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SOCI - Standing Committee

Social Affairs, Science and Technology

 

Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology

Issue 25 - Evidence - November 7, 2012


OTTAWA, Wednesday, November 7, 2012

The Standing Senate Committee on Social Affairs, Science and Technology met this day at 4:14 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]

My name is Kelvin Ogilvie. I am a senator from Nova Scotia and chair of the committee. I will start by asking my colleagues to identify themselves.

Senator Eggleton: I am Art Eggleton, a senator from Toronto and deputy chair of the committee.

Senator Munson: Jim Munson, a senator from Ontario.

Senator Cordy: I am Jane Cordy and I am from Nova Scotia.

Senator Neufeld: I am Richard Neufeld from British Columbia.

Senator Doyle: Norm Doyle from Newfoundland.

Senator Martin: I am Yonah Martin, also from British Columbia.

Senator Seidman: Judith Seidman, from Montreal, Quebec.

The Chair: Thank you to all of the witnesses who have joined us here today. To remind everyone, we are dealing with the second phase of our study on prescription pharmaceuticals. In this phase we are dealing with post-approval monitoring. We will keep our questioning to that aspect of pharmaceuticals. The theme of today's meeting is research and surveillance.

We have the witnesses before you. I will call them in the order that they are listed on the agenda for today and introduce them at that point. Without further ado, I will go to Canada Health Infoway, and I will recognize Mike Sheridan, who is the Chief Operating Officer; and Jennifer Zelmer, Senior Vice-President, Clinical Adoption and Innovation.

Jennifer Zelmer, Senior Vice-President, Clinical Adoption and Innovation, Canada Health Infoway: Thank you very much.

Honourable senators, I would like to start by thanking you for the opportunity to be here today to discuss the post-approval monitoring of pharmaceutical products. I am joined by Mike Sheridan, Infoway's Chief Operating Officer.

I want to thank the committee for your recognition and support on the importance of electronic health records in your report on the 2004 health accord and of course the Government of Canada for its contributions to Canada Health Infoway.

In fact, the committee's focus today offers a real example of the value of electronic health records, both to individual Canadians and to the health system more broadly. Digital health solutions can and are helping to support post-market surveillance initiatives in four main ways.

First, as we have seen with a number of high-profile medications in recent years, both side effects and contraindications are not always identified before drug approval. As previous witnesses have pointed out, identifying rare effects, in particular, requires following large numbers of patients, often for longer periods of time than is typical in a clinical trial. Drug information systems do just that. Their main role is to allow authorized care providers to view a profile of all a patient's medications which helps to ensure, to the degree possible, that a new medication is safe to prescribe for that patient.

Analyzed in a privacy-sensitive way, data from drug information systems can also be helpful for post-market surveillance. For example, Canadian researchers have used them to explore the effects of long-term use of medication for osteoporosis and the risk of different types of hip fractures, as well as the association between a common class of antidepressants and the risk of bleeding in the upper GI tract. I know you have already spoken with CIHR and colleagues from the Drug Safety and Effectiveness Network and these are the types of tools their researchers can use.

Medication profiles in drug information systems are currently available for more than half of all Canadians, with remaining provinces indicating that they will be complete by 2016.

Second, digital health solutions contribute to making it easier to identify and report adverse events when they occur. For example, systems at the point of care may prompt a clinician to submit a report when an adverse event is detected. They may also save time by automatically populating basic information in a report. Several organizations have been trialing this type of approach to learn how it might be used most effectively, including the Food and Drug Administration in the U.S., as the witnesses from there told you recently.

Digital health solutions may also make it easier for patients to report side effects. For example, I am just back from the International Society of Quality in Health Care meetings, where colleagues from Boston reported on an automated phone system that calls patients four weeks after having been prescribed a new medication. The researchers found this a useful way of tracking how often adverse events occur in actual clinical practice, which may differ from the original clinical trials.

Third, digital health solutions can help to prevent medication-related problems. We have seen this recently in a study from Colin Dormuth and colleagues for the Drug Safety and Effectiveness Network. They looked at the effect of providing B.C. pharmacists with real-time medication profiles through PharmaNet. Within six months of implementation, filled prescriptions for opioids and benzodiazepines that were likely inappropriate were down by between one third and half for certain types of patients. This is consistent with the national survey of pharmacists using drug information systems where more than 9 in 10 said that the systems improved their ability to reduce fraudulent medication use and to reduce drug-related problems.

The benefits are not only for pharmacists. Appropriate decisions support at the time of prescribing can help make it easier for prescribers to access and use the latest evidence on safe and effective medication practices.

Finally, IT is an essential tool to help busy clinicians respond to the results of post-market surveillance. Suppose there is a drug recall or a major change in contraindications. It is not easy for a practice using paper records to reach out to identify the patients they need to call. In fact, a recent study by researchers from McGill and St. Mary's University found that it was about 30 times faster for those with electronic records to do searches like this, and those practices were also more confident in the results they had obtained. That is why, for example, early adopters were able to call patients who were taking Vioxx before they actually heard about the issue on the six o'clock news.

Use of electronic medical records is now accelerating across the country, and about half of physicians use them. With current investments, we expect this number to rise to between 60 to 65 per cent by 2014.

To conclude, drug information systems and other digital health solutions can provide an evidence base for post-market surveillance, they can improve timely reporting of adverse events, and they can also help clinicians to proactively prevent and address medication-related problems. That said, it is also clear that these are enablers as part of a much broader program, which includes appropriate training, policies, clinical protocols and workflow, regulatory frameworks, and more.

Mr. Chair, that concludes my opening statement. We would be happy to answer any questions.

The Chair: Thank you very much. I will now turn to the Health Council of Canada. We have John Abbott, the Chief Executive Officer; and Ms. Ingrid Sketris, the Councillor.

Ingrid Sketris, Councillor, Health Council of Canada: Thank you, honourable senators. It is a pleasure to be here today to speak on the topic of post-approval monitoring of pharmaceuticals, generally referred to as pharmacovigilance.

By way of background, I am a licensed pharmacist and a professor at Dalhousie University. I have been a member of the editorial board of the Canadian Journal of Clinical Pharmacology and I am a Fellow at the Canadian Society of Hospital Pharmacists and the American College of Clinical Pharmacy. My research looks at the effect of drug policies on drug use and costs.

However, I am here today in my capacity as a councillor with the Health Council of Canada. Joining me is John Abbott, our CEO. The Health Council is no stranger to this Senate committee, having appeared several times; nor is the Health Council a stranger to the topic currently before the Senate committee.

I believe you have been provided either electronic or hard copies of the Health Council's commissioned paper on this topic, which we released in November 2010. Our paper entitled Keeping an Eye On Prescription Drugs, Keeping Canadians Safe sought to raise awareness among Canadians about issues related to monitoring drug safety and effectiveness, and to stimulate dialogue about steps that can be taken to build a more effective pharmacovigilance system in Canada. It drew attention to the fact that governments had agreed to act on drug safety issues as part of the National Pharmaceuticals Strategy. We believe these hearings help contribute to keeping these issues alive in the minds of Canadians as well as their governments.

As everyone around this table can appreciate, this is a large topic. For the purposes of my testimony today, I will limit my comments to the Health Council's paper. This is an evolving field, and changes have been made by Health Canada and other countries' regulators to improve post-marketing policies since we released our paper. However, we need to bring awareness of these different approaches and learn from one another for the benefit of patient safety.

With that, and if agreeable by everyone, I will proceed to highlight the key findings of our work, which focused on how we can improve the monitoring of the safety and effectiveness of drugs after they enter the Canadian market. Following my brief presentation, I would be happy to answer other questions regarding this work and my comments.

For example, we know that drugs, once they reach the market, tend to be used by a wider range of patients than in clinical trials, often in patients with multiple medical conditions and for a prolonged period of time. As such, it only makes sense that post-marketing be an integral part of the drug approval process.

As you know, there have been recent national media reports that suggest that Health Canada is not providing enough follow-up of adverse drug reaction reports by patients and providers. Taken together, this makes the need for increased awareness about drug safety and patient issues all the more important.

With our paper, we want to discuss what concrete steps can and should be taken to build a more effective pharmacovigilance system in this country. We know other countries are also dealing with these issues, and there is an opportunity to learn from them. One of the things we have learned from others is that voluntary and passive approaches to reporting adverse drug reactions cannot and do not adequately identify problems with drugs that are already on the market.

We know that, at present, unlike some other countries, Canada lacks the authority to require companies to conduct post-market studies, although there are some limited exceptions, and to monitor the drug companies' patient registries. We also know that our communication of risks and safety issues are not as effective as others, that our regulatory agencies and research networks have limited access to post-marketing data, that other regulators are seen as responding quicker to drug safety warnings than Canada. We need to have a more prescriptive and transparent regime.

In terms of surveillance models, we have looked at international models that actively monitor the safety and effectiveness of drugs after they enter the market, many of which hold potential for Canada, given their more independent and transparent monitoring approaches.

Consider the FDA, for example. It is currently the only regulatory agency that requires product sponsors to submit raw, unanalyzed clinical trial data. Their advisory committee meetings are held in public. Besides the FDA, the European Medicines Evaluation Agency recently announced its intention early this year to have raw clinical data submitted to the regulator. It also requires registration of post-market studies. Again, in the U.S., new accountability legislation allows for more active surveillance on the risks and benefits of drugs, and is helping to build research capacity.

In Canada, we have to rely on voluntary collaboration between regulators, researchers, health care professionals, provincial drug plans and industry to obtain data to facilitate post-market research. This is proving to be insufficient.

There is also a strong need to improve Canada's research protocols and capacity — that is, research separate from industry — to undertake the rigorous, unbiased and transparent post-market drug safety and effectiveness research to ensure greater patient safety.

As you have heard from earlier testimony, the Drug Safety and Effectiveness Network, DSEN, is just beginning to take off in Canada. It currently funds seven research teams in three collaborating centres, which comprise more than 150 researchers working in eight provinces. It also collaborates with international research networks. However, DSEN does not have the regulatory responsibility and can only commit to the level of research funded by Health Canada. It has been recognized that Canada needs to allocate more public funding to ensure that the required independent post-market surveillance and research is conducted.

This all leads to the importance of transparency within the drug monitoring system. There have been many people and agencies who have spoken out about or raised concerns with how Health Canada operates with respect to post-approval monitoring and the manner in which industry shares its data. Health Canada and industry need to be more transparent in their transactions in order to maintain public confidence in our drug system, especially now that we are in the age of viral communications.

Finally, the need to enhance patient safety needs to drive all our public policies related to drug approvals and post-marketing monitoring. It should always be our first priority. There can be no compromise on this objective. When our system is seen as failing our patients, Canadians will lose trust. Without trust, our entire drug system is in jeopardy.

With that, I would be happy to take your questions.

The Chair: Thank you very much. Now we will move to the Institute for Safe Medication Practices and hear from Sylvia Hyland, the Vice-President.

Sylvia Hyland, Vice-President, Institute for Safe Medication Practices Canada: Thank you, Mr. Chair. It is very nice to be here. On behalf of the Institute for Safe Medication Practices Canada, also known as ISMP Canada, thank you for inviting us to be part of your study of post-approval monitoring of prescription pharmaceuticals.

Briefly, we are an independent national not-for-profit organization established to analyze incidents of preventable harm from medications, to identify system improvements, and advance medication safety through collaborative programs and projects.

I will present four key advances that have been made in post-market prescription drug monitoring and comment on future opportunities for excellence.

First, Health Canada is making progress towards a life cycle approach to drug safety oversight, and this work recognizes the need for continuous evaluation of the use of a drug and its benefit/risk balance in the real world experience.

Pharmacovigilance activities are now also being viewed more broadly as relating not only to adverse reactions but also any other drug-related problem. For example, following analyses of medication errors, we have worked with manufacturers and Health Canada to improve label design so that critical information including drug name and strength is the most prominent information rather than, for example, emphasis placed on branding or marketing. In this way, we can reduce the risk for error.

With the efforts towards a life cycle approach and regulatory modernization, we envision increased authorities for Health Canada. Such authorities would include greater influence on the unique considerations for the package and its label, the product monograph, the package insert and the patient information that is provided. We also see increased authorities in the area of access to information about product uses, and requiring post-market research studies.

Second, Canada has shown global leadership in transparency as one of only a small number of countries, including the U.K. and the Netherlands, to have made the database containing adverse reaction report information freely available to the public. Our adverse drug reaction database is available online.

We also have the Canadian Medication Incident Reporting and Prevention System, a medication error reporting program that shares the learning from incidents through safety bulletins and informs standards development.

Both programs benefit from "concerned reporting." Our experience shows that reporters tend to report the severe and unexpected cases of harm from medications and this helps detect new signals.

Recognizing that since each data source will have its limitations, there is a need to better integrate or connect information from a variety of sources — poison control centres for example — for optimal analyses and continuous evaluation of a drug's benefit/risk balance.

We also envision more focus in the area of interpreting the information to assist the health care professional and patient in their decision-making processes. Ultimately, pharmacovigilance includes ensuring that practitioners, together with patients, have enough information to make an educated decision about drug treatment.

The evidence used in risk/benefit assessments will need to be openly available and Canada is well positioned to continue global leadership in transparency.

Third, with the broadened scope of pharmacovigilance, we see increasing collaboration among provincial, national, and international stakeholders. There are good examples where data sharing or collaborative efforts have improved signal detection and analyses.

One mechanism that will further advance medication safety is the use of standardized pharmaceutical automated identification, such as bar-coding. Foundational work has been accomplished through the Canadian Pharmaceutical Bar Coding Project, a collaborative amongst 40 organizations involving six health care sectors including Canada Health Infoway, and also endorsed by the Health Council of Canada. Consensus has been reached on a national bar code standard and it is being adopted for commercial pharmaceutical products.

The opportunity is to link this work with other advancing technologies, such as the electronic health record and thereby continuously improving data capture on the use of medications.

Lastly, the fourth key area of advancement has been an increase in consumer engagement in post-market monitoring activities. Patients today are highly informed about their disease and they want to participate actively in their treatment.

SafeMedicationUse.ca is the consumer component for the medication error reporting program. In addition to supporting a proactive role in medication safety, the website provides links to Health Canada programs as well as a growing number of organizations working to advance medication safety. This work has informed collaborative efforts with Health Canada and industry, for example, around look-alike, sound-alike drug names.

An area of current interest is the safer use of prescription narcotics, also known as opioids. As an example of data sharing, we are collaborating with the provincial offices of the chief coroner and chief medical examiners. Preliminary findings have identified incidents involving opioids as a top area of concern. There is growing evidence of a need to provide updated information to practitioners about the pharmacodynamics of these drugs and also to consumers about their safe use.

Finally, our experience with consumers shows that Health Canada has high public trust and it can be difficult to measure the harms that have been prevented in this country as a result of the efforts to date. Building on some key advances, we have an opportunity to continuously evaluate and improve the various efforts that are aligning for synergy and impact.

Thank you again for this opportunity and I look forward to our discussions.

The Chair: Thank you very much. I will turn to my colleagues to begin the questioning.

Senator Eggleton: Thank you for your three very good presentations. Let me start with Canada Health Infoway.

In terms of digital health solutions, you have suggested that there are a number of ways. You list four in your presentation that you think can help in terms of reporting adverse reactions and contributing to the post-market surveillance for pharmaceuticals.

Some of them have an international scope, so that all seems fine. However, have you talked with Health Canada about this? Where does this stand with Health Canada and how much is dependent on getting more people on to electronic medical records?

You said it is going up. You said you are up to 50 per cent and hope to have it to 60 or 65 per cent in a couple of years. That is the electronic medical records within the doctor's office, the clinic or whatever. The electronic health record goes broader afield and has a more comprehensive use, as we found when we did the health accord. How will you get this into effect? It seems like a good idea. How responsive is Health Canada and how far can you go before you get more people on to EMR and EHR?

Ms. Zelmer: To start, it is important to note that some of it is in effect already. PharmaNet in British Columbia began many years ago. We can track and see the results of some of those early efforts. You are right; efforts are in progress and not yet available across the board. As that continues, we need to see what we can learn from the early adopters and bring the experience to the other jurisdictions to get those benefits for everyone as quickly as we can.

There has been significant growth over the last fewer years in the use of electronic medical records. The program we have has a component that links them into components from the EHR as well so you can access the patient's medication profile right in your electronic medical record, exchange information about lab test results or whatever the need of the patient might be at that time. You are absolutely right that you need both components. You need the point of care tool at that point where you are seeing your family physician, for example. They also need access to your full medication profile to be able to care for you. In the realm we are talking about today, it is important to have information about all of the prescribers involved in a patient's care, because a given patient may actually have interaction with many different points in the health system. Any of those may relate to interactions between medications, for example, or may be an opportunity to pick up an adverse reaction.

Senator Eggleton: How far away are we from implementing many of these? You say some of this is already being used now.

Ms. Zelmer: Yes.

Senator Eggleton: It is quite a comprehensive package. How far away are we? Is it another in five years or so?

Ms. Zelmer: It varies across the country. If you think about drug information systems, for example, they are now available in all of Western Canada.

Senator Eggleton: You can roll this out gradually across the country?

Ms. Zelmer: Different jurisdictions are ahead in one area, others are ahead in another. Everyone is on the same path but they have chosen different points to start with. The intent is that it will come together.

Senator Eggleton: ISMP has a number of suggestions. How are they progressing in terms of your cooperation with Health Canada?

Let me ask you specifically about this matter you raised towards the end regarding look-alike, sound-alike drug names. Can you cite some examples of that kind of thing?

Also, is this something that you think Health Canada needs authority over in terms of being able to change the label?

Last week, we had some people from the States telling us about the black box system they use in terms of labelling. Would that system, plus further authorities at Health Canada, help in terms of the look-alike, sound-alike drugs?

Ms. Hyland: I will give you an example of how it is working now, which is to say voluntarily. It is working well in many instances. For example, every manufacturer in Canada now is putting a warning on their neuromuscular blocking agents, which are paralyzing agents. Voluntarily, every paralyzing, neuromuscular blocking product in Canada has a warning that says "Warning: Paralyzing agent." We found that sometimes vials can look a bit alike. They get picked up by mistake and the drug can be administered to someone who is not intubated.

Voluntarily, by working with the manufacturers and giving compelling information from learning from error, they made that change and Health Canada supported it. As well, that information is now being put in the Health Canada guidance document for a new guidance document for labelling, so that the learning will be sustained.

That is how it is working now, and it is voluntarily. Ideally, Health Canada will have that authority. It is possible that one of the five — I believe there are five — might not be want to do it for whatever reason, and if Health Canada has the authority, they can use that.

That is an example of labeling packages and how it works now, which was your first question.

Regarding look-alike, sound-alike names we find that we sometimes discover post-market that a name that was selected looks or sounds like another name. We discover that through medication error reporting. We will work with the company in the risk-management plan, hospitals or Health Canada to come up with strategies on how to reduce the risk of those mix-ups. There has been a couple of name changes post market because of look-alike, sound-alike names.

Right now, we are looking at a process with Health Canada to proactively look at the names being selected premarket and see if we can come up with processes to identify in advance that a name being chosen might be a look-alike, sound-alike. That is the work we are doing now.

The bar-coding will add a layer of safety to the system as well, because there are over 20,000 marketed health products. It is inevitable that sometimes it can be hard to foresee that a particular name or look of a vial will be a problem.

Senator Eggleton: Should we go to more mandatory requirements in this regard and give more authority to Health Canada?

Ms. Hyland: Yes. I think there should be more authority with Health Canada to request what that label or package will look like premarket. In that way, Health Canada will be able to ask before a drug goes on the market that they would like to look at the label design and packaging to assess it for potential risks for error.

Senator Eggleton: Thank you.

Health Council, I like your report and what you are saying. Again, my question will be along this mandatory line, and you had more down that line instead of voluntary and passive approaches. There was a bill that the government brought out in 2008 called Bill C-51, and it would have provided for some authorities that are more like what they already have in the United States or Europe. The government has not brought it back; it died when Parliament died at that time.

There are things about mandatory recall provisions. Health Canada does not have that but they say they have other means of persuasion, and there are some other authorities they have that are less than an absolute mandatory recall provision.

Do you think there should be a mandatory recall provision?

Ms. Sketris: I think that it is useful for Health Canada to have the regulatory authority it needs to keep the Canadian public safe. If you look at what is happening in other jurisdictions — for example, in the FDA — they can require that companies put together a risk evaluation and management plan when the drug comes on the market.

For drugs that are a new class or if there is something in some of the early data that suggests a warning, then it is useful to be able to have that plan and to require it by legislation.

Senator Eggleton: Very good. Thanks for your answers.

Senator Munson: Thank you, Chair, and thank you, folks, for being here. To keep following on from Senator Eggleton's questions, in the Health Council of Canada report, you talked about the voluntary collaboration. There have been some answers to that. You are saying in this way with health care professionals and industry that this is proving to be insufficient. What do you mean by "insufficient"? Are people and programs falling between the cracks? It seems to be a rather polite word.

Ms. Sketris: In the voluntary aspect, you have both health care providers and patients providing information about drug signals. What you also need is a systematic examination of the data to determine more clearly the risk and benefit of a drug.

If you look at what the FDA is doing, they have brought together researchers from across the country, including Veterans Affairs, the Department of Defense, Indian Affairs and other people. They now have 100 million lives in whom to examine both the risks and benefits of the drugs.

In Canada, we have the Drug Safety and Effectiveness Network, which is just starting to go down that path. It needs to be strengthened. DSEN does not have regulatory powers so that it can put out information, but Health Canada has to have the regulatory authority to use it in the ways that are needed.

Senator Munson: Thank you for that. You also said that Canada needs to allocate more public funding to ensure that required independent post-market surveillance and research is conducted.

What kind of public funding are you talking about?

Ms. Sketris: Once a drug comes onto the market, there are many things we do not know about. For example, a drug might come onto the market with only three years of data, but it might be taken for somebody for life, so they might be taking the drug for another twenty years.

The other thing is that the drug may come onto the market with so-called "surrogate markers" — there might be changes in lab tests — but you might want to know whether the drug increases life expectancy or improve quality of life in the long-term. Those studies are not always done prior to marketing.

There needs to be some funding to conduct that post-marketing research.

Senator Munson: Do you have a dollar figure of any sort?

Ms. Sketris: No.

Senator Munson: Regarding the Canada Health Infoway, I am curious about you coming back from Boston and this automated system that phoned patients four weeks after they had been prescribed a new medication. Could you go into a bit more detail about how such a program would work in this country? Who would conduct the automated system? You looked on it favourably. Across the country, how would it work?

Ms. Zelmer: It is important to point out that the project in Boston was a study; they were trying different ways of implementing it themselves to find out what would work best, because it is a new idea globally. It would be important in a Canadian context, if there was interest in doing something similar, to ensure there was an evaluation plan that went along with any kind of introduction. With anything new, it is important to understand how something may work best in the circumstances.

The program was for particular types of medications — there was an automated alert. Whenever that new medication was prescribed, there was an automatic phone call placed four weeks later to the patient and there was a series of questions: Are you still taking the medication? Have you had any nausea? It is the common types of side effects as well as others that were part of a standard battery.

They validated some of the results of the initial clinical trials. Some of the things they thought to be common, were. However, they also found differences, which are expected as a drug starts being prescribed in a broader population and potentially for slightly different reasons than it was originally approved for. It was a tool they found useful in understanding, post-market, what some of the experience might be in actual clinical practice.

Senator Munson: Would it be expensive to have a national nation-wide automated system?

Ms. Zelmer: I do not know if anyone has costed it, but there are similar programs in place in Canada. For example, in some hospitals after discharge from a heart attack you will be called afterward to ensure you are on the medications prescribed at discharge and whether you have had a follow-up with your family care provider. It is not an unknown service, but it is used in a different context.

Senator Munson: I have a question dealing with national media reports that Health Canada is not providing enough follow-up on adverse drug reactions.

We have had good things and negative things said about Health Canada. You suggest that it is not providing enough follow-up on adverse drug reaction being reported by patients and providers. How does Health Canada get around that?

Ms. Sketris: Even in their own plan they suggest that adverse reactions are being reported, but they need a more systematic way to look through them and see which ones are the most important, the priority ones and which ones require further study.

In their documents, they suggest that is in their current plan of work to look at that and to make it more systematic.

Senator Munson: Thank you.

Senator Seidman: Recently we heard testimony from three health professional groups — physicians, nurses and pharmacists — who recommended that an adverse drug reaction reporting mechanism be included in the electronic medical record.

Also, recently there was a piece in the journal of the American Medical Informatics Association that said that a signal detection strategy that combines adverse event reporting system of the FDA and fronting health records by requiring signals in both sources created a much more accurate picture of adverse reaction detection.

Would you please comment on that?

Ms. Sketris: I think that we have a number of different sources of information and they are complementary. We have voluntary reports from both health care professionals and patients and they provide some information. Looking at the United Kingdom, they say patients' experiences are broad and detailed, and sometimes report different drug classes than physicians because, for example, patients might not have access to lab tests.

We do a lot of information with administrative databases, which is what the FDA has with its 100 million lives and that provides some very good information, large populations. In administrative detail one can link pharmacy data with outcomes such as myocardial infarctions, but it does not have detailed information on the patient's diet, for example. Are they taking natural health supplements? Are they a smoker? Some of these things affect whether a patient gets an adverse drug reaction. The electronic health record has more detailed information. So all those sources can be combined as Health Canada decides whether to add a warning or other type of regulatory action.

The Chair: Anyone else on that?

Senator Seidman: If I could move a little from that, your Health Council of Canada report in 2010 provided an example of miscommunication between Health Canada and physicians, which involved three letters warning against the use of atypical anti-psychotics in elderly patients with dementia. Your analysis showed that the risk communications did not work and prescriptions for atypical anti-psychotics for seniors increased between 2000 and 2007. We talked about lot particularly vulnerable population groups, such as seniors, pregnant women and children.

Do you see a role for particular types of signaling in these populations, especially if they have not been included in clinical trials and have not been tested on these medications at the outset? How would you see this? How would we monitor it? Would we monitor or signal it in a very specific way?

Ms. Sketris: One of the tools that Health Canada and manufacturers can use is a Dear Doctor/Health care professional letter. Those have not been found to be very effective. They are passive. They are sent out and you are not sure whether the health care professional receives them. There are a number of people looking at more active communication strategies, as well as information technology, so that there would be alerts right in the computer system.

In terms of your comment about vulnerable groups, sometimes the various kinds of patient organizations are best at getting out information to their patient groups and having them further disseminate it. There are a number of strategies that can be used to help get the message out. It has been shown that the Dear Doctor/Health care professional letters have an effect but it is quite limited.

Senator Seidman: Ms. Zelmer might have something to say about this given the electronic record aspect. Would you see any usefulness in targeting vulnerable population groups so that as soon as an adverse reaction comes in, it is immediately dealt with in some way?

Ms. Zelmer: I think there are two ways that the electronic health record can be helpful in terms of vulnerable groups. The first is on the identification front. Particularly for medications that were approved some time ago, often the clinical trials may have been conducted on a specific population. It may only be as you have a much larger database — whether the one in the U.S. or the opportunities we have in Canada with the data from drug information systems — that you can start understanding the experience of different patient populations.

As Ms. Sketris pointed out, it is important to look at the crossmatch of all the sources of data, but this is a critically important piece of information for populations that may not be able to have access in other ways.

The second way is that at the point of either prescribing or dispensing — as information has become available and there is a better understanding that this particular medication may not be suitable for a particular population — it is possible to start using decision support. It will allow you to reach out to patients who may have been previously prescribed something that is now understood not to be effective, prevent that prescription in the first place for new prescriptions and give advice about the latest evidence. It would be available at the point at which that decision is made about whether to prescribe or not.

Ms. Hyland: In addition to what we just heard, there is a little piece around the knowledge translations and interpretation of the information. Sometimes there is a gap between the regulator's role to raise awareness of a risk. The practitioner then wonders how it fits in the balance of risk versus benefit. There is an opportunity to do more around helping to interpret that information and what it means so that practitioners are aided more in their choices. How does this risk compare with another option I might pick? Is it going to be risky or not? There is that piece of bringing this with the electronic record and the IT, but also that interpretation, knowledge, translation of the information. What does it mean for best practice? That is the opportunity.

Senator Cordy: Thank you very much.

Our committee has spoken about the importance of Canada health records and having all the information easily transferable so you do not have patients repeating their health history over and over again and the easy transfer of knowledge.

It has been eight years and it is 50 per cent. I guess that the glass is half full or half empty. It is projected to be 60 per cent by 2014, 10 years after the accord came into place to promote this. Are there incentives we should have in place to get it up closer to 90 per cent? Is there something we should be doing that we are not doing? How can we make it more effective and get a higher percentage of people using it?

Ms. Zelmer: There are actually two very interrelated but separate efforts underway in terms of the numbers in counting the progress. One is on the electronic health record. When the original goal was established, it was to get to 50 per cent by 2010, which we got to three months later. The second goal was to get to 100 per cent by 2016. We are still anticipating that we are on track for that goal, based on all the information we have heard from our jurisdictional partners.

This is a team effort. There are a lot of people involved. Therefore, we all need to hold hands to make this happen, absolutely.

The other important component is the electronic medical records at the point of care. To be able to provide those tools that will allow clinicians both to serve the needs within their practice but also to links up with components of the electronic health record is a new effort. That has only been started in the last couple of years. We have actually seen significant progress in the last few years. That is where we are anticipating getting to 60 or 65 per cent by 2014, and hopefully there will be an opportunity to move beyond that, as well.

Senator Cordy: Do you work with the CMA; are they one of your partners?

Ms. Zelmer: Yes, we do work with the Canadian Medical Association. They sit on our Clinical Council and our Physician Reference Group.

Senator Cordy: This question is for the Institute for Safe Medication Practices. How do you get your information? You are independent. Are you government funded?

Ms. Hyland: Yes. The Canadian Medication Incident Reporting and Prevention System is a partnership with the Canadian Institute for Health Information and Health Canada and is now also supported by the Canadian Patient Safety Institute. Much of our funding comes from the federal government.

We also have funding from provincial governments. For example, in Ontario, they now have a mandatory critical incident reporting program in hospitals for critical incidents involving medications or IV fluids. They have partnered with CIHI, our partner in the national program. Those incidents are actually going into the national database. It is an example of provinces and national organizations coming together to share information.

I hope I answered your question. It is mostly federal or provincial government funding for our work.

Senator Cordy: You gave some examples of things that you looked at, like the look-alike kinds of packaging that could be harmful, or the containers. You explained that. How do you get that information from people? Does a patient or doctor tell you?

Also, do you look at dosage; is that part of your mandate? Do you look at people taking too much, taking too little, or that it is the proper dosage for a 5-year-old or those kinds of things?

Ms. Hyland: I am trying to remember the first question, because you have asked me two questions there. Where do we get the data from? We have a program that receives reports from individual practitioners, and we keep all data anonymous. Due to our partnership with the Canadian Institutes for Health Information, we have a data-sharing agreement with them, so we have access to all the data that is submitted to the CIHI database. As of two years ago, we launched a consumer reporting program. We do get medication error reports directly from consumers, and some of those involve over-the-counter products.

This group is looking right now at prescription pharmaceuticals, but we also need to look at over-the-counter products in terms of how user-friendly some of the packaging and labelling is.

Regardless, we get reports from all of those, and community pharmacies also report to us. We learn from all of those reports. We do have prioritization frameworks for analyzing the information.

Looking at doses is interesting. I mentioned that one of our areas of interest right now is opioid medications. New evidence is showing that, with the introduction of the longer-acting opioids, it has been shown that the average dose is increasing compared to when we were using the shorter-acting opioids with Tylenol — a mixture. Recently, there has been an association with the dose increasing per day and mortality related to opioids. We want to look at that a little more. We do look at that.

Senator Cordy: Thank you very much.

For the Health Council of Canada, Ms. Sketris, you have some great recommendations in your presentation. You said Health Canada lacks the authority to require companies to conduct post-market studies, to compel companies to make post-market labelling changes or to monitor drug companies' patient registries. You also said that we need to be more transparent and independent in our monitoring approaches. You gave some good examples of other countries that are doing these things.

What changes do we have to make in Canada to ensure that Health Canada would have the authority to do the things that you have mentioned in your presentation?

Ms. Sketris: One of the changes is regulatory, so that it can compel the companies, for example, to put the risk management approaches in place and then also to determine whether they are doing it. In Europe, they found that they had some of this legislation, but sometimes the companies were not following through, so they also needed to have a way to find out whether they were following through on the plans they said they would. That is one thing.

Another thing is them being able to get the data they need. With the FDA and now in Europe, the regulatory agency has access to individual-level data so that it can re-analyze it if it wants to do another approach. There are a number of different methods to analyze data, and if they are able to get the individual patient data, they might do a re-analysis of the data on their own, as well.

Senator Martin: I am following up on some of the questions that have been asked, and some of my colleagues have asked the questions I originally intended. I have my question regarding the Canada Health Infoway technology and trying to integrate Health Canada's ADR system with electronic health records. I am just envisioning the challenge of inoperability of systems and, depending on what computer models are in place, that certain systems do not run properly or it appears quite different onscreen.

Would you speak a bit to that challenge and what you would be doing to prepare for potential challenges in that regard?

Ms. Zelmer: There are really two components to that. One is the kind of analysis that Ms. Sketris was talking about where you extract data from electronic health records, obviously in a privacy-sensitive way with the appropriate safeguards, and then conduct analysis to be able, for example, to look at a medication for a particular patient population and post-approval — those kinds of questions. In that context, a lot of work has been done on establishing the standards for that data so that it can be extracted and used from drug information systems, for example, in a consistent way. That is one of the big things that DSEN has been looking at early; they want to ensure they can put together that information and be able to analyze it in ways that make sense. It is still a relatively new area, globally, so there is a lot to learn in terms of how to do that kind of analysis in the most effective way.

The second side of things is the ability to submit an alert at the point of care. That is a bit different. That is not taking the data out and extracting it separately; that is saying, "I am now a pharmacist or a physician. A patient is in front of me. There is a potential alert." How do you integrate that?

A few different approaches have been used to do that. One is to generate it automatically. For example, if someone has inputted information into a patient record to indicate that the patient is having a problem, it would have something pop up to say: Is this an adverse event? There have been other approaches where there have been buttons put in, and so on. This is an area where there is still research underway to be able to identify what is most effective so that it fits with the work flow of a practitioner and the reports are as useful as they can be at the end of the day when they land in the hands of someone like Ms. Hyland or in Health Canada to ensure the needed information is there.

That is where some of the initiatives like the bar-coding that Ms. Hyland talked about will help, because it can automatically populate some of that information. It saves the clinician at the front line time and the ability to include the information only they have access to, but being able to extract information that is available on the record.

Does that help?

Senator Martin: Yes. It is intricate and complex. Are we in a position to have an optimal system? Are there things that we still need? Obviously the answer would be yes, but compared to other jurisdictions, would you say that Canada is doing well in this regard?

Ms. Zelmer: Compared to many other jurisdictions, in terms of being able to have a full medication profile for a patient that comes from all of the prescribers, Canada is doing quite well. We are actually involved right now in a benchmarking effort under the OECD. I hope to be better able to answer your question once the data are collected for that, but that is not until next year. On that front we are doing well.

In terms of electronic medical records at the point of care, compared to other countries we are sort of in the middle. There are many countries that are ahead of us, other countries that are at about the same point, and some that are behind us. In terms of actually be being able to integrate adverse reporting at the point of care, it is new globally. That is an area where active research has been going on in terms of what mechanisms might be appropriate. I talked about the study from Boston, and at the same conference there were also researchers there talking about some different approaches they had been testing in terms of what might work best in different circumstances.

Senator Martin: That is very clear. Thank you.

Ms. Hyland, when you talk about the importance of interpreting the information accurately, effectively, to educate or bring practitioners to a certain level of expertise, would it be Health Canada's role? Would several partners be charged with that task? Would you expand on that a little?

Ms. Hyland: That is a good question, because I had thought about that myself. I think the regulator's role is to identify the risks as part of the pharmacovigilance. That is their role. They also want products on the market that a have a favourable benefit-to-risk balance. I am not sure Health Canada can do that interpretation work on their own without partners that close the gap between their responsibilities as the regulator and the real-world experience. I believe it needs collaboration with partners to make that happen. It is not an easy thing to do. That is the future. I see that in the future we will be focusing our efforts to take all this information and help interpret it so that when the practitioner receives it, they have some guidance on what to do with it. I think it will be collaborative.

Senator Dyck: Thank you for your presentations. Sorry I was late.

Ms. Hyland, I noticed that in your presentation you talked about using bar-coding. If we were to have a system like that in place it will likely increase the accuracy of the database, but would it also help out in terms of caregivers being able to contact patients? Would the bar code help health care professionals keep up-to-date with what is happening with respect to drug recalls? Would that aid them in identifying which products are being recalled? How would that be integrated? Would the patients then be able to access something by scanning their bar code? Could they go to the Web and look at alerts? Could you take your BlackBerry, scan your bottle and it would go to the Web and have something equivalent to a black-box warning? Do you envision that?

Ms. Hyland: I will start and Ms. Zelmer might be able to help.

Unlike some countries, there were no regulations in Canada around bar-coding. We knew we had to come together and at least lay the foundation for a standard bar code approach. That was done voluntarily and it will inform Health Canada in the future. In a way it might have been a good thing because other countries have tried to regulate it too early and the technology is advancing so quickly that it has been tricky.

The purpose for it starting was very much around adding a layer of safety to the system as a redundant check that this is the right drug going out of the pharmacy to the patient. That was the original intent. However, the vision is that the bar code can be a bit of a gateway and a connector amongst information systems, like drug information systems, vendor softwares that help create systems in hospitals that would be involved in recalls.

You are familiar with QR codes where you can scan and immediately see information on your iPhone or on the Web. The standard right now suggests that that is okay for marketing and branding, but it will not be the true drug product information. That will come from a separate database, so it will be more controlled.

I think that will all be possible and we are just doing one step at a time.

Ms. Zelmer: It is interesting you raise that, because just over a year ago we did an open call for the best ideas to improve health and health care using health IT. There were some that came forward around medical devices, but with the same concept that you can scan a bar code and information could come up. That idea is out there. There are a number of things must be sorted out to have that information available in a means that would really make sense. However, with increasing interest in consumer health solutions, those are the kinds of possibilities that we can start to look at.

Senator Dyck: Do you think it would increase the likelihood that a patient or pharmacist would report an adverse drug reaction if that kind of system were available? Would it make it easier to report?

Ms. Hyland: I am not sure. I will not answer yes or no. However, I do believe one thing about reporting: If practitioners and consumers see the value of the reporting and if the value of reporting is very visible, I do not think they see it as a burden.

If what will be important to report is quite clearly defined and the value is seen — and I think Health Canada has an opportunity to measure its value more make it more visible — I do not think people perceive it as a burden to do the reporting. Having said that, I think with advancing technologies, things like reporting will get easier. I believe that bar-coding will be an important technology in the medication use system in years to come.

The Chair: I would like to come to some questions. I want to get them into the dialogue. We will have researchers up next on this, and I would like to get input from you to start the conversation on it if you have information relative to it.

We are dealing with post-approval monitoring, which means at the point the drug is actually chemically synthesized or produced; in the case of the biologics it is produced slightly differently. However, the point is they are produced and then they are put on the market.

With regard to those that are of chemical base, we understand that fabrication occurs around the world. Inputs into this occur in various countries in a sequence almost like the construction of an automobile, and just-in-time delivery sort of thing.

How do you feel with regard to our monitoring of the quality of the chemical composition of the drug as opposed to its impact on the patient? Of course, if it is not correct the impact could be quite severe, not from the drug but whatever the contaminants are in it. Do any of you have any comments in this regard?

Ms. Hyland: It is a very complex and difficult question to answer. I think I will not attempt it. The balance of wanting to bring the drugs in and make them accessible is a true challenge for Health Canada. Then how do they verify the quality of that chemical that has been produced elsewhere? I think that is truly a challenge. Again, I think they have to balance their decision making in those times.

The Chair: The second part of that question was the issue of counterfeit drugs, which we know is a serious issue in certain parts of world. We understand that we have fairly good surveillance. Is that an issue that any of you have any particular input on?

I do not see an answer. I will go to the next one, then, which is slightly related but perhaps closer to home in its context. We are accumulating now some evidence that the generic form of a drug does not have the same activity in the patient as the original drug that was licensed for sale through the original companies. In fact, there is a report out just this week where the FDA in the United States is taking fairly significant action. It is the first of its kind for the FDA, but they are taking action with a slow-release drug. These are drugs that are consumed and released slowly over time, so that you have to take fewer pills, but over time you get perhaps the same or a slightly larger dosage, as you indicated, Ms. Hyland.

The finding in this particular case is that the generic drug had no effect and yet purportedly had the same chemical composition.

I will not go into this in a lot of background, but it has been known for a long time that the formulation of the drug — that is, all the powder around the active ingredient that gives you the pill that allows you to consume it — can have a real impact on how the drug performs in the body.

In terms of post-approval monitoring, which ultimately includes that the drug will go off patent and it will become generic if there is any value in the drug in the long term, do you have any comments with regard to how well we monitor the comparison of a generic drug and the original patented drug in terms of the actual activity in a patient?

I am getting silence. I will wait for the researchers, then. I want to get this on the record because I want it to be part of our study. I thought perhaps you might have come across some information. By the titles of your organizations, you are collecting data in certain ways, and if it has occurred, I wanted to hear from you.

Ms. Hyland: I would only offer that I think any research of that nature is very limited. I am not familiar with much of that research. Some of the things we have talked about here are the need for Health Canada to have some authority over asking for additional research to be done if there are signals or if problems are identified with any product; they ought to have the authority to ask for that additional research to be done. I think it falls into that kind of realm. That is all I have.

The Chair: Thank you. I want to come back to the issue of identifying and reporting adverse reactions and the post-approval era. You have all touched on that to some degree today and we have heard it and dealt with it and asked the questions in many of our previously meetings. It is increasingly apparent what actually constitutes an adverse reaction that relates to the drug, as opposed to some other event in the medical treatment, particularly when one gets into the issue of particular subgroups, perhaps elderly patients with a number of drugs in their portfolio. You have indicated that we have to move up the scale. I think we are hearing that, indeed, the incidence of reporting of adverse drug reaction appears to be quite low in the reports, at least those that are coming before us.

I was quite struck, Ms. Zelmer, by the pilot project — I think that would be the appropriate term for it — that you referred to in the U.S. A number of aspects of that struck me immediately. First, it struck me as the basis for a very good approach to what I think Ms. Sketris referred to; namely, the difficulty of moving up somehow to require more reporting. If you actually contact patients who have been given a new drug after a month, you have at least the opportunity to get a lot of input.

I think I see a way around this on the basis of your subsequent, related answer to this in terms of dealing with patient confidentiality. In the U.S., presumably, it is somewhat easier because they have the insurance programs that provide and cover the drugs and they have a right to follow up with the patient with regard to prescriptions that are paid for by the insurance company. I can see how it is easy to use the database there, because the patient is automatically in the database; you are not dealing with the release of patient information to a third party.

Perhaps I will come back to this question: Should this pilot project look like it is a winner, do you think there will be a fairly easy way in the Canadian context to deal with the patient confidentiality issue?

Ms. Zelmer: There are a couple of things I can say about the pilot project and then answer the last part of your question. The first one is that the patients consented to be part of this. Not everyone consented; there was a high rate of consent, but not everyone agreed to be followed up on, and it was their choice.

The second thing in terms of the pilot project is that while the researchers had an interest in understanding the prevalence of adverse events, there was also a component where, at the four weeks, if there was any adverse event reported, there was follow-up by the original prescriber or by that institution. Equally, there was an opportunity for patients to say at the end of it "press 1 if you would like to be contacted because you have concerns," and then their original care provider would follow up. It was an integral part of their care and follow-up in terms of this medication being prescribed, as well as their consent for a research project.

There were some particular circumstances around that.

As you look at this kind of thing, and certainly the experiences that have happened in Canada with similar types of programs — not necessarily on the medication front, but on other fronts — have typically originally been a core part of the patient's care. For example, we have to ensure that, after a heart attack and they have gone home, they are getting the care they need. Then in some cases patients are invited to participate in research studies, as well.

As you would well know from the broader context of patient privacy, there is a set of frameworks and rules around access to information: When is consent appropriate and required, and when can data be made anonymous and used in different ways, subject to research ethics or other requirements? There is a framework, both legislative and regulatory, in place on that front as well.

The Chair: Yes. In that regard, your answer is partly what I anticipated with regard to the Canadian situation. We know that hospitals have the authority to follow up with patients with regard to their treatment, care, specific issues and so on. I can see that there might be the possibility of contacting patients through that mechanism with regard to drugs, particularly the elderly; I would think it would be very easy to incorporate that into a follow-up care kind of situation.

A question arises, however: If the hospital follows up with the patient from that hospital, or the doctor follows up from the patient in that clinic, and there is a reporting of someone feeling rotten in a context that the doctor or the hospital thinks this may well be an adverse reaction to that particular drug, under the current Canadian situation, does the hospital or the clinic have the right to follow that up as an adverse reaction?

Ms. Zelmer: There are frameworks around reporting adverse reactions and how you would do that. This is one of those examples where the technology is the easy part. The technological solution is relatively easy to do and is well established. It is the ethical/policy/practice framework that you need to put around that to make this appropriate and effective as part of a broader system, both of care for individual patients and also for drug safety for the country.

The Chair: I agree entirely. It seems to me that this is actually a real win. Everyone who takes their automobile in for a checkup these days, the auto industry is so keen to know whether your service was good that they follow up electronically and otherwise. It struck me immediately that this might very well be a mechanism to move the issue forward.

We have heard testimony to this point that attempts to regulate and require deliberate reporting of adverse reactions have not been terribly successful, from a legal standpoint. Indeed, we have heard suggestions that they are not likely to be for all kinds of reasons, given the complexity and uncertainty on what really is being reported as an adverse reaction, the liability of the physician and so on.

It seems to me that this mechanism offers an easy route and one that consumers are increasingly familiar with. They may not find it quite as intrusive or annoying as reporting how their car service went, but nevertheless it is an easy mechanism to follow up. I thought that was an excellent input. I was pleased to hear that suggestion.

I would like to move it one more step with regard to the IT aspect. We have heard from Canada Health Infoway before with regard to the electronic issues. You have summarized many of them here. One of the things that occur in a number of database systems — yours is a database or quasi-database system, the dispersal of information across a common system — is that key words can be used to trigger an automatic report. In your efforts to get physicians in all hospitals, clinics and independent offices on to a common system that can use Canada Health Infoway with the capability that it provides, would there be the possibility of identifying a key word that would be easy for a doctor to put in — being aware that that is a key word relating to an adverse drug reaction — that would automatically send a signal to a database that would begin to pick this up in some way? Ignore the issues of patient confidentiality for a moment and look at the technological possibility. Is that a possibility in the systems you are establishing?

Ms. Zelmer: I think there are a number of technological possibilities. One thing we are working on now, particularly in the primary care area, is looking at some standards for terminologies and problem lists. This was primarily thought about around things like ensuring you could identify all the patients with diabetes in your practice, or all the patients who had a heart attack, regardless of whether you had written down acute myocardial infarction or AMI.

Work is ongoing to look at how to integrate those kinds of terminology standards so they are transparent to the clinician. The clinician can use the language they need to use. They will record information for the care of that patient, but there is a set of standardized terminology in the back end that allows you to better analyze and understand that information. This is for the sake of individual patient care. It gives the ability to say this person with diabetes is here in front of me. Have they had a foot exam recently because that is part of the recommended care protocol? However, it could potentially apply more broadly.

It goes back to the point that you made earlier that patients who are taking multiple medications for complex conditions may not know that a certain symptom they may be experiencing is an adverse drug reaction. That is where the understanding of large numbers of patients and the ability to do the analysis that Ms. Sketris was talking about comes in. You are able to see things in different ways and bring different types of information together.

The Chair: That is why I was referring to your interaction with the doctors. They are the best ones, initially, to be able to have a sense that it is. If there was a key word in an electronic system, it can be used to trigger another pickup. Thank you very much for that.

The final thing that I would like to touch on is the sheets of paper that are provided to patients who receive a prescription that provide summaries of the various possible reactions that they could have. Some of them are colourful. We heard testimony that suggests the way some of these are developed can actually scare patients off and there is evidence that some patients do not consume the medication because of the depth of anxiety they get from all the things that could possibly happen if they take it. Have any of your organizations looked at that issue from the point of view of finding a way to work with the pharmaceutical companies and Health Canada to establish patient information that would help get a good idea of the real potential aspects of the drug, but without terrifying them? Is that an issue? If it is not, just say, no, that is not something we are dealing with.

Ms. Sketris: It is not something that the Health Council looked at but there is quite a bit work going on patient decision tools. Some is being done by Peter Tugwell at the University of Ottawa. They have pictures and you will have so many smiley faces and so many sad faces. Here is your benefit and here is your risk, and those can be tailored. They are getting quite sophisticated and there is a researcher at the University of Laval, France Légaré, who has done this with antibiotics. We know there is a good chance that when you go in it is a virus and not likely to benefit you. She has pictograms that say this is the chance it will benefit you, but antibiotics have all these different side effects and these are the risks.

We need to get better at helping patients understand the risks and benefits. The physician can help them walk through it because every drug has risks and benefits. Some of the medications now are being used for prevention. You do not actually have a disease but you might take the drug for the next 30 years. Your risk tolerance is different than if you have a very severe disease. People are working on systems about those.

The Chair: It is probably difficult to get around it for all the reasons that you indicated. We have a different legal framework than in the U.S. where it is more of an issue in that regard. The importance is to cover all of those aspects and for people taking multiple drugs, particularly the elderly, it is serious. There is probably no simple way around it other than the full stack of paper.

Thank you very much for your testimony today. I think you have been extremely clear in your responses. Watching my colleagues with regard to your answers to their questions, it seems to me that you got across the points that you wanted to make and they were very well understood by the committee. I want to thank my colleagues for their questions that have elicited responses we have not heard to this point, and some which I have tried to come back to and I think could be extremely helpful as we move forward.

Colleagues, on your behalf I will thank all the witnesses today. I will remind them that if something pops into their heads after they leave and they say, "I wish I had used that example," we would welcome any follow-up input on anything that you have heard today that occurs after you leave. With that, I declare the meeting adjourned.

(The committee adjourned.)


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