Good morning, ladies and gentlemen.
I would especially like to welcome our medical professionals today. We have people from the Canadian Medical Association, the Federation of Medical Regulatory Authorities of Canada, the Ontario Ministry of Community Safety and Correctional Services, and the Canadian Men in Nursing Group.
We welcome you. We're very happy you could make it to our committee this morning. We will have your presentations very shortly.
Before we do that, I would like to remind members that we should leave approximately 15 minutes at the end of the meeting to deal with the motion from Ms. Wasylycia-Leis. We also have a budget to consider for future witnesses. Some of our witnesses are coming from quite far away, so we really have to deal with that today.
Pursuant to Standing Order 108(2), I would like to welcome you all to the fifth meeting on post-market surveillance of pharmaceutical products, prescription and non-prescription.
I would like to remind the witnesses that you have 10 minutes per organization to make your presentations. Keep your eyes on me, because I will cut you off and I don't like to do that. I just want to make sure everybody gets a chance to speak, and that all members around the table get a chance to ask you questions. We will hear all your presentations before proceeding to questions.
Let us begin with Dr. John Haggie, chair of the Canadian Medical Association.
Good morning, ladies and gentlemen. On behalf of the Canadian Medical Association and our more than 67,000 physician members across Canada, I welcome the opportunity to participate in your committee's study on post-market surveillance of prescription drugs.
In addition to being the chair of the CMA board's committee on pharmaceutical issues, I'm also a practising physician from Appleton, Newfoundland, so I can also speak to the clinical aspects of this issue.
To effectively monitor the safety and effectiveness of the country's drug supply, the CMA believes a strong post-market surveillance system should include an effective process for gathering drug safety data coupled with a simple, comprehensive, and user-friendly reporting system; a rigorous process for analyzing this data to identify significant threats to drug safety; and a communications system that produces useful information distributed to health care providers and the public in a timely and easily understood manner.
Canada's current post-market surveillance system requires considerable development if this is to be accomplished. In our more detailed submission before you, the Canadian Medical Association presents recommendations that will support optimal patient health and safety and meet the information needs of health professionals and the public.
The CMA recommends Health Canada be given the tools, including regulatory authority, to require post-market studies of newly approved drugs if clinical trials identify possible safety risks that require manufacturers to disclose information if Health Canada deems it germane to making a decision in the interest of patients' safety, and to take action if post-market research uncovers new safety concerns. This could mean ordering changes to product labels, or even pulling a product off the market.
However, this enhanced authority will be useless unless Health Canada is given more resources to analyze and evaluate the information it receives. Without additional resources, merely increasing the number of ADR reports will only add to the backlog in the in-boxes of analysts.
In 2007, a coalition of Canadian research centres prepared a document, a business plan, for a drug effectiveness and safety network that proposed an integrated and comprehensive network of centres of excellence to support evaluation of drug safety and effectiveness in Canada. The committee should consider this concept and recommend moving forward.
On the reporting of adverse drug reactions, it's important to emphasize that this is only one possible way of gathering drug safety information. More structured post-market studies should also be considered as a way of augmenting spontaneous reports. The CMA acknowledges that ADRs are under-reported both in Canada and worldwide. We support measures that would strengthen Canadians' capacity to report these reactions.
Such measures could include a user-friendly reporting system, improved follow-up capacity, linkages to international post-approval surveillance systems, active solicitation of ADR reports from all health providers, and limits on what should be reported. There's no reason to require reports of side effects that are already known to be associated with given drugs. The reactions Health Canada most needs to know about are those that are unexpected or occur in newly approved drugs. There should also be incorporation of the ADR reporting process directly into the electronic medical records.
Our list does not include mandatory reporting of adverse drug reactions. If you build a comprehensive, efficient, and effective post-market surveillance system, physicians will participate actively in it. Forcing them to participate before the system has been built will result in failure and alienation. Moreover, we strongly remind the committee that provider reporting by itself does not constitute a rigorous system of surveillance.
Post-marketing surveillance doesn't exist in a vacuum. We believe that government should take other measures as well to promote the safety and effectiveness of prescription drugs. Real-time information is essential for effective surveillance. CMA strongly recommends that governments invest in supportive information technologies that will greatly increase physicians' capacity to report adverse drug reactions.
New prescription drugs, especially those that represent a therapeutic breakthrough, must be made available as quickly as possible to those who could benefit from them. However, improvements to post-market surveillance should not be used as a justification to lower the standards for a pre-approval review.
The CMA supports a risk-based approach to product safety assessment, with regulatory requirements that are greater for products with greater risk and lower for those with less risk. Health professionals and the public must have access to all information, both positive and negative, about new products. Health Canada should make the results of all clinical trials available to health professionals and the public. However, physicians believe that direct-to-consumer advertising, or DTCA, of prescription drugs inflates the market for potentially risky drugs and does not provide the public with enough information to make appropriate choices. We recommend that brand-specific DTCA not be permitted in Canada and that the loopholes permitting a limited amount of brand-name promotion be closed.
Canadians do have the right to accurate, unbiased information on prescription drugs and other therapies to help them make informed health decisions. The federal government should develop and fund a comprehensive program to provide accurate, unbiased, and independent prescription drug information for use both by patients and health professionals. The CMA is prepared to work with other stakeholders through a comprehensive program to promote optimal prescribing and drug therapy monitoring by health professionals. Such a program should be founded not on sanctions but on education, including objective academic detailing to ensure that information is accurate and impartial; the use of information technology and practice tools; be organized and implemented with the participation of professional and patient organizations; and include strategies to improve patients' knowledge of, and adherence to, drug regimens.
The Canadian Medical Association will develop a vision for an optimal prescribing program and implement portions of it over the coming year. The CMA commends both the standing committee and Health Canada for their intent to reform Canada's post-market surveillance system. Canada's physicians are prepared to work with governments, health professionals, and the public in strengthening this system to ensure that the prescription drugs Canadians receive are safe and effective.
Madam Chair and committee members, I thank you for the opportunity speak to you today on this important issue of post-market surveillance. My name is Douglas Anderson, and I am the president-elect of the Federation of Medical Regulatory Authorities of Canada, or FMRAC. I'm also the associate registrar of the College of Physicians and Surgeons of Ontario.
I'm addressing you today on behalf of FMRAC and its 13 members, the provincial and territorial medical regulatory authorities. These are more commonly known as the colleges of physicians and surgeons in each province. They are statutory bodies established by provincial or territorial legislation to do the following: serve the public interest, establish and maintain the standards and honour of the profession, establish rules for the proper professional conduct of its members, determine qualification for registration and licensure, and determine and evaluate the competency and conduct necessary to maintain registration and licensure.
I will address two issues regarding post-market surveillance: first, respective roles of Health Canada and our member medical regulatory authorities; and second, the responsibilities of practising physicians.
Monitoring the safety and the efficacy and quality of prescription and non-prescription drug products after they have reached the marketplace is a complex process. It includes surveillance and inspection, adverse reaction reporting with subsequent reports, communication of health risk to professionals and the public, and compliance verifications and investigations. The medical regulatory authorities have a number of policies dealing with drugs and prescribing issues. For example, the College of Physicians and Surgeons of Ontario, where I work, has specific policies. I won't bother to read these, considering the time.
These policies for the most part focus on clinical, administrative, or prescribing issues: for example, appropriate clinical indication for some drugs, appropriate office procedures for managing drugs, and avoiding medical errors, etc.
Another member, the College of Physicians and Surgeons of British Columbia, has a review program to evaluate prescribing by physicians of mood-altering drugs and narcotics, identify multi-doctoring for the purpose of obtaining addictive drugs, oversee and ensure the appropriate prescribing of methadone in addiction treatment, and evaluate the treatment of chronic non-malignant pain through the appropriate use of narcotics. The College of Physicians and Surgeons of British Columbia has access to detailed data on physician prescribing that is not available in other jurisdictions. B.C. PharmaNet is a province-wide network that links all B.C. pharmacies to a central set of data systems. PharmaNet supports drug dispensing, drug monitoring, and claims processing.
Endeavours by the federal government to work with the provincial and territorial governments to expand this kind of initiative across the country would be greatly supported by FMRAC and its members.
It is important to note that these policies and programs do not directly address the safety, efficacy, and quality of prescription drugs and non-prescription drugs after they have reached the marketplace. We agree it is important for physicians to report adverse drug reactions. It is the opinion of FMRAC and its members that the coordination of this activity is best handled by Health Canada. I'll address this later.
The role of the medical regulatory authorities can be a facilitative one, in the form of transmitting information through their respective publications or websites. There are several examples of this across the country. Even this role presents a challenge to our members. The medical regulatory authorities frequently receive bulletins from Health Canada describing drug recalls, adverse drug reaction problems, cautions with respect to specific agents, and so on.
It is not clear to the medical regulatory authorities what Health Canada expects them to do with this information. Information can be posted on the websites with links to Health Canada, or it can be highlighted in a newsletter. However, information sent by Health Canada to the 13 provincial and territorial medical regulatory authorities is not necessarily passed on to all practising physicians, for several reasons, including the cost consideration, legislative mandates, and timeliness of our publications. We cannot assume responsibility for confirming that practising physicians have had access to and have read and understood the materials produced by Health Canada.
As I stated before, FMRAC and its members believe in the importance of reporting adverse drug reactions. Several have promoted this issue to practising physicians through various means, including publications—for example, newsletters, and websites.
A reporting system that encourages reporting rather than one that potentially penalizes non-reporting would be more fruitful in the longer term. Technically a mandatory reporting system should be accompanied by means to monitor and enforce this compliance. FMRAC is of the opinion that in the current federal-provincial-territory structure for health care, this is not possible. The medical regulatory authorities have no means of detecting lack of compliance, other than by the established complaints process. If a provincial or territorial medical regulatory authority receives a complaint about a physician who has not reported a serious adverse drug reaction, it will deal with it, as with all other complaints, through our due processes.
We would support a simple reporting system for physicians, possibly linked to the electronic medical record. At this pre-implementation stage of the EMR and the electronic health record, EHR, it would be useful to create a field for quickly reporting an adverse drug reaction directly to Health Canada. If the tool is intuitive, timely, and easy to use, this reporting could be done as part of the regular patient-physician encounter.
Any reporting mechanism is only as good as the ultimate use that is made of the information provided. It will be important to include credible, timely monitoring of this information. This role should be within Health Canada's mandate.
Here's an example. A physician reports a mild to moderate adverse drug reaction through the EMR. Health Canada has been monitoring all the reports, and it notices that this represents the one hundredth such report across the country within the last year. The surveillance is raised a level and a request for more information goes out to the 100 physicians. As this activity now requires a significant time commitment on the part of the physician, it would be helpful for Health Canada to have worked with its provincial and territorial counterparts on appropriate remuneration for this activity.
From a medical regulatory perspective, a system for reporting adverse drug reactions should also be a learning tool for the providers, physicians, and others. Once a report has been filed with Health Canada, it would be useful if there was an electronic exchange of information between Health Canada and the health care professional. An example of meaningful educational information from Health Canada would be data on trends, numbers of reports received on a particular drug and the nature of the reports, and suggested courses of action. Providers are more likely to make the effort to produce and submit a report if they know they will receive valuable, timely information in return that will help them provide optimal care to their patients.
It would also be very useful and educational for the physician who has filed a report to receive information on the end result: were the modifications made to the drug profile, to the recommended dosage? In addition, an acknowledgement to the physician for their valuable input is always welcome.
Once a simple and timely system based on sound educational principles is in place, FMRAC and its member medical regulatory authorities would gladly promote its use to practising physicians across Canada.
I would like to thank you for your attention, and I would be pleased to answer any questions.
Good morning, Madam Chair and members. I'm here representing Dr. Bonita Porter, the Chief Coroner for Ontario, who unfortunately couldn't be here and sends her regrets.
What I'd like to do this morning is give the members a brief overview of death investigation in Canada and in Ontario in particular—which is what I know best—speak about our role in adverse drug event reporting, and perhaps offer some suggestions to the committee for their consideration.
In Canada we have a mixture of death investigation systems. We have medical coroners, as in Ontario; lay coroners, as in provinces like British Columbia; and medical examiner systems, as in Newfoundland, Alberta, and others. Dr. Haggie represents one such system. In the Northwest Territories, Nunavut, and the Yukon, there are lay coroners. That's simply related to the lack of resources and people in those areas, and the vast distances.
All coroners and medical examiner systems, however, have the same goal in mind. There are mandatory questions that must be answered about deaths that are investigated, there is a need to support the criminal justice system, and finally, there is the goal of advancing public safety.
In our office in Ontario we investigate about 20,000 of the 80,000 or so deaths that occur per annum in the province. Those investigations are conducted by approximately 300 coroners, all of whom are practising physicians in Ontario and all of whom have full-time jobs doing something else, except for people like me; I represent one of the nine regional coroners who report to the chief coroner for the province.
Of the 20,000 deaths we investigate per annum, approximately 15,000 are determined to be natural, and it is in that category of death that we find most of the adverse drug events. Over the years we have not had, in my view, the majority of cases reported, and I think this parallels reporting in other jurisdictions and other systems. A variety of factors relate to that, many of them common to the difficulties faced by physicians in practice in general.
For your information, over the last five years there were 176 adverse events reported that were associated with death but did not directly cause the death. Those are “involvements”, or what we term to be “significant contributors”, but not the actual cause of death. Over those five years we had 18 cases reported in which it was felt that the adverse drug reaction itself caused the death. My strong suspicion is that this number under-represents the total significantly. I think the committee should be aware of that, and it does speak to the need to enhance the reporting mechanisms available in Canada to report these kinds of events.
In our work as coroners we make liaison with organizations such as yours, obviously, in the Parliament of Canada, and also with ministries in Ontario, such as the Ministry of Health and Long-Term Care and the Ministry of Labour. We've recently had dialogue with Health Canada and had a visit from Ms. Pepper, who represented the Canada Vigilance program and spoke to us about the need for us to liaise with them. We certainly support that need and initiative and want to increase and enhance our involvement with Health Canada in this regard.
Since 2001 there has been a formal request directed at coroners on behalf of the chief coroner to ensure that adverse drug events are reported. We have recently revamped our investigation information system, which is comprehensive and computer based, to allow us to capture more accurately the type of drug adverse reaction that has occurred, so now we capture the adverse drug reaction, which we define as a “noxious or unintended response to a drug that is used at therapeutic, prophylactic or diagnostic doses” and “directly leads to death”. That's a situation in which we would call it the death factor or the prime cause of death.
We also track, however, what are termed as “involvements”. An involvement, to us, is a serious adverse drug event that contributes to the death, but doesn't cause it directly. This is our definition; it differs from the Health Canada definition. Perhaps it is most germane to think of those as the iceberg and the small number of cases in which death actually occurs as the tip. Nonetheless, both are very important.
We do a number of things in response to situations in which an adverse drug reaction has caused a death. We may call an inquest. An inquest in Ontario is a relatively uncommon event now, for a variety of reasons. There used to be hundreds; there are now perhaps 50 to 70 per year, and of those the vast majority are mandatory.
We may call what's called a regional coroners review, which is a formal review in a committee-like setting with the health care provider or institution to discuss the event that occurred and hopefully generate findings and recommendations aimed at the common goal of advancing public safety and preventing a similar death in the future.
We may refer the case to one of our expert committees, and one of those committees is the patient safety review committee, which I chair. That committee is comprised of a multidisciplinary group. The Institute for Safe Medication Practices is represented by Mr. David U. There are various specialists in medicine, nursing, systems safety, and we will review cases in a paper manner and produce a report, which is then distributed to the concerned parties, including the providers and, of course, the next of kin.
That information is often disseminated through other media—one such example would be the Dialogue of the College of Physicians and Surgeons of Ontario, or the Canadian Medical Association Journal, and so on—to try to increase the knowledge of practitioners and people who ought to be aware of the problem.
We find at that committee that about a third of the cases we see have some involvement with medication. It is a very prevalent and prominent issue for us, and we think it is for you as well.
I would just say in closing that we are most prepared to participate in reporting and liaison with Health Canada to try to advance the common goal of improving the safety of the public in Canada.
Good morning, honourable members of the committee. It is with great pleasure and honour that I speak to you today about post-market surveillance of pharmaceutical products.
My name is James D'Astolfo, the founder and president of the Canadian Men in Nursing Group.
Our organization represents men in the nursing profession and is made up of registered nurses, practical nurses, and nursing students. Our organization's mission is to provide a voice for men in nursing, in the hope of supporting and strengthening the image of nursing. We intend to pursue our mission by collaborating with governments, organizations, and other health care professionals and by showing leadership in our communities and internationally. Additionally, it is our organization's mandate to ensure that health issues are being heard both by governments and within other organizations.
I'm sharing my time today with Mr. Irfan Aslam, vice-president and director of finance for the Canadian Men in Nursing Group.
Nurses play an active role in the safety, efficacy, and handling of prescription and non-prescription drugs and provide administration, education, and support to patients and their families, both in their communities and in acute and non-acute health organizations. We have outlined a number of recommendations, which we hope the committee will adopt as part of its blueprint for renewal.
Here are our recommendations on consumer safety. Consumer safety is an important aspect in the handling of both prescription and non-prescription drugs and plays an important role in ensuring that the safety of Canadians is of high priority.
Recommendation one is to provide front-line health care workers, like nurses, with information on changes to pharmaceutical products.
Recommendation two is to ensure that nurses are equipped with resources and ongoing educational training to prevent medication errors in both acute and non-acute health organizations. The California Institute for Health Systems Performance stated in its report in 2001 that in improved work environments, promoting ongoing education was of importance.
Bar coding medication systems, other assistive devices, and educational workshops and in-services also play a critical role in reducing medication errors. The bar code system has been used to prevent medication errors. The bar code proposal would create a system in which patients receive a bar-coded identification bracelet that is linked to their medical history. Scanners linked to computerized medical records would verify that the proper medication is used. It was estimated through the FDA that the bar code system would reduce medication errors by 50%, making a significant financial saving.
Recommendation three is to ensure that medication labels are required to have both the generic and trade names on their products, that medication instructions are included and given to both the consumer and the health professional, that these instructions be translated into different ethnic languages to ensure effective compliance, and that they be made available through pharmacies in Canada.
Medication guidelines have been used by the U.S. Food and Drug Administration to help patients avoid serious adverse effects, inform patients of side effects of their products, and enhance the directions for the use of the product for its effectiveness.
Recommendation four. Canada being a very multicultural country, many ethic groups do not use only prescription and non-prescription drugs, but herbal and natural remedies as well. Some people believe that herbal products are harmless, but it is estimated that about one-third of drugs, including digitalis, morphine, and several chemotherapeutic agents, were developed from plants. So indeed, herbs are potent products.
Herbs can affect body functioning, and therefore, when herbs are taken concurrently with drugs, interactions are possible. This is why it is important that the committee look at including interactions between herbal remedies and pharmaceuticals as part of the Canadian adverse drug reaction monitoring program.
My name is Irfan Aslam, and I will go on with another recommendation.
Recommendation five is to ensure that Canadians are informed of any pharmaceutical product approval and non-approval in an open-access system that includes a summary of the rationale for approval or non-approval and supportive data. The consumer can then make an informed choice, along with their health care providers, as to future use.
As a member from the Canadian Medical Association suggested, the clinical trial data should be available to researchers who are conducting the research and also to Health Canada. Once we have all the available information in one place, it would make it easier to see what additional information is needed. Then action can be taken as to the safety of the drug.
Recommendation six is to provide evidence-based information in an efficient manner. We are living in an age of information technology, and I think the best way to perform this task is by having an e-learning tool for pharmaceutical education. The tool would be web-based e-learning for patients and health care professionals. It would include the correct way of taking medication, some dos and don'ts, and links to government web pages and different community supports so patients and health care professionals could learn more about the medications.
The next recommendation is about adverse event reporting. Currently, health care professionals are not obliged to report any adverse event. This can be changed. However, it should only be changed once the other pieces of the post-market surveillance system are in place. When we have all the other systems there to support the health care professional, you might want to consider making it mandatory, but it should not be done at this time.
The next recommendation is about the capacity for monitoring, surveillance, and research. We feel that more can be done in the area of monitoring non-prescription drugs, or what are called over-the-counter medications. One way to address this problem would be event monitoring. According to the British Medical Journal, many health professionals and researchers in England have found that prescription event monitoring provides a valuable addition to pharmacovigilance of prescription products in England. Many pharmacies have put in place the electronic linkage of computerized patient drug records and point-of-sale systems. This linkage could allow the systematic collection of data on the use of non-prescription medications, which might be a useful tool for monitoring over-the-counter medications.
Now, with all these recommendations and the recommendations that have been put forward by other colleagues, you might be able to come up with the best post-market surveillance program for pharmaceutical products. However, such a program will be useless unless you have enough personnel to implement the program. So our last recommendation is to recruit more health care professionals--doctors, nurses and people in Health Canada--to analyze the reported information. That would ensure that the proper implementation of any post-market surveillance of our pharmaceutical product program would be possible.
We would like to thank you for your time in hearing us today, and we hope you find some of our recommendations useful as part of your blueprint for renewal. We look forward to answering any questions today and in future.
Again, many thanks to the committee. Thank you.
Thank you, Madam Chair. I'm just going to ask a bit of a question, and then Susan will finish. If you would answer them together, that would be helpful.
To begin with, I wanted to hear whether you believe that in order to do your jobs better, in order to ensure patient safety, a diagnosis should be part of the prescription pad or that hopefully one day we will be e-prescribing.
Speaking to Mr. Anderson's concern about whether doctors have actually read something, in the electronic age it is quite possible to send something out and have it marked as read, at least. Should we not have the capacity in this country for Health Canada or somebody to speak directly to doctors? I know that during SARS we would have thought that it was a good thing.
Should there not be also, if it looks as though there's a cluster of trouble, an alert going out saying, remember, Vioxx is only for patients who have gastric problems; it is not recommended broadly. We could maybe have avoided something.
I guess that's just where I'm coming from in terms of using the technology to actually do what we need to do for Canadians.
Go ahead, Susan.
Thank you. Yes, it's along another line actually.
Mr. McCallum, you mentioned there was a discrepancy in the definition of “adverse drug reaction” between Health Canada and you, and you also broke it down that there was “involvement”, as you called it, or “contributing factor” and also “cause of death”.
I think we'd like to hear a little more elaboration on that, because that would seem to be very significant in terms of maximizing the information to prevent deaths due to adverse reaction.
If we have time, to the Canadian Men in Nursing Group, considering that the reporting is not mandatory now but rather optional, when as health care professionals do you feel it's necessary to voluntarily report? In other words, is there a common standard or criterion?
As well, if we have time, do the physicians discuss this issue with you? What is your role essentially, and are you relying on the physicians to report it? What is that relationship in terms of adverse drug reactions?
I'm glad you asked the question because I think I've left you with a mis-impression. There isn't a significant difference between the definitions as we put them versus Health Canada's. The wording might be slightly different, but the intent is very similar.
Let me just read to you the definition we use versus theirs, just to reassure you. The food and drug regulation definition of an adverse drug reaction is this: “A noxious or unintended response to a drug occurring at doses normally used or tested for the diagnosis, treatment or prevention of a disease or modification of an organic function.” That's Health Canada's definition.
Our definition is this: “Noxious, unintended response to drug when used at therapeutic, prophylactic or diagnostic doses. Significant morbidity/injury to patient, but did not directly cause death”. This is the involvement code.
We track involvements as well as death factors because it's important to have a three-dimensional picture of what happened to a person who died. So the involvement is a sublethal, if you like, or not lethal involvement of a drug, whereas if it's a death factor it is thought that the drug actually caused the death.
So our definitions are not significantly different, but we do have a different end point. Obviously Health Canada is interested in all drug reactions. We're interested in our population.
Because my colleagues seem to be catching up with the translation, I'll have a go at this.
I'm assuming that you're talking about off-label use of prescription drugs.
You are essentially talking about off-label use of drugs.
Several weeks ago, at a Health Canada meeting, I was surprised to discover that, for certain drugs in certain populations, such as the pediatric population, off-label use is more extensive than on-label use. The figures are really quite astonishing. You are right to say that this is not consistent with the regulations, but the fact is that medicine is constantly evolving, and off-label use of drugs can have some fairly significant beneficial effects.
I believe this brings us back to the previous question, which has to do with communication. There has to be a means of communicating quickly with the people writing prescriptions, the people using them and Health Canada, so that we can bring all those results together and arrive at a system that offers maximum benefits to patients.
That is a little outside of parameters of your question, but it is a very difficult issue.
I think everyone's looking at me.
I think there are a couple of very important points here. One is medication error. Medication issues have been highlighted in other jurisdictions, and in the Baker and Norton report, as a major issue.
I think I will just put that point to the side and concentrate on Madame Gagnon's initial point, which is about off-label use.
I think there are several factors that need to be recognized. One is that the label is related to the licence that's issued for that product. Often these licences are actually very narrow. For example, there currently are anti-arthritic or anti-inflammatory agents on the market that are indicated or labelled for use for arthritis in the knee only. If you write that prescription for somebody with a hip problem, you're using it off-label. From a pharmacological point of view, it's very difficult to justify scientifically why a drug will work on the knee rather than the hip. To be honest, I personally believe this is a marketing ploy, because it allows them to change the label later on, with the patent continuing to run from the date of the new label. That's one factor in terms of what's on the label in the first place.
The second thing is that there is an art to medicine as well as a science. In the negotiation on a case-by-case basis between a physician and a patient, it may be appropriate to use a drug in situation A that you wouldn't use in situation B. Technically that is outside the label. With time a lot of these things become established practice.
I think one of the reasons that pediatric practice makes bigger use of off-label indications is that when drugs are initially released on the market, they are labelled for adult use only; there are no comparable medications for children. Therefore, under those circumstances, do you treat or do you not? You have to say, well, this is technically off-label, but as an experienced pediatrician or pediatric surgeon, I have no reason to believe the pharmacology in the children in this situation is any different; therefore, this offers me an option that doesn't otherwise exist. If you look at some drugs on the market now, they were originally marketed as anti-tumour agents and are now used in children for rheumatoid arthritis, for example. That was started by experts in the field using the drugs on a case-by-case basis for off-label purposes.
So I think you have to allow the clinician a certain amount of leeway. And some of the issues with labelling may actually relate more to the label rather than the use.
You're right, there is a huge knowledge gap. The bulk of the information about pharmaceutical agents that the average practitioner receives comes from the pharmaceutical industry directly just because of ease and convenience. That's what the drug companies do. That's how they operate.
Our proposal incorporates moving away from that, to provide unbiased, impartial, peer-reviewed material available to a physician when he or she has a clinical problem in front of them and wishes to write a prescription. We provide excellent training for undergraduates in pharmacology and for residents in internal medicine and a whole variety of specialities in pharmacology. Those resources, with a little adaptation, could be made available to physicians who have been in practice for 20 years and haven't crossed the threshold of a medical school in that period.
So the work is there; it is how you deliver this. You can do it on an educational basis. Whilst we don't have a mandate as an association to do that, continuing education for our members is a vital interest. Dr. Shortt here is our new director and assistant secretary general of knowledge transfer, and that's going to be his mandate over the coming years.
In terms of actually writing a prescription in day-to-day office work, you need real-time electronic database access to something as simple in the electronic record as an Agilent. If you write a particular medication electronically for a patient who is, say, under three years old or over 80, and that is not appropriate...and there are such things as the Beers list. The list itemizes and updates the drugs that are inappropriate for the elderly, for example.
So by just incorporating that simple list, if you wrote a prescription for a patient over the age of 80 for a medication on that list, it would stop you at that point and say, “This is worth reconsidering. Is there a better drug you can use?” Perhaps it would even list some better drugs.
These are decision support tools. The pharmaceutical industry, or rather the pharmacists, have gone a long way to providing that network for their members at the dispensing stage, which is really a very appropriate and very easy point to do that. But a vast majority of clinicians in this country still use a paper and pen. Until you get around that and move to a system akin to the pharmacists', and that will speak to the pharmacists, you're kind of stuck with--
Thank you, Madam Chairperson. Thanks to all of you for very informative presentations.
Of course I'm tempted to ask especially the doctors and nurses what their reaction is to the federal budget, which didn't mention the shortage of doctors and nurses in our country today, but I won't.
I will, though, start my questioning—and if you want to skip it , feel free. I will reference the federal budget in this context of post-market surveillance. We saw in the budget what I would consider a rather piddling amount for health product and food safety, $113 million. I'm not even sure if that includes pharmaceuticals at all. I raise that in the context of the adequacy of our system now to ensure safety of products.
I reference the CMA's brief, where you make a very excellent point about...and I'll just quote from you because I think it is well worth putting on the record time and time again: “A strengthened post-market surveillance system should not be used as justification for lowering approval standards”.
I also reference the Men in Nursing brief, which says that “Ensuring that Canadians are informed of any pharmaceutical product approval and non-approval in an open–access system...” is absolutely critical.
I want to get at two big issues. One is to get your comments about the present system with respect to pre-market approvals and what's needed, from the CMA's point of view, to ensure we aren't condoning any attempt by the government to fast-track drugs by participating in this and making recommendations, follow what it would call the business transformation program, and do everything on the basis of pressure from the big brand-name pharmaceutical companies to get drugs through quickly without adequate testing. I want to know your reaction to that, what needs to be done.
Secondly, what mechanism would you put in place to ensure accountability and transparency in terms of drug information? Both of you and the others have mentioned this as well.
We've had a number of different suggestions. One is for the government being required to put everything on its web page in terms of all the studies and adverse effects that researchers and others have identified for every drug approved or not approved, and as well, to have an independent advisory board to offer advice and evaluate prescription drug safety.
I raise those two issues. I think you're all right in terms of suggesting that too much emphasis on mandatory adverse drug reporting leads us down a path where we will ignore the big issues. I'd like some advice around both the pre-market approval process and the transparent and accountable system you have in mind.
Does anybody want to start?
I can comment about the findings you mentioned about information we have available.
It is true we have a lot of information available over the Internet about different drugs, but sadly, most of that information is not evidence based. A lot of patients in my practice go to the Internet and look at different medications. They are obviously concerned about their health and the health of their loved ones, so they read this information and ask questions about one website saying one thing and another website saying the total opposite, and they're wondering which one they should believe.
I think government can do a lot about that. We can have just one system; we can have information available on web pages, some kind of e-learning tool that we proposed in our recommendations. It would have comprehensive information about the drugs. The patients don't have to look around for information that is not evidence based.
In this age of information technology, information is everywhere, but we need to try to promote the right kind of information that will be helpful to our patients and will help solve their concerns and current medical status. If they get that information, then they know the right questions to ask or who to approach for that information.
Thank you all very much for coming and providing your expertise.
I was listening to Madame Gagnon asking a question on the number of deaths in the United States. I expect it's not as high, but it's pretty bad in Canada as well. That's why we're holding these hearings as to how this can be improved.
I look at the issues, most of which you've addressed, which are whether reporting should be mandatory or voluntary, reporting serious reactions versus all reactions, and who's to do the reporting. Should everybody be involved: medical practitioners, nurses, pharmacists? I think the only mandatory reporting is with the pharmaceutical companies. I think we're talking about hospitals now.
And you get to the question where someone dies or has a very serious reaction, and there's a lawsuit. Everybody gets sued. Health Canada, the pharmaceutical company, the doctor that prescribed it. They don't know; no one knows. I think you gave an example of a drug that may have been prescribed for a hip and someone took it for a knee. So you don't know these things.
It would be useful if the committee had statistics as to the amount of litigation in this country on all these issues. Does anybody have any statistics? If there are only some for Ontario, that would be useful.
There are all kinds of causes. There are errors in prescriptions or that the drug should or should not have been approved. There's a patient who takes increased medication, or not enough; in other words, they broke the rules that the practitioner was recommending. There are genetic issues, the issue that Dr. Haggie raised about something that is good for one part of the body but not for another part. Are there statistics out there that could help us?.
When my mother was discharged from the hospital in early January, she was discharged with a piece of paper that contained the names of over 25 medications. Some she was to continue, some she was to stop, and some she was to start. There was a mistake, which I picked up. The pharmacist didn't know; it was on the piece of paper. Once they had plugged all the information into the pharmacist's computer, a drug interaction showed up.
We have the tools to do this; we're just not communicating. My mother has more than one physician—she has five physicians. Connecting this information is going to be very key to what we can do from now on.
Concerning your comment on the seriousness of the adverse drug reaction, the example we proposed was for a mild to moderate drug reaction. If somebody at the other end, at Health Canada, is monitoring the reports coming in through the electronic medical record, they have predetermined a number: if the severity is this, one is enough to get some feedback; if it's not, 100 may be enough.
Somebody has to be doing this work at the receiving end of the reports. Then we'll have a system in place that will be useful, educational, and used. That's where the “mandatory” may not be so important.
The issue of reporting an adverse event has been very cumbersome until lately. It has improved with Health Canada's MedEffect. Having said that, I would suggest that probably 60% of my colleagues aren't actually aware of its existence, even though it's been up and running for a while.
The difficulty with it is that the vast majority of primary care physicians, who probably write the vast majority of prescriptions in this country, aren't clear on what it is they're supposed to be reporting.
The side effects profile of a drug is documented in a thing called the Compendium of Pharmaceuticals and Specialties, which is a huge book and which has an arcane indexing system based on both the trade name and generic name. It takes probably four or five minutes to find the right page simply because of that. When you do, the information there, which is in very small print—and as you get a little bit older, that becomes an issue—is in a very logical and ordered fashion, but it's not usable. It doesn't tell me anything more about how that patient is likely to behave with that drug than I could have had, probably, without reading it, if it were a drug with which I'm familiar. Really and honestly, when you look in there for side effects....
I had a patient a few months ago who had what I thought was a significant reaction to an antibiotic I'd prescribed. They were jaundiced and they got worse, and I wondered if it might be the medication. I went to the CPS, and after 20 minutes of rummaging through there found that jaundice was a side effect of this particular medication. I stopped the medication, and the patient got better—and I did know more about it.
It was a significant adverse reaction, and it lengthened the length of stay with the patient. But the reason I stopped was that it was well known, well documented, and there was a percentage figure there in the book. Was my report going to add anything to the body of knowledge, based on what I understood of the system? I said to myself, no.
If you were dotting the is and crossing the ts there, then perhaps I was in some way culpable for not doing a report, but this is just a reflection of the utter lack of clarity about the current system. I didn't know whether it was a valuable thing to do, whether I was going to have problems with doing it, and whether it was indeed going to add anything. If it wasn't, then quite honestly I wasn't even going to spend the five minutes that would be required to log in on the Internet and do it, because I had other things to do.
I appreciated the comments you made.
I've been struggling with some of the testimony we've had. We know that we don't want our family practitioners to be burdened with more paperwork that doesn't have value. We know that we ask them now, if we need CPP, if we need insurance claims, to do a lot of paperwork that doesn't necessarily contribute to our health and that wastes our time. And that's very difficult in a time when we know that we have a lack of medical professionals.
But you made a point, I think, that if we structure this properly, this could be a very useful tool on both ends. You could have an electronic system that helps you in prescribing, as it did the pharmacist in Madame Lefebvre's mother's case. It could help you in prescribing and also make it very easy for you to report incidents without having to worry about whether they're significant or not significant. In the case of the jaundice situation you were talking about, you could have reported that case. It would have been two keystrokes rather than you having to spend an hour typing out a report. I think that would be useful, with the proper analysis.
It seems to me that with the initiatives we're taking on the Canada Health Infoway and with those investments being made--we already have a digital data transmittal system for billing for family practitioners--those things could be achieved, and I hope they will be.
Before I come back to it, I had a couple of questions for clarification for Dr. McCallum. You're saying that in the case of Ontario, you had 20,000 deaths that involved the coroner and that 15,000 of them were seen as natural deaths but involved a coroner. And a number of those were drug related. Some of them, you said, had a death effect and others were involvement. What were the numbers in each of those two categories?
Madam Chair, I wish to express our concern in this regard. Where health care is concerned, we have the Quebec clause as to how the motion should be interpreted. This may suggest that the Minister of Health should get directly involved in health care matters in the provinces. I want this to be included in the motion because it is consistent with the position taken by the Quebec Minister of Health—namely, that nothing is to be interpreted in a way that would interfere with Quebec's jurisdiction. That is the intent and the will of the Government of Quebec.
I don't know whether this would result in the provinces being given directives. If it only refers to exchanges of information, I have no problem with that. In any case, I think we could take advantage of the Minister's visit to ask broader questions, rather than limiting ourselves to the Canada Health Act alone. We could ask him about rare diseases, for example, or ask him to give us his impressions of our report. However, as regards the health care or drug insurance schemes, Quebec retains exclusively responsibility for planning, organizing and managing health care services in its area of jurisdiction.
This motion was moved by a member of the New Democratic Party whom I respect for her values and her contribution to discussions of the health care system and other policies. However, her propensity for excessive centralization is tantamount, as far as we are concerned, to non-respect of provincial jurisdiction, particularly as regards health care services.
I just want to make that point so that, if we do pass this this morning, that can be done based on the direction I have just laid out. Thank you.