Welcome, everybody. I would like to bring the meeting to order.
Welcome to our guests who are here today. We have with us the Cancer Advocacy Coalition of Canada, the Expert Advisory Committee on the Vigilance of Health Products, the Institute for Safe Medication Practices Canada, and representation from the University of Montreal.
Pursuant to Standing Order 108(2), I'd like to welcome you all to the seventh meeting of the post-market surveillance of pharmaceutical products, prescriptions, and non-prescriptions.
I'm going to ask the witnesses to give a 10-minute presentation. After all the presentations are finished, we'll get the questions from the committee.
We're very grateful that you took the time to join us this morning, and we're eagerly listening to all the insightful information that each one of you will tell us. Could we please begin with the Cancer Advocacy Coalition of Canada?
Thank you for recognizing the importance of post-market surveillance and for providing the opportunity to many groups like ours to present suggestions for improvements.
We are very gratified that you've seen fit to act on one of our previous recommendations, made when we presented our views to you during your hearings on the common drug review last year. Please accept our congratulations on your December 2007 report regarding CDR. In our view, your recommendations, if implemented, will substantially improve the cancer drug approval process in Canada.
The Cancer Advocacy Coalition of Canada is a full-time registered non-profit group, comprised of physicians, patients, and business executives from across the country, who are all unpaid volunteers. We publish the annual Report Card on Cancer in Canada, the only independent evaluation of cancer system performance in the country. In the just-released 2007 report card—which you should have in a day or two, as it's in the mail—we examined the allocation of research funds, the needs of young adults with cancer, the clinical trial research process, health human resources, access to diagnostics and drugs, and the role of nurses in supportive care. We publish these reports to identify barriers to better cancer control and to offer constructive solutions that are also realistic and implementable.
For the past three years, the articles about access to cancer drugs have recommended phase four, or post-approval, trials to confirm treatment results in the cancer population at large; and for two years in a row we have recommended increased translational research to identify the subsets of patients that benefit from these new drugs. Post-market surveillance is an appropriate portal to initiate these proposals, and it could encompass a more comprehensive system of information that is analyzed, shared, and disseminated to benefit patients.
When a new cancer drug is approved, the only obligation at present is the reporting of unexpected adverse events—and even this is not done comprehensively. From the physician's perspective, lack of effectiveness is an adverse event, when the treatment has added toxicities and other health risks to the patients, with no good result.
The information available to physicians about a new cancer drug is often not very helpful in the real world. Patients in preapproval clinical trials represent, at best, 3% of the wider population; and when patients at late stages of disease are treated in these trials, they generally achieve a response rate of 20% or less. Evidence suggests that response rates in the real world can drop to 10%. But for responders, the outcome could be a cure.
There are notable exceptions, such as Herceptin, where a tumour marker has been identified to improve patient selection. In such cases, the response rate is impressive and can include cure. However, most drugs do not have biomarkers, and for the majority of patients who do not respond, we are subjecting them to a drug with potential severe adverse effects with no hope of benefit. The objective, then, is to use every means at our disposal to identify the patients who will benefit and to spare those who will not benefit from the wasted time and avoidable adverse effects.
If post-market surveillance were formalized to capture information on positive results, as well as adverse events, then the characteristics of responders and non-responders could be captured for analysis. The immediate benefits would be remarkable. Better patient selection for the use of these expensive new drugs would save a huge amount of money that is otherwise fruitlessly spent. To accomplish that goal, post-market surveillance must collect additional reporting, and much of this must come from physicians, who can offer the important clinical detail necessary for further analysis. Reports ought to be submitted on every patient treated with a newly approved cancer drug within 12 weeks of initiating the treatment to ensure the accuracy of the information.
Physicians and others will not cooperate with an onerous paperwork exercise that produces nothing useful for their knowledge or their patients' well-being. The reporting we envisage could be done on a single computer screen; indeed, the proposal is undermined by anything more time-consuming. The information system required has to be linked to appropriate research by qualified entities, such as the National Cancer Institute of Canada, and have some assurance of timely outputs that are readily available online. Then the effort is worthwhile.
The data gathered should be readily available online and be presented in a manner that offers greater meaning than mere compilations of reported events. Indeed, if this undertaking is to serve its intended purpose, physicians and health administrators would find many other valuable uses for the data, including guideline writing and biomarker research.
In the final analysis, as this new knowledge becomes available, the true potential of each cancer drug would be realized, patient access would be increased, and treatment results improved.
A three-month increase in average survival translates into years for the 15% or so who respond to a drug. Three patients are alive well beyond three years after taking one of these new drugs and have reported their stories in our report card this year. Their written reports are very compelling stories. I would encourage you, when you get this report in a few days, to look at their proposals.
The Cancer Advocacy Coalition encourages you to focus on what is possible and needed, rather than what is already done. A robust post-market surveillance system could be an integral system providing valuable information and education, benefiting all Canadians and saving money.
I want thank you for your time and interest.
: Bonjour, madame
. Thank you very much. My presentation will not be very long.
Thank you for the opportunity to participate in the proceedings of this committee.
My name is Diane Brideau-Laughlin and I am the Chair of the Expert Advisory Committee on the Vigilance of Health Products. I would like to take a few moments to discuss the mandate of the Committee, as well as its current composition.
The Expert Advisory Committee on the Vigilance of Health Products constitutes an integral part of the health product and food branch's post-market surveillance strategy. Its mandate is to provide the branch with ongoing external expert advice on broad strategic policy in regard to the safety and therapeutic effectiveness of marketed health products for human use. It also provides a mechanism to involve the public, providing them with a forum to have their views heard by experts, who can discuss their input and incorporate the discussions into the recommendations provided. In other words, it consists of real people who work in the real world and who have the opportunity to speak to real people about real issues regarding their health.
The committee was established in November 2007 and has met twice so far. The inaugural meeting was an orientation session on the branch's various post-market strategies. The second meeting, held recently in February, in Longueuil, Quebec, discussed issues relating to adverse reaction reporting primarily.
The current membership is composed of eight women and nine men from across the country. We have representation from the Atlantic region, Quebec, Ontario, and the western provinces. We also have an individual with aboriginal expertise on reserve and in rural settings. The membership includes health professionals, patient and consumer advocates, and researchers in academia as well as in industry. It has individuals with interests in ethics, epidemiology, biological sciences, human medicine, health product vigilance, public health, social sciences, risk assessment, as well as communication and risk management.
It's a privilege to be the chair of this committee, and thank you.
Thank you, Madam Chair.
On behalf of the Institute for Safe Medication Practices Canada, I would like to thank you for inviting us to be part of your study on post-market surveillance. ISMP Canada is an independent national not-for-profit organization established for the analysis of medication error or incident reports. Our purpose is to identify underlying contributing factors or causes and to make system-based recommendations for enhanced patient safety.
We are working together with the Canadian Institute for Health Information and Health Canada to develop the Canadian medication incident reporting and prevention system. We also work closely with the Canadian Patient Safety Institute and other organizations and associations working to advance medication safety and patient safety at a provincial, national, and international level.
Our area of expertise is analysis of the preventable subset of adverse drug events. We know from a number of studies, including the Canadian adverse events study and two studies in the U.K., that a large proportion of adverse drug events are in fact preventable.
Through the shared learning from reports of medication incidents that we have received, we've made approximately 195 recommendations for consideration by hospitals as safeguards in their medication use systems. Of those, approximately 50 have now been adopted by CCHSA, the Canadian Council on Health Services Accreditation, as required practices.
Having 50 of our recommendations adopted by the accrediting body influences 3,700 health care sites and exemplifies how learning from reports and their analysis can lead to knowledge translation and proactive system enhancements.
I would like to take this opportunity to provide you with some examples relevant to Health Canada's regulatory mandate.
The first photograph I have for you is a picture of a transdermal patch introduced into the market. Because the patch was almost invisible, practitioners in emergency departments reported not knowing that patients were receiving a highly potent narcotic; the patches were being missed. The manufacturer responded very quickly and added both the name and colour to the patch, as seen on the next page. Medication patches are relatively new, and these incidents inform the need to include regulatory guidelines for labelling of patches.
On the next page you'll see two bags. The bag on the right, which is intended for pharmacy use only, was inadvertently infused intravenously instead of the IV solution on the left. We received three reports, one of an incident leading to serious harm, and we knew that in the U.S. there had been a fatality reported due to a similar error. We worked with the manufacturer, and they changed their label, as seen on the next page. This is a significant improvement.
There is still opportunity to improve the packaging of the bag. Until we make it impossible to connect a product not for IV use to an IV line, such dangers continue to exist.
On the next page you'll see two ampoules that were mixed up and reported as a near miss. The risk for harm is high. We have worked with individual manufacturers to improve such labelling, and we've provided an example of how the labelling can be improved on the next page, where you see the upper ampoule with print on glass and the lower ampoule.
We think printing critical information directly on glass should not be permitted. Ultimately this learning needs to be incorporated into regulations or guidelines so that the knowledge is translated into current and future manufacturing practices.
The next example is interesting because the label meets regulatory requirements for display of concentration. However, the product is not prescribed in millimoles; it is ordered by the physician in grams, and the conversion is not an easy calculation. We acted after only one report. The manufacturer quickly changed its label and thanked us for not just identifying the problem, but for providing recommendations for improvement. Note that this company took the extraordinary step of removing their logo from the label in order to give prominence to critical information.
In the last example we show five neuromuscular blocking agents. Neuromuscular blocking agents have been identified as high-alert drugs, which means that the drugs, when involved in an error, have a high incidence of causing harm. Three of the manufacturers voluntarily chose to follow our advice to place a warning on the top of the vial and two did not. This is a good example of a situation in which we could evaluate the recommendation together and, if it is reasonable, make it a requirement, again so that the learning is not lost on future products.
The key message is that underlying practice errors are opportunities for system enhancements to help prevent recurrence. Unless underlying risks are mitigated, it could be predicted that the errors will repeat again and again.
A key component of reporting programs is the follow-up and analysis and being responsive. For medication incidents, this includes identifying whether there are preventive strategies. It is also important to demonstrate to reporters that they have made a difference through their efforts to report, and this will in turn increase reporting.
ISMP Canada is aware of Health Canada's plans and initiatives to strengthen post-marketing surveillance, such as additional regulatory authorities post-market with labelling, and we would like to offer our assistance where possible.
Thank you very much for providing me with this opportunity to present my views. I would also like to mention that I'm the current president of the International Society for Pharmacoepidemiology, and for several years I have been an expert consultant for regulatory authorities such as Health Canada as well as the European Medicines Agency, EMEA, as well as for the pharmaceutical industry. It's important also that I say that my presentation presents my views and not those of the organizations I'm affiliated with.
At present in the post-marketing setting, safety surveillance is mainly conducted through spontaneous reporting. While it is recognized that spontaneous reporting is the best method to detect a previously unknown safety issue at the level of the entire population, it is not suitable to quantify a risk. Spontaneous reporting is highly efficient to generate a signal, but not to evaluate the risk. Therefore, at the present time drug safety data originate mainly from randomized controlled clinical trials at the time of approval and spontaneous reporting thereafter as the main safety net to monitor drug harms.
What we have observed under this model is that over the past 30 years in Canada there have been 121 drug withdrawals due to safety issues. This represents extreme, if not catastrophic, regulatory decisions that should be avoided because of the major negative impacts at many levels, such as drug companies, regulatory agencies, and eventually loss of confidence by the public.
In other jurisdictions, such as the U.S. and the E.U., it has been recognized that the current model is insufficient to properly monitor the benefits and harms of medicines. Hence, there has been a major shift in paradigm for drug safety surveillance. Instead of relying entirely on randomized clinical trial data to assess the benefit-risk of a drug and afterwards on the spontaneous reporting system, authorities have introduced in their regulations risk management in all phases of drug development.
Since 2005, a pharmaceutical product is authorized on the basis that in the specified indication at the time of authorization, the benefit-risk is judged positive for the target population. However, it is recognized that not all actual or potential risks will have been identified when an initial authorization is sought. In addition, there may be subsets of patients for whom the risk is greater than that for the target population as a whole, or there may be subsets of patients for whom we are willing to accept greater risks because the condition for which they are treated is serious and they do not respond to any other available therapy.
Furthermore, there may be potential risks that need to be addressed, and to conduct additional randomized trials prior to the submissions will probably not bring the answers that are needed because some of those adverse events are extremely rare. Instead, an active surveillance system from the time of marketing would allow us to properly monitor these potential risks.
Finally, the benefits of a drug must also be monitored in the post-marketing setting, because even though a drug has been judged efficacious according to clinical trial results, the benefits may be much lower in the real-life setting. This is the case, for example, with anti-depressants, whereby more than 50% of patients discontinue their treatment before the minimum recommended duration of six months. Hence, patients are exposed to the risks that occur early in the treatment and to very little benefit since the drug must be taken for an extended period of time. Again, this would not have been reported in clinical trials.
Tools are available, such as observational epidemiological studies, to bridge this information gap and ensure that the benefit risk of a new drug is maintained. Should problems be identified in the usage of these drugs, or at-risk patients be identified, then interventions can be rapidly implemented to maintain the benefit-risk within the acceptable range. Such interventions are referred to as risk minimization action plans.
So the current risk management model involves various phases that can be summarized into detection, evaluation, minimization, and communication.
In the EU, all new drug applications must be accompanied by risk management plans. In the U.S., although not mandatory, such plans are expected by the FDA. In fact, drug approval may be delayed if the plan is judged not satisfactory.
Pharmaceutical companies are now realizing the huge economic consequences of not taking full responsibility for properly managing the risk. We are moving away from a reactive process to a much more proactive approach involving a broader evidence base and a widening of expertise, resources, and methodologies. Studies are conducted in the context of conditional approvals, and denial of marketing occurs if commitments are not met.
For many years Canada has been a leader in the area of pharmaco-epidemiological research, with one of the highest concentrations of experts in the world and access to invaluable resources, such as prescription and medical services databases that are available through our public health care system. Yet studies conducted in Canada are mainly investigator-driven. In the absence of legislation, those studies are not being implemented right at the time of marketing to ensure that real-life data on drug safety is generated as soon as possible and fed back to the regulators, who can then reassess the benefits and risks of a drug. In the absence of such legislation, regulatory authorities such Health Canada have very little leverage to request these studies.
Finally, an important element of risk management is risk communication. In addition to the package inserts, the evidence being generated must be fed back to the health care professionals and patients as soon as possible. The process by which the risk is being managed must be transparent and no longer a top-down approach.
In conclusion, the current model, such as the one used in Canada, is deemed insufficient to appropriately optimize the benefits and risks of medicines in the post-marketing setting. Risk management is the new paradigm that will use complementary sources of data and methods. Although the methods and expertise have been available in Canada for many years, they have not yet been packaged to be part of the drug regulatory process.
There are many resources in Canada that remain underutilized, such as claims databases, that could be useful in improving the analysis of spontaneous reporting of data and in evaluating the risk in the post-marketing setting.
: Merci, madame la présidente
Thank you all for your presentations. They were very informative.
There seem to be recurring themes in the presentations on this subject. As I think Dr. Moride pointed out, it's not necessarily that we have a lack of information in the country; it's how we use it and how it's interlinked. We also have the question put forward on whether practitioners would willingly provide information on adverse effects—or even the larger question of post-market surveillance, I presume—if there were feedback, if valuable information came back to them that helped them in their practices. It's a shame that we haven't got to that point yet.
We are wrestling with whether there should be legislation. Should mandatory reporting be necessary? Would that assist us? It's a difficult question. I think it's made a little more complicated by Dr. Gowing, because his definition of adverse effects is a little different from what we've been dealing with so far. It's beyond somebody being rushed to the hospital; it includes somebody not receiving the effect you would expect from a therapy.
I want to open the question to all of you. We've heard of two possible elements here of change, aside from the technological aspect. One is progressive licensing, where medication would come on the market at different levels and be progressively licensed as information was available. The second one that we heard a lot about is off-label use. We've heard of the necessity for off-label use because of the way we license our drugs and the therapies they eventually become useful for.
It appears to me that both of those instances would be a great way to get a lot of the data you were talking about, Dr. Moride, because the uses wouldn't necessarily be the ones they were licensed for. So you could expect the community to feed back more at that time if the health treatment community was getting useful information from it.
I open it to all of you to comment.
As regards antidepressants, I remember that, a few years back, patients were unaware of the fact that there has to be a period of desensitization before the treatment is discontinued, and that you can't just suddenly stop taking antidepressants. That can even lead to suicide, because the patient feels very badly and there are psychological effects, as well as an effect on a person's mental balance. Few physicians actually told their patients that. Again, that was something that appeared in the headlines, and that is how we found out that some patients were experiencing extremely adverse effects, which could even lead to death.
I would like to come back to Dr. Gowing, who says that he is collating a lot of information and has a lot of data about adverse effects that are not really being passed on. There seems to be a number of different ways of reporting the information, in order for people to be made aware of the adverse effects of certain drugs. I am a little surprised to hear you say that, because we are always told that the practitioners, who most often are professionals, are the ones reporting the most information to Health Canada through the various data banks, including MedEffect, but there is also the Canadian Health Network, which collates certain kinds of information.
Could you suggest a mechanism that would be more efficient, since the information does not seem to be getting out, and that is exactly what we would like to see happen?
Thank you, Madam Chairperson.
Thanks to all of you for your presentations.
I want to touch a bit on the off-label question and the whole area of what I would see as a problem, and that is the involvement of the industry throughout the process of post-market surveillance.
There have been concerns raised about the government's new direction around risk management and the progressive licensing system as it relates partly to the off-label issue. That is, it might actually lead to a fairly rapid approval of already approved drugs for new indications without that company having to go through the rigour of the clinical trials and the surveillance and full disclosure before an old drug just gets automatically licensed for new indications.
Is that not a problem, from any of your points of view?
That is a significant problem, particularly in the older drugs that have been on the market for several years. Most of these drugs are not even available through the originating company or industry that actually created the molecule. Aspirin comes to mind. It's ancient, yet it's used primarily now for indications completely separate from what it was intended for years ago.
The difficulty then lies in who's responsible for the clinical trials, who is going to do the research, and where the funding is going to come from for the research. So, yes, it is definitely a problem.
In terms of new medications, I think that should be included within the progressive licence process. As indicated by my colleague, if at the outset, within phase two trials, within that licensing it's implied that off-label use for predictable other uses should be considered, that needs to be in the plan for the continuation of that product so that the evaluation continues.
I appreciate the balance that we have to try to strike. I guess what I'm worried about is that we have a system with an incredible lot of influence by the brand-name drug companies over the whole drug approval process. I want to make sure that we end up with recommendations that actually protect against that. So what I want to know from all of you is, how do we do that? What is the best way?
I'm especially curious because the Cancer Advocacy Coalition of Canada does get a lot of backing from drug companies. In fact, I think every drug company in the western hemisphere has donated to your organization.
From the Expert Advisory Committee's point of view, I don't know about your committee, but some advisory committees in Health Canada have indicated that there are industry members on those committees. So how do we ensure that if we move to this risk management model and this progressive licensing model, we have that independence of opinion and surveillance right across the board, every step of the way?
I think that's what Canadians are most interested in, so we're grappling with whether or not we need an independent board or body that actually evaluates prescription drug safety. We've grappled with the need for a complete listing on the government's website of all drug approvals and non-approvals. We're grappling with whether or not there shouldn't be a complete review of all clinical trial data used to reach any decision made and that being made available to the academic community.
Those are a few ideas. Are there other—
I'd just like to address one point you made.
The Cancer Advocacy Coalition of Canada gets unrestricted grants from the pharmaceutical companies. We provide them with a list of things that we're going to do, and they either do or don't support them. As you can see from this year's report card, only two of the 10 articles had anything to do with drugs, and our emphasis is on much wider aspects than that.
That said, I think we also have to say, on behalf of the drug companies, that they're not all bad people. They have their interests, and this is a capitalist society, after all. If they didn't work, we wouldn't get the drugs. So I don't think it's fair to impute motives to them that are beyond the ethical boundary.
That said, I agree with your point. An independent body needs to be doing this surveillance, but the essence of the success will be draining off the information from all the electronic systems that are already getting this information in medical records across the country, particularly for cancer drugs. The information is there; we're just asking that it be drained off for surveillance and addressing the issues you've just raised.
Yes, and thank you for your question.
I think Health Canada's approach to collaborating with partners and coordinating efforts of different groups interested in safety and pharmaco-vigilance is the way to go, and I think it's to be commended. As was mentioned before, there are various pockets of information in different databases, and their outputs can be coordinated. We've heard about claims databases, we've heard before about coroners' offices reports, and there are poison information centres, so there will always be pockets of information that we can analyze differently and coordinate in terms of outputs. I understand that Health Canada is considering the idea that there are various databases that we can pool together and learn from together.
With regard to privacy and transparency, I also think Health Canada's efforts to bring the adverse reaction reports online are to be commended. Yes, they are planning to improve the database and the searchability of that information; however, there is now information online, and it's transparent. Transparency is the way to go; in terms of privacy legislation, provided the information is de-identified and factual, it can be shared. There are ways to share important information in a transparent way that falls under the umbrella of privacy legislation and privileged acts.
As has been stated, we are moving in the right direction, and working together is the approach.
I don't think the strategy is concerned with that, because of its mandate.
But to answer your question, the specific program we're talking about isn't being done, but it could easily be done. All the western provinces now have electronic data systems, which could easily be interrogated—to answer a previous questioner—and have the data drained off and the adverse effects and failure to respond also made immediately available. This isn't a big deal for the western provinces.
For the provinces that don't have cancer agencies and don't have electronic data systems, it is a big deal. But as I said earlier, if you want to start small, with a pilot study for these expensive cancer drugs, go to the systems that have electronic data systems, drain off the information, and see what you have.
Thank you, Ms. Chair. I thought that was the order, but I guess we got mixed up there for a second.
I have a few questions. I'll raise them all at the beginning, and then you can comment on them where appropriate.
I've asked previous witnesses, as they gave us their expert advice, about the use of new technology and the role you believe that could have. One thing that was mentioned before was a hand-held device where there would be real-time access to Health Canada updates. We were told by the Canadian Medical Association that sometimes notices are mailed out or faxed out, so the time period to get them can sometimes be quite lengthy. I want to see if you have any suggestions on that.
We also heard from an individual, Terence Young, who spoke on behalf of a victims' advocacy group about the need to better share international data, saying that if a pharmaceutical company does a study, it should be shared with Health Canada within 48 hours. If that pharmaceutical company is producing pharmaceutical products in Canada, they should be required to share studies they've done abroad. I want to know your thoughts on that and whether that would be helpful.
I also want to know if you could comment on the Beers list. We heard at this committee that there is information compiled about how a specific pharmaceutical drug could affect a specified category of individuals--in this case, seniors. What ability would you suggest Health Canada should have to create other lists, and is that our role? Should there be a list of drugs that could adversely affect women or children, in the same sense that we've had that Beers list that was compiled?
A lot of the discussion has been at the 30,000-foot level. I want to ask some questions from right on the ground.
Twelve years ago, when I was in the hospital looking at the doctor's notes, I assumed the doctors were literate, though you'd never know it from reading their handwriting. Fast forward to the present. The doctors I've seen over the years are definitely not technically savvy. Today there are reports in the media that doctors are one of the main culprits in spreading superbugs in hospitals, because they don't have time to wash their hands.
The issue of compensation has come up. How will doctors be compensated for the time they're going to be spending filling out reports?
How would this work at the ground level? What stimuli could be provided to the doctors? It's easy to talk about cultural change, but we're talking about a massive change in the way doctors operate.
I want to respond that health care is a little behind in utilizing technology, but there are efforts under way to implement computerized order entry systems, recognizing that there are problems with handwritten notes. There are also initiatives under way with manufacturers to look at voluntary bar coding standards, so that bar coding technology can be utilized in health care where appropriate. This is also an opportunity to look at the labelling of products, as there are a lot of products that do not have bar codes on them. This is an opportunity for improvement.
The other thing we have done, and which is being adopted, or being considered for adoption, in the accrediting standards for hospitals, is...the use of dangerous abbreviations. We recognize that there are abbreviations that are dangerous if used in the handwritten form, and in the electronic form. Those can be avoided.
Also, I do believe that when a prescription is handwritten, the patient should be able to read that prescription; it should be legible and not be in Latin. That is a safety thing, as well, for the pharmacist. As a pharmacist, I would like to be able to read the prescription.
I just wanted to comment on that.
Thank you, Ms. Laughlin, and thank you, Mr. Fletcher.
If you don't mind, I would just like to ask a question as chair of the committee. There's one aspect I was just wondering about. When we're talking about drugs, I know that drugs for something like chemotherapy are very expensive; usually you're prescribed four, five, or six drugs, depending on the level of chemo. And sometimes those drugs don't work.
Have there been any answers as to who picks up the cost of those medicines that absolutely do not work? If you're experimenting, whether it's with cancer or another disease that is very dependent on the medication, has there been any examination of that in the medical world?
A doctor could prescribe a pill and really do the best he or she can in doing that, and they might spend a lot of money on that bottle of pills, but they might find out after you've taken one pill that, oops, we have to go to another one. Has there been any examination of that kind of predicament that patients get into?
Thank you, Madam Chair.
Welcome to the witnesses.
This is not usually the committee I sit on, so I'm finding this discussion quite interesting and a little alarming.
There's the whole discussion on informed decision-making. If you don't have a process that's entirely transparent and you don't have that risk versus benefit list, how can you make informed decisions? I guess that's more of a rhetorical statement than anything else, but it's very difficult. I don't know how you do that.
The other thing I'm quite shocked about is the electronic health records. I listened to my colleagues talk about doctors' handwriting, which is an old joke, but they're not alone. Most people have illegible handwriting today. There's hardly a kid in school who can write so you can read it, but everyone can use a keyboard.
I think we've looked in the wrong area. We've been blaming the doctors when we should be giving them more assistance in filling out the electronic records. They're busy; they're trying to see as many patients as they can in a day. Frankly, there's no reason why a doctor shouldn't be able to tell their assistant to fill out a prescription for the pharmacy so that it comes to you in typed format.
I don't understand why we don't have a complete electronic record in this day and age, especially at the hospital level. It just doesn't make any sense. It would be easy to do. You wouldn't even need a patient's sheet to write on. You would have a keyboard instead. It would come up on the screen and automatically go out to everybody.
I don't know how many drugs are allowed into Canada and registered every year, but I assume there are hundreds of them.
I'll respond to something you said.
I think the practical solution to the 23,000 drugs problem is one that I encountered when I was practising in Detroit, at the cancer centre there. The pharmacist was in the clinic with us, and he or she had access to the electronic database. At about every second patient, we would have to interact as a team to make sure the drugs were the right drugs--and not just the cancer drugs, but all of the other drugs. So there are practical solutions to that.
To answer Mr. Fletcher's question about having just been released from the park because I've promised to use electronic systems, the synoptic reporting system that is being introduced in a wide variety of clinical circumstances will greatly simplify that. You just tick off the boxes, and the questions are arranged in a way that you can't escape giving the right answer. That system actually works quite well.
I want to thank you very much. We've come to the conclusion of the questions the committee wanted to ask today.
I really want to thank each and every one of you for having come here today and given your expertise and your advice. This is a very important study, and a lot of your information has been very insightful and very useful to all of us. So I certainly want to thank you for that and wish you well. I look forward to hearing more from you in the future, I'm sure, on other topics as well.
For the committee, there is another committee coming in, so we are going to be adjourning very shortly.
Next committee, Thursday, we have just a small group of witnesses coming in, and we will also be doing committee business at that time.
Thank you, ladies and gentlemen.
The meeting is adjourned.