priority. Safety needs to be part of the entire chain of events that begins when the prescriber orders a medication until the results are apparent in the patient.
A strong system must be in place to ensure safe and effective use of medications—one that includes a progressive early warning system for adverse drug reactions, post-market surveillance, and education of health care professionals.
I have prepared a chart in order to explain the complexity of the process to you, which begins from the moment a problem is discovered, whether it be by a health care professional, a doctor, a pharmacist or a patient. You can see that the process is complex and has the potential for an adverse event and potential harm. You must always remember that the patient is at the centre of the process.
We begin by recognizing the problem and beginning treatment, taking into account the analysis that has been done of the case and the patient's situation. Then, we implement was is called the health care plan and the treatment objectives. The information is given to the patient, who is supposed to use the drug according to instructions while watching for signs of improvement and adverse effects. The patient finds himself or herself managing the treatment and informing the professionals of what is happening. It is a cycle that repeats itself: the patient is satisfied or has adverse effects.
Whether or not the medication is prescribed or non-prescribed, there are different actors involved in the process, including the patient.
There are many adverse reactions. According to the statistics, from 37% to 68% of adverse drug events are said to be preventable. But in order to prevent these, the right decisions have to be made at each stage of the process that I have briefly described to you. Moreover, health care professionals are being asked to make rapid decisions, often with limited information or support.
Patients have little support to be involved in the decision-making process, but increasingly, within the context we are discussing here, they are being expected to take on greater responsibility for their care, as well as that of family members.
To help health care professionals and patients make better decisions, we believe education, information and tools must be readily accessible to them.
Before getting into our recommendations that relate specifically to issues around improving drug safety, I'd like to comment on the concept of mandatory adverse drug reaction reporting, which we believe is being confused with overall steps that need to be taken to improve drug safety.
The Canadian Pharmacists Association is strongly supportive of measures to increase patient safety. We were one of the founding organizations of the Canadian Patient Safety Institute, and we certainly support the need to increase the reporting of adverse drug reactions. However, we believe a multi-pronged approach is needed and are concerned that too much attention is being placed on mandatory ADR reporting as the quick-fix solution.
In terms of making reporting of serious adverse drug reactions mandatory, we question whether all other avenues have in fact been exhausted. Increasing the quality and richness of ADR reports is as important as increasing their number, perhaps even more important, since high-quality reports allow for high-quality analysis.
We feel that mandatory reporting will not improve the quality of ADR reports, it will simply increase their quantity. It may even compromise the system's efficiency and effectiveness by increasing the volume of clinically insignificant reports.
Another concern we have is the issue of enforcement. When you use the word “mandatory”, it often goes with enforcement. We question whether this is feasible and whether Health Canada would be able to devote and maintain sufficient resources for mandatory ADR reporting in terms of compliance or analysis.
We also see the potential for such a development to place significant burdens on already time-pressed health care providers. In fact, we can find no evidence from other jurisdictions that mandatory ADR reporting really supports improved patient safety, and we wonder why mandatory reporting has been singled out for discussion when a more integrated approach to informing Canada's drug safety system is called for. Prior to launching a program whose success is yet to be proven, other viable and perhaps more effective alternatives, we believe, should be examined.
With that in mind, we'd like to make the following recommendations.
We need to establish and aggressively promote education and training programs for health care professionals that focus on better use and better ADR reporting. Health care providers should be encouraged to participate voluntarily in reporting ADRs. An international experience demonstrates meaningful participation when those involved are willing participants. A successful ADR system must be simple to use and must fit into the busy practice of the health care provider. This will also allow for effective expert analysis of the quality data gathered so that we're better able to identify hazards and trends.
We believe that government should invest in innovative research relating to methods of detecting, evaluating, and reporting adverse drug reactions, and support quality decision-making during the prescribing and medication use processes. That's critical to long-term safety and effectiveness. I think a particular focus of the research needs to be the role of the consumer with respect to non-prescription medications and natural health products.
The federal government, through Health Canada, should invest in an electronic ADR reporting system that will integrate reporting forms into the software used by health care professionals at the point of care. These electronic systems should be integrated into prescribers' offices, pharmacies, and hospitals. They essentially should become part of the future developments around the electronic health record.
On another note, we believe that the federal government should fully fund the business plan for the real world safety and effectiveness of medicines in Canada, a project developed as a part of the national pharmaceutical strategy. We need to support the development of the network of centres of excellence proposed in this report.
Pharmacists must also be supported to play a greater role in ensuring the quality use of medications and in reporting adverse drug reactions. Pharmacists are the only health care professionals with a full-time university education devoted entirely to drugs and their use. Better integration of their knowledge and skills into the health care system through collaborative practice arrangements will go a long way to solving many of the problems in medication use in Canada.
Our final recommendation is that we must include the pharmaceutical industry as a partner in establishing programs and processes to ensure the safe and effective use of medications. The pharmaceutical industry possesses considerable data that, when combined with adverse drug reaction data collected by Health Canada, will help decision-makers and health care providers take steps to ensure the safe and effective use of medications. The industry has very effective methods for collecting and disseminating information that can be used to the advantage of Canadians.
On behalf of the Canadian Pharmacists Association, thank you for the opportunity to present our views on this important subject today.
Madam Chair, distinguished members of the House of Commons Standing Committee on Health, allow me to introduce myself. My name is Claude Gagnon, pharmacist, and I'm president of the Ordre des pharmaciens. Ms. Manon Lambert is the director general and secretary of the association.
We wish to thank the members of the Standing Committee on Health for giving us this opportunity to share some of our thoughts on the subject of post-market surveillance.
The mission of the Ordre des pharmaciens du Québec is to protect the public by ensuring the quality of pharmaceutical care and services provided to the public, and by promoting the appropriate use of medication in society. In order to fulfil its mandate of protecting the public and thus fulfil its mission, the Ordre des pharmaciens du Québec delivers licences to practice, guides pharmacists in the exercise of their duties, ensures that the competence of its members is maintained and evaluated, receives complaints from the public and deals with them, controls the illegal exercise of the profession and intervenes publicly on issues related to the use of medication.
The Ordre des pharmaciens du Québec has almost 7,000 members who practice in various work environments, but mainly in the private sector—community pharmacies—and in health care institutions.
As is true of many federal organizations, including Health Canada, the reason for the existence of the Ordre des pharmaciens du Québec is first and foremost the protection of the public.
That's why we would like to take this opportunity here this morning to share our thoughts about federal authorities in the framework of this committee. Although we are aware that we are not directly addressing Health Canada officials, since the result of your work may well influence federal policies and procedures, some of the comments we make here today will therefore be addressed to the federal government in general.
Post-market surveillance and pharmacovigilance in general regarding healthcare products sold with or without a prescription are at the heart of the pharmacy profession in Quebec and in Canada. Since we don't have much time here, we will limit our speaking points to some of the main topics of discussion on this subject, notably pharmacist expertise in post-market surveillance; the need for a surveillance process the integrity and transparency of which are beyond reproach; adequate communication between professionals and organizations; and an effective pre-marketing approval process .
Our health care system is currently confronted with unprecedented challenges both in terms of material resources and organizational and human resources. It is difficult to imagine changes in the way we do things without increasing expenditures. Some of what we will say here today will therefore be based on the assumption that it is necessary to invest funds to improve the system. The result will be Canada's increased capacity to face the challenges of the 21st century in this matter.
The delivery of our health services is provided by professionals who have developed multiple skills over the years, but these are not always utilized in an optimal fashion. This is particularly the case for pharmacists, and we constantly repeat that they are among the most underused health professionals despite their accessibility, availability and unique skills in pharmacotherapy.
In Quebec, the Pharmacy Act lists six activities that are reserved to pharmacists. Among them is the surveillance of medication therapy. This surveillance is not just concerned with the effectiveness of therapy, but also its safety. Indeed, side effects, whether or not they are expected, account for a considerable number of interrupted or modified therapies.
It is a reflex among many health care professionals to wonder whether a certain symptom or health problem could be relieved through medication. However, few such professionals, in fact none except for pharmacists, have the reflex of wondering whether a medication is not the cause of the symptom or medical problem in question. The training and skills of pharmacists in this regard are undeniable. We have to learn to use them better and, in addition, make pharmacists more aware of regulatory bodies. We'll get back to that.
Over the past few years, the pharmaceutical industry has had its share of problem situations which, it must be admitted, undermined its credibility somewhat, or even a great deal. One simply has to think of Vioxx to understand the effects of such a decision on the public. For society, the same issues come to the fore whenever similar situations occur. What did the manufacturers of the product really know? How long did they know it? One could also raise a number of questions regarding the organization responsible for approving the marketing of the product and the agency responsible for post-market surveillance, namely, Health Canada. In a case like that of Vioxx, it is easy to see at the very least an apparent conflict of interest between public safety and corporate profits. In such situations, we must also ensure that the regulatory body responsible for protecting the interests and safety of the public always act quickly and transparently.
Health Canada approves the marketing of a product in good faith, based on the information provided by the manufacturer. In that context, the same organization must constantly face the dilemma of allowing access to innovative new therapies as quickly as possible while respecting the safety of users. Conversely, given the obvious risks for public health, the organization in question must act with the same celerity to demand the withdrawal of a health care product that is too risky for users in spite of the potential benefits.
The federal government must take the necessary means to ensure that its regulatory body acts at all time with full integrity and transparency.
When Health Canada receives information about adverse reactions, it logs it and attempts to determine whether the reaction can be related to the drug in question. In order to do so, Health Canada seeks the manufacturers' cooperation, and this is done not in a confrontational manner, but in the spirit of partnership. This is, after all, the era of partnerships. As a result of this working relationship, a significant number—if not the majority—of communiqués sent to health care professionals are issued by manufacturers and not by Health Canada. This allows manufacturers to demonstrate their apparent willingness to be actively involved in post-marketing surveillance. Such a modus operandi could be indicative of Health Canada not having sufficient resources to do the work itself, or it could be that legal considerations at least partly explain the decision to proceed in this manner.
Whatever the real reason may be, if everything were being done effectively, quickly and in the best interests of public safety, the end could perhaps be said to justify the means. There is evidence to suggest, however, that that is not necessarily the case. In November 2006, Health Canada approved the anti-inflammatory non-steroid drug Prexige (lumiracoxib) for sale for the long and short-term treatment of signs and symptoms of knee osteoarthritis in adults. In July 2007, the indications were broadened to include general osteoarthritis in adults.
It is worth noting that the FDA never authorized the drug for sale in the US. It should also be noted that lumiracoxib is part of the same family as rofecoxib (Vioxx).
In August 2007, Health Canada's Australian counterpart, the Therapeutic Goods Administration, withdrew Prexige from the market due to a number of reports of serious liver adverse events. On August 15, 2007, following the Australian decision, Health Canada published an information update on new safety information regarding Prexige. In this update, Health Canada stated that once it had reviewed the available data, new information would be released to Canadians and Canadian health care professionals, including any resulting recommendations.
Would it not also have been appropriate to advise professionals of this?
On October 3, 2007, Health Canada informed Canadians and the health care professionals that it was stopping sales of the drug following its assessment of safety data provided by Novartis carried out following the Australian government's decision to withdraw the product from the Australian market.
Health Canada stated that decisions issued by other countries can be interpreted as a red flag when dealing with new drugs for which little data is available. In spite of this, a drug which had been deemed dangerous, and which had been withdrawn from the market in at least one other industrialized country, was still available to Canadians for almost two months. Bear in mind that we are talking about a drug that belongs to the same family as Vioxx, withdrawn from the market in probably the most dramatic circumstances we have seen in recent years.
Why does Health Canada have to analyze data for two months before withdrawing market authorization, even temporarily? On the same day, Ms. Meena Ballantyne, an assistant deputy minister at Health Canada, made public project 1540, which proposed the addition of five medicinal ingredients to schedule F of part I of the Food and Drug Regulations. Included amongst these new ingredients to be added to schedule F, as I am sure you will have guessed, was Prexige.
This is what project 1540 had to say about lumiracoxyb:
||Lumiracoxyb is a non-steroidal anti-inflammatory drug that is used to treat pain and swelling in adults, such as osteoarthritis of the knee. Treatment with lumiracoxyb requires individualized instructions or direct supervision by a practitioner, particularly in patients with heart or liver disease. The patient may also require treatment with other drugs and routine laboratory monitoring. Lumiracoxyb may cause undesirable or severe side effects at normal therapeutic dosage levels.
Here in Canada, following an event such as an air crash, it is not for the manufacturer, or indeed even the Department of Transport, to carry out an inquiry. Instead we have the Canadian Transportation Accident Investigation and Safety Board, which is directly accountable to Parliament via the Queen's Privy Council for Canada and is independent from all other departmental and governmental bodies. To foster public confidence in the investigations and inquiries, the investigative body must not only be objective, independent and free from any conflict of interest, but must also be perceived as such.
Is it not about time that the government consider setting up a similar body to ensure transparent post-market surveillance of drugs? A system for ensuring the communication of information concerning adverse drug reactions ought to be clearer, bidirectional, and as effective as positive.
The National Association of Pharmacy Regulatory Authorities is honoured to appear before this committee today.
Our organization represents most of the provincial and territorial pharmacy regulatory authorities. During this presentation I'll be speaking to the role of the pharmacy regulatory authorities; the regulatory tools that are currently employed, specifically with regard to adverse drug reactions reporting; the challenges posed by mandatory ADR reporting; as well as the opportunity that partnerships could bring.
The Food and Drugs Act and the Controlled Drugs and Substances Act and their associated regulations define how prescription drugs may be manufactured, advertised, labelled, and sold. This legislation informs pharmacists and others of their responsibilities in the procurement, sale, and recording of the sale of prescription drugs.
However, the practice of pharmacy comes under provincial and territorial jurisdiction. The territorial governments retain responsibility for regulating the profession. However, the profession is self-regulating in the provinces, with the authority to regulate delegated through provincial legislation to the members of the profession. The fundamental role is protection of the public.
The Pharmacy Regulatory Authorities regulate people, places, and things. They regulate the practice of pharmacists, the operation of pharmacies, and the conditions of sale of non-prescription drugs. The regulation of pharmacists is accomplished through three core processes defined within legislation: registration or how to become licensed or enter practice, complaints resolution, and continuing competency assessment.
In addition to provincial acts and regulations, other regulatory tools include standards of practice, bylaws, and codes of ethics. These tools combined form a robust system that fully defines the expectations required of pharmacists in order to fulfill their duties. Any deviation from or dereliction of these duties is cause for complaints to be brought against a pharmacist. The complaints are investigated by the regulatory authority, and if sufficient evidence is found, the pharmacist is required to appear before a jury of his peers to answer to the allegations.
The reporting of adverse drug reactions is an expectation of practising pharmacists. In British Columbia, adverse drug reactions reporting is mandatory, as expressed in bylaws, which are approved by provincial government. Bylaw 44(4) states: “Where an adverse drug reaction as defined by the Health Protection Branch, Health Canada, Guidelines for Reporting Adverse Drug Reactions is identified, the pharmacist must notify the patient's practitioner, make an appropriate entry on the patient record and report the reaction to the BC Regional Adverse Drug Reaction (ADR) Reporting Centre.”
In Alberta, standard of practice number 4 states: “If a pharmacist determines that a patient has or is likely to have a drug-related problem, the pharmacist must take appropriate action.” This is further defined under section 4.2, “the appropriate response may include any one or more of the following:” and includes (g) reporting an adverse reaction to the Canadian adverse drug reactions monitoring program.
Ontario's standard of practice number 1.7 states: “The pharmacist documents and reports any unexpected adverse drug reactions to the prescriber and other health care providers as appropriate, and complies with formal adverse drug reactions reporting programs.”
Other provinces have addressed adverse drug reactions reporting within standards of practice, guidelines, and professional practice policies, or alternately, have referenced the Guidelines for Reporting Adverse Drug Reactions to Marketed Drugs publication by Health Canada. In short, the regulatory tools to encourage adverse drug reactions reporting by pharmacists already exist.
The reporting of adverse drug reactions is a key component of a robust, comprehensive post-marketing surveillance program on the use of medications in humans. Yet it has been estimated that only a small percentage, less than 10%, of these events are reported. The regulatory tools are already in place to require pharmacists to report adverse drug reactions where appropriate. Yet it seems that neither the presence nor the absence of regulatory tools is the trigger that drives adverse drug reactions reporting. This suggests there are many more challenges that need to be addressed and that mandating adverse drug reactions reporting does not seem to provide a plausible solution.
Many challenges have been identified to adverse drug reactions reporting, many of which have been previously addressed in the 2005 Health Canada discussion paper “Designing a Mandatory System for Reporting Serious Adverse Reactions”. They include lack of training and recognizing adverse reactions, lack of awareness of the existence and benefits of a reporting system, time and effort required to do so, and the lack of familiarity with how to report. I am uncertain that the implementation of a mandatory adverse drug reactions reporting system addresses these challenges.
Another challenge not identified in the discussion paper is the lack of comprehensive, reliable data upon which to assess whether or not an adverse drug reaction has occurred. Great strides have been taken in the development and implementation of a pan-Canadian electronic health record. It is Canada Health Infoway's goal for 50% of Canadians to have their electronic health record available to health professionals by the year 2010. However, until health professionals are able to access the electronic health record for all Canadians, the depth and the quality of information that's required may not provide the results desired with an adverse drug reaction reporting.
Enforceability is yet another issue, and brings forth the question of where the responsibility lies. Pharmacy regulatory authorities have the authority to perform practice audits and site visits to monitor registered pharmacists and licensed pharmacies. However, not all hospital pharmacies are licensed by the pharmacy regulatory authority in each province.
In addition, this is a very resource-intensive activity for the pharmacy regulatory authorities, who rely almost exclusively upon fees collected from licensing and registration of pharmacists and pharmacies as an annual source of revenue.
Finally, should adverse drug reaction reporting be mandated through federal regulation, there is now the question of who should have the responsibility for monitoring and enforcing the regulation.
NAPRA is supportive of adverse drug reaction reporting as part of a comprehensive post-marketing surveillance system that has the ability to look closely at real-world experiences with the goal to identify adverse drug reactions in populations outside a clinical trial setting in order to protect the Canadian public from harm. However, NAPRA does not feel that mandating adverse drug reaction reporting and increasing the regulatory burden will accomplish this goal. It may be more appropriate to adopt a systems approach with other partners and stakeholders contributing to a surveillance and reporting system with a common goal of promoting quality health outcomes.
What is required is a substantive culture change, facilitated through education and communication, to build awareness of the importance of adverse drug reaction reporting as well as the clarity of what is expected. Enhanced development of advanced technological solutions that are easy to use will encourage the reporting of adverse drug reaction to be incorporated into daily practice. Effective data analysis and reporting mechanisms to ensure that informed feedback is available and accessible to health professionals in a timely manner will serve to reinforce the practice of reporting.
We need to think about the role of the federal government, the provincial and territorial governments, professional regulatory authorities, and health professionals, as well as such stakeholders as industry, the Canadian Patient Safety Institute, the Institute for Safe Medication Practices, and academia. If attention can be focused here, and a willingness can be secured from all parties involved to make this issue a priority, it is a certainty that adverse drug reaction reporting events will continue to increase, as they have in the past, without the need to mandate.
What you are telling us here today is very interesting. For our part, we want to understand how the system works and how the Department of Health is involved.
Mr. Gagnon, you talked about subjects which to me are worrisome. We see that there are medications on the market with known undesirable side effects. You mentioned Vioxx. You said, among other things, that certain products should perhaps be withdrawn from the market, given the data from countries where they have been withdrawn. Gardasil caused the death of five people. I do not know if it was in Belgium, but it was in Europe.
The other day, I asked someone from Health Canada whether, given the five deaths that occurred in Europe, there shouldn't be a moratorium on this product, and whether we could use the data. I was told that this was not up to Health Canada but rather up to the Canada Public Health Agency. Already, this is complicated. Health Canada has told us that this is not the department's responsibility because it is a vaccine that comes under Public Health, and yet, Health Canada approved the marketing of this product.
You are saying the product should be withdrawn, but does this have to be immediate? What kind of tests could be done? I know that in Europe, they are analyzing the effects of the product and the reason why it may have caused deaths.
I am putting the question to Mr. Gagnon, but other witnesses can shed light on this subject for me. For our part, we are going to have to recommend steps with regard to Health Canada, and that is one of the issues at stake.
Allow me to respond. I omitted part of my speech. That was precisely my point.
I would not want people to lose their trust in the system, be it the professionals or the general public. When we offer a product for sale in our pharmacies, it is because we think it meets the standards for protecting the public. Of course, we know that there are adverse drug reactions, but that they are not major ones; they are supposed to be minor and acceptable. In fact, patients are informed about them.
What is serious is that products that may lead to death among certain people can get through a gate that we can't imagine. We think that the tests done in advance by the manufacturer should be able to detect that kind of thing. Right now, marketing may be accelerated. Post-market surveillance is being demanded in order to detect problems. However, I do not think it is normal that we wait for deaths to occur before we take action, regardless of where they occur on the continent. Whether there are one, two or three deaths, a red light should flash and we should temporarily suspend the sale of that drug until we have the answer. It is up to the company to provide that, and it should not be the public who pays the price. This is where we want to raise public awareness.
Many products are currently at the pre-marketing stage. They have not been licensed and are sold illegally, in theory, since they are accessible to the public. This year, 64 products were withdrawn from the market. Of these, sixty were contaminated by bacteria, contained toxic heavy metal and had not undergone the pre-marketing process. Post-marketing is all very well, but the pre-marketing rules should also be respected. A product should not be sold if it has not received all the authorizations, all the patents necessary to guarantee its quality to the public.
That is the main message we want to convey, and I think it is important for you to take a look at this.
As a general rule, the pre-market review reveals the most common ADRs.
Normally, between 2,000 and 3,000 patients will have tried the drug before it is marketed, although, of course, it all depends on the type of drug. In light of the number of patients who participate in trials, it is clear that we endeavour to strike a balance between getting the drug onto the market and having adequate knowledge of it. Obviously, asking manufacturers to test the drug on a larger number of patients will delay its introduction to the market. Nonetheless, in some cases, I think that is what needs to be done. In spite of pressure brought to bear by manufacturers for financial reasons, in some cases, that is indeed what needs to be done. As I said earlier, however, in other cases, depending on the type of disease, or whether the drug constitutes a therapeutic breakthrough, or whether the patients have no other options available to them, it is sometimes preferable to accept a greater degree of risk. I think that is important to assess the risks and the benefits, and to take stock of what constitutes acceptable risks in a given situation. I do not, therefore, believe that it is appropriate to use the same approach in all cases.
The progressive licensing concept is an attractive concept, because I think we know from our experience and the drugs we've talked about—Vioxx, Cisapride, and there's a long list of drugs that we've had over the last 20 years—that we really only truly learn about drug safety through use. Conceptually, there's lots of attraction around just getting the drug into the market as soon as we feel it's reasonably safe, and then monitoring its use in 10,000, 20,000, or 30,0000 patients in order to know whether it's truly safe or not.
So I think the concept of progressive licensing is probably where we need to go. I think the challenges are around actually making sure the systems are in place at a practice level to ensure that we can effectively collect all of the relevant data to make sure we can make a good assessment of safety. And then further, on top of that, there is this need to really better develop systems that support the safe and effective use of drugs.
We've just published a book written by a Canadian who won the Harkness Scholarship this year. It is called Safe and Effective. The Eight Essential Elements of an Optimal Medication-Use System. It deals with issues around the evaluation of drugs prior to marketing, but more importantly, it deals with what needs to actually be done in practice to make drug use safe. We can make a copy of this available to committee members.
I think that conceptually, progressive licensing is probably the way we need to go. But a lot of work has to be done in terms of building the systems that would actually support that in the practice environment.
I'm glad you didn't find something that was completely opposite to what I'd said this morning.
We know development happens slowly. I think, from the profession's perspective, we recognize that we actually have to try to change and develop better systems.
One of the things we've done as an association that publishes a lot of information about drugs is actually shift a lot of our material into a digital format. It can be accessed through a web portal and made available online to health care professionals at point of care. So from our specific association's perspective, we've done a lot to improve the delivery of information to health care professionals.
I think the other thing that's happened is that we, and most of the associations represented here, have actually started to build our links with two groups—other health care providers, in our case particularly physicians, and also patient groups—to begin to understand some of the issues that consumers have. We have made some progress in terms of developing more collaborative approaches.
I think the question of an independent agency comes up fairly frequently. I think that's an interesting one that we may have to look at more closely.
Something that we've called for, as an association, is what we've called a national medication management centre that would look at drug safety, effectiveness, and appropriate use, and that would be a stand-alone, independent agency. I think we've made some progress, but obviously there's still more work needed.
As Mr. Tilson pointed out, four years ago the committee suggested that mandatory reporting would be a good idea. I think at that time we heard the reaction from both physicians and pharmacists that they were too busy and it wouldn't really help that much, and it had better be user friendly. Four years later, we're still having 10% of adverse reactions being reported. So I don't think we've done a very good job changing the culture or doing the education or all these things that were supposed to be done in a voluntary way.
I also was a little confused last week by the testimony, on the hospital side, about incident reports, because my experience in hospitals is that the incident report is usually done only if you've been given the wrong drug. It isn't necessarily a predictable reaction. A little rash or something doesn't usually get an incident report.
So if we are going to develop a real learning culture around this, and we only have 10% of the data, what are we going to do? I don't know whether it's in the nice blue book over there or not, but I think in terms of Myrella's testimony, it's just noise if you keep hearing the same things again. And if you're not disaggregating the data.... Is this only women that the noise is about? Is it only women who had grapefruit juice for breakfast? Is it only women taking echinacea? We actually could be learning if we actually report and then find all this out.
How are we actually going to design a system in which we have 100% of the data or even 85% of the data, instead of this pathetic 10% with which we cannot, I don't think, learn.
It has gone extremely well. We launched the product into the marketplace two or three years ago. It's a web portal.
As you know, we publish the big blue book, the Compendium of Pharmaceuticals and Specialties, which is a collection of Health Canada product monographs. We also publish a book called Therapeutic Choices, which is like a set of clinical guidelines to drug use in particular diseases. As for what e-Therapeutics is, we actually integrate the content from those two publications and make them available online.
So the system is working. It's working very well.
For a physician who is treating a particular disease and wants some information, it recommends drugs that could be used, but then the physician can click on that drug and go to the full monograph to get information. The important value of it as well is that we are able to incorporate advisories from Health Canada directly into that system. So in the example we had about the warning from Australia about the risks of serious hepatic adverse drug reactions associated with the non-steroidal anti-inflammatory drug, as soon as Health Canada issued that advisory, we had it on our website being delivered to those physicians, pharmacists, hospitals, and institutions that subscribe to our e-Therapeutics product.
The uptake has actually been slower than what we had anticipated. As you know, the funding was issued on the basis of it being a sustainable business model. We're close to sustainability, but one of the things that are hampering uptake a little bit is the delay that we've seen in the implementation of provincial drug information systems. But the system has been incredibly well received by practitioners.
If I could make a comment, I would urge caution here. We have to be careful not to blow things out of proportion without good reason. As long as information is provided appropriately, some drugs can be available freely over the counter. Obviously, it is important to educate the public, it is important to have awareness-raising campaigns and to underscore the importance of not exceeding the recommended dose. It is not the product itself that is dangerous, it is the amount that people take. No drug — be it non-prescription, pharmacy-only sale, or prescription — is without risk if the patient does not follow the instructions or fails to take the recommended dose. This is something that the general public has to understand.
We have a message to communicate. We cannot be negligent, it is imperative that the public receive the right information and that they are educated. Adverse effects frighten people. People have to be aware that they exist, they have to be educated, but they must also be reassured. What is important is how we can empower people.
Health Canada gets information after the horse has bolted, but at any rate, I think that there is a general realization that the department has no authority and, hence, no power to act. In what is, I would imagine, an attempt to show good faith, manufacturers withdraw their product from the market even before an official recommendation has been made. That probably explains why the general public is informed ahead of health care professionals. I think that Health Canada should be the first to be informed and should then immediately notify health care professionals.
Professional associations in Quebec, and in other provinces as well, I would imagine, post information on the Internet to facilitate quick access. Furthermore, when a product is considered dangerous, a fax is sent to all Quebec pharmacists. If we have the information in time, it will be delivered in time, but we have to have the information. At the moment, there is no feedback. I think that that is one of the shortcomings.
I want to thank our panel of witnesses. Unfortunately, we've run out of time. My apologies.
We're really going to have to get all of you back again. There are so many questions to ask, and there's so much to hear.
I want to wish you a happy Valentine's Day, I want to thank you for your presence here, and I want to ask a special favour of you. We're going into committee business, so I'd be so pleased if you could depart in a very timely manner. If anyone wants to talk, I would wish that you would go out of the room, beyond that door, to do that.
Thank you, panel.
I would like to have the committee go directly to committee business. We have committee business that we need to attend to.
First is the notice of motion put on the table by Mrs. Wasylycia-Leis.
Mrs. Wasylycia-Leis, would you like to read into the record your motion, please? Then we will discuss it.
I didn't really want to read it into the record, but I did want to explain why it's here.
It really isn't to challenge the government on what it has done or not done in the area of health care, but to acknowledge the fact that we have, by law, a health act that requires annual reports to Parliament. That report is a very important tool for monitoring and analyzing the effectiveness of the system. But we've had some difficulties getting that report dealt with—even to this committee. I'm not sure how you've dealt with it in the past few years, but early on, when I was a member of this committee, it was often very hard to get the report on a timely basis and then to get the minister to the committee to talk about the report.
So I'm suggesting the motion because of that, and because of the fact that we've had an Auditor General's report talking about the fact. I just wanted to mention her concerns about the failure to properly monitor the Canada Health Act. That was in 2002 report of the Auditor General. Back then she said, “Health Canada has made only limited progress in addressing the weaknesses we identified in our 1999 audit. As a result, its monitoring still does not allow it to assess and report the extent of provincial and territorial compliance with the Canada Health Act.” Therefore, we don't really have a way to resolve disputes, even if we can identify them.
So I want this to happen, just so the committee can have a mechanism to be involved in a very important process to ensure that the act is being enforced, and so that we can have a good conversation with the minister about any problems identified and whether or not there are enough resources being put towards monitoring the system.