Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 23 - Evidence - October 24, 2012
OTTAWA, Wednesday, October 24, 2012
The Standing Senate Committee on Social Affairs, Science and Technology met this day at 4:18 p.m. to study prescription pharmaceuticals in Canada (topic: post approval monitoring).
Senator Kelvin Kenneth Ogilvie (Chair) in the chair.
[English]
The Chair: Honourable senators, I call the meeting to order.
[Translation]
Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
[English]
The Chair: My name is Kelvin Ogilvie. I am a senator from Nova Scotia and chair of the committee. I will ask my colleagues to introduce themselves starting on the left.
Senator Eggleton: Senator Art Eggleton, from Toronto, and deputy chair of this committee.
Senator Dyck: Senator Lillian Dyck, from Saskatchewan.
Senator Enverga: Senator Tobias Enverga, from Ontario.
[Translation]
Senator Verner: Josée Verner, from Quebec.
[English]
Senator Seth: Asha Seth, Toronto, Ontario.
Senator Martin: Yonah Martin, B.C.
Senator Seidman: Judith Seidman, Montreal, Quebec.
The Chair: I want to welcome our witnesses today. They have decided on the order in which they will present, and I will welcome them in that order. I welcome Carole Bouchard, Executive Director of the National Association of Pharmacy Regulatory Authorities.
Carole Bouchard, Executive Director, National Association of Pharmacy Regulatory Authorities: Good afternoon, honourable senators. It is my pleasure to appear today before your committee. Our association understands that the committee is examining the overall issue of prescription pharmaceuticals in Canada and that the current discussion pertains to the post-approval monitoring system thereof. We are pleased to have been asked to present our view on this important topic. Let me first explain who we are. NAPRA is the National Association of Pharmacy Regulatory Authorities. It is a not-for-profit organization that represents all provincial and territorial pharmacy regulatory authorities whose mandate is the protection of the public. Our membership also includes the Canadian Forces' pharmacy services.
Our members play a key role to ensure that optimal regulatory practices are in place for a safe practice environment for the benefit of all Canadians.
For your information, over 35,000 pharmacists are licensed by our members to practice pharmacy across the country and operate within specific regulatory practices and requirements.
In my presentation today, I will be sharing with the committee information on four key areas: A general perspective on post-approval monitoring activities, the pharmacy's role in post-approval monitoring when it pertains to the reporting of adverse drug reactions, the challenges and opportunities associated with adverse drug reaction reporting and other areas that we believe should be examined by the committee as part of your review.
In my presentation, I will refer to "health products'' instead of "pharmaceuticals'' to include the range of products that Health Canada has approved on the Canadian market and for which monitoring is required. It is important to establish that our association supports the overall drug safety net system in existence in Canada, namely the pre- and post-approval activities. We believe that the activities undertaken in the post-approval stage are as important as the activities included as part of the drug approval process, which are the pre-market activities.
A fundamental part of the post-approval monitoring activities is the reporting of adverse reactions.
This leads to the second key area of this presentation, that pharmacists continue to play an important role in the reporting of adverse reactions. This activity is supported by the various professional standards, codes of ethics and bylaws developed by our members. The reporting of adverse reactions is an expectation of a practicing pharmacist. Pharmacists play a key role in the health care system as medication management experts. They work collaboratively with other health care professionals to ensure optimal drug therapy for patients. Reporting of adverse drug reactions is done, on a voluntary basis, by health professionals. From a pharmacy, regulatory standpoint, there is no compelling reason to change that reporting activity to one that falls under a mandatory scheme. We believe that a mandatory reporting scheme for adverse drug reactions would not increase the quality of adverse reaction reports but would increase challenges such as the inability to enforce such measures.
I have just returned from the International Pharmaceutical Federation World Centennial Congress where representatives from the WHO Collaborating Centre for International Drug Monitoring stressed the importance of the spontaneous, voluntary adverse drug reaction reporting by health professionals. Despite this reinforcement of Canada's current post-approval monitoring approach, the third item I would like to present to the committee centres on the challenges and the opportunities associated with adverse drug reaction reporting.
Improvements to the overall post-approval monitoring system in place at Health Canada have been made in recent years. Continuing to improve the system, along with ensuring that Health Canada has appropriate authority to impose changes regarding identified products, should be priorities of the government. What continues to be required is a substantive culture change. There is a need to continue to build, through education and communication, awareness of the importance of adverse reaction reporting, as well as the clarity of what is expected. Enhanced development of technological solutions that are easy to use will encourage the reporting of adverse drug reactions and the activity's incorporation 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 come to reinforce the practice of reporting.
We also need to think about the role of the various stakeholders. If attention can be focused here and willingness can be secured from all parties involved to make this issue a priority, it is certain that adverse reaction reporting will continue to increase, as it has in the past, without the need to mandate this activity.
Finally, I wish to speak about other suggested areas that the committee should focus on as part of their review. As the committee mandate seems to focus primarily on prescription pharmaceuticals, it is imperative to stress the importance of having post-approval monitoring activities carried out for non-prescription products as well, which are the over-the- counter products. There are more non-prescription health products on the Canadian market than there are prescription health products. As of February of this year, there were, for human use, approximately 8,400 prescription products and almost 47,000 non-prescription products, including natural health products.
All of these non-prescription products cannot be put aside with the idea that post-approval monitoring is not required. In fact, the opposite is true. All of these products have to be included in post-approval monitoring as they bear a different level of risk.
The number of non-prescription health products will likely increase in the future, as discussed at the recent congress I attended. Worldwide trends point to the introduction of an increasing number of requests from the industry for a switch from prescription to non-prescription status. In certain situations, these drugs might be for chronic use by patients. Having this in mind and depending on the nature of the products being reviewed by Health Canada for non- prescription status, the post-approval monitoring activities become even more imperative.
Our association manages a program that serves to recommend the best location and condition-for-sale of the non- prescription product for adoption by the provincial and territorial government. This program, developed in the 1990s with Health Canada and other stakeholders including the industry, can be affected by changes made at the federal level. To improve the post-approval monitoring of non-prescription products, the Government of Canada must work with our association and other stakeholders to ensure that the system and program in place are part of a continuum of essential steps of pre- and post-approval activities.
Another area of utmost importance for our association is to ensure that drug supply in Canada meets the ongoing needs of Canadians. The drug shortages situations that Canada has encountered over the past few years can be problematic for Canadians and need to be prevented. Our association has endorsed the recommendations formulated in a report prepared earlier this year by four health professional groups in Quebec, including our member pharmacy regulator. The report specifically asked that the Government of Canada take the following actions in the public interest: That federal, provincial and territorial health ministers develop a national vision and action plan to ensure access to medically necessary drugs, that Health Canada adapt its regulations and programs to address the problem of drug shortages and that legislation be passed requiring manufacturers to provide one year's advance notice before the voluntary discontinuation of a drug. As much as the benefit and risk profiles of the prescription and non-prescription health products need to be monitored, the maintenance of a stock of health products sufficient enough to respond to the essential needs of Canadians is imperative. We hope that the committee members will tackle this item since it can be argued that, from a public protection perspective, the detection of anticipated shortages is part of post-approval monitoring activities.
Mr. Chair and honourable senators, there are other areas to be included under post-approval monitoring such as prescription drug misuse and the integrity of our drug importation and distribution chain. I realize that I have broadened the scope of the post-approval monitoring activities than what might have been presented. However, this broadening is essential as the monitoring activities should be patient centered rather than primarily drug-centric.
It is a vast topic that the committee has before it today on which there is much to say. However, in respect of the time allocated, I will end my presentation here. Thank you once again for the opportunity for our association to appear before you. I will be pleased to answer your questions.
The Chair: Thank you very much.
I will now turn to the Canadian Medical Association, Dr. Reid, President, and Millicent Toombs, Director, Public Health Department.
Dr. Anna Reid, President, Canadian Medical Association: Thank you very much, Mr. Chair, and good afternoon.
The Canadian Medical Association is pleased to appear before this committee as part of the second phase of your study on prescription medication. As the newly elected President of the CMA, I want to extend our appreciation for it this invitation.
We previously outlined our position on clinical trials and the drug approval process. Today I will discuss the system for post-approval surveillance.
Prescription drugs are crucial to high-quality, cost-effective health care, which is why the CMA continues to urge the federal, provincial and territorial governments to deliver on their long-standing commitments to a national pharmaceutical strategy. This would ensure that every Canadian has timely access to an adequate supply of safe and effective prescription drugs, and that is our overarching recommendation today.
I will use my time today to discuss two elements of this recommendation: ensuring safe and effective drugs and ensuring an adequate supply of drugs.
On ensuring the safety and effectiveness of drugs, the CMA supports a robust regulatory framework and system for researching and approving new pharmaceutical products, but even the best pre-approval system cannot identify every potential problem with a new drug. Many problems are identified only after widespread, long-term use. Canada must, therefore, have a robust regulatory framework and system to monitor the performance of prescription drugs after they come on the market.
We believe such a system should contain three elements. The first is a comprehensive process for gathering drug safety and effectiveness data. Since a major source of data is adverse drug reaction reports from physicians and other health care professionals, Health Canada should encourage reporting by making the system as convenient to use as possible. One way to do this would be to incorporate the reporting form directly into electronic medical systems as these are developed.
The second element is capacity for rigorous data analysis. Information gathering in itself does not constitute post- market surveillance. Of greater importance is the monitoring and analysis that occurs once an adverse drug reaction report has been received. We believe Health Canada should cultivate the capacity for analysis that is rigorous and timely, enabling it to quickly isolate reports that indicate a serious health risk.
Post-market monitoring should also provide information about a drug's efficacy and effectiveness. Does it achieve the health outcome for which it is being marketed? Does it perform better than other drugs or therapies for the same condition?
The third necessary element is effective communication. When a safety risk or other new facts about a prescription drug are found, physicians and other health professionals must be informed as quickly as possible and be advised on what they need to do. Should they monitor patients more closely or should they pull them off a certain drug? Nearly one quarter of the new drugs approved in Canada will eventually receive a serious safety warning.
Given the potential risks to patients, we further believe Health Canada should be given the authority to, for example, require post-market studies of newly approved drugs if clinical trials identify possible safety risks, and to take action. Such action could include pulling a product off the market when post-market research uncovers new safety concerns.
I would now like to turn to the key matter of ensuring an adequate supply of drugs. The CMA, among others, is deeply concerned about the persistent drug shortages in this country and believes monitoring drug supply and drug shortages to be essential to effective post-approval surveillance.
In a physician survey conducted by the CMA in September 2012, two thirds of respondents said drug shortages were significantly affecting patient care and outcomes. Of those physicians, 70 per cent indicated that a patient had received a less effective medication and 20 per cent had patients who suffered clinical deterioration because an alternate drug was substituted. About one quarter reported that a patient had suffered financially due to the cost of the substituted medication since many of the drugs in short supply are older, low-cost generics.
Physicians are also frustrated with the time it takes to find an appropriate substitute drug, time that would be better spent caring for patients. Although pharmaceutical companies now support a drug shortage reporting website, there is no certainty that it captures all of the drugs in short supply, and it lacks search functions for finding product listings easily. Also, a mechanism by which practitioners could obtain information on possible therapeutic substitutions would be of value.
Finally, the CMA believes an investigation into the root causes of ongoing prescription drug shortages is warranted. We recommend that Health Canada work with provincial and territorial governments, industry groups and health professionals to find solutions.
In closing, the CMA wishes to commend this committee for bringing these vital issues to the forefront. We, as Canada's physicians, stand prepared to work with governments, other health professionals and the public in strengthening Canada's post-approval surveillance system and to ensure that prescription drugs are safe, effective and available to all who need them.
The Chair: Thank you very much.
I will now turn to Ms. Barbara Mildon, President of the Canadian Nurses Association.
Barbara Mildon, President, Canadian Nurses Association: Thank you for the opportunity to present the nursing profession's position on the importance of post-approval monitoring of prescription pharmaceuticals.
The Canadian Nurses Association represents more than 146,000 registered nurses from our country, the largest group of health care providers. Registered nurses have more interaction with patients and more regularly than most other health care professionals. Thus, we believe our perspectives in two key areas are important.
First, the incidence of adverse drug reactions is underreported and can be increased through user-friendly processes and information campaigns by Health Canada. Second, post-market surveillance of prescription pharmaceuticals must be adequately funded and analyzed to achieve safety and effectiveness. Adverse drug reactions are unintended and undesirable responses to a prescribed medication. They pose a serious threat to many Canadians who rely on prescription pharmaceuticals to manage and treat their health conditions. Adverse drug reactions remain among the top 10 leading causes of death in Canada. When used and managed appropriately, pharmaceuticals are a valuable contributor to the health of Canadians. For many patients, prescription drugs have prevented serious disease, reduced hospital stays, replaced surgical treatment, and led to greater comfort and improved capacity to function productively in the community. These benefits often offset other health care costs.
In 2011, Health Canada received more than 27,000 domestic adverse reaction reports. Experts suggest that this number only represents between 1 and 10 per cent of actual adverse drug reactions.
The Canadian Health Services Research Foundation estimates that 95 per cent of adverse drug reactions go unreported in Canada. Several factors are understood to contribute to these low reporting levels in Canada. First, health providers are not required to report adverse drug reactions; it is done on a voluntary basis. Evidence indicates that reporting rates are influenced by the severity of reaction and the health care provider's workload. Competing demands on a provider's time make it difficult to complete the reports, especially as they are already inundated with administrative work.
Reporting rates are also influenced by institutional protocols. Barriers such as lengthy chains of commands or the lack of clear and accessible policies must be removed. A common standard regarding reporting must be in place for all sectors of the health care system.
The CNA recommends that registered nurses be more involved in reporting adverse drug reactions. In hospitals, community health clinics, long-term care health facilities and many other settings, the registered nurse is the health care professional who is most frequently at the patient's side. Their constant presence means they are likely to have the greatest understanding of the symptoms and impact that the patient is experiencing during and following an adverse drug reaction.
Registered nurses are a key link in the chain of safety and their knowledge and leadership must be central to developing and sustaining a comprehensive national commitment to safety and quality in health care and services.
CNA also recommends that electronic health records include an adverse drug reaction reporting mechanism to further support timeliness and consistency in reporting.
Although reporting rates are low, they have increased considerably in the past decade. This is in due part to efforts to encourage consumer reporting. CNA recommends that Health Canada achieve further advances in consumer reporting by making user-friendly reporting processes available to patients and the public, and undertaking information campaigns to encourage reporting and promote awareness of post-market surveillance.
CNA also recommends that Health Canada works to ensure that the post-approval surveillance system includes simple, comprehensive and user-friendly reporting processes that enable health care providers to promptly report adverse drug reactions. Currently, post-approval surveillance falls to the Marketed Health Products Directorate, which is situated within Health Canada's Health Products and Food Branch.
This directorate is considerably smaller than the part of that branch charged with the drug approvals process. As such, nurses have raised concerns about the directorate's ability to adequately study and analyze reports and communicate necessary information back to relevant physicians and nurses. Indeed, RNs have indicated that the reporting of adverse drug reactions often feels like a one-way communication because they do not receive the results of any investigation or recommendations.
Adequate resources must be devoted to Health Canada's Vigilance Program to ensure rigorous analysis of reports so that significant threats to drug safety are identified and communications systems that produce useful information and a feedback loop to health care providers and the public.
As the committee has heard from other witnesses, there is the potential of uncertainty with side effects and adverse reactions from both recently approved and long-standing drug therapies used over long periods of time. Since most clinical trials are undertaken on a short-term basis and within relatively healthy populations, the effects that drugs will have over the long-term on older or young Canadians, women and people with multiple conditions who are taking several medications have not always been thoroughly studied. Ultimately, every effort should be made to evaluate prescription products for their real world effectiveness and safe use in practice.
Providing safe, competent and ethical care to patients within the health care system is a shared responsibility. It requires involvement and action at every level, including the patient and the public, the individual provider, the multidisciplinary team, the health care professions and the health care system, with leadership and support from different levels of government. Increased information sharing and collaboration among health care professionals is paramount to protecting and promoting patient safety in Canada.
I provide these comments in the larger context of the need for a national pharmaceutical strategy that includes a comprehensive plan to address not only the safe and appropriate use of medications, but also universal and equitable access to pharmaceuticals for all Canadians. This committee recognized the importance of action on this strategy as articulated in Recommendation 28 of your review of the 2004 health accord. We support your efforts to advance a comprehensive national pharmaceutical strategy, and Canada's nurses are ready to be partners in the future and further development of such a strategy. We appreciate the opportunity to be here today and look forward to responding to your questions. Thank you.
The Chair: Thank you all. I think you have provided very interesting information for us along the lines we were hoping to hear about, and I am sure my colleagues will have lots of questions.
Senator Eggleton: Thank you for your presentations. You have made many good suggestions. I notice at least a couple of you talked about drug shortages, and we probably need to talk a little bit more about that. I see the pharmaceutical industry is interested in us dealing not only with prescription drugs but non-prescription drugs, of which there are many — some 46,000. That would take a while to get a handle on, but I think you have made some good points in that regard.
I appreciate your comments about the national pharmaceutical strategy. Yes, that is absolutely needed.
Let me ask you about this question of ADRs, the adverse drug reaction reports. We are told it is estimated that over 50 per cent of newly approved drugs have serious side effects, but only 10 per cent are reported. I think Ms. Mildon noted the fact that there is a low reporting problem and you have made some suggestions as to how we might improve it.
A couple of you have also suggested more electronic medical records being used, to use technology in a better way. One of the other ideas came in a bill that the government previously brought forward in 2008 — it died on the Order Paper — called Bill C-51, which was to make it mandatory. Ms. Bouchard, I think you said you do not think it needs to be mandatory, but let me ask the other two about whether or not it should be mandatory, and if it is not, how will we get the numbers up?
You have suggested that various things, including EMR, would help do that. However, Health Canada has been here and told us that they have been doing things, but we still do not have the kind of reporting that we should be getting. If it is not mandatory, what is it that will really move this reporting system?
Dr. Reid: Yes, the CMA has actually not called for mandatory reporting for a number of reasons. One is that unless you have some mechanism for enforcing that reporting, there is really not much point putting a system in place. We feel that energy would be better spent improving the voluntary aspect.
I can tell you as a practising clinician that it was mind-boggling through the years trying to figure out how to report an adverse drug reaction. You would have to fight your way through the Health Canada website and it was not easy to use. We understand that Health Canada now is beginning to use electronic reporting off of the Web. You do not have to fax it back like you did until very recently, which seemed fairly archaic. Movement has been made by Health Canada, and we applaud them for that. We think it needs to be moved up even more quickly. It is a very serious problem.
One of the problems is the difficulty finding the form and the whole hassle of how you get it back.
There is not very much information flowing to physicians in a very effective way about drugs that could come up that might have a problem because we do not have a good labelling system. For example, the FDA actually has a black box warning on certain drugs. That is the sort of thing that would actually allow physicians to be better alerted to a potential drug problem that might come up and hop on the bandwagon a little more.
There is a lot that can happen, in particular with the EMR, to incorporate these forms directly into the record that will really improve. If it is just one more button you have to go to, it makes it a lot easier.
Senator Eggleton: What about the feedback from Health Canada? Do you get much from that?
Dr. Reid: No, and I must say all the times I have ever reported an adverse drug reaction — it has been quite a few times during my 25-year career — I have never had any feedback as to what happened to that. It just went into the void, as it were.
The Chair: Ms. Mildon, would you care to respond?
Ms. Mildon: The Canadian Nurses Association would agree that making it mandatory is not where we would go at all with that particular process. There are several reasons: There can be overlapping signs and symptoms of multiple diseases; there can be episodic care that delays timeliness; and, also, there are medications that have known side effects that we expect. If you think of antibiotics, they are well recognized to have gastrointestinal side effects, for example. There is a potential for confusion there.
Also, there is the question: Mandatory for whom — for the prescriber of the pharmaceutical, or for the nurse who might be providing care? There are several issues that come to mind in terms of making it mandatory.
We would definitely agree that tightening up and inventing other processes, such as my colleague Dr. Reid has just suggested, would be much more effective in increasing the rate of reports.
The Chair: Thank you.
Senator?
Senator Eggleton: I think she made her point on that one.
Ms. Bouchard: I could add more.
Senator Eggleton: Over the years, it has been a struggle to get participation in EMR. I guess the Canada Health Infoway has been the prime mover of trying to get that in place. Is there something that they can do or that they are doing with regard to the improvement in the system for adverse reaction reports?
The Chair: Dr. Reid, would you like to comment on the Canada Health Infoway with regard to this issue?
Senator Eggleton: I wonder if maybe we should recommend that they do something in their work.
Dr. Reid: I do not think it is up to Canada Health Infoway to do that. We have many different EMR systems around the country. Some work well and some do not. There has been a lack of good coordination between those systems and, in some jurisdictions, a lack of political will and funding to help physicians and other health professionals get those systems up and running.
I do not think it is necessarily Canada Health Infoway's responsibility to do that. However, if we do decide that we will make it easier for health professionals, pharmacists and the public to report these adverse drug reactions, I think we will have to think about how we will then incorporate it into the electronic medical record. It can be done, but I do not think Canada Health Infoway is necessarily the organization that needs to lead that.
Ms. Bouchard: It might not necessarily be the Canada Health Infoway, but we do support the facilitation of reporting adverse drug reaction by electronic means. It is really essential here. I think I would also stress the importance of the government, particularly Health Canada, ensuring that when there are changes in the policies, guidelines and legislation that they do also consider the impact on some of the electronic systems that exist out there.
I can give you an example where the introduction of a specific regulation in Canada, the Natural Health Products Regulations, created some difficulty at the beginning. It still continues to create some difficulty. In creating a new category of products called "natural health products,'' some of the software vendors providing services to health care institutions had removed this category of products from their system. Therefore, pharmacists who sometimes count on those systems to also identify some drug interaction or other problem with some products were unable to do it anymore.
That information was coming from the system that Health Canada has through their drug product database. It took a little while for us to be successful to have them change their drug product database that they maintain in the department to ensure that the proper tools and the proper information were there to really help and assist the health care professional, particularly the pharmacists. This is all related with adverse drug reactions. We do not want patients at the end to have an interaction with two different products without there being notices on that. I think everybody would like and agree that we aim to avoid that type of situation. That should be the goal.
[Translation]
Senator Verner: Thank you for being here today. My questions will be along the same lines as Senator Eggleton's on the matter of reporting adverse reactions. We know that, for a majority of Canadians, except patients in hospitals or senior citizens' homes, the front door to the system is the pharmacist.
You go off to get a prescription for a medication that your doctor has prescribed and the first contact you have with that medication is through your pharmacist. Ms. Bouchard, on page 5 of your presentation, your statement is quite clear. You say that there is no compelling reason to make reporting mandatory. I understand your point very well.
But, accepting that it is not mandatory, and knowing that pharmacists are very often standing at the front door to the system when there is a problem with a medication, what do we do to improve the situation?
I speak from very personal experience. I spent hours watching my mother dying because she was not able to get an appointment with her doctor. The only medical avenue open to her was her pharmacist. She is not alone. I am not saying that most people have side effects that lead to death, but even so, what do we do to improve the situation?
It is not just prescription medications. Is there a way to make sure that information gets to patients for over-the- counter medications and natural products?
Ms. Bouchard: I would be happy to answer in French because French is my first language.
Senator Verner: We are in a bilingual country.
Ms. Bouchard: First, I am really sad to hear that there were problems with your mother's health. I would like to provide some clarification because you make some important points and I would like to clarify the points we raised in our presentation.
When we talk about a mandatory reporting framework for adverse reactions, that clearly involves the federal level. That does not necessarily bring about an improvement in the quality of the reporting of adverse reactions. But it will cause a lot of difficulties in the way we are going to make sure that people report. It will be the federal government that will be coming into pharmacies and medical clinics. I feel that the government already has enough inspecting to do. From the standpoint of protecting personal data, it would not really be ideal.
We will have to see whether that will be the reason for not making it mandatory. However, we say that pharmacists, like other health professionals and as members of a self-regulated profession, have standards of practice. There are codes of ethics, among other things. Our association promotes certain standards that our members adopt or comply with completely. Yes, it is important for practicing pharmacists to make sure that adverse reactions are reported when they become aware of them. Yes, at times, pharmacists are the first point of contact when it comes to giving medications. But when there are serious adverse reactions that can lead to hospitalization, others are going to see it first, before the neighbourhood pharmacy.
Your other point as to what can be done to improve the process, it is not making it mandatory, but rather working to make it easier to report. And also to provide feedback on what is reported. What does that mean, in a nutshell? Health professionals are able to evaluate the benefits and the risks of a given situation.
People need to be informed. In terms of promoting this, it is really about changing the culture of health professionals. If you look at that group, they need to be provided with tools that make their work easier and faster, and they need to be able to know how their contribution makes a difference in the system. Those points were made in some studies and they are important in terms of motivating people to report. I am talking about all health professionals.
I am also a pharmacist by profession. Each and every health professional has their patient's best interest at heart and wants to make sure that the patients in front of us will be okay. Reporting is not required by the federal government, but it is a good idea to provide health professionals with the tools they need to continue reporting. Our duty is to find the optimal therapy for each patient. With all the changes to the scope of practice of pharmacists in the provinces and the territories, they are going to play a more significant role in the future.
I know that there were various parts to your question and the third part had to do with non-prescription drugs. To reiterate what we have said, we are talking about a rather large category of products on the Canadian market. And though we may say that they do not pose the same risk, there is still a risk associated with those products, particularly when they are taken by patients with a medical condition or who are following another treatment. It is very important to consider that aspect in the post-market surveillance program in Canada.
Senator Verner: Do you know whether reporting is mandatory in other countries or whether they have other systems? I imagine you are up to date on that.
Ms. Bouchard: Some countries in the world require health professionals to report adverse reactions, but only very few. I do not have that information with me, but there are maybe four or five. Very few countries are required to do so by the federal government. However, we also have to allow for the fact that the health care system and the culture in those countries may be different from what we have in Canada. It is important to have a system that meets the needs of Canadians and of our Canadian health care system.
[English]
The Chair: I will move to Senator Seidman to be followed by Senator Martin and Senator Seth.
Senator Seidman: You have all touched on this issue, and I would like to address it directly. Clinical trials usually do not include certain subgroups such as pregnant women, children and seniors. In your opinion, should there be a mandatory reporting system post-market to ensure the adverse effects for these particular subgroups are captured? I know you have talked about your reluctance to have a mandatory reporting system as a general rule, but I would ask specifically with regard to subpopulation groups that are not included in clinical trials in order to capture what you call your "real life situation.'' If so or if not, how would you envision improving our capacity to capture these adverse events in these particular subgroups?
Dr. Reid: I would argue that there are many subgroups in society. There are geriatric subgroups. There are marginalized populations that do not have adequate access to health care professionals that are all at high risk, including pregnant women, so I do not necessarily think we should single out certain groups.
I want to go back to something that Ms. Bouchard said, namely, that the feedback from Health Canada about adverse drug reporting is very important to physicians. If we give a report or if other physicians have given reports, we need to have early timely notification that there is a potential problem.
We do know that one in four new drugs may go on to have a serious adverse drug reaction. We would like to have mandatory post-market studies of new drugs that, during their clinical trials, have shown to have potential safety concerns when they go ahead. We would like those drugs to be studied post-market and then be notified back to physicians, other health care professionals, pharmacists and the public about those particular products so we have a way of capturing drugs that we know ahead of time may be a problem. If we then have a way to put that back into the electronic medical record, so that if we get a warning back in a timely fashion from Health Canada about a new drug, we can plug it into the pharmacy record, the physician's office record and in the EMR, it will highlight all the patients we have on that medication. We could contact those patients and ask if they are having any problems that they may not have reported yet. We would like to see that sort system in place. We think that would be more beneficial rather than picking out one group as high risk.
Your point is well taken that there are vulnerable groups, but I would argue they are more widespread; in my world there are, anyway.
Ms. Mildon: I would agree that rather than making it mandatory we need to put another step in the post-market process. In my everyday world, we would call it "evaluation.'' You put something in place and then you evaluate it. The step that is missing from an organized perspective is that evaluation piece, and if that were tied to the release of the drug and mandated within the approvals branch, perhaps, as opposed to the surveillance branch, it may be a way to advance that. Certainly, I would suggest it needs to be linked to the approvals process and mandated at that level.
Ms. Bouchard: I also support what my colleagues have said about this specific issue.
If there are subgroups that have not been studied during clinical trials and they are of importance for the specific drug in question, it would be definitely useful that at the pre-approval stage they highlight the notion of the need to conduct more studies during the post-approval stage. If my understanding is right — again, sometimes Health Canada has limitations with its current legislative authority — if the industry were to be mandated to do post-market studies on a specific drug, then they have to report adverse drug reactions during those studies. Again, this is my understanding and it is not confirmed. I agree it has to be attached with the pre-approval, has to be needed and depends also on the nature of the product that is going to be reviewed.
If my understanding from Health Canada is right, they do risk management plans on some of the products that may be given an approval to be marketed on the Canadian market. For example, as a post-approval monitoring stage, if it is not necessarily a study, it might be that there are other types of features they would like to see happening with this particular drug, as within a risk management plan for those particular substances. I think those have usefulness as long as the components of that plan can be monitored and enforced and can be linked with every other organization that needs to be linked with. I am saying that because I am also aware of a situation where we had a substance on the Canadian market where pharmacists were caught a bit in the middle when the condition for sale required a physician to be trained in a certain way in order to be prescribing that, but there is no way a pharmacist could know whether the physician had completed the training. Everything has to be integrated and be known.
Senator Martin: I can hear from your responses how there is definite overlap but as well how complementary all of you are. I see all of your professions being essential to the care of the patients.
Even with great technology and moving toward trying to implement better systems, who would be best positioned to coordinate all that? You have all talked about overlap, but you would all be collecting different kinds of information that all complement each other but there would also be overlap.
I am thinking of conversations I have had with pharmacists, nurses and physicians. In this greater system, who would be best positioned to coordinate the information and the system itself?
Ms. Mildon: I could not agree more that inter-professional teams are the way to go. That is what we need for patient-centred care and excellence in outcomes. I am very pleased to be with my colleagues.
I suggest that we come back to the primary provider. Most members of the public have a primary provider, although we know that in some areas of the country there are many unattached people. The primary provider, be it a physician, a nurse practitioner or inter-professional staff within a clinic, should know the patient the best. It needs to come back to the individual to whom the patient goes first. That also speaks to why we need sufficient medical and nurse practitioner resources so that patients have a primary provider and understand who to go to when. Within that, the primary provider is linked to an inter-professional team that includes pharmacy and our allied professions.
Dr. Reid: I totally agree with Ms. Mildon. It has to be the primary care provider, and that person is the captain of the football team, if you like, and knows the most about the patient. We are working hard now in a new era of team building with physicians, our nursing colleagues and pharmacist colleagues. We are looking at a new chapter in how health care is delivered at the primary care level in Canada, and that will only improve care.
Senator Martin: I often feel like I am the primary care provider in that there are many pieces. In terms of drugs and adverse drug effects, it would be good to have a central place or someone who feels like the coordinator who has that information accurately.
What about the product that is the issue? I know that we do not have mandatory recall of such drugs. Would any of you support legislation for mandatory recall? If not, in what instances should the minister have that kind of authority, such as other jurisdictions have? There should be some way to ensure the safety of the next patient.
Dr. Reid: Mr. Chair, I will ask Millicent Toombs, the CMA's expert in that area, to answer that question.
Millicent Toombs, Director, Public Health Department, Canadian Medical Association: Regarding a mandatory recall, it often happens that we identify health hazards with a certain drug and Health Canada may decide that there is some benefit to keeping the drug on the market despite the health effects. Champix, for example, had some serious psychological effects. Many people think that as long as the patient is informed of those side effects it is probably safer to have the person on the drug than to have the person continue to smoke.
If there is a recall system, there should be some flexibility built into it, and this should be part of the risk management plan that Ms. Mildon talked about. I see it as one of the things that would go into a risk management plan when the drug is reviewed and approved.
Ms. Bouchard: With regard to your question about the mandatory provision for recall of drugs or withdrawal of drugs from the market, a few years ago Health Canada conducted discussions on regulatory modernization of the food and drug legislation. I think this aspect was discussed, and from our perspective we believe that it will be necessary to provide Health Canada with more authority and power to undertake certain activities when required. It should be well developed with regard to when such actions can occur, because it cannot be occurring for no reason, but when there are risks serious enough to question certain things there are probably instances where the drug should be withdrawn while more study and review is done. It depends on the level of risk, but I think that now their hands are often tied with regard to what they can do, and that may create delay, as we have seen in the past in certain situations.
It is important that they be at least equipped with the level of authority required to act when needed, and also perhaps to reduce the amount of time that is required to negotiate with the drug industry on what will happen and on what will be communicated and how.
Senator Martin: Ms. Bouchard, you spoke briefly in your presentation about a substantive culture change being required. Is that a concern in Canada? Is it a very different culture than other jurisdictions that may be doing better, or are we in good standing at this time?
Ms. Bouchard: We probably added that word to be more provocative, but a culture change is required. Statistics on adverse drug reaction reporting over the past 10 years show that it has increased, so we have made progress with the pharmacovigilance post-market approval system. There is still more progress to be made, and culture change is something we all do daily. It must include my colleagues in the health care community, industry, the public and academia. We have to ensure that reporting adverse drug reactions is done in the best interests of the patient all the time. That can only come with a culture change, but we need tools to help the health professional community and other stakeholders involved to do that.
What we do at the academia level is also important, because as we teach our future health care professionals, it is important to bring that notion. Reporting is also incorporated into the competency statement that the Canadian Patient Safety Institute has put together for professionals where we are promoting the notion of reporting adverse events and all of that.
"Substantial'' may be a big word for now, but I do not think we should stop. We should continue.
Senator Seth: This has been very interesting.
Dr. Reid, I see that you have quite a bit of experience practising in the northern territories. How do physicians and patients in these areas receive information on how to handle drugs, and do they get all the information on proposed trial drugs?
Dr. Reid: We get the information the same way as every other health professional in Canada gets it. We get some communiqués from Health Canada, but we do not get feedback when we give an adverse drug reaction report, nor do we get information about drugs that are at high risk.
I do not think it is any different in that way from the other health professionals around Canada. I can say that in the Northwest Territories we now have a highly integrated electronic medical records system that is very soon going to reach every one of our 33 small communities so that we are able to transfer information around for our patients — who are quite mobile, as you can imagine — being transported. I cannot emphasize enough how key EMR is in terms of how to spread the information around. It may sound utopian, but if we can get the forms and information that link into the drugs that patients are on, I think we will have half of the problem beat.
Senator Seth: You said the doctors or physicians are often quite overloaded by their work. I would like to know about that. What is the solution? How can they participate more in the programs and what is the solution for that?
Dr. Reid: Again, I will come back to electronic medical record. If I see a patient and they are having side effects, right on my chart I can quickly link to this form and if I can email it off two seconds later, it will happen. If I put it to the side and have to download a form from Health Canada and wade through the charts again at the end of the day, it is time consuming. It must be at point of care, and it has to be there for the physician and nurse practitioners in the community. I think with our technology we are going to be much better served to do this.
Senator Seth: Why is this electronic data system taking so long, which is so important to get to the point? You would know much more in a broader way than we know now because, I would say, maybe 50 per cent of doctors still do not have an electronic data system.
Dr. Reid: Without being too tongue-in-cheek, we may not be able to get through the answer to that question by six o'clock tonight; it is complex. There are smaller jurisdictions, such as where I work in the N.W.T., where we have been able to use one particular provider to march out our program across our communities. As you can imagine, in the other provinces, there are different providers for other parts of the province. Different physicians use different systems and lot do not talk to each other. At times, there has been a lack of will between provincial and territorial governments to help health professionals with the financial amount of money to put in EMRs, which are expensive. There is probably a political lack of will in some areas and a lack of budget in some areas. We also have IT problems where our systems do not talk to each other. It is very complex, but the CMA and the CNA are working hard on this issue to try and make it work better.
Senator Raine: It is a pleasure to be here. I am not on the committee on a regular basis, but this is a very interesting subject for me.
Senator Martin alluded to this but I wanted to ask what you think the role is for the patient or the patient's family in terms of actually being able to commence and monitor adverse drug reactions. If they have the information, as I assume they do, when they get the prescription saying that they should watch for side effects — instead of waiting until they can go back to their doctor and tell them about it — if there was a way to immediately start the system, would that not help?
Ms. Bouchard: Thank you for the question. First, with regard to the patient and the family, they definitely have a role to play in all of that because they have to be self-responsible with regard to the treatment. Again, they do not do that alone. They are supported by health care professionals and as we said earlier, often we are the first entry point for getting prescription, drug or other advice on the non-prescription product will be the pharmacist.
There is the first level of information given at the beginning of treatment, but when patients note certain things, they often go back to their pharmacists and discuss the points that they have been noting. However, the patient can begin the process at any time and, it is my understanding, can report to Health Canada. They have adverse drug reaction regional centres that take information from the consumer. That is good on one side because they are able to share what they are experiencing but on the other side, the patient really needs to know what they have to do. Is it serious enough that I have to stop my treatment or is it non-serious and can perhaps be managed by other means?
They also definitely have to be in a position to talk to a health care provider. Often a pharmacist will be the first door they will go back to because that is where they received the medication. It can also be done in other settings of the other health care providers. This is a daily activity that is happening; patients will also share the experience on that and then there are questions that prompt to what is really needed for that particular patient. However, they still have to have a role to play in the overall surveillance of their own condition and treatment in association with all the other health care providers.
Ms. Mildon: Thank you for the question, Senator Raine. You reminded me of Senator Martin's eloquent comment that she felt like she had to be the go-to person for her family.
The first thing is to be informed. The patient and family need to be informed and ask questions. When I think of Ms. Bouchard's discussion of culture, we see a generational difference. Our elders have traditionally been quite submissive in receiving care. We now see new generations that are at least more tempted to be engaged and the advent of going into a physician or nurse practitioner with a sheet of papers taken off the Internet.
This notion of being informed is important and knowing where to go for help. There are local resources, such as our pharmacies, home care programs, and most communities in Canada now have health call-in lines. I am not sure they are as well-used as they could be. They are 24/7 and available in the middle of the night when patients may first have symptoms appear. The patient and family have a responsibility to have a primary care provider and not to rely on walk-in clinics. The dilemma is that their care is episodic; they cannot see the same provider and put the pieces together as easily as when you have the whole record in front of you all at once. Those are things I suggest would help our families and patients to be more informed.
Dr. Reid: I have one thing to add. My mother used to call me. When she would be put on a new prescription medication, the printout that came with the medication was several pages long. She was alarmed because she had all the side effects. I think we need to be better at making the information we provide to families and patients much clearer. We need to have bullet points about the serious things you need to look for and perhaps notification that in the pre-market trials there were potential problems with this drug so people are more alert to those particular things.
It is a little bit of a tsunami when you look at this three-page printout, and it is hard to wade through. Families and patients are overwhelmed about going back to the pharmacy about it. I agree with the other speakers.
Senator Raine: The second question I have has to do with the drugs that are disappearing — the tried and true products — and we now have the new improved model. At least with the old model or the old version of a pharmaceutical you knew the side effects. There was a body of knowledge out there in the medical profession to know what to expect. It is so traumatic when you cannot get your medicine because they no longer make it and it has gone off patent and for some reason. In those instances, is that a serious issue? How do we deal with that?
The Chair: I will interject. That question is not related to the surveillance; it gets into another issue. Therefore, I will keep you focused on the actual post-approval surveillance issue.
Senator Raine: I will go back to my surveillance question. Do pharmaceutical drugs and off-the-shelf products have bar codes that describe the molecular properties of the products so that the bar codes could be inserted and you could, through bar code, tell if there will be adverse reactions? Is that part of the regime?
I am thinking about it because we went to a gala the other night where they were honouring innovators. One of the award winners had come up with a system to track blood in the hospital from the time it was donated to the time it was used, and it was very innovative. Maybe that is something to think about.
The Chair: I think the answer with regard to the bar code and pharmaceuticals, generally — I see you all shaking your heads — it is not the case that there is a bar code with regard to the chemical entity; is that correct?
Ms. Mildon: I would defer to my colleague.
Ms. Bouchard: I cannot answer all angles of that question because the label is really also under the drug industry and manufacturing. There are prescription products that we only find behind the counter that are only available for pharmacists to prepare. However, the over-the-counter products have what Health Canada asks — that it be on the labels. Then, to the best of my knowledge, they may have some tracking numbers. For some products, they have the drug identification number and other natural products numbers, but it is not necessarily attached to a series of information on the molecule and the effect.
Having said that, though, there are some programs that exist in Canada — at least for the over-the-counter medication, and one of the programs is managed by our association — where we look at the product and recommend the best location and condition of sale for that product. That is to help the patient to have all the assistance possible of a health care professional, if it is necessary for that product.
In a sense, there are four categories. In the pharmacy, you find products that are behind the counter that can be dispensed by the pharmacist with a certain series of questions and also with guidance as to how to take it. There are products that we only find in pharmacies, as well as products that we find outside of pharmacies for over-the-counter products. There is a program in Quebec managed by the Office des professions du Québec. The other program is managed by our association.
These programs assist patients with a certain level of questioning with regard to the best medication for them to select in this wide range of over-the-counter products.
Senator Dyck: Thank you for your presentations tonight. They certainly fit together very well.
My first question is whether the definition of "adverse drug reaction'' is clearly understood by the different professions in the same manner. If it is not clear, could that account for a portion of the low incidence of reporting of adverse drug reactions in that people probably would tend only to report those that they considered to be the most serious? Does Health Canada, for example, have a list or a grading of drug reactions, and then says, "This is the level at which you should be reporting''?
Dr. Reid: Thank you for that insightful question. In my experience, reporting was basically "anything goes.'' I think you hit the nail on the head insofar as a practising physician may have a patient that, if I may, has a little bit of diarrhea, or this and that. It might not end up being a serious adverse drug reaction. However, perhaps another physician has a patient on the same drug who has overwhelming gastrointestinal side effects that are actually serious, and maybe for my patient it was a serious effect but was not manifesting as strongly. I think that is part of the problem.
I also think part of the concern with the mandatory reporting is around how we sort this out. It is a wide range, and in my experience it has been mostly left up to the practitioner to decide what to report.
Senator Dyck: Are there any other comments?
Ms. Mildon: I would be pleased to add that I believe the definition is clear. Speaking for nurses, they have a clear understanding of that definition. However, I would concur 100 per cent with Dr. Reid that the appearance of those symptoms varies from person to person, so even being given a list of symptoms, they can have different manifestations across different people. That complicates the reporting piece.
Senator Dyck: You have all talked about the reporting system and how it is not working, and you have suggested that a voluntary system should be improved. From what you are saying tonight, I get a very strong sense that all of you should be involved in the process of designing it. If there is to be an improvement, who should be designing it? If Health Canada does it, should there not be representatives from the patient groups, families, doctors, pharmacists and nurses? You all have to access it at some point and wish to get information back in different formats, as well. How should it be improved, or who should be part of that process?
Dr. Reid: Yes, I agree with you. In general, as we look at problems in the health care system, the people on the front line — no matter what kind of health professional they are — have not really been involved in looking at the solutions to the problem.
I very much appreciate your comment about patients and families, because a lot of things that do not work in our system in many ways have been identified by patient groups and families and not actually by health professionals, and certainly not by the bureaucrats.
In answer to your question, it would be very helpful if Health Canada formed a working group that involved representatives from all of the constituencies that you identified. Again, I think you hit the nail right on the head.
The Chair: Ms. Mildon or Ms. Bouchard, do you have anything different to add?
Ms. Mildon: I just have an augmentation. If we look at some of the tools that the Institute for Healthcare Improvement has introduced — the lean methodologies, et cetera — they always involve the patient and the user groups. It stops us from working in silos. Therefore, I think your approach is quite wonderful and would endorse it 100 per cent.
Senator Enverga: You said that about 10 per cent are reported. Who reports the 10 per cent? Is it the nurses? Who reported it more: the nurses, the pharmacists or the medical practitioners?
Ms. Toombs: I think the largest proportion of reports come from various health professionals, and that is from the entire health professional community; physicians, nurses and pharmacists all contribute to it. I think a third of them do come from the patients and consumers at this point.
Senator Enverga: Therefore, it was the consumers; the ones who were most likely affected were the ones who reported.
I do not know if this question applies to you. The Auditor General testified on October 3 that there had been some sort of implementation. Has ADR implementation reached you? On October 3, the committee heard that implementation of ADR reporting had begun.
The Chair: I think Health Canada indicated that they had begun to implement practices to achieve the issues identified in the Auditor General's report. The Auditor General was not reporting that Health Canada had moved on certain areas; rather, Health Canada was saying that they feel they have been moving quite far on certain areas.
Senator Enverga: The question is, have they reached —
The Chair: Yes, I understand your question. I think Health Canada partly indicated that it was building the infrastructure to be able to roll them out. Therefore, I will try to focus the question, starting with you, Dr. Reid.
Has there been any major change brought about by Health Canada in the reporting requirements from physicians in the last six months?
Dr. Reid: My understanding is the main thing that has happened since the Auditor General's report is that Health Canada now has electronic reporting available online. That is a great step and we applaud that.
Ms. Toombs, did you have anything to add?
Ms. Toombs: No, I do not really have anything to add to that.
Senator Enverga: You mentioned that you have reporting. Has it been used at all? Is it being utilized by our practitioners, the ones they have given you as a tool?
Dr. Reid: I cannot answer that question. We have not done a survey yet regarding how many are using the electronic form. We just know it is available at present, which is new.
Senator Enverga: Is there a way we can get some report on who will be using it?
The Chair: We will discuss that issue in the committee. What we are doing is getting testimony from the witnesses that we have here today, and we will look at the follow-up questions that arise from testimony.
Senator Enverga: Thank you.
Senator Eggleton: I want to return to some of the provisions that have been discussed in terms of modernizing the regulatory framework for Health Canada. Again, that bill was here shortly in 2008 and has not come back.
There were a couple of other mandatory requirements — I have your views on mandatory reporting — and one of them was mandatory in terms of drug manufacturers being required to conduct post-approval studies. Another one was requiring label changes, and then there is the question, although I do not know if it was part of that bill, about mandatory drug recalls. I think you already commented on it.
The department does have other means of bringing its opinions to bear in situations where it is concerned about drugs, but mandatory drug recalls are something that they have in Europe and in the United States, I believe. Could you comment on those possibilities regarding mandatory provisions?
Ms. Mildon: I feel somewhat out of my element on that particular question. I think the principle we are trying to bring to bear with mandatory reporting is that if what needs to be reported is not clearly defined, when and by whom, it runs into the problems of confusion and of people either over-reporting, which does not help the problem anyway, or with not knowing when to report. I would just underscore that piece.
Senator Eggleton: I am off the reporting. I am on to these other elements now.
Dr. Reid: The CMA is certainly calling for a requirement for post-approval studies of drugs that in their pre-market trials have been shown to potentially have serious adverse effects that might come up.
We are certainly asking also for better labelling of drugs.
The CMA at present has not developed a policy on mandatory drug recalls.
Ms. Bouchard: To add to the three elements that were part of the discussion about regulatory modernization, on those three points and based on what was presented by Health Canada during those discussions, we were finding that those were bringing a little more strength to what they could do in the overall pre- and post-approval activities.
I think labelling is one of the important issues, particularly when we look at over-the-counter medication, because at this point in time there is a limitation of what Health Canada can do at certain stages with regard to labelling. This has brought at times some inconsistencies with products having different ways of presenting the information. We are more aware of those inconsistencies because we are managing the program that has to entertain some drug submissions by drug manufacturers on over-the-counter medication.
The Chair: I would like to follow up in some of these areas.
Ms. Bouchard, I would like to start with you with regard to the issue of reporting, and I want to make a general comment. First of all, I understand very well what you have said with regard to the issue of mandatory reporting. There is not a point of introducing a procedure, perhaps, if it cannot be upheld in some way. On the other hand, there must be a way of encouraging a much higher degree of reporting of potential adverse reaction than we are seeing at this point.
One of the things that you mentioned, Ms. Bouchard, was that you felt that the pharmacists are in a position to provide a fair amount of input, provided there is an easy mechanism — perhaps an electronic mechanism — to put forward observations that the pharmacist would make with regard to an adverse drug reaction.
Do you have any idea right now what percentage of pharmacists across the country has actually made an adverse drug reaction report? In other words, if we get away from mandatory and we come back to voluntary, then we have to see some sign that a group of people are actually participating.
We know that overall we are not doing well right now, so I am not trying to put the pharmacists in a unique position. Indeed, we have heard that they have one of the best electronic systems within the profession of any of the health care providers. We have heard that from pharmacists, of course.
We are not getting into a debate about whether they are absolutely correct, but that would imply that they think they should be in a position to put forward these reports. I do not want a large explanation. I just want to know whether you have any sense of what percentage may be reporting adverse drug reactions.
Ms. Bouchard: I do not have any information from our association itself, but I think the best source of information will be from Health Canada. I do have in front of me the statistics from their 2011 year, where they bring forward the number of reports per health professional group. Pharmacists were not necessarily at the top of that. They were at 12.9 per cent to be very precise, but consumers and patients were the first group. Again, pharmacists have been the first group for reporting adverse drug reactions for years, and then I think that those statistics should also be reviewed in light of what kind of changes Health Canada may have made, particularly when it comes to the Adverse Reaction Centres of Health Canada, which are now part of their department and not an outside private institution. They do represent a large number.
How many do every day? We cannot say. I think with respect to the notion of adverse drug reactions, we also have to take into consideration that those are all suspected adverse drug reactions. We do report, and I think it is part of every health care professional's duty to report when we see those ones, except they are to be reviewed and analyzed later on. We also have to keep in mind that there are extra steps to be taken on those reports to be meaningful.
The Chair: Right, I understand.
Dr. Reid, you answered much of what I was going to ask when Senator Dyck asked her question with regard to the physicians' reporting and the kind of instruction that health care workers in general might get — right now I am focussing on physicians — as to whether the CMA has a process for encouraging physicians, as part of its interaction with its members, to be proactive with regard to the reporting of adverse drug reactions.
Dr. Reid: I do not believe we have had anything in place thus far, but I can tell you that one of the big initiatives in the Canadian Medical Association is an online education program for various aspects of medicine for which physicians who are members sign up for free education. It would perhaps be an interesting module for us to develop.
I would also like to say that this is the sort of thing that we need to bring back right down to the medical school level. We need to start talking about it. I do not ever recall any education, through my training or at any other time in my career, about this reporting. I do not remember it ever being discussed. I think I only found out about it accidentally, partway through my practice to be honest. Clearly, we have ways to better communicate the educational component. A specific education module with our Department of Ethics may well be something that the CMA will look at.
The Chair: You touched on electronic reporting and the incompatibility, shall we say, of some of the systems, even within a given office within the medical system. We heard a fair amount about that when we did our study of the 2004 health accord, although your districts — the northern districts — were clearly identified as having some of the best examples we heard with regard to that. One of the issues was that they tended to have more standardization of operating systems, and so they were able to communicate with each other and across some part of the region at least.
We know that human nature is an interesting part of this equation. Do you see health districts taking a stronger hand in ensuring that the physicians within their district move towards compatible operating systems or at least software systems with regard to the various aspects of electronic reporting?
Dr. Reid: Are you asking specifically about government health systems, or are you talking about the physician health districts?
The Chair: I am not trying to put you in a difficult spot here. I am just asking for advice from you with regard to how we encourage members of your association to become interactive amongst themselves where their software systems are not compatible within their own medical communications and, therefore, within the health system itself.
Dr. Reid: I think there are two parts to the answer. One is that our provincial and territorial medical associations are working hard with their members to make sure that the systems that are approved by each individual province actually are systems that do talk to each other. Certain provinces, such as Saskatchewan, for example, have two vendors that supply their particular systems in the province. The government is helping physicians to fund those systems. I am just talking about physicians. They are funding two vendors because they are systems that actually talk to each other. Also, in other jurisdictions, for example where I am — the Northwest Territories — the government, not the medical association, has been the key player in that. I think both sides are working towards that. We recognize that it is a huge problem, and we do have working groups that involve members of the IT industry, government and medical associations around the country working on solutions to this huge problem.
The Chair: Thank you.
I will get reaction from all three of you on the following. I do not want a long reaction but just your instantaneous reaction to the concept.
Within the last two weeks, there has been reported in the news media an example in another country where certain districts are using Twitter feeds to have feedback from patients with regard to adverse drug or adverse procedure reactions. One of the issues that is clearly emerging in the study is that part of the problem in the low amount of reporting is the difficulty of reporting. The Twitter phenomenon appears to be spreading across the generations and taking the world by storm.
I would like a quick comment from each of you, starting with Ms. Bouchard. Do you think that Health Canada having a Twitter feed that would deal with potential adverse drug reactions would be a reasonable idea?
Ms. Bouchard: We should aim to increase all the tools we can use, but I think privacy and the usefulness of the information would have to be assessed. We have to evolve with technology, and that has to be taken into consideration.
Ms. Mildon: I would definitely agree. Anything that increases communication is a good thing, but it does have to be put through those screens.
Also, Senator Ogilvie, I have a report on the percentage of reports made by the various health professionals that I am happy to share.
The Chair: That would be great. If you could provide that to us afterwards, that would be wonderful. Thank you very much.
Dr. Reid?
Dr. Reid: Well, I am known amongst all my friends as a Luddite and have never tweeted, so I am not sure how well positioned I am to answer this question. However, I totally agree with what the others say. We need to use every method we can to try to communicate, but privacy in the transfer of electronic medical information is a huge issue. We have to be very careful how we move forward with respect to privacy legislation.
The Chair: There is a limit to the number of characters and all that, so I was just trying to get across the idea.
I do not want to be prejudicial to Health Canada, but I think I recall they indicated to us that they have improved their risk communication to health care providers in recent months. Am I correct in recalling that? Have any of you had any experience with new and improved risk communication with regard to pharmaceuticals?
Ms. Bouchard: I have not specifically read everything, but I feel that the number of risk communications that we have received over the past few months has definitely increased. An effort is probably being made in communicating more often on some issues, but this has definitely increased because we feature those risk communications on our website for pharmacists and others.
The Chair: Thank you very much. You have all been remarkably clear in your presentations and thoughtful in your answers to us. As Ms. Mildon has indicated, she has some documents she will provide us with. After you all leave here, there are often thoughts that occur, this issue or this document or this observation that you wish you had thought of at that particular time.
We would welcome you following up with any thoughts that you might have with regard to anything that you heard today that might help us to think of recommendations and identify processes that help to facilitate the communication of potential adverse drug reactions.
With that, I also want to thank my colleagues for the clarity of their questions.
(The committee adjourned.)