Health Committee on March 29th, 2012
A recording is available from Parliament.
On the agenda
- Richard Chisholm President, Canadian Anesthesiologists' Society
- John Haggie President, Canadian Medical Association
- Gail Attara Chair of Operations Committee, President and Chief Executive Officer, Gastrointestinal Society, Best Medicines Coalition
- Suzanne Nurse Representative, Best Medicines Coalition
- Diane Lamarre President, Ordre des pharmaciens du Québec
- Myrella Roy Executive Director, Canadian Society of Hospital Pharmacists
The Chair Joy Smith
Thanks so much for your very insightful witness today. I appreciate your being here.
We'll now go to the Ordre des pharmaciens du Québec.
I hope I haven't butchered that entirely. I'm working on my French. I have three kids in my family who speak it wonderfully. My apologies if I have not done that right.
We'll start, I think, with Madame Diane Lamarre. Will you be sharing your time with your colleague?
Okay, go ahead, Diane.
Diane Lamarre President, Ordre des pharmaciens du Québec
Madam Chair, members of the committee, we thank you for providing the Ordre des pharmaciens du Québec with the opportunity to discuss disruptions in the drug supply and, especially, potential solutions for preventing those shortages and limiting their impact on the health of Canadians. Joining me today is Manon Lambert, Director General and Secretary of the Ordre des pharmaciens du Québec. She can also answer your questions.
Stability in the supply of pharmaceutical products was a key concern for the order well before the media began reporting on the crisis we are witnessing today. In March 2011, we established a multipartite committee to study the causes of the shortages and prioritize recommendations for possible solutions. We will present the results of that work in mid-April in collaboration with the Collège des médecins du Québec, Quebec's college of physicians; the Association des pharmaciens des établissements de santé, the association of health-care institution pharmacists; and the Association québécoise des pharmaciens propriétaires, Quebec's association of owner-pharmacists.
At the beginning of this process, our findings were cause for concern: the number of supply disruptions between 2006 and 2010 had quadrupled, and the disruptions would last several months. What is worse, it appears that the shortages entail major clinical risks, as exemplified by some 15 related deaths in as many months in the United States and, closer to home, 65 surgeries that were recently postponed in the Outaouais owing to a shortage of injectable medications. Some groups, particularly people living with cancer, are especially vulnerable to these shortages and are often their first victims.
The Ordre des pharmaciens du Québec and its partners view the drug supply problem today as a public health issue that calls for immediate and concerted action by the various players involved. At the federal level, our recommendations address three complementary and overlapping elements.
First, Health Canada must assume leadership in dealing with this major issue. To do so, it must create a monitoring unit. The role of this unit would be to monitor disruptions internationally and nationally, as well as to support the provinces in their efforts to prevent shortages. In addition, this monitoring unit will have to develop reciprocal relationships with other regulatory authorities, such as the FDA.
Second, the federal government must implement a legislative framework that requires companies to give notice of the following two situations: one year for any halt in production, and six months for any expected disruption in the drug supply.
Last, a Canadian list of essential drugs must be compiled in order to prioritize efforts to mitigate clinical risks and provide particularly proactive monitoring. I will expand on those three recommendations.
In the first recommendation, we are working from the premise that a drug, given its life-saving capacity, is an exceptional consumer product that, as such, deserves a customized legislative and organizational framework. We feel that the stability of the drug supply today should be the focus of a national vision, and our first recommendation is to establish a hub for monitoring and concerted action across Canada.
In the United States, the FDA monitors the global situation in order to eliminate the problem of drug shortages at the root. We believe that, in Canada, an independent national organization should be responsible for identifying risks that could affect the supply, and for encouraging information-sharing among the country's regulatory bodies. Beyond this simple observer role, the organization should also have mechanisms that would enable it to react quickly and prevent shortages, or at least reduce their impact on the health of Canadians.
We feel that Health Canada should take the initiative in creating this monitoring unit—in association with the provinces—by making it a priority on the agenda for the next conference of federal-provincial-territorial health ministers, to be held in Halifax on September 27 and 28. I will now discuss the second recommendation.
That being said, a unit like this will not have the means to carry out its mission unless it receives relevant information in time to implement mitigating measures. The entirely volunteer process the pharmaceutical industry currently uses to report production problems or changes that might affect a drug's availability seems to us to be clearly inadequate.
For example, manufacturers in France are required to inform regulatory bodies of any factors that could influence a drug's availability one year in advance. In some instances, such as single-source essential products, a manufacturer that wants to cut back or stop production may even be legally required to keep producing until an alternative can be put into place. Canada must enact a similar measure.
We also believe that Health Canada must impose a legislative framework for manufacturers, requiring them to report any significant changes in the production chain that could limit access to one or more drugs a minimum of six months in advance, or as soon as they know about it. A non-binding resolution would not provide the safeguards needed to protect Canadians.
Under a coercive system like this, Sandoz would have been required to inform the authorities, back in 2009, that the FDA had issued it a notice of non-compliance. In this specific instance, as in many others, the voluntary system appears to have shown its limits.
Lastly, as is done in a great many countries, we hope Health Canada will coordinate the compilation of a list of the essential “single-source” drugs used in the different provinces.
These so-called single-source drugs, manufactured by a single company, obviously present a greater risk for shortages, since no other supplier can step in to resolve a reduction or stoppage in production. In these cases, not only is the health of Canadians jeopardized should production difficulties arise, but the manufacturer's monopoly position also limits the negotiating power of regulatory bodies in the event of a crisis.
Once again, the recent example of disruptions at Sandoz, the sole manufacturer of many drugs, has made all the players in our health care system aware of the vulnerability that comes with dependence on a single supplier.
An interruption in the supply of essential drugs creates major problems of a medical, ethical and human nature. The disruption involving CaelyxTM, a drug used to treat ovarian cancer, is a recent dramatic example. Faced with shortages, some Quebec hospitals were forced to give priority to those patients who had already begun treatment, thereby delaying administration of the first dose for other patients. We believe that no patient should have such crucial treatment suspended or delayed.
We are convinced that, by ensuring minimum stockpiles of essential drugs, Health Canada would increase the network's ability to adapt and thus limit the risk of out-of-stock products.
There is an urgent need for action. Such measures have already been adopted in other countries and must be introduced here as quickly as possible.
In the meantime, we hope Health Canada will adapt the special access program to the new reality of supply disruptions. We find it inconceivable that this program, which is the main recourse for hospitals for access to international stock, is currently not more effective in the fight against stock disruptions. The program should also be available to the patients of community pharmacists.
Our three recommendations represent a major paradigm shift that places the supply issue in the context of national public health and, above all, proposes a proactive and collaborative approach to replace the reactive mode that typifies current federal and provincial actions.
Therefore, our efforts are aimed at prevention and action, rather than at enduring situations that are unfortunately bound to recur. We want to reiterate that the measures we are proposing have but one aim: to protect the health of all Canadians.
Thank you for your attention.
The Chair Joy Smith
Thank you, Ms. Lamarre. That was a very profound presentation.
We'll now go to the Canadian Society of Hospital Pharmacists. Dr. Roy.
Myrella Roy Executive Director, Canadian Society of Hospital Pharmacists
Madam Chair, honourable members, ladies and gentlemen, I thank you for the opportunity to present to you today.
My name is Myrella Roy, and I am the executive director of the Canadian Society of Hospital Pharmacists, also known as CSHP. Before accepting this position, I spent 17 years as a hospital pharmacist and clinical manager with the Ottawa Hospital.
The society is the national voice of hospital pharmacists in Canada. We are a not-for-profit organization with voluntary membership representing pharmacists committed to patient care through the advancement of safe, effective medication use in hospitals and other collaborative health care settings.
Today, I wish to bring to the committee the perspective of our 3,000 members across the country on the issue of the role of government and industry in managing the drug supply in Canada. I also want to propose concrete steps that our members believe governments, both federal and provincial, can take to help bring about resolution to the current crisis. These steps include a robust national drug supply management system that can anticipate and efficiently mitigate the impact of drug shortages, a strong drug supply chain that can prevent future shortages, and a strong role for the federal government in shaping global solutions to what is, in many ways, a global problem.
Before I delve into these solutions, I would like to tell you briefly about pharmacists who work in hospitals and other collaborative health care settings. This information should help you understand our perspective.
Hospital pharmacists do far more than dispense drugs. They work closely with physicians, nurses, and other health care professionals to make sure that the health goals of individual patients are met while keeping the medication system safe and effective. They help select the right medication for the right patient, adjust doses, identify and manage medication side effects and interactions, and educate patients on how to take and store their medication. Hospital pharmacists are integral to patient care. Their efforts help our publicly funded health care system.
During drug shortages, the work of hospital pharmacists becomes significantly more complex and the risk to patients grows. A recent survey conducted in the United States by the Institute For Safe Medication Practices revealed an association between drug shortages and medication safety incidents. The necessity of using alternative medications, or alternative concentrations, strengths, or dosage forms of the same medication, may introduce additional complexity and opportunities for error into the processes of prescribing, preparing, administering, and monitoring medications. What's more, the alternatives are often less effective, more toxic, and more expensive for patients and hospitals.
Furthermore, there is a significant potential for errors when hospital pharmacists and pharmacy technicians compound medications from raw materials without adequate expertise, facilities, equipment, staffing, and other resources. Our members understand these risks and must deal with them every day. Patient safety remains a fundamental value of our organization, and we are committed to proposing and contributing to concrete solutions that will address drug shortages now and in the future.
Now let us discuss some solutions. As you know, drug shortages have been occurring for around a decade, and the problem is only getting worse. What past experience has taught us is that Canada and Canadians need a national drug supply management system. When a drug shortage situation of the present magnitude, and without sufficient advance notice, occurs, a significant amount of pharmacists' time is quickly reallocated to developing reactive plans with other health care professionals, implementing temporary mitigating strategies, and finding suitable clinical alternatives for their patients. The lack of a single national drug supply management system that would set minimum timeframes for notification of impending drug shortages and drug discontinuation by manufacturers leaves health care practitioners scrambling to explore and implement mitigating strategies and leads to very significant duplication of efforts.
CSHP is already active in fostering this kind of nationwide collaboration and sharing of information. In order to alleviate some of this duplication, our society is hosting an online drug shortage forum for its members.
Since the spring of 2011, CSHP has also been intimately involved with other national health care professional organizations and drug manufacturer associations to develop a national drug supply management system. We are thankful to the Canadian Generic Pharmaceutical Association and to Canada's research-based pharmaceutical companies for their generous financial contribution to the development of such a system.
However, the sustainability of the system is challenged by a lack of financial resources. We believe that Health Canada should play an active role in delineating a sustainable funding model for this system with the provincial and territorial ministries of health, such that health care practitioners from coast to coast to coast can more efficiently manage drug shortages and ensure quality care for patients across Canada. Such a role would be within its mandate and mission as a department responsible for helping the people of Canada maintain and improve their health.
As I made clear in my earlier remarks, all drug shortages pose safety risks and may affect the health outcomes of Canadians.
The next two solutions we would like to propose are closely connected, and also point to an important role for Health Canada. In order to identify and procure alternative medications, pharmacists consult Health Canada's drug product database and may also request medications not approved for sale in Canada using Health Canada's special access program. Unfortunately, the drug product database is not being kept up-to-date, with some listed manufacturers no longer operating a business in Canada or some listed drugs no longer marketed in Canada.
Furthermore, the current drug shortage has served to highlight the chronic weaknesses of the special access program and has further underscored the need to modernize the program, drug shortages obliging or not. The tediousness of the request process adds unnecessary delays in receiving the drug and contributes to the additional workload for pharmacists and physicians. Timely updating of the Health Canada drug product database and modernization of the special access program are urgently needed to assist health care practitioners in dealing with actual or impending drug shortages.
Finally, CSHP would like to see Health Canada taking the lead in ensuring the continuity of drug supply at a global level. Drug shortages are not unique to Canada, and many other countries are experiencing them. Numerous mergers and consolidations of companies over the past 15 to 20 years have led to a mostly multinational drug manufacturing marketplace. In many instances, the production of medications is dependent on the provision of ingredients from other countries or the occurrence of different manufacturing stages around the globe.
During its most recent congress in India last fall, the council of the International Pharmaceutical Federation, representing 130 member organizations from around the world and more than three million pharmacists, met to discuss the emergent issue of medication shortages. The council then called on all stakeholders, including governments, pharmaceutical manufacturers, pharmacy wholesalers, pharmaceutical purchasing agencies, medicine insurance plans, pharmaceutical regulators, and the pharmacy profession, to urgently evaluate these issues and work to ensure continuity of medication supply, so that the appropriate treatment of patients can be initiated and maintained.
We encourage Health Canada to engage in discussions with their regulatory counterparts in the U.S.A., Europe, and other countries to collectively learn more about drug shortages and to contribute to local and global solutions. Drug shortages are a global problem that call for global avoidance and mitigation strategies, formulated and implemented by Health Canada and health care regulatory authorities from other countries in collaboration with multinational drug manufacturers.
The Canadian Society of Hospital Pharmacists continues to be an innovative part of the solution to the current crisis. We remain committed to protecting the safety of our patients and to working with all stakeholders in Canada's health care system to find and implement solutions to the present crisis and in the future.
Thank you very much for the opportunity to present our concerns and solutions. I would be pleased to answer any questions you might have.
You may ask questions in the official language of your choice.
The Chair Joy Smith
Thank you, Dr. Roy, for your very insightful presentation.
We'll now go to questions and answers. We have seven-minute Qs and As, and we'll begin with Ms. Davies.
Libby Davies Vancouver East, BC
Thank you very much, Chairperson.
First, thank you to all the witnesses for being here today. I thought your presentations were excellent. A special thank you to Dr. Chisholm, who's here from Argentina. I don't know if there's a time difference, but it's wonderful that you took time out from your conference to participate in this very important committee hearing today.
What really jumped out at me is how remarkably close you all are, first of all, in identifying the serious and urgent problem we have of drug storages, but also what needs to be done.
We've already had one meeting when we heard from industry representatives, and I have to say the government members clearly went after Sandoz, which was warranted, but there's a huge issue here about government responsibility, or lack thereof, in what we've seen, and I think you've all identified that.
Frankly, it's quite shocking to hear today in the testimony that the anesthesiologists association wrote to the minister in January of 2011, drawing attention to and putting out an early warning about shortages. We know the Competition Bureau also issued warnings to the government in 2008. So it's really quite shocking that nothing has been done. While there are issues around how the industry has performed, I'm hoping that today we can focus on what the government needs to do to address this problem.
Dr. Chisholm, you noted in your testimony that we need to predict, identify, and manage around supply disruptions. You may be aware of the motion that was passed unanimously in the House of Commons that uses very similar language; it said “anticipate, identify, and manage”.
The CMA certainly said a very similar thing: we must have a monitoring, an early notification system.
I'm very interested in the Best Medicines Coalition's suggestions that we need a regulatory framework. We need mandatory reporting.
That's really my question. We know this is being looked at in the U.S. We know that New Zealand has a model whereby they require the manufacturers to provide much more information in terms of looking for alternate sources. Now that we have this motion passed, what is it that you want to see Health Canada specifically do and the Government of Canada come back with, and how quickly? If you could give us some idea of the priority, what needs to be done first, what needs to be done second, that would be very helpful.
To Dr. Chisholm, I note that you mentioned that a resolution had been passed unanimously at your world congress in Argentina, and I'm wondering if you could send that resolution to us when you get back home, plus anything else that came out of the congress, because obviously you had a lot of discussion there. I'd appreciate it if you could forward that to the committee.
I'd ask the witnesses to address that question of your immediate priorities and then the longer term, and your timeframe of what needs to be done.
The Chair Joy Smith
Who would like to begin?
President, Canadian Medical Association
I'll take a stab at that. Thank you.
I think there are two things that need to happen simultaneously. One is you have to remedy the gap that's there at the moment. I don't have any handle on what's in the supply chain. I don't know anything about the business of manufacturing drugs, but looking at it from the patient's perspective, these have vanished in an unpredictable way.
The first thing is to stabilize the problem, stabilize the patient, and find some new drugs. Boucherville, for example, is not the only plant in the world that manufactures injectables. At the same time, you need to address the problem. We've heard some solutions, and we've heard some very good suggestions from my colleagues on either side.
I hope this committee had some testimony from the pharmaceutical industry. This is their problem. Why is it these drugs have vanished? It's a complex problem manufacturing it. My role as a surgeon is to explain to a patient under the concept of informed consent what it is that I want to do. I have to make the functioning of your gastrointestinal tract, for example, something that you can understand. That's my job.
I would suggest that we need to get that kind of information so that it can be used on a go-forward basis to prevent it from happening again. I don't know what I don't know about drug manufacturers. All I know is that with the gaps at the moment, unless they are filled, Dr. Chisholm and I work on opposite sides of a drape on a patient, effectively. He can't do his job and I can't do mine, in the way that Canadians expect, without these medications.
The Chair Joy Smith
Do you want Dr. Chisholm...?
We only have a minute left.
Libby Davies Vancouver East, BC
I just have a brief follow-up.
Do you believe that the voluntary system we've had so far has been adequate?
President, Canadian Medical Association
I'd turn that question around and be a bit cheeky. Imagine you're a patient lying there with acute appendicitis. They really don't care why the antibiotic isn't there or why their pain meds aren't there. That's for you guys to fix.
We need some leadership in terms of whatever levers you've got—and I don't know those because I'm not a member of government—and we need some security for the future. So that's a pharmaceutical issue. The facts of the case are that I can't make the drugs. Should the pharmacies be doing it off the cuff in the hospitals? That's another issue, and we've heard about that.
The Chair Joy Smith
Dr. Chisholm, we have less than a minute. Could you please try to address Ms. Davies' questions?
President, Canadian Anesthesiologists' Society
To be very short, I would echo what Dr. Haggie has said. I agree with what he said. I just have one thing I would add.
You mentioned New Zealand. One of the things in New Zealand is that they have an agency that covers the entire country, which is not the way it is in Canada because we have our silos with our provinces. When I asked them about drug shortages, they said it was a problem. I forget the name of the agency, but they addressed it, found an alternative source, and the problem went away.
So talking to colleagues from other countries, they have less of a problem than we seem to have in North America. The question of why that is, as Dr. Haggie said, I don't know, and I turn to you to find out why.
The Chair Joy Smith
Thank you so much.
March 29th, 2012 / 9:40 a.m.
Kellie Leitch Simcoe—Grey, ON
Thank you very much, everyone, for your presentation today. I appreciate it.
Similar to Dr. Haggie, I'm also a surgeon. I'm a pediatric orthopedic surgeon. Your points were well taken. I don't think a patient gets too worked up about who decides when. They just want to make sure they can have their surgery or have their procedure.
Dr. Haggie, you're a surgeon. You've worked in a hospital. Dr. Chisholm has as well. We had met before, but there's an anesthetist....
It's very clear to me, and I stated this in the House. When I run into a problem with a drug in my operating room, I don't pick up the phone and call the Minister of Health; I call my pharmacist. We also deal with our provincial formularies, and we deal with the circumstance of our hospital making sure that the supplies are available to us. That's who's actually doing the negotiating.
I want to be very clear that I think we understand that this is health care and the provision of those medications is a provincial responsibility, a provincial negotiation, a hospital negotiation. I just want to make sure that we're on the same wavelength on that, and then I have another couple of questions for you.