Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 9 - Evidence - March 26, 2014
OTTAWA, Wednesday, March 26, 2014
The Standing Senate Committee on Social Affairs, Science and Technology met this day at 4:15 p.m. to continue its study on prescription pharmaceuticals in Canada.
TOPIC: The nature of unintended consequences in the use of prescription pharmaceuticals.
Senator Kelvin Kenneth Ogilvie (Chair) in the chair.
[Translation]
The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
[English]
I'm Kelvin Ogilvie, a senator from Nova Scotia, chair of the committee, and I'm going to start by asking my colleagues to introduce themselves, starting on my left.
Senator Eggleton: Art Eggleton, senator from Toronto and deputy chair of the committee.
Senator Enverga: Tobias Enverga, senator from Ontario.
Senator Tannas: Scott Tannas, senator from Alberta.
Senator Seidman: Judith Seidman from Montreal, Quebec.
The Chair: Thank you, colleagues. I will remind us all that we are dealing with prescription pharmaceuticals in Canada and the fourth part of a four-phase study that we've been carrying out, this one dealing with the nature of unintended consequences. Today we are pleased to have representatives from health professionals' organizations, and they are national in scope. Welcome to our witnesses.
I will recognize you as I invite you to speak. We already have an order in which we will proceed, and following your presentations, I will open the floor up for questions from committee members. Once again, thank you for being here.
I'm going to start, then, with the Canadian Pharmacists Associations. We have Janet Cooper, Senior Director, Membership and Professional Affairs; and Phil Emberley, Director, Pharmacy Innovation. Ms. Cooper, please proceed.
Janet Cooper, Senior Director, Membership and Professional Affairs, Canadian Pharmacists Association: Thank you, Mr. Chair. I'll be sharing this presentation with Phil.
First off, we're very pleased to speak on this topic on behalf of the Canadian Pharmacists Association. We are the national organization representing pharmacists across Canada. CPhA is also Canada's leading publisher of evidence- based drug and therapeutic information for health care practitioners.
CPhA is very pleased that your committee is undertaking this study and that the federal government has taken a keen interest in improving drug safety and effectiveness. The announcement in the 2014 Budget that $45 million over five years will be spent to prevent prescription drug abuse and the introduction in December 2013 of Bill C-17 — otherwise known as Vanessa's Law — are steps in the right direction, and CPhA supports these initiatives.
Phil Emberley, Director, Pharmacy Innovation, Canadian Pharmacists Association: For pharmacists, patient safety is a top priority, and pharmacists do all they can to ensure that medications are taken both effectively and safely. However, the fact is that unintended consequence can and do occur. Canada's population is aging, and with one quarter of seniors taking 10 drugs or more each day, the risk is high.
According to the Institute for Safe Medication Practices Canada, 1 in 9 emergency room visits are due to an adverse drug-related event, with 70 per cent of these events being preventable. Not only do these unintended consequences cause harm to the patient, they represent avoidable costs to the overall health care system. For example, these ER patients have higher hospital admission rates and longer lengths of stay.
Clearly, we need to do more to address these challenges. There are a number of actions and strategies that could be implemented to address unintended consequences. We will discuss three recommendations that we believe could improve patient outcomes.
First, one of the clear trends that have occurred across Canada in pharmacy over the past several years is an expansion in pharmacists' scope of practice. Among the services that pharmacists can now provide are things such as comprehensive medication reviews, flu shots, treatment of minor ailments, smoking cessation counselling and chronic disease management, such as for diabetes and heart disease.
Research shows that pharmacists' services improve patient adherence and outcomes and reduce hospitalization. However, whereas provincial jurisdictions are increasingly providing the regulatory and compensation frameworks for pharmacists to provide a greater number of services, the federal government is not following suit for its own programs.
For example, the federal government has not kept up with provincial jurisdictions in covering the cost of expanded medication management services for First Nations peoples covered through the Non-Insured Health Benefits Program. This is putting these patient populations at a disadvantage and is preventing them from receiving the same high-quality pharmacy care services that are available provincially.
Therefore, CPhA is recommending that the federal government extend coverage for expanded pharmacists' services for those populations for whom it provides health services.
Ms. Cooper: Second, CPhA believes that one of the ways to address unintended consequences is better information sharing and collaboration among health care providers. Provincially integrated and interoperable drug information systems, or DIS, that include electronic prescribing would ensure that physicians, pharmacists and other practitioners can share valuable information on each patient's medication history and use. Access to a complete drug record and e- prescribing will help lower the incidence of preventable adverse drug events and also reduce inappropriate use and drug diversion.
In 2013, the Canadian Medical Association and the Canadian Pharmacists Association released a joint position statement with a vision that e-prescribing would be in place across Canada by 2015, in which all prescriptions would be created, signed and transmitted electronically. This is currently not the case, and fax machines continue to be the most important means of electronic communications between pharmacists and prescribers.
CPhA is therefore recommending that the federal government, through Canada Health Infoway, work with the jurisdictions to accelerate the adoption of electronic prescribing.
Third, CPhA recognizes that electronic patient-specific information for providers is invaluable in improving care and preventing unintended consequences, but so too is having up-to-date, evidence-based clinical information on medications and their therapeutic use. This information needs to be available at the point of care as part of clinicians' electronic medical records systems.
Various sources of clinical and drug information are currently being used by practitioners. However, in the push to automation over the last several years, many of the technical platforms in use today incorporate sources that are non- Canadian; they don't include Health Canada-approved monographs and new drug safety information and/or do not include the best available evidence to support clinical decision making.
Several years ago, CPhA partnered with Health Canada to create e-Therapeutics, an innovative, made-in-Canada clinical decision support tool providing drug and therapeutic information for health professionals. Today, practitioners need just-in-time access to Canadian evidence-based drug therapy and new drug safety information integrated into their electronic patient record systems.
Therefore, CPhA recommends that all governments support and facilitate point of care integration of reliable, comprehensive Canadian content in the system, such as physicians, electronic medical records, hospital systems, pharmacy software systems and future e-prescribing systems, and we would like to work with Health Canada to make this happen.
Mr. Chair, we recognize that the problem of unintended consequences of medication use is a complex one with no easy solutions and one that requires a multifaceted approach. The recommendations we have presented today are three of the ways CPhA feels we can work together to address the issue. By expanding coverage of new pharmacist-provided services to federal populations, implementing interoperable drug information and electronic prescribing systems, and integrating Canadian drug therapy resources into electronic patient record systems, all Canadians will benefit.
Thank you, Mr. Chair, for the opportunity to present. We look forward to your questions, and to the Canadian Pharmacists Association working with you to play a key role in implementing solutions.
The Chair: Thank you very much.
I will now turn to the Federation of Medical Regulatory Authorities of Canada, FMRAC, and invite Fleur-Ange Lefebvre, Executive Director and Chief Executive Officer, to present.
Fleur-Ange Lefebvre, Executive Director and Chief Executive Officer, Federation of Medical Regulatory Authorities of Canada: Thank you very much, Mr. Chair. We also welcome this opportunity. This is a very important topic.
The Federation of Medical Regulatory Authorities of Canada provides a national structure for our members, the 13 provincial and territorial organizations that license physicians. Our members exist to serve in the best interest of the public by ensuring that only qualified doctors are licensed to practise medicine in this country.
We were given a number of issues for consideration by this committee, and we will address two of them: serious adverse reactions; and abuse, misuse and addiction.
On serious adverse reactions, prescribing is an important area of medical practice. It requires physicians to have the appropriate knowledge, skill and professional judgment. The drug prescribed must fit the patient's diagnosis.
Physicians must also consider the risk-benefit ratio to the patient. Physicians can assist in preventing medication errors that can cause harm, and even death, by minimizing the use of verbal prescriptions that can lead to error; making using of all available information in databases and elsewhere on patient medication history and interactions; ensuring a sufficient amount of information on prescriptions is transmitted to prevent accidental substitution with a look-alike drug; being knowledgeable about high-alert medications and the special precautions that these medications require; participating in the creation of special checks and balances when prescribing for vulnerable populations — we mean pediatric, geriatric and medically complex patients — and high-alert environments, for example, in emergency procedures; involving the patients in the decision making and management of their prescription drugs, including listening to their expressed concerns; and finally, reporting any and all adverse drug reactions to the relevant organizations and encouraging their patients to do the same.
I will turn now to the abuse and misuse of drugs and addiction. I want to begin by saying that we presented a lot of the same information to the House of Commons Standing Committee on Health in early December, as they were also studying this topic.
We're very concerned about drug abuse in this country, in particular, opioid abuse. We've done a lot, but it still gets worse and worse. It is now bordering on an epidemic. We are ranked second in the world for prescribed opioid drug use. What we have done to date has not only failed but, as I said, things are getting worse.
One of the issues is that there are several players: the prescribers, mostly physicians; the dispensers, mostly pharmacists; and the patients and public, through inappropriate demand and diversion. We are concerned primarily with the role of the prescribers and of course the role of the medical regulators themselves, the organizations that we represent.
Several years ago, we undertook a comprehensive review of the issue of prescribed opioid use in this country. As a result, FMRAC and its members ended up with this incredibly wonderful guideline called the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-cancer Pain. The main objective was to develop a guideline that relies on the best available experience and expert opinion consensus. This is important, as it recognizes the legitimate and appropriate use of these drugs for pain management in the majority of cases. We must not throw out the baby with the bathwater.
Another objective was to develop and implement a knowledge transfer strategy that ensures transition of the national guideline to practice as a useful decision-making tool for physicians who treat patients with chronic non- cancer pain.
The guideline, finalized in 2010, contains 24 recommendations under these five headings: the decision to initiate opioid therapy; second, conducting an opioid trial; third, monitoring long-term opioid therapy; fourth, treating specific populations with long-term opioid therapy; and finally, managing opioid misuse and addiction in patients with chronic non-cancer pain.
Our members have made their physicians know that they are expected to follow the parameters of this guideline. In addition, it has been well received at both the national and international scenes. Recently, in an article in Annals of Internal Medicine entitled ``Opioid Prescribing: A Systematic Review and Critical Appraisal of Guidelines for Chronic Pain,'' 13 guidelines were reviewed. The Canadian guideline was one of the two that received high ratings based on applicability to a broad range of patients, the use of comprehensive, systematic reviews and rigorous methods for formulating recommendations, as well as frequent linkages of recommendations with the evidence that is available.
There is now a grant application going forth to update the guideline, if appropriate.
We have four recommendations. The medical regulatory authorities and other medical stakeholders must work with the pharmacy stakeholders and the federal, provincial and territorial governments on this issue. There are just too many people involved.
More education is needed, targeting patients, the public, prescribers, health care institutions, et cetera. That's our second recommendation. In fact, we have recently recommended to Health Canada that in the revisions of the Controlled Drugs and Substances Act, they actually make reference to this and other guidelines, and that Health Canada can play an active role in disseminating this information more broadly.
The third recommendation is that we think more and more stringent regulation is required for the medications, the prescribers, the pharmacists and law enforcement.
Fourth, a drug information system should be developed to record and monitor all prescriptions in real time, and this data should be made available in real time to the regulators and even law enforcement agencies.
I know you're getting some repetition right now between what you're hearing from the people here.
In closing, on behalf of my organization and our members, I extend our appreciation for the interest of the Senate committee and the Government of Canada on this critical issue. Only with the help of all stakeholders will we succeed in implementing reasonable and effective solutions.
The Chair: Thank you very much, and we're delighted to have repetition in your presentations.
From the Canadian Medical Association, we have Owen Adams, Vice-president, Health Policy and Research; and we welcome back Millicent Toombs, Director, Public Health Department.
I understand you will be presenting, Mr. Adams.
Owen Adams, Vice-president, Health Policy and Research, Canadian Medical Association: Thank you, Mr. Chair.
Good afternoon, honourable senators, and thank you on behalf of the CMA for the opportunity for to us to be back here on a topic that is of great concern to physicians and the patients in their care.
No physician will deny the importance of prescription drugs in patient care. Physicians want all Canadians to have access to medically accessible drugs that are safe, effective, affordable and appropriately prescribed. Sensible policy on prescription drugs is an integral part of the patient-centred health care that is the CMA's ultimate priority.
Unfortunately, prescription pharmaceuticals have resulted in significant unintended consequences, which is the focus of our presentation today. In our brief, we cite five unintended consequence that we believe stand in the way of the effective patient care Canadians deserve.
As Fleur-Ange has said, of particular concern to us is the rise in the use of opioid painkillers. It's been noted that Canada has the second highest per capita consumption of prescription opioids in the world, just behind the United States.
Opioids serve a legitimate therapeutic purpose, controlling pain due to cancer or other causes. However, they also pose significant health and safety risks. The high they produce makes them sought after for recreational purposes. In addition, they are highly addictive. As a result, many users resort to illegal behaviour, such as doctor shopping, forging prescribers' signatures and buying from street dealers to acquire them.
The CMA is particularly concerned about the impact of prescription drug abuse and misuse among vulnerable populations, notably seniors, youth and First Nations persons. We believe the federal government should work with provincial and territorial governments and other stakeholders to develop and implement a national strategy to address the problem of prescription drug abuse and misuse in Canada, and we outline four elements in our brief.
Another problem we didn't anticipate is drug shortages. They are serious and persistent. Canada's doctors are deeply concerned about this. In a survey of physicians conducted by the CMA in September 2012, two thirds of respondents said the shortage of drugs was a significant issue in terms of its impact on patient care and outcomes.
We met recently with our national specialty societies. They told us the problem isn't going away. The CMA calls on governments and manufacturers to take necessary actions to minimize the impacts of shortages on patients.
Another serious unintended consequence is adverse drug reactions. These can be devastating, and there are too many, plain and simple. Health Canada has traditionally approved drugs for general use based on clinical trials that tend to be of short duration and have relatively few participants. As a result, when a prescription pharmaceutical comes on the market, there is still limited information about its safety or effectiveness, and there is a need to keep gathering information from people using it in real-world conditions.
At present, notification and information about the potential for adverse drug reactions is not making its way into the hands of health care practitioners or patients in a timely manner. These adverse reactions are all too common in Canada. According to the Canadian Institute for Health Information, 1 in 200 patients over 65 is hospitalized because of adverse reactions to medication.
As such, CMA once again recommends that Health Canada work to strengthen the capacity of its post-market surveillance system, and in our brief we lay out several ways of doing this.
CMA also prioritizes increased efforts to support optimal prescribing. In an ideal world, all patients would be prescribed the medications that have the most beneficial effect on their condition while doing the least possible harm.
Multiple medications among seniors is a significant concern. According to a 2011 report from CIHI, 62 per cent of seniors on public drug programs use five or more drug classes, and nearly 30 per cent among those 85 and older have claims for 10 or more prescription drugs. So the use of multiple medications, then, can also lead to unintended consequences.
In our brief, we outline four elements to support optimal prescribing.
Finally, another consequence of the increased role of pharmaceuticals in health care is that since they are not generally covered by the Canada Health Act outside hospitals, Canadians without coverage may not be able to afford them, and so they may not be able to follow a treatment plan. Research done for CMA found that 1 in 10 Canadians goes without prescription medication because they cannot afford it. Our research confirms previous results from the Statistics Canada 2007 Canadian Community Health Survey.
CMA would recommend that governments, in consultation with the life and health insurance industry and the public, establish a program of comprehensive prescription drug coverage to be administered through reimbursement of provincial, territorial and private prescription drug plans to ensure that all Canadians have access to medically necessary drug therapies.
I'll leave those thoughts with you, honourable senators, and I look forward to the discussion.
The Chair: Thank you very much. I will now open the floor up to questions from my colleagues.
Senator Eggleton: Thank you very much for your presentations and some very helpful ideas that you've given us. Some we're familiar with, we've looked at before, but I'm glad to hear you're reiterating things like e-prescribing, and that you've touched on abuse and overuse, et cetera, of medications, and CMA touched on drug shortages.
There are a few other aspects to unintended consequences that we've been hearing about. They include the antibiotic resistance issue, which I will at some point get into, maybe not during this first round of questioning, and environmental concerns as well. I'd like to hear from the Canadian Pharmacists Association about how it might help on that, but let me start off with an issue that we dealt with very recently, and that was on substandard foreign drugs coming into the country and counterfeit drugs.
In the substandard situation, what we have learned is that the vast majority of our medicines and medical ingredients today are imported from countries such as India, China and Brazil, and some of the quality is substandard.
We particularly heard about a company out of India called Ranbaxy, which ran into trouble with the FDA in the United States, information provided via whistle-blowing legislation. Ranbaxy ultimately was prosecuted and pled guilty to seven federal criminal accounts of selling adulterated drugs with intent to defraud. They ended up agreeing to pay $500 million in fines, forfeitures and penalties, but they're still in business. They're still working away in the United States. They're one of the bigger foreign generic manufacturers that supply drugs into the United States.
Well, they also do here. In fact, one of our witnesses said there are some 160 prescription drugs provided by that company that come into Canada, some of which are no longer allowed in the United States, but here they are.
I haven't heard a single thing from Health Canada about this company and anything that it's doing.
That has got to be of concern to you. This is risking the health and security of patients. What do your associations say about this? What do you think needs to be done about this? How do we better protect Canadians?
The Chair: We're starting with this question with regard to the quality of pharmaceuticals and the types of offshore drug companies that Senator Eggleton just referred to.
Ms. Cooper: I'll go first. Given the vast array of the different types of unintended consequences, none of us was able to touch on everything, so we're looking forward to the questions that are going to come up.
Counterfeit drugs, adulterated drugs, are a big concern. It's not as big an issue in Canada as it is in many other countries around the world because of the controls we have here, but I still think a lot of the inspections of the pharmaceutical manufacturers, especially when the product is manufactured offshore, are not as rigorous as they need to be within the country before they do get marketed.
The other big issue with counterfeit drugs is actually drugs that are not approved in Canada. People are buying them through the Internet, and that is a much bigger concern for us. Most products, once they're sold through the wholesale legitimate market in Canada, there's a lot of QA in place. I won't comment on a particular manufacturer. I'm not suggesting that it's a perfect situation, but with the drugs that people can buy over the Internet, many of these sites that seem to be legitimate Canadian sites that people are going to trust are not. They're Chinese, Indian, whatever. That is another huge risk for Canadians.
Specifically for approved medications in Canada, the regulatory and the monitoring processes of the federal government need to be in place to make sure that their manufacturing facilities and imports are all meeting the stringent criteria we actually have in place in Canada.
Senator Eggleton: I was going to raise the question of counterfeit separately, but now that you've responded to it, I'd like to hear all of your comments on both of those.
There doesn't appear to be any suggestion that the law is being enforced at all in this country with respect to counterfeit over the Internet. There hasn't been a single prosecution in Canada, yet you say you're concerned about it. What do we need to do?
Ms. Cooper: We hear a lot about it through our international colleagues. It's really hard to detect if there are a lot of counterfeit drugs coming in through Internet providers. It's a difficult area to regulate. The pharmacy and medical regulators try to regulate if it's a Canadian Internet pharmacy, but most of these are not Canadian businesses, and they're being mailed to patients. A lot of it is public education that this is just an unsafe practice.
Senator Eggleton: Let's hear from the others.
Mr. Adams: I really can only concur with Janet because our members have not raised this issue as something they've encountered in practice. Maybe they have, but it has not been brought to our attention yet. Obviously, we support measures that can stop that practice to the degree that we can identify it.
The Chair: Following up on your question on offshore, to the pharmacists, could you describe your procurement policy? After all, many of the products that you are dispensing come in from outside the country in some manner. Could you give us a little indication of how the procurement of your members works with regard to the acquisition of the products that you are dispensing?
Mr. Emberley: I'd like to pre-empt the answer by saying that under the regulated system, we have a very safe and effective supply of medication.
Pharmacy is regulated through our provinces and territories, through regulatory authorities. For example, in Ontario, we have the Ontario College of Pharmacists. The regulations provided by these regulatory bodies are very specific on how drugs are procured. They have to be procured through manufacturers that are represented in Canada, global manufacturers or wholesalers that are registered and known. The product itself has to go through these channels; it cannot be acquired. A pharmacy, for example, cannot acquire its medications online or through other sources. It has to be through this strictly regulated system.
That would suggest, then, that counterfeiting through our existing system through pharmacies is simply not possible.
The Chair: Leaving the counterfeiting aside, with respect to the issue of the quality of the drug, Ranbaxy pharmaceuticals were imported into Canada. There is currently insulin on the market from another Indian company that is of serious question. How do your members ensure the quality of the products coming from those places? Just because they're international doesn't make them good.
Ms. Cooper: I guess every product a pharmacist can purchase and dispense has to have a notice of compliance and market approval through Health Canada. They would not be able to sell anything that did not have a drug identification number, DIN. All those Ranbaxy products have a DIN through Health Canada, and they should be going through the appropriate controls and evaluation that the federal government has in place.
The Chair: Thank you very much. That's where I wanted you to go, and that was to explain to us that you acquire through those that are approved and have a DIN from Health Canada. We will deal with other issues, but I wanted to get that on the answer to the senator's question.
Senator Eggleton: Can I get one more in?
The Chair: Yes.
Senator Eggleton: Let me go to antibiotic resistance resulting from overuse, misuse and non-medical use of antibiotics. Particularly, we've heard that the vast majority of antibiotics in the United States, about 80 per cent, go to animals to fatten them up for sale purposes with respect to food. The World Health Organization considers this to be a global crisis, and other entities in the world have also said that this is a very serious issue.
Drug companies seem to have very little interest in developing new antibiotics. It costs a lot of money — we know that — to bring a drug onto the market. They could make better money with the kind of drugs that you would use every day as opposed to one that you might use every now and then, so that's a bit of a problem.
Certainly, you represent front-line people who have to be concerned about this antibiotic resistance, this global crisis. What do you suggest about that? How do you think we should combat this problem?
Millicent Toombs, Director, Public Health Department, Canadian Medical Association: In fact, our members have repeatedly brought this issue to our attention, particularly, to follow on the senator's point, the use of antibiotics in agriculture. At our last few annual meetings, we've passed resolutions calling for much stricter controls and monitoring of the use of antibiotics in agriculture, particularly the ones that are not used for therapeutic purposes. One other statistic I've read is that a lot of the antibiotics in agriculture in cattle are used either to prevent the spread of illness in very overcrowded farms or as growth enhancers, not to treat existing illness. We have also learned that many of the controls that the industry places on itself are voluntary codes of practice.
So we've passed, as I've said, several resolutions calling for stricter monitoring of the use of antibiotics in agriculture, particularly stricter monitoring of import by agriculture and for own-use or off-label purposes.
Senator Eggleton: Anybody else?
Ms. Cooper: We don't have a formal position calling on that, but I would say that pharmacists would share physicians' concerns and support the need within agriculture to have more regulation and more monitoring because I don't think it's an area that has a lot of oversight.
On the other side, when we look at overuse of antibiotics, it is an issue within the human population as well. We see overprescribing of antibiotics, with patients, parents coming in and expecting to leave with an antibiotic. This issue has been going on for a very long time, and there have been different public awareness campaigns, not just overprescribing of antibiotics but overprescribing of the newer antibiotics that should be saved for more serious infections when the older antibiotics aren't working, if I can keep it simple.
In pharmacy practice, Phil practices regularly in a community pharmacy here in Ottawa, and pharmacists see a lot of unnecessary overprescribing of antibiotics or the wrong antibiotics often being prescribed.
Ms. Lefebvre: I think this is where education comes in. We all know about the overprescribing and the overuse in food production, but it's not getting down to the public. Even when I go to the doctor after two weeks with a cold, I know it's viral and won't respond to antibiotics, but I would feel much happier if I left with an antibiotic prescription, and I know, but a lot of people don't. That's an important element. The users, in part, are driving this. At some point, I can imagine, my doctor is shorter than I am; I can probably persuade her a little bit. It's a real issue.
Physicians are expected to follow guidelines, and they try. I think most physicians do follow guidelines and do very well. We're not talking about the majority here who are prescribing inappropriately or who are at least trying not to prescribe inappropriately.
Senator Seidman: I'm really pleased to hear that you all repeated each other and mentioned the advantages of using the digitized world and electronics in some fashion in many aspects of this. I think I will probably leave that issue for now because you made your points very well.
We have been hearing witnesses here since the end of January, and they've all raised very interesting issues for us. If you might allow me perhaps to read brief quotes from them and then ask you a question related to that, I would appreciate it.
I think you've already touched on this one. We did hear from Brian O'Rourke, Canadian Agency for Drugs and Technologies in Health, that the polypharmacy issue is of major concern, particularly in the nursing home community. We know that a lot of falls are related to drug interactions or polypharmacy. How can prescribers or dispensers contribute to a culture of de-prescribing?
Mr. Emberley: If I can respond to that on behalf of the Canadian Pharmacists Association, I think that's an area that pharmacists are becoming increasingly involved in. As we get more access to medication profiles that patients have, we have an opportunity to go through them line by line to see what is actually required, what is duplicative and needs to be removed because it's potentially adding to side effects, and in some cases what needs to be added because there are also situations in which patients are not receiving the medication they need.
We need to have greater access to information, as we've talked about, but also information about the patient. Having more information about the patient, for example, the diagnosis that the patient has, or diagnoses, is critically important because then we know exactly what medications this person should be taking and what things they should perhaps be avoiding.
Ms. Cooper: I could add to that as well. We debated whether we would put de-prescribing in our speaking notes because it's kind of a complex topic. There is a big initiative under way in Ontario now that the Ontario government is funding, and our colleagues at Bruyère and other leading pharmacists are working on a de-prescribing initiative on de- prescribing guidelines on how you get people off the benzodiazepines and a number of other medications that result in falls. Frankly, seniors lose their independence and they end up in a nursing home or hospital because they're on too many medications. It's a slow process. It takes a lot of time for physicians and pharmacists to work together.
Pharmacists are sitting down now and doing a medication review with an appointment-based type care in their pharmacies. They're looking at whether all these medications are needed in Ontario. We don't have a complete record of what patients are on. You don't know. West of here, you do have a complete record of what patients are on through the province-wide systems, but we need that.
We have a conference coming up and we will be hearing a lot more about the concept of de-prescribing and getting people off medications because a specialist will start them and people don't even know they're on them.
The transition from hospital back home is another area where medications are continued and they need to be re- evaluated.
Ms. Lefebvre: On a personal story, my mother was a very complex patient in the last years of her life. I don't think anything she was on was something she didn't need. When she came out of hospital one time — and she had very devoted daughter monitoring absolutely everything she was taking — it was the pharmacist who picked up two red flags. It wasn't so much the drug; it was the way the drug was being delivered that was wrong. It took two days to correct it. Why didn't the physician have this at his fingertips? The pharmacist did. We have work to do. We have the information. I was smart enough to always get my mother's drugs from the same pharmacy. That's a very basic recommendation, don't you think? Don't go around to lots of pharmacies.
Senator Seidman: That leads me to my next question. The point was made by Dr. Susan Ulan of the Coalition on Prescription Drug Misuse that the role of the college as medical regulator is to identify high-risk prescribing and to manage that. What mechanisms do you have in place to identify high-risk physicians?
Ms. Lefebvre: That is where the disparities around the country in the way this information is gathered really come to bear. For instance, British Columbia has PharmaNet, and it is an excellent system. The regulator can go in on a fishing expedition. They can say, ``Today we will look at this particular drug and we will identify the outliers.'' It's easy to do because they have the information and they've had the information for some time now. Once they've identified the outliers, they contact them. Often the outlier is behaving appropriately given his or her patient population, but sometimes they're not. We have evidence across the country that sometimes just being contacted by the regulator who is looking at your prescribing patterns may in fact bring those patterns into the appropriate range of behaviour quickly. Often you have to remember if the physician has a particular patient population this may be justified, but you need to ask the question.
Other jurisdictions may have the data, but the regulator can only look at a physician's prescribing if they have a reason to do so. Already there's a disparity; the same data, different access. Privacy legislation in this country has really good sides, but it also has sides that are inhibiting this exchange of information, and other jurisdictions simply do not have the data. We are a mixture, which is why one of our recommendations is let's get this information into the hands of the people who can actually go in and make a difference before harm is done.
Senator Seidman: We also heard that labelling is very important, especially with respect to opioids. If I might ask the pharmacists, you're essential to patient education. You're sort of first-line contact, and I know these days a lot of patients rely on their pharmacists to learn about their medications much more than they do their physicians.
What do you think about a label as an effective tool to further education of patients?
Mr. Emberley: I would have to say that labelling is really important. What often happens with medication, unfortunately, is that people use a portion of their prescription and may set it aside for later, and later they don't remember what it was for. The completeness of information provided is important to steer away from potential problems. Pharmacies are regulated in such a way that prescription labels have certain entities within them. There may be an opportunity to look at that again with an eye to steering away from potential, unintended consequences. I think that's a valid point.
Ms. Cooper: I would add that labelling is not enough. You need to have that dialogue with the pharmacist and not just at the time of getting a new prescription but when you're coming back for a refill the pharmacist is having that conversation with you. Are you taking it the right way? Are you having any issues? If they never get it refilled, then what's happening there as well. If we had better electronic systems, we would be better able to monitor that. If someone starts on an anti-hypertensive and they don't come back and get it filled then there are unintended consequences of having uncontrolled high blood pressure, for example.
Ms. Toombs: I favour labelling as part of a comprehensive education piece in which not only the pharmacist is involved but also the physician who is prescribing the drug to the patient. Is there a protocol for education that you can tell the patient and that would be consistent with what the pharmacist can also tell them?
Senator Enverga: Thank you for all your presentations. They are sometimes real eye-openers.
During my research I checked the Canadian Medical Association website and from February 17 of this year, following a symposium on the issues of prescription drugs. A staggering statistic was mentioned. A review of the benefit program in Ontario found that 898 opioid prescriptions were dispensed for 1,000 First Nation individuals in 2007. Is that true? If it is, do you know the national average? How is it possible that this is happening in one province?
Ms. Toombs: I'm afraid I don't have the answer for a national picture. I think this is one of the problems we are facing. There's very inconsistent and incomplete national data on opioid use and opioid abuse. I think this particular First Nation may have been one. We don't even know if the pattern is consistent across all First Nations in Ontario or in Canada. That's why the national prescription monitoring is so important to us, so we can use it to gather that data and get a picture of who is being prescribed the opioids.
Senator Enverga: But the picture here is just the First Nations. How about the rest of Ontario? How would you compare it to the rest of Ontario?
Mr. Adams: There's no doubt that that's a staggering statistic that you refer to. The previous health minister raised this with us as an issue. There's no question, I don't think, that it's much higher. But we can't really quantify that, or I can't anyway.
Senator Enverga: Maybe Ms. Lefebvre can answer. Do they get special training when dealing with First Nations patients? Is there anything we can do about it?
Ms. Lefebvre: We do recommend that physicians get to know their patient population very well. I am going to go back to something, though. The numbers you quoted are staggering, but let's not forget that a lot of opioid prescriptions are in fact appropriate. Whether they're getting to their targeted receiver at the other end is of serious concern, and something where partnering with law enforcement would be very important to do.
Senator Enverga: That was 2007. How about 2014? Are there any changes at all? Have we made any progress?
Ms. Lefebvre: No, it's getting worse; we know that. We are now ranked number 2, after the U.S. Not a place we want to be.
Senator Enverga: What's your prescription for this problem? Do you have any prescription, any special recommendation just for Ontario or the First Nations? Any specific thing we should worry about or you could recommend for this?
Ms. Lefebvre: Our recommendations on the topic that I read out earlier address specifically the misuse, abuse and, of course, addiction. We really think it's a collaborative effort. We all have to get together.
Regulation happens at so many levels. We have the federal government regulating drugs, we have us regulating the practitioners who are prescribing the drugs and we have law enforcement. A lot of issues with this problem are law enforcement issues. We need to educate people. We do our best to educate the prescribers. We ask them to follow the guidelines. We also need to make sure that we can share the information.
Ontario is a big province. Ontario does not have all the information that we were talking about earlier. Other jurisdictions do. Let's make sure that the privacy legislation doesn't get in the way of this, that it actually does what it's supposed to do and doesn't inadvertently get in the way of our doing a better job.
Our biggest recommendation on all fronts with prescribing is let's get the information collection and availability to the regulators standardized across this country.
Mr. Adams: I would like to add a couple of points on that. Obviously education is key, but something else we noted in our brief is the whole business about access to treatment services. You hear a lot of concerns about access to pain management service and that. I think if more was done in that area, too, that could mitigate this as well.
Mr. Emberley: I would concur about education and take it a step forward and say that educating patients is extremely important and it has to start at a very young age. I think people need to know what medication is used for, what its limitations and benefits are and what role medication plays overall in the health care of individuals. We need to start that young, but we also need to have patients take control of their lives and not let these medications control them.
Senator Enverga: Actually, Mr. Emberley, you created a document in which you claimed that extending the authority for pharmacists to renew prescriptions on narcotics and controlled drugs is a step to limit abuse of such medication.
I have some problems understanding your logic on that. I do not see how making people able to provide these drugs will lead to less use and potential abuse. Can you perhaps expand on that?
Mr. Emberley: Sure, I'd be happy too.
I think what I was getting at when I made that statement is that pharmacists very often become aware of problematic use of medication. They are often initially the ones who are made aware that a person may have a problem with a certain medication like an opioid. Perhaps they are getting into problematic use, increasing their use of it. I believe there's a role for a pharmacist to intervene in those situations and have some control over whether that medication is continued. They can play a role and maybe highlight where there needs to be further consultation as to how that problematic use can be addressed.
In other cases, where the use is quite appropriate, I think there is a role for pharmacists to continue the medication and to continue to be involved with that medication use in that patient. I don't think it is contradictory. I think we're talking about the ability to continue medication when it's warranted and to be able to discontinue it when perhaps it's becoming problematic or to get involved with physicians and prescribers to have that dialogue further.
Ms. Cooper: I don't think we're suggesting that all 26,000 community pharmacists have the authority to renew and prescribe narcotic drugs. This would be for those pharmacists who perhaps have a specialization in the area, who are working as part of addiction treatment programs and narcotic pain management. It's not a blanket that anyone can prescribe, because then we'll just make the problem worse, as I think you're referring to, but that pharmacists can detect when there are problems there. Maybe it's changing the dose — that's prescribing as well — or decreasing those or helping to get somebody off of those narcotics, because you can't just stop them. People get started on narcotics and then they can't get off of them, and that's where pharmacists can help. It takes time to get somebody off narcotics as well.
Senator Enverga: Can doctors comment on that as well? Would you allow that?
Ms. Lefebvre: Doctors don't get to allow pharmacists to do what they do. Certainly it's a partnership. I think that Janet is right that often it is the pharmacist who sees the patient who picks up his prescription on day one and goes back on day three to get the renewal when it is a 30-day prescription; the pharmacist sees that maybe something is awry. I think there's a role to be played.
Again, if we collected the information and made that available to the appropriate people for the appropriate use, I think we would go a long way to beginning to identify the exact problem and the best way to get around it.
Mr. Adams: I think the point we would make is that these things should generally be done in a collaborative spirit, or I think Janet used the word ``partnership.''
If you look at what's happening across the land now, in a lot of the newer primary care models, there is an explicit incorporation of both physician and pharmacist services and other providers as well. I think that's more of a team practice. It's probably more the way of the future.
Mr. Emberley: Further to something that Janet said, one of the other unintended consequences that I come across when I practise is patients who try to take themselves off medication, perhaps without a physician being involved.
For example, I had a patient a few weeks ago who wanted to take himself off a sleeping medication. He said, ``Instead of just taking a tablet a day I'll just take half a tablet,'' thinking that would make perfect sense. That's a 50 per cent decrease in dose over the course of a day, and 50 per cent in the course of a week. That will actually set him up for withdrawal, for other issues to take place. So very often having pharmacists involved in that situation, again working collaboratively, to steer people away from these things that we don't even think about as unintended consequences, I think is really important.
Senator Eaton: I want to follow up on something Senator Seidman started with you, Ms. Lefebvre, which was going to the same pharmacy. I know personally, and all of us know, you go to different specialists for different things. They each prescribe something that will fix that specialty of theirs.
We've also heard on this committee that doctors have not taken up the digitalization of patient files. It's coming, but it's been very slow. So the only person who really knows what you're taking is the pharmacist, if you go to the same pharmacy, isn't it? And they're the only person who can look and see, oh, that's cross-indicative to specialist A and specialist B; they're going at cross-purposes. Is that not right?
Ms. Cooper: In Ontario, if you went to the same pharmacy, then the pharmacist would have a complete record. The Shoppers Drug Mart at this corner doesn't share their information with the next one.
Senator Eaton: They have all my prescriptions and they phone me up.
Ms. Cooper: Phil can speak to this: He practised in B.C. If you are a pharmacist or a physician there, you have access to every prescription that was dispensed for that patient in the province and you get a complete record. That's what we're talking about when we say ``drug information systems.''
Senator Eaton: Yes. We want to get the medical records on file first, and then the prescriptions will go on file. But right now, do you know if pharmacists, as a practice in Ontario, see cross-indications? Will they say to a patient or a client, ``Listen, Senator Seth, perhaps you shouldn't take this; you should take that. I'm going to call your doctor''? Do you usually take that upon yourselves to do that?
Mr. Emberley: Yes. Where we see interactions, we will be proactive. Where we see a potentially serious situation unfolding, we will definitely collaborate to prevent that harm. We don't have access to medication that people get at other pharmacies.
Senator Eaton: If we could educate the population right now to go to the same pharmacy, you will be proactive?
Mr. Emberley: Absolutely, and the more information we have about the patient, the better. It's a bit of a Catch-22. The more information we have about other things, such as diagnoses and even, for example, lab tests that patients may have, the greater our ability to intervene and suggest a sensible option for the patient, to steer them away.
Senator Eaton: That's good to hear.
Ms. Cooper: Pharmacy software systems, which we've been using for over three decades — pharmacists were probably the first adopters of electronic health records from health care providers — actually have alert systems to identify drug-drug interactions or drug-food interactions, allergies and those types of things, and they're obviously taken very seriously.
Senator Eaton: Now in terms of further cooperation with doctors, say that I have a chronic disease and I'm on an opiate or I have terrible pain. By changing the opiate on a regular basis, do you lessen the chance that I'm going to become addicted to that opiate, or changing my painkiller or how I take it?
Mr. Adams: With apologies, senator, I'm not a physician; I can't answer that.
Senator Eaton: You can't either?
Ms. Lefebvre: No. I'm not a physician either.
Senator Seth: No one can answer that question.
Mr. Emberley: If I could respond to that. An opiate actually attaches to a receptor in the brain, and all opiates attach to the same receptor, essentially.
Senator Eaton: So by changing my drug or my drug regimen, you're not going to stop me from becoming addicted?
Mr. Emberley: No. There is still going to be dependence and reliance on that medication and continued use of that medication as long as it's an opioid. There are other classes of medications that are used for pain that work on a different receptor, so that is something that can be suggested to a patient who no longer wants to take that.
Senator Eaton: Do you occasionally do that?
Mr. Emberley: We do, most definitely. Adjunctive pain therapy is a strategy that is often used when a patient is only getting so much help from an opiate, or they may come to you and say, ``Look, I'd like to stop taking an opiate. I don't want to take this anymore.'' That happens, and we will suggest alternative options.
Senator Eaton: Would you suggest giving a prescription for two weeks, but at the end trying to figure out something else?
Mr. Emberley: Yes. That's a very common strategy. One obviously has to respect patient choices, how they would like their health choices to go, and also work with the physician. It's really a triangle. That's how we see it.
Senator Eaton: The triangle has to become stronger from the physician point of view?
Mr. Emberley: It does.
Ms. Lefebvre: I want to come back to the bit about the single pharmacy. If you come out of your doctors' office and you're 10 kilometres away from your pharmacy that you use all the time and there's a pharmacy right outside that doctor's office and you're not feeling well, from the perspective of patient safety, we really need the drug information system. That is the mechanism that is going to work.
The Chair: We clearly heard that the PharmaNet system in B.C. is the ideal one to deal with the answer to this question. The practicality of every individual always going to the same pharmacy is simply not there in today's world. I think the substantive answer was the reference to the PharmaNet system.
Senator Cordy: Thank you very much. It's been excellent. There has been some repetition, but as the chair said, that's not a bad thing, because we take note of the number of times that things have been repeated. That clearly means that they're extremely important.
Ms. Lefebvre, you spoke about the use of opioids and the guideline, the recommendations, and you said this is respected around the world and in Canada. However, we're still number two in the use of opioids, which is not a good thing. Are people using these guidelines, these recommendations, universally around Canada?
Ms. Lefebvre: I can't tell you if people are using them universally. I can tell you that our members, the 13 organizations that license physicians, have made it clear; they've directed the licensed physicians to follow their recommendations when considering and managing opioid prescribing in their practices.
Regulators, unless they have a tool that they can go and monitor, like drug utilization or billing — which is another form of database that can be monitored in some jurisdictions but not in others — function with a complaint-based system. When you know that something has gone wrong, it's because you have received a complaint.
We keep saying we need more education about these guidelines. We think we're reaching a lot of physicians. Obviously, there are still some issues out there.
Some of the problems that are arising may be completely inappropriate use; that is, the person using the drug is not the person for whom the drug was prescribed. There are a lot of things going on now.
Mr. Adams: I'd just like to follow on that. One of our staff was involved in the development of the 2010 guideline that Ms. Lefebvre mentioned, and we have just launched a CMA module on our website related to this guideline. We will certainly be looking at how the awareness of that develops.
Ms. Cooper: One of our recommendations was actually having clinical decision support or therapeutic information right at the point of practice, just in time, when you're ready to write a prescription, or in your electronic medical record system you've put in a diagnosis that you should access that information.
There are lots of great guidelines out there, evidence-based. Some of them are a hundred pages, which no one is going to go through at the time of prescribing.
I referred to our e-Therapeutics program, which we worked on with Health Canada, through the Primary Health Care Transition Fund, to get that out there. It's a consolidation of the best guidelines and evidence that's there.
Still, people are so busy. They don't have time to look up things and read it. They need the nuggets right there when they're making a decision. When they make a diagnosis of ear infection or community-acquired pneumonia or how to treat chronic pain, then they can get the drug and therapy information they need, and the guidelines: Which drug do I use? When do I use it?
For these patient populations, there's new safety information. It's not good enough to have guidelines. We've all been through enough over the years. The guidelines are there, but how do you get people to apply the guidelines in practice? We need to look at facilitating that through their electronic medical record systems and giving that information, whether it's just a scroll-over info button or whatever, so that if they want to see it, it's there and they don't have to do 15 clicks and wait for the website to load, that it's part of the actual application they're using every day, be it on a desktop or an iPad or something like that. It's important that they can get that information and that it's concise, bullet point, and that it's what they need at the time of prescribing or monitoring medication use and those types of things — and also providing patient information there, because we've got a lot of different sources of patient information out there that is not necessarily the Health Canada information, which is great information, but no one has access to it.
Senator Cordy: We have heard that before, too, the challenges of working your way through the Health Canada website. I think your comments about it being concise and succinct also hold true when you get down to the patient level. You're not going to go home before you take your medication and read 25 pages, but you will read bullet points or nuggets, I think you called them.
Mr. Adams, you spoke about drug shortages, and we've heard that before at this committee, and what should be done. You spoke about working on the website and that drugs should not be single-sourced, I think you said.
You also said that we should be looking at the root causes of the shortages. Do we not know what some of the root causes of the shortages are, number one? Number two, we did hear that perhaps pharmacists and doctors should be given more notification if there is likely to be a shortage of a particular drug, so that they can, in fact, look at alternative drugs. I wonder if you could comment and expand a bit on that, and perhaps Ms. Cooper.
Mr. Adams: Certainly having better notice. As you said, we had a recent meeting of our specialty societies, and things were coming up on them suddenly, with little warning, and then they had to scramble to find alternatives. That would be great.
In terms of the root cause, I don't think we have a particularly good fix on that. The whole supply chain is a complicated business. Sole sourcing has been mentioned, but there's probably a range of factors, too, that merit further study. Again, the problem certainly hasn't been going away.
Ms. Cooper: I was at that specialist forum for the discussion. We were jointly discussing drug shortages and hearing stories from physicians; we hear them all the time from pharmacists. This is a huge issue out there. There are huge patient care and patient safety outcomes. Think of somebody who is on a medication for epilepsy, and it is short and they have a seizure. The consequences — not just their health consequences but they lose their licence and what it does to their whole life and ability to drive and all that. It is a huge issue. It is a huge time-waster for physicians, pharmacists, and others, when you're just trying to source medications. It is so complex. It's a global problem, not just a Canadian problem.
There is a lot of work. We've been leading a coalition now for a number of years that CMA has worked extremely closely with us on, and we've done joint surveys of our members. We're now very involved with Health Canada and Alberta co-leading the work from the government perspective on that. It's not an easy one to fix.
There is a national drug shortages website that we've been a part of. It's less than an optimum situation. It needs a lot more reporting and it needs to be easier to find. There are some things to fix up as well, but what it does not have right now is your therapeutic alternatives.
Senator Cordy: And it's not always up-to-date is my understanding.
Ms. Cooper: It's not always up-to-date. However, it's a start, and it's better than nothing. A lot can be done to improve it. That's one thing we're saying repeatedly, that this monitoring website needs to be improved in terms of the reporting by the manufacturers as well as giving the clinicians better information on what to do with a shortage.
Senator Cordy: You also spoke, Mr. Adams, about 1 in 10 Canadians not being able to afford prescription drugs. I know those numbers are higher in Atlantic Canada than in other parts of Canada. I'm from Nova Scotia, so that's of great concern. I assume that people are maybe not getting the drugs or maybe looking at the Internet to get what they think are great but really aren't so good and may in fact cause them harm.
Are you suggesting that perhaps we have a national pharmaceutical strategy?
Mr. Adams: Well, the position that we've previously recommended in the brief and our opinion, basically, is that Senator Kirby got this right in 2002 with the recommendations that the federal government fund 90 per cent of prescription drug expenses above a threshold for both public and private plans; because of that, 42 per cent of the current drug bill is paid for publicly. Essentially, $9 billion is spent by private insurance every year; $5 billion is spent out of pocket. To say that you can have a public plan is a non-starter. For one thing, too, I don't believe there is an industrial country in the world that has first-dollar pharma coverage. For example, in England the National Health Service, NHS, prescription charge is £7.62. We think the private plans will continue to exist, so that could be one option as the Kirby commission laid out in 2002.
Senator Cordy: I was part of the Kirby committee; I was going to mention that.
Mr. Adams: Well, I think you did good work.
Senator Cordy: I'm really glad that you did because I think it was well thought out and provided a solution that I think provinces would agree to.
Mr. Adams: As a quick supplement, that's essentially the kind of plan that New Brunswick is putting in place now, the Quebec model. That would lend it to what had been recommended by your committee.
Ms. Cooper: We certainly would also support not first-dollar coverage, but we need a better system in this country for affordable access. No Canadian should be unable to have access to necessary medication. That's not just very expensive drugs for rare conditions. Those are relatively inexpensive drugs for people who have a number of chronic conditions but who can't afford their medications. That also includes appropriate prescribing. A lot of time patients are being prescribed expensive, brand-name drugs when perhaps within the same therapeutic class there is a generic drug that is just as effective that might be 15 or 20 per cent of the brand name. It's also cost-effective prescribing and use as well.
Pharmacists spend a lot of time contacting physicians when patients can't afford their medications and suggesting alternative but equally effective medications.
Senator Nancy Ruth: I want to pick up on this idea of pharmacists contacting the doctors, because you've used phrases like ``team practices,'' ``collaborative'' and ``being proactive.''
If I presented a prescription and you thought it was nuts for whatever reason, you'd tell me, but what would I do about it? What would you do about it? Would you ever contact the doctor and say she's on this or on that and you shouldn't be prescribing this?
Mr. Emberley: As pharmacists, we often will communicate with prescribers to clarify prescriptions, to make suggestions and to give some information as such as when the patient can't afford their medication. There is this fairly open communication channel. Ultimately, we want what's right for the patient. We want the patient to leave the pharmacy with the mediation that will best meet their outcome.
Ms. Cooper: I mentioned the importance of electronic prescribing, which includes electronic communications between physicians and prescribers. Now what happens is it gets handwritten on a fax and it gets faxed to the doctor's office. Then they pull the fax off and that comes back to the pharmacy with their change in the prescription. We will be successful when we don't see fax machines in physicians' and pharmacists' offices anymore.
The Chair: I'm sure you will find numerous recommendations in our recent reports with regard to this issue of electronic communication. We are convinced on this matter and all you are doing is reinforcing that.
Senator Nancy Ruth: May I ask, though, if this conversation is electronically done, is it added to my file so that anyone who has access to that file will see this debate?
Ms. Cooper: I wouldn't say it would be added to your physician's EMR, your pharmacy's software system. That doesn't mean everybody has access to that. There are levels of information that would be accessed through electronic health records, and every note that a physician and pharmacist makes is not out there for everybody to see.
Senator Nancy Ruth: The final recommendation would be on both servers?
Ms. Cooper: Yes, the change in prescription and the reason would be documented.
Senator Nancy Ruth: So the next time I went to another doctor for another ailment, that would be picked up?
Ms. Cooper: Maybe in some jurisdictions, yes.
Senator Nancy Ruth: If there was a system like B.C.
Ms. Cooper: Ultimately, yes.
The Chair: Let's be very clear here: There is an electronic medical record, which is the one you are talking about. An electronic health record is the total health record. That doesn't exist in Canada today. There are various areas where it is more advanced and less advanced. We have gone into that in great detail in our earlier reports. It's a critical issue, senator. We have made substantial recommendations in that regard and find it inexcusable that we are as far behind today as we are, and we've put that on the record.
Today we're dealing with unintended consequences, so let's move into those areas. But it's an exceedingly important area, senator.
Senator Seth: Whatever we discuss, we come back to an electronic data system, which we definitely need in order to act in a collaborative way.
I would now like to talk about the question here regarding the option of controlling the overuse and misuse of antibiotics in agriculture. In 2011, the Canadian Medical Association proposed requiring a veterinary prescription for the use of antibiotics in agriculture production. Is that a study that the CMA continues to support?
Ms. Toombs: Absolutely, yes.
Senator Seth: Are there any people opposed to that? Could you explain a bit? I'm not quite clear here.
Ms. Toombs: I think it goes back to the fact that it is possible now for farmers or agriculture producers to acquire large supplies of therapeutic antibiotics without a prescription. This is an oversight or something that we definitely think needs to be corrected.
Senator Seth: I would like to know the method of prescribing for the largest scale of animals. How do they do it?
Ms. Toombs: I'm afraid that I wouldn't be able to answer that, sorry.
Senator Seth: According to the FMRAC website, the organization develops and promotes a national perspective on medical regulations. What regulations should be developed to prevent abuse and misuse of pharmaceutical drugs?
Ms. Lefebvre: Physicians are regulated on several fronts. One is that they must prescribe based on their knowledge of the most available evidence of the indications and contra-indications of a specific drug for a specific patient population, looking at the specific patient who is sitting in front of them. Physicians are, on average, pretty good at that, but there's a lot of knowledge coming into the system at a very rapid pace. The guideline that we produced is hardly the nuggets that Janet described. It's a big document. It does satisfy the requirements for evidence, however, and for expertise brought to bear on developing the guideline.
There's pressure from the public. There are physicians who don't follow guidelines. They are in the minority. We tend to identify physician groups who need a little bit more monitoring than others. We know that physicians over a certain age need a little bit more monitoring than others. They need to have a look-see a little more often. They tend to get comfortable in their practice patterns. But I will tell you that our evidence indicates that most physicians are behaving rather well in the context of the care for that patient.
Lots of things, however, are going a bit wonky when it comes to prescriptions, and it's a huge issue. We will keep telling you that it's not just the regulators. We have to work with the team, with the pharmacist, with the other team members, with the providers and with governments.
Health Canada regulates the drugs in this country. We regulate who gets to prescribe them, but Health Canada regulates what they can prescribe. Don't get me going on medical marijuana, okay?
Mr. Emberley: I think one thing that's important to realize is that the initiation of prescribing is often quite benign in the sense that something may happen, someone may be involved in a car accident and they are prescribed an opiate for a very legitimate purpose and a very appropriate reason. What can happen, though, in the course of that patient's treatment is that it becomes problematic. I believe that dealing with that problematic use in the past, we probably haven't done a great job, but now we're starting to focus on how we appropriately treat addictions and help people get off this kind of medication. It's almost an emerging science, but I'm optimistic that we're starting to move in the right direction, that we're starting to work on the same page to move along that continuum, to help those patients get off those medications.
Ms. Lefebvre: Or make sure they don't get addicted to begin with.
The Chair: Before I go further with the questioning, I want to go over a few things just for clarification for the record. Ms. Cooper and Mr. Emberley, I want to follow up on two or three things that have come up. I want to start with the one issue where we led you to make a comment that is extremely important to us, but I'd like to make sure that we get it clearly on the record with regard to the suppliers to pharmacists. You indicated that you can only purchase from corporations that have a recognized certification from Health Canada. Could you give me the right words on that, please?
Ms. Cooper: If I have the words correctly, the only pharmaceuticals that a pharmacy can purchase and dispense — and that would be hospital pharmacies as well as community pharmacies — would be those that have been approved for sale in Canada. They're going to have to have a drug identification number, a natural health products number, those types of approved drugs. That's also regulated through the pharmacy regulators; that's all you're allowed to sell.
There is a process within the federal government for a drug that's not approved for use in Canada, and it's an emergency access or special access program, where you can bring products in.
Pharmacies are purchasing either directly through a manufacturer, or most of their drugs would be coming through a regulated wholesaler that is distributing the drugs that they purchase from the manufacturers. Again, they're only drugs that are approved for use in Canada, that have their NOC, notice of compliance, with Health Canada and their market authorization.
The Chair: We understand the approval of the drug, the nature of the drug. That's a chemical identity that is approved. There is a formulation that is approved, but let's go back to that supplier. That supplier says they are supplying to the pharmacy group purchasing the approved drug. What evidence does that supplier have to provide that they're approved by Health Canada for the actual importation? What evidence is there that the material they supply meets the requirements and standards of that approved drug?
Ms. Cooper: That would all be part of the Health Canada process, through the Therapeutics Product Directorate and the regulation that happens with Health Canada in terms of products that are on the market in terms of the manufacturer. If a pharmacist gets a product that doesn't have a DIN on it, then it would certainly be suspect. I don't think that happens very often, but it is coming through the market approval through the government.
The Chair: So it would be up to Health Canada to test products entering Canada to meet their standards, not the pharmacy associations?
Ms. Cooper: No, they can't. The FDA has been doing a lot more of that than Health Canada is, and we're finding problems with Canadian products through the American guidelines.
The Chair: We are going to pursue this, but I wanted to get it on the record from you with regard to how this is done and make sure there is no diversity there.
I also want to clarify the issue that two or three of the senators have asked with regard to antibiotics in animals. There are two categories, are there not? There's the bulk purchase by distributors of material that is distributed to farms in large quantities that do not go through a prescribing process through pharmacists. What about the prescriptions for Little Missy, the family pet? Those prescriptions are written by a veterinarian and filled where?
Mr. Emberley: There are two ways in which they are filled. They could be filled at a veterinary office. That has traditionally been very common. A lot of pharmacies will also fill prescriptions. I do that myself. I fill prescriptions for pets. I wouldn't be able to say what proportion is which, but both venues are possible.
The Chair: The point is, within the area of treating animals for an identified disease or injury, there is a normal prescribing and dispensing process for that?
Mr. Emberley: Yes, there is.
The Chair: Thank you very much. Again, it's important for us to have these answers for clarity.
An issue has come up with earlier witnesses with regard to another unintended consequence of pharmaceuticals, which is how you get rid of unused drugs. We have had indications that individual pharmacies in communities have often been involved in setting up some sort of recovery program. Could you expand a little bit on this area from the point of view of the pharmacist with regard to practices that exist and what you would recommend as a best practice for encouraging and recovering those prescriptions whose contents have not been completely consumed by the individual patient?
Mr. Emberley: I would mention that I've worked at many pharmacies in my career, and almost every one of them had a voluntary system. The pharmacy participated in a system where they would accept any medications returned, even if it wasn't from that particular pharmacy. We were encouraging our patients to return anything that was unused. We typically had a contract with a disposal organization. The product would be professionally incinerated and appropriately dealt with so it could not be diverted in any way. This is extremely common across Canada, and patients are encouraged to bring anything back. Anything left on a shelf in a medicine cabinet in the home is a target for other members of the family to take; it can be expired and harmful. There are many unintended and serious consequences with unused medication.
The Chair: Absolutely. You indicated it is a voluntary process on the basis of the individual pharmacists. With your experience in seeing what is happening with this voluntary approach, is there anything that you would recommend with regard to a deliberate national process, for lack of a better term, in dealing with this issue? It would include an educational component, but there would have to be a deliberate plan to encourage the return of unused pharmaceuticals. Do you have any thoughts in that regard?
Mr. Emberley: I'm not aware of it ever having been mandated by any organization in Canada. For many pharmacists, we think it's the right thing to do. There are pharmacists who feel that manufacturers should play a role. If they are the ones selling medication, then they should play a role in receiving unused medication, especially if we talk about the environmental impact of medications.
Ms. Cooper: There has to be a big public awareness around this. We've been approached by the chiefs of police of Canada, whatever their organization is called. In May, they want to do a ``Take Back your Medications Program'' and work with pharmacies to increase the public awareness of it.
People's homes will get broken into. If somebody who has cancer and has been on high doses of narcotics passes away, they know those prescriptions are in the home. There are a lot of challenges besides the appropriate disposal. There needs to be a spring cleanup where people realize that you don't keep that old stuff in your cabinets, because there's a poisoning potential with kids or pets and unintended consequences. It's really around education.
It can be expensive, if pharmacies have to incur the costs of disposal of these medications, especially when people come with giant bags full. The actual disposal costs of these medications should be funded provincially or federally.
The Chair: Are your suppliers required by law to take back unused medications?
Ms. Cooper: They would be if it expired, if it's stock in the pharmacy that has never left the pharmacy; there are processes in place. I'm not familiar enough with it to comment. Things that have been dispensed, no; there would be none whatsoever. If someone brings something into a pharmacy, pharmacists can never re-dispense that. It's what's left on the premise.
The Chair: I meant taking it back once it gets to the pharmacy.
Mr. Emberley: No. There are drugs that are particularly problematic. One of them is a pain patch that is called the Duragesic, or fentanyl, that even when the patch is used up, there's still some drug remaining in the patch. It's a bad opportunity for this kind of drug to be diverted.
In the pharmacy where I work we take those back. We say if we are going to dispense more, we need to have the ones that are done returned to the pharmacy so that diversion won't happen.
The Chair: Thank you.
Senator Eggleton: That was one of the two areas I was going to cover. Very interesting response. You're a national pharmaceutical association. Lead the way. Create a greater public awareness program.
I've never heard from my pharmacy about returning. I'm sure if I went and brought them there, which I intend to do, they'll take them. I don't think the public is aware of this. They tend to either flush them down the toilet or put them in the garbage system where they can eventually leach through the landfill.
I hope you and your members would be able to get that type of a campaign going. We've been hearing that prescription drugs are creating a problem in our water system. We will be exploring that further with studies that have been done on this issue.
Let me go back to drug shortages. Senator Cordy was getting towards this whole question of identifying alternative therapies. You said the pharmaceutical association doesn't have a protocol on that. You deal with the issue of trying to make sure that you've got the information about what isn't available or what might not be available in the future, but the question of identifying alternative therapies, when we had the pharmaceutical industry in here, they said they think that's something that needs to be determined between the physician and the patient.
Well, what kind of guidance do the other two organizations here give with respect to therapeutic alternatives in times of drug shortages? You've indicated it's a serious issue. We agree it's a serious issue; so there's got to be alternatives.
Mr. Adams: Honestly, I think that would be more a matter for individual specialty societies to do that. When they had the recent meeting, they talked about a variety of things they have to do. That would be an interesting challenge to put to them. We've done surveys of the membership and we get all kinds of different things reported in shortage. I think it would be fairly difficult for us to issue guidance on that. Certainly specialty societies would be in a better position.
Ms. Cooper: If I could add to that, our organization could provide therapeutic alternatives. We probably have 200 physician specialists who work with us on our evidence-based information. We can draw on them and the specialty organizations that often they are very involved in, but right now the drug shortages monitoring website is one that's coming from the brand and the generic industry. It's not ours. Nobody seems to be prepared to fund any kind of therapeutic information to be on that website. That information could be out there, and we're having conversations this week on a drug that's short for epilepsy. How are we going to get this out to the providers in terms of here are a couple of options if you have to switch that patient.
Senator Eggleton: You think you can do that now in terms of determining what the alternatives are, but the problem is getting the message out.
Ms. Cooper: There's getting that information out there, and if that could be part of electronic records, which I won't get into again, we don't have the capacity or the resources to do that as a relatively small not-for-profit.
Senator Eggleton: So you need money.
Ms. Cooper: Yes. We've said repeatedly to the pharmaceutical industry, both brand and pharma, that pharmacists and physicians did not create this problem and it should not be our members that have to pay to fix it and get the information into the hands of providers so they can make the right decisions.
Senator Eggleton: But you have the knowledge; you just need the resources.
Ms. Cooper: We have the knowledge, but we need access to the people who have that knowledge. There are a lot of physician specialists out there, and we could bring that process together and get that information. We do it sometimes, but it's not consistent and easily accessible.
What you have now are pharmacists, physicians in primary care, community pharmacists as well as hospitals all spending an inordinate amount of time trying to source drugs and alternative treatments, and it is such a waste of health care resources out there when it could be better spent on patient care.
Ms. Lefebvre: It's not only a waste of health care resources, but the patient is also at risk now. Some of them go get their drugs at the very last minute. They only have two days left at home, and now they have found out that what they've been using for X number of years is no longer available. It may require them to go back and be reassessed by their physician. Now we're dealing with the time things and potential harm to patients.
It's a real issue, but the physician will try to act with patient safety in mind and try to resolve the issue. If I come back to my mother, one time it was 10 days without her antibiotics.
The Chair: With regard to the drug shortages website, do you think it's appropriate that the pharmaceutical companies manage that, or, as in the case of the U.S. where the FDA manages it, should it be Health Canada that manages that?
Ms. Cooper: Right now CPhA is saying it should be a voluntary website. If you mandate it and make it regulatory, it will probably be many years before it is up and running, and the bureaucracy behind it. However, if a voluntary site doesn't work then we may need to look at a mandated, regulatory one.
The industry should be responsible and should be posting the drug shortages. It's hard to even define what a drug shortage is. Just because a pharmacy doesn't have it, it may be a supply chain issue that is not because there's a province-wide or nation-wide drug shortage.
I think for the industry, they have to be reporting into this site. We also have to work with them, both Health Canada and our organizations — physicians, pharmacists, others — in terms of making sure that practitioners also have the information they need, not just here's a shortage; so what? You need to know what to do.
The Chair: With regard to shortages, in many common areas there are multiple drugs that could possibly be prescribed, depending upon the individual patient and so on. Is one of the issues that the number of options is limited by the particular formularies in a given province? The formularies are not harmonized and they are quite different, in some cases, from province to province.
Is the issue of the limitation of the number of options on the formularies in the provinces part of the issue in terms of once a shortage arises?
Mr. Emberley: If I could respond to that, I think potentially it is. I've actually worked for a provincial drug plan in British Columbia, and in those instances where there was a fairly limited number of options and one of those options was short and the other option was not on the formulary, amendments were made. For example, they may have listed a non-formulary drug on a temporary basis to manage that shortage because it was the most appropriate alternative to what was not available. So there is that flexibility that formularies have.
The Chair: How long did that take?
Mr. Emberley: I would say the turnaround time was quick. Within a week or a few days they could actually make that change. It's a matter of entering a new drug or basically making a software adjustment on a screen, and then they can open up the floodgates immediately.
The Chair: Again, we understand the fact that if a drug is really needed for a significant quality-of-life issue, of which you gave examples, a week is a relatively long time.
Mr. Emberley: It is.
The Chair: I just wanted clarification. There are many areas for which there are a number of drugs that have been approved by Health Canada, but the formularies in given provinces often restrict the number of options. Is that correct?
Mr. Emberley: Yes. Yes, they do.
Senator Seidman: Actually, I was going to ask about drug shortages, so we've almost covered it, but I do want to put to you with regard to drugshortages.ca, the website, that when industry was here, we asked a lot about this. I have a quote from them from early March where they said that you can be advised by clicking that as soon as a record is posted, it would be sent to your inbox. I don't know how much more assertive we can be in that respect on the website itself in terms of its functionality. Basically, the claim is that the website provides an alert function for health professionals, or anyone else who wanted to go to the website, as soon as the information is known. I guess I'm trying to understand what the real problem of functionality is on this website.
Ms. Cooper: There are a number of issues with the website. Some of it is just technical, where you can't search as well as you should be able to; there are no drop-down fields, all of that. I get those emails.
For a busy practitioner, if 20 emails come out or potentially 20 new drugs are posted within the course of a week or a month, maybe there's one that's relevant to your practice, maybe there are none that are relevant. It's just noise, and it has to be relevant and there has to be some context around it. You get this information that a drug shortage has been posted; well, so what? Is my patient actually not able to get their prescription filled? It's not enough information. It's better than nothing, but it's still not enough information.
Senator Seidman: In a way, it's too much information but not enough of the information the physician needs? You're saying there's information overload of all these drug alerts, and maybe they will require only one of those?
Ms. Cooper: Yes. I think very few physicians, let alone pharmacists, would even know you can sign up and be on that list. There certainly wouldn't be 90,000 practitioners getting those emails on a regular basis. People don't even know the information is there.
Senator Seidman: The other part of the question on drug shortages — we've touched on this — has to do with the options, the alternatives. You have said an inordinate amount of time is being spent on this by all the professionals involved here. You invoked the specialists and said they should be involved.
I guess my question is this: What would you propose, then? What would you suggest that would cut back this overload on all these professionals and this inordinate amount of time in trying to come up with alternatives?
Ms. Cooper: Ideally, we want to decrease the incidence of shortages, but there will always be drug shortages to some extent. We would like to see a system similar to the U.S. where there is the FDA's drug shortages site. There's also the American Society of Health System Pharmacists, which is a national organization. They have a site where drug shortages are reported, and they give very good clinical information of how you deal with a drug shortage. We would like to see similar information.
That means you would need specialized drug information pharmacists who will research that information, post it, deal with the specialists in that area, be they physicians or pharmacists, and what the best alternatives are. Is it really a shortage? It's so complex, and obviously then it has to be individualized to each patient. It would be great to have a system somewhat like that, but you can't do that without spending a few hundreds of thousands of dollars a year on it, which to me isn't very much money at all considering the cost of drug shortages. Every major hospital in this country is probably spending at least one full-time equivalent of pharmacists dealing with drug shortages, anesthesia shortages and all of that.
Senator Seidman: What you are saying is that it can be done?
Ms. Cooper: Absolutely it can be done.
Senator Seidman: At the pharmacist level?
Ms. Cooper: Well, not just pharmacists but pharmacists and physicians. Kind of that drug information role that pharmacists have, they could provide that information. They're doing it now within their own workplaces.
Mr. Emberley: One important piece of information is that these resources are very important, but also, every patient is unique. If you have a heart patient who is no longer able to get their medication, you can't simply say, ``Here's a reference that says let's use this one instead.'' You need to go back then and look at that patient's unique requirements, their diagnosis and what they were taking. It's a systematic process that needs to be followed.
There will always be extra work associated with shortages, although we can find these resources that would make it simpler.
Senator Enverga: This question has been asked before to our previous presenters. It's about the abuse of drugs. We heard about the narcotic painkiller OxyContin, which was recently removed and was replaced by OxyNEO, which contains the same active narcotic ingredient but it's more difficult to abuse.
Can you comment on how this works? Should we make this a standard for all medicines that are considered to be addictive? I just want to get an idea about this.
Mr. Emberley: If I can make a comment on it, OxyNEO was actually designed from the ground up to be a less abuseable dosage form. Everybody recognized the hazards associated with OxyContin, the fact that it was being ground and then either snorted or injected. The problems were known, so this new formulation was devised in a way that it could not be taken apart the way the precursor was. It could not be manipulated.
The information we're hearing mainly from south of the border is that the strategy is working. OxyContin is no longer a target, and OxyNEO is no longer a target for people breaking into pharmacies and robbing them or writing illegitimate prescriptions. It doesn't seem to be as big of an issue.
Unfortunately, one of the unintended consequences is that people are moving to other types of narcotics to abuse. OxyContin is less of a target now than it was. That suggests to me that the strategy with OxyNEO was actually sound; it helped alleviate some of the big problems we were having with OxyContin.
Ms. Toombs: Some of the medical people that I've spoken to have led us to suggest that maybe Health Canada should explore approving tamper-proof formulations of any opioid from here on in.
That may not be a panacea. Some people are switching to heroin or something, but if it has been shown to work, that is something we would encourage.
Ms. Cooper: Last week, we submitted our response to a Health Canada consultation on the Controlled Drugs and Substances Act, and raised this issue when OxyNEO came on the market, and then the generic version of OxyContin was allowed to be marketed in Canada. So you had a product like OxyNEO specifically designed to address a situation, and there was no way for Health Canada not to allow the generic version that didn't have all those controls around the product design in place, and we think that needs to be in place.
Health Canada can actually look at the societal issues around a drug, not just that it's allowed to be a generic product. There have to be some controls in place. What is best for Canadians and for Canada? The minister said she couldn't do anything about it. She had to approve it for use in Canada, and we don't think that's right.
The Chair: Doesn't Health Canada have a risk-benefit requirement in its approval of any pharmaceutical?
Ms. Cooper: But that product had already gone through the brand product.
The Chair: But with further evidence, it became a risk-benefit issue; did it not?
Ms. Cooper: I don't think that particular risk-benefit was part of what they considered. I don't know enough about the whole situation.
The Chair: I realize I'm getting into a new area here, but it is an observation.
Senator Enverga: It is actually disturbing. Have the doctors mentioned this to Health Canada? Just like what they did with OxyContin, have you ever related that to Health Canada?
Ms. Toombs: CMA made a submission just a few weeks ago, just as CPhA did on the Controlled Drugs and Substances Act. What we would like to see generally in the Controlled Drugs and Substances Act is a little bit of tightening of the requirements for approving certain controlled substances. Tamper proofing is just one of them — maybe require more follow-up studies or more pre-approval studies of anything that is a controlled drug or potential narcotic drug. There are a number of areas where we can tighten controls on what is allowed into the market.
Mr. Emberley: Just further to that, too, I believe there are precedents in the Canadian market where this has already happened. Years ago, there was a drug called Talwin Compound, which was a narcotic that was highly abused due to its specific formulation. There was a tiny pellet of opiate in the middle, and there were people who were chipping away the outside core of the medication, melting down that little pellet and injecting it. For that very reason, that drug was removed from the Canadian market, no longer made available. So we have done this in the past. There's no reason we can't do it going forward.
The Chair: That's an excellent example. Thank you very much.
Senator Enverga: We have to do something about it.
The Chair: I think there are ways that it could be dealt with in a firm direction. We'll look into this issue, because it's something that we can clearly look at and make recommendations on.
Thank you all very much for these very articulate, open and clear answers to these questions on these very important subjects, and I thank my colleagues for their questions.
With that, I declare the meeting adjourned.
(The committee adjourned.)