Ms. Davies, I'm sorry to interrupt you, but we have received that motion. It needs 48 hours' notice. We'll present it next.... Thank you so much.
It is very common to have motions at the committee, so thank you, Ms. Davies.
Pursuant to Standing Order 108(2), we are studying the role of government and industry in determining drug supply in Canada. We have witnesses from the Best Medicines Coalition: Gail Attara, chair of the operations committee, and president and chief executive officer of the Gastrointestinal Society; and Suzanne Nurse, a representative. Welcome, and thank you so much for being here.
From the Canadian Medical Association, we have John Haggie, the president. Welcome again. It's nice to see you here.
From Ordre des pharmaciens du Québec, we have Diane Lamarre, president; and Manon Lambert, director general and secretary. Welcome. We're so glad you could make it.
From the Canadian Society of Hospital Pharmacists, we have Myrella Roy, executive director. Welcome. We're glad you're here as well.
We have, via video conference from Buenos Aires, Argentina, from the Canadian Anesthesiologists' Society, Richard Chisholm, president.
Mr. Chisholm, welcome. Thank you so much for being here. We're very honoured to have you join our committee.
We will begin. We'll have a ten-minute presentation from all participants.
Mr. Chisholm, please make your presentation.
Madam Chair, members of the committee, on behalf of the 1,900 members of the Canadian Anesthesiologists' Society who are practising anesthesia in Canada, I would like to thank you for this opportunity to participate in these hearings about the role that governments and the pharmaceutical industry play in ensuring Canada's supply of the drugs we require to meet Canadian health care needs.
This subject is drawing significant attention now from governments, from the media, and from the general public. Much of that attention arose from letters sent by Sandoz, a generic drug manufacturer, to its customers in mid-February of this year announcing that the company's Canadian manufacturing facility in Boucherville, Quebec, would be closed to redress manufacturing issues identified by a recent site visit by the U.S. Food and Drug Administration.
Those letters triggered a very real crisis in Canada's drug supply. I'll have more to say about that in a moment, but first I want to make it very clear that for Canada's anesthesiologists our drug supply concerns did not begin and will not end with the current Sandoz difficulties.
In January 2011, more than a year before the Sandoz letters, we wrote to the federal Minister of Health to say our members were reporting shortages of Propofol, a preferred anesthesia induction agent, and were concerned about reports of reductions in supply of Pentothal, an older but still useful drug.
We asked, “Does Health Canada have a methodology to identify situations where supply constraints meet the definition of a drug shortage that requires prescribers to choose an alternate therapy?” To her credit, the minister has taken a number of initiatives to begin to address our concerns. But the simple answer to our question about the department's ability to identify and anticipate drug supply problems was “no” then and is still “no” today. The fact that we desperately need an effective system to predict, identify, and manage around supply disruptions is even clearer today than it was then.
Nothing proves that more convincingly than the sorry history of the Sandoz manufacturing interruption. That interruption meant that dozens of critical medications would no longer be manufactured, while others would be available on allocation, based upon previous usage, for anywhere from 12 to 18 months. As I think you know, in many cases Sandoz is the only Canadian supplier of essential medications.
There were immediate impacts on our members and the patients we serve. Hospital by hospital, anesthesiologists began to encounter shortages, and they found themselves operating in an information vacuum. How bad was the problem? What measures were being taken to resolve it, to locate alternative suppliers or medications? Who was managing this problem?
Of course, the anesthesiologists called us, asking what was going on and saying they felt out of the loop. As we looked at it more closely, we realized that we weren't being left out of the loop of communications, consultation, and joint planning to manage the crisis; there simply was no loop. The information, consultation, and joint planning that should have been flowing to and among industry, governments, and health service providers just wasn't happening. That's because we have no system in Canada today to make sure it does.
Your committee is focusing on the roles of industry and government in the drug supply. Let's start with industry. In this case, we are talking about Sandoz, a reputable and competitive generic drug manufacturer that succeeded in obtaining sole-source contracts for key medications. The chronology here is interesting.
Sandoz was informed by the FDA in November 2011 that they would have to upgrade their manufacturing facilities. We don't know if or when Health Canada and provincial ministries of health became aware of this FDA order, nor do we know if they understood the potential impact closing this manufacturing facility would have on Canada's drug supply. But we do know that Sandoz did not inform their customers, Canada's health care system, until mid-February. On February 15 and February 17 they sent out letters, first reporting on the FDA order and two days later announcing an immediate reduction in the available supply of essential medications.
Could it have made a difference if governments and people such as Canada's anesthesiologists had been informed earlier? That question answers itself. There could have been time for hospitals to stockpile drugs. There could have been time to arrange alternative supplies from other manufacturers or to source suitable products from outside of Canada.
As we understand it, Sandoz was under no legal obligation to provide the earliest possible warning about these supply disruptions to its customers or to the Government of Canada. From a purely commercial standpoint, keeping their sole-source position as long as possible by delaying the announcement might seem to make sense. But it makes no sense at all from a patient's perspective. I repeat, there was no legal obligation here apparently, but I leave it to you as to whether or not there might have been a moral obligation on the company to share this information as early as humanly possible.
As we go forward and hope to avoid any repetition of this debacle, I hope your committee will recommend in the strongest possible terms that Canada adopt legislation placing a clear onus on companies to immediately inform governments and the health services system of any events that may jeopardize drug supplies.
What about governments and their role in all of this? I think it's fair to say that governments at all levels have been too slow to recognize the fragility of Canada's drug supply system, and that fragility affects drugs across the spectrum of costs. Oncologists are encountering supply problems with higher-cost medications needed for chemotherapy. Anesthesiologists are encountering shortages of drugs that, relatively speaking, are inexpensive.
We think the root of the problem lies in the fact that governments have, understandably, not focused on drug costs, while taking it for granted—given the tens of millions of dollars we have to spend—that supply would just naturally be there. Clearly, that's wrong. It's not the way it works in the real world.
Frankly, we don't have the answers to this problem. We're anesthesiologists. Our focus is the inescapable reality that the quality of health care—and the health services experience for millions of Canadians every year—depends on the capacity for anesthesia to contain and limit pain and suffering. You have to help us make sure we have the tools to do that all important task.
Some measures seem obvious: no more single sourcing, for example, and better monitoring of the pharmaceutical universe across health services in Canada. As to other elements in our overall efforts to contain drug costs, we need a renewed sensitivity to their impact on drug availability.
We need a requirement for industry to tell about events that might disrupt the drug supply and an acceptance by government of a requirement to ask, to monitor and make sure.
I have two last points. The first is the reality we are living with today. The truth is that the Canadian health service system does not routinely know, with any accuracy, which medications are or are likely to become in short supply. As a result, far too often these shortages are addressed clinic by clinic, hospital by hospital, city by city, region by region, province by province, drug by drug, and manufacturer by manufacturer. That's what's happening now in Canada with respect to the Sandoz supply disruptions, and that's simply not good enough.
The last point I want to make is just how well men and women throughout your health services system are doing and dealing with this crisis, clinic by clinic, hospital by hospital, city by city, region by region, and province by province. We hear a lot of doom and gloom about Canada's health services, but I assure you, you'd be proud to watch hospital pharmacists and anesthesiologists as they manage around the shortages by substituting one drug for another, or supplementing one with another, or manufacturing our own injectables from powder.
One final note. Canada is not alone in facing these challenges. Earlier this week, the WFSA, World Congress of Anaesthesiologists, in Buenos Aires, unanimously passed a resolution that called upon governments and industries to work with us to alleviate the drug shortage that affects patients all over the world.
So we're not alone, but the fact that there are new international problems of drug supply does not make it any less urgent that we take urgent action here in Canada.
That's the message Canada's anesthesiologists want to leave with your committee today. Our job is to keep pain at bay. We are very good at it. Please, urge the government to make sure we have the drugs we need to achieve that goal.
Thank you very much.
I want to begin by thanking the committee for the opportunity to appear before you on behalf of the Canadian Medical Association. The CMA also submitted a brief to the committee.
On behalf of the 76,000 doctors represented by the CMA, and the millions of Canadians they serve, I have one message for you today. As members of Parliament, you are among our country's leaders. At a time like this, when Canadians are facing what is nothing less than a national crisis, they look to you and your peers in legislatures across the country to exercise that leadership and live up to the trust that has been placed in you.
At the risk of sounding harsh, the early finger pointing between governments was anything but a demonstration of leadership. Since then, I believe there has been progress. Recently, the federal government announced that it would open its stocks of medicines to provinces experiencing shortages. While I'm not sure of the types of drugs this would cover, or what the process involves, it is nonetheless a step in the right direction.
Also encouraging is the fact that Health Canada has fast-tracked approvals of alternative drugs, but I am disappointed that the focus of the generic and brand-name pharmaceutical companies has been on providing information on drug shortages. Information about the problem of drug shortages is no substitute for fixing the problem of drug shortages.
I'm going to take a moment now to identify the impact of these drug shortages and the lack of information surrounding them on physicians and the patients we care for.
Clinical treatment is interrupted, putting patients at risk of relapse and worse. Surgeries are cancelled, leading at best to delays and at worst to a real deterioration in the health of those patients forced to wait.
Sometimes there are no alternative drugs, or the alternative is not covered by insurance. Sometimes people simply can't afford the new medication. Whatever the reason, when an appropriate alternative therapy is not available, sick people must go without.
As all drugs have risks, there is a risk of side effects from alternatives. Further, the alternative might not work as well as the drug originally prescribed, and it's even possible that the alternative is a drug that has been tried before without success.
Changes in the timing and dose of medications can be confusing, particularly for those on long-term therapy or those for whom learning a new regimen is difficult.
Finally, all medications being taken by a patient must be reviewed for potentially harmful interactions with any new medication. This might require blood tests or trials of dosage that will further delay treatment. Any of these situations can harm our patients and do damage to their health, particularly in the case of patients with complex problems.
At the CMA, patient organizations are telling us about the anxiety, pain, and harm that drug shortages are inflicting on patients. I committed to some of those patient organizations that couldn't join us to share their experience with you.
Allow me to read excerpts from a few messages we have received.
The Brain Injury Association of Canada told us, and I quote:
Any drug medication shortage endangers Canadian patients. In the brain injury community, anti-depressants are prescribed to some, as is pain medication, so if there is a shortage some members in the community will be endangered even if the medication is altered.
The interim president of the Canadian Arthritis Patient Alliance, Louise Bergeron, wrote to us:
Actually, I have had this happen to me on three occasions and it is quite scary when you know you will not have access to certain drugs for an extended period of time, since you know your health will be on the line.
Sharon Baxter, executive director of the Canadian Hospice Palliative Care Association, says:
All are encouraging the government to find a solution very quickly as pain medication at the end of life is essential and urgent. I don't think we are at the stage where people are dying without access, but getting to that end is totally unacceptable in a country like Canada.
Shortages also lead to an increase in the consumption of health care resources because of the need for additional monitoring and multiple consultations among health care providers, including physicians and/or emergency room visits. To put it bluntly, while doctors are trying to source medications or alternatives for drugs that should be readily available to patients, other patients have to wait longer to be seen and cared for.
Last but not least is the greater cost to our economy. Healthy citizens are productive citizens, contributing to their families and communities and to our country's economic prosperity. How can it make sense from an economic standpoint to have people ill and off the job because of a lack of access to medically necessary therapies?
In order to deliver the best possible care to patients, physicians require timely, comprehensive, and accurate information about current and anticipated drug supply shocks and constraints. More to the point, our country requires an uninterrupted supply of medically necessary medication for patients—period, full stop.
With that objective in mind, we have provided input to government and to the pharmaceutical industries. As health care providers we must have a monitoring and early notification system for pharmacies and physicians, and there must also be a proactive, systematic mechanism to prevent interruptions in the provision of medically necessary medications to our patients.
In a survey of physicians conducted by the CMA in January of 2011, two-thirds of respondents said the shortage of generic drugs had negative consequences for their patients and practices. The gap between what we have in Canada and what we need is even more clearly evidenced by the current shortfall of injectable drugs.
We recognize that other countries are also grappling with drug shortages. We've noted with interest that President Obama signed an executive order last fall directing the Food and Drug Administration “to take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines”.
The CMA encourages the Government of Canada to consider every lever available, including the economic inducements it provides to the pharmaceutical industry, to ensure Canadians are assured of an uninterrupted supply of medically necessary drugs. Drug shortages are a serious and escalating problem, one that needs to be fixed and one that Canadians expect their elected representatives to act upon.
The bottom line is that the pharmaceutical industry itself must resolve its supply challenges. My responsibility as a physician is to provide care; theirs is to make sure we have the medications we need for our patients when they need them.
Thank you for the opportunity to come before you regarding this very important issue. I would be happy to answer your questions.
First of all, Madam Chair, thank you very much for the invitation to come here and discuss some of the issues.
Our coalition is an alliance of 27 health charities and individuals who are advocating for better health care around access to medications, including the drug shortages and safety and supply.
I just want to touch base, so you get the context. Our submission is available through bestmedicines.ca, if you don't already have it and for those others who are listening.
We cover chronic illness for as many as 20 million Canadians. This is a huge number, and I just need you to listen to some of the diseases we cover: arthritis, asthma, breast cancer, epilepsy, hemophilia, pain, skin disease, intestinal—which I represent with gastrointestinal—and liver disease. Other coalitions are also members of our coalition, so we kind of stand as the figurehead across the country. There are coalitions within Alberta and British Columbia that also represent a whole number of other disease areas. We also have kidney cancer, lymphoma, ovarian cancer, and Tourette's, just to cover off some of the core illnesses.
We really are here to just remind everyone that the object of the exercise here is patients. If we didn't have patients, we wouldn't need drugs, and drugs are clearly what we're talking about today. We're looking to the government to take a role in that, a very active leadership role. We're looking for an in-depth study on what really went wrong and solutions. But in saying that we're looking for the government to take a leadership role, we're asking, please, for patients to be at the table, because if you don't get feedback, that intrinsic natural kind of feedback from the actual end users of a product, then you're probably missing a huge piece of the information you need.
So we're asking to be there all the way along, from figuring out what went wrong to looking at possible solutions, and we're looking for pragmatic solutions because we're patients and we want it to work. We don't want to look at lots of regulations and things like that. We want something that's going to be working and will pay attention.
The drug shortage issue is not just a recent issue. In gastrointestinal disease, we had this issue in 2006, 2009, and again recently. It is an issue that keeps coming up, and it has obviously come to a head because it has affected perhaps more groups recently, but it is really a critical thing.
We are absolutely looking for patient involvement. We have a couple of examples in our submission, but we actually have way more than what is in our submission. I just want to take a minute and ask my colleague, Suzanne, if it's okay with the chair, to give one example of epilepsy.
Can we switch and allow my colleague to say something at this point?
I also am a member of the Best Medicines Coalition, and I'm also here today as a representative of the Canadian Epilepsy Alliance.
I'm going to describe, just as an example, what's been happening in the field of epilepsy as a result of drug shortages.
People with chronic medical conditions such as epilepsy require consistent access to medications.
Epilepsy is a chronic neurological disorder that's characterized by recurrent seizures. The main treatment for epilepsy is anti-epileptic drugs, or AEDs, and they must be taken daily to prevent recurrent seizures. When AEDs are stopped or changed abruptly, recurrent seizures can be more severe or more prolonged than previous seizures. Prolonged seizures lasting more than five minutes are a medical emergency and can be life-threatening.
Between late 2009 and now, there have been shortages of at least five different AEDs, and that's a conservative estimate. Some of these medications are manufactured by a single pharmaceutical company. The AED shortages have led to some people being switched to a different formulation, if there is one available, or being switched cold turkey to an alternate drug. It's actually not known if there have been other people affected by a shortage who have simply stopped taking their medication without seeking medical care.
Some people switched to an alternate AED have experienced episodes of prolonged seizures, which are life-threatening. Physicians who specialize in epilepsy have reported that they have had patients with previously good seizure control experience breakthrough seizures as a result of drug shortages.
Even if people have enough medication on hand to see them through a shortage or are able find a pharmacy that still has some stock of their drug, there is a tremendous amount of stress, because people are not sure they are going to have enough drug to last them through the shortage. They are concerned that they will run out.
People with good seizure control have worried about the potential impact of breakthrough seizures on their health and also on their independence, because they could result in the loss of a driver's licence. And unfortunately, for some people, it could result in the loss of their careers.
Parents, spouses, and other family members have been very concerned about the safety of their loved ones.
People have been extremely frustrated and upset by the lack of information about drug shortages. Individuals affected by shortages do not have a place to go for general information pertaining to drug shortages, for information about specific drugs, or for advice on what they should do. Some people have had very good support from their health care providers and/or their pharmacists, but they still seek an authority on drug shortages for additional information.
Many people with epilepsy who have been affected by drug shortages are initially shocked when they find that their drug is not available. They are often very angry when or if they find out that there is no regulation to ensure supply. And they are desperate to see their drug back on pharmacy shelves.
If the committee has questions later, I have examples of individual patient situations.
In summarizing, what we're saying here are three clear things. First, patients need to be involved all along the way. Second, we're looking for the government to take leadership in an investigation as to what happened. Third, we want to know how we can come up with some really workable solutions, and we'd love to be a part of that.
One of the things we'd just like to put out there today is a premise that the approval to market a drug should include an obligation to have a consistent supply of that drug. For us it means a lot. We know there's a commercial enterprise out there looking at all these things that way. It really doesn't matter to us who's making money in health care as long as the patient's needs are met, and are met consistently, and that the physicians who are caring for the patients have all the tools they need to make sure it works for patients.
Again, we have a lot of examples of things that have gone wrong and where they've gone wrong. I think this committee clearly understands that things have gone wrong, and we don't have to dwell on that right now.
We're looking to the future, and we are hoping we can come up with something very quickly to resolve it. We don't think it's just a current issue; it's been an ongoing issue. We are concerned about putting all our eggs in one basket, which speaks to the idea of getting bulk medications from one source. It is problematic, no matter who takes it on.
I think we'll stop at that point. Thank you very much.
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.
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.
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.
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.
If I may respond, that group, the working party that sent the letter....
You're right. Events have overtaken us. The bottom line with that group is quite simply that we were there to provide the health care provider and the patient's perspective to a group that did not have that mix, quite frankly.
We're agnostic on the subject of whether you want to legislate a fix to this, or have a voluntary mechanism, or you want to use economic levers. I really don't mind. One could almost say I really don't care, as long as the end result is security of drug supply.
In terms of what I know about the issues of drug shortages, quite frankly, we rely on the drug companies to tell us. That system, to call on my teenage daughter's phrase, sucks. It really does not work. The lists of supply are incomplete, there are gaps there in drugs that I know have been in short supply for two or three years, and they're still not there on what is allegedly up to date.
They are a poll system, which means in my terminology you actually have to go there every day and spend time going through this shopping list of medications. There are often no alternatives listed. It's simply a rudimentary system, and quite frankly, we cannot find out from the manufacturers, be they generic or branded, what these shortages are and how long they're going to last with any accuracy.
We are in the position the patients are in, one of complete ignorance.
Yes, we have to try to explain it to our patients, but we're the middleman. We're stuck in the middle. I would suggest that as an answer to your question.
We are not trying to place the blame here, but rather to find solutions. Across Canada, the responsibility for this complex mechanism is shared by federal and provincial entities.
We have a many ties with European countries. As my colleague from the Association des pharmaciens des établissements de santé said, this is a global issue. I went to the same congress organized by the International Pharmaceutical Federation, and I can confirm that statement. So, it is not a matter of feeling more or less guilty, but rather of asking ourselves what needs to be done so that Canadians can have proper access to their medications.
So, various aspects are involved. The government is responsible for approvals. We met with Sandoz officials. That company has 37 factories abroad, but very few of them can produce injectable medications. Therefore, Sandoz was really limited to one or two close factories that could offset that deficiency here.
The only organization that can recommend expediting the approval for importing drugs from other international pharmaceutical companies is Health Canada.
That said, there are some province-wide responsibilities involved. Incidentally, we have a long list of responsibilities in our report we will present in two weeks; there are some adjustments. However, since we are here before you today and you are open enough to welcome us, we have made our objectives and requests specific to the federal government.
Other countries have some more explicit requirements, and that is the second point: the industry should really inform the authorities when it receives a notice of non-compliance and when it anticipates a stoppage—at times voluntarily—in the production of certain medications. That is its choice. We cannot stop the industry from doing that. A very exceptional measure must be involved, but when the industry decides to stop production, we must allow it and we must find other international pharmaceutical industries ready to produce those medications. That information is currently missing.
Thank you very much, Madam Chair.
I want to thank all the witnesses here today for your input on this very important topic. I want you to know as well that quite often we share your frustrations with the way Canada's health care system works. You mentioned internationally the example of New Zealand—I think it was brought up—where they have one national system, so that a lot of things can be input.
But I think that saying where these silos are is just a question of where you want to draw the lines. As far as the delivery of health care in Canada is concerned, the reality is that it is a provincial jurisdiction. The provinces are responsible for delivering this health care.
One thing that I think is important to get on the record is—I think, Madam Attara, you brought it up—about piggy-backing. Health Canada does have a role. What we do is look at the safety and the efficacy of the drugs that are on the market, and we test for these.
Right now, just to give you an update, we've had submissions from other companies—17 recent submissions—and have already approved seven. With the SAP program, there were 61 applications received recently; in the last couple of weeks, 39 have been approved.
In our role, whether the drug is coming from the U.K., whether it's coming from the United States, what we do is approve how safe it is and whether, where it was manufactured, there are good manufacturing practices that are effective. Then we permit the provinces to go shopping with that approval.
That's one of the frustrations, and I want to ask you this. If you were a health minister, or if you were in one of these buying groups, first of all, would you sole-source a drug that is deemed to be medically necessary or essential? Is that the way you would do it?
Thank you, Madam Chair.
I want to thank all the witnesses. Your comments are somewhat reassuring, but they also call for government involvement.
I was rather confused and concerned when Dr. Leitch said that the federal government had no responsibility regarding this issue, even though you all agree that it is a matter of public health. This morning on Radio-Canada, the Association médicale du Québec, Quebec's medical association, and the Fédération des médecins spécialistes du Québec, Quebec's federation of medical specialists, said that the federal government should get involved. All of you agree with that.
As has been said here, the regulations on drug safety, effectiveness and quality fall under federal jurisdiction. Suppliers must be approved, and that also comes under federal jurisdiction. It is being said that drugs are produced abroad and that shortages are an issue. I believe it was you, Ms. Lamarre, who said that, since 2006, shortages have quadrupled. The situation is serious. Something must be done. Patients are the ones caught in the middle of this.
I would like to know whether you feel that a security clause should be included in supply contracts to ensure that alternatives are always available. That echoes what the Canadian cancer association suggested before this committee last Tuesday. Ms. Attara talked about a Canada-wide guide for patients and doctors. That would make it possible to obtain the information in a consistent manner and to react to those issues.
I would first like to hear from Ms. Lamarre, and then from Ms. Attara.
We are convinced that a mandatory system is necessary, because there is the issue of the ability to respond to these shortages as well as the required response time. We are seeing that right now. Findings have been made. At the end of the day, the Sandoz case brings to light all the problems, all the causes and all the consequences. It is an unfortunate situation, but it still gives us an opportunity to learn and respond.
These considerations must be recognized. A mandatory system is needed, because every minute counts. Sandoz was notified in November, and the warning was issued in February. I am not trying to single out Sandoz, but I want it to serve as an example for us, just as health professionals would learn from a patient's case.
There was a three-month window when they could have responded. The lack of a mandatory requirement made us more vulnerable and put us at the mercy of others. Companies, even after they are given the go-ahead for production, take months to respond and adjust their production. That is key.
I have also seen that, on the American side, the FDA has managed not quite to eliminate all the shortages, but to reduce them dramatically. We are seeing that in 2010, a total of 38 shortages out of 178 were avoided. In 2011, some 195 shortages out of 250 were avoided. That is a meaningful improvement. In 2012, from January 1 to February 9, there were 18. That is significant.
We have to use these methods. We have a social responsibility toward Canadians to take all measures necessary. Various levels come into play. Certainly, there is the monitoring component and the obligation to report problems as soon as they are identified.
Sometimes, certain companies make choices. We can respect those choices, but they must be announced immediately. When you are dealing with situations that affect production increases—as in the case of Sandoz—warning must be given, and the manufacturer must have an obligation to alert authorities immediately.
Thank you, Madam Chair.
First off, I want to offer a special thanks to my colleague Anne Minh-Thu Quach for being the first member of Parliament to raise the drug shortage issue involving Sandoz in the House of Commons. I am proud to belong to a party that sees drug shortages as important and one that shows leadership.
Ms. Quach then addressed a question to the , Mr. Carrie. He replied that he would see to it that the appropriate information was provided to the right people at the right time and that, as a result, doctors, pharmacists and patients would be informed of what was happening with enough advance notice to adjust treatments if need be. That was his reply. If I go by that, I am inclined to think that the government is showing leadership, although everything you have said suggests that the federal Conservative government has failed to show any leadership in this matter.
Furthermore, Ms. Lamarre, I was quite struck by something you said: between 2006 and 2010, shortages had quadrupled. You even said the most recent shortage was widespread. That is disturbing, indeed.
I want to pick up on what my colleague Libby Davies pointed out. In 2008, the industry minister, Tony Clement, was made aware through a report by the Competition Bureau. In 2011, the Canadian Anesthesiologists' Society also contacted the , Ms. Aglukkaq, who has been on the job for four years. Unfortunately, raising the matter with cabinet or even Ms. Aglukkaq's office does not do any good. I agree with you, the government is failing to show leadership on this issue, and I find that appalling.
What's more, as Dr. Haggie mentioned, the current government prefers to point the finger at the provinces. Ms. Leitch, a Conservative member, repeated that position today. She blamed health professionals for not monitoring the situation, and the provinces, saying it was their problem.
What it boils down to, in my opinion—and I would like Dr. Haggie to comment on this—is a lack of leadership by the federal government and a passing of the buck to the provinces. It is already common knowledge that there is a doctor shortage in the provinces, at least in Quebec, and given the scarce drug supply, some treatments and surgeries are being delayed. Provincial wait times to see a doctor and receive treatment for a variety of conditions will increase. So that will be the provinces' problem, not the Government of Canada's. I am appalled by this lack of leadership. I want to hear your thoughts, Dr. Haggie, on what I just said.
Looking at it from a patient's perspective, they don't have a grasp of the niceties of jurisdictional disputes. They really don't understand how it is that the drugs they get actually get to them. To be perfectly honest, before these last few weeks, I was pretty well completely ignorant as well. I'm not sure I'm any wiser now, because what this whole exercise has highlighted to me is that there isn't a seamless approach to health care. There isn't a seamless approach to the issue of pharmaceuticals.
You could almost argue that pharmaceuticals now are the defining modality of medical management. When I trained, we were on the end of fixing things surgically. Diseases I treated with a knife, as a resident, are now treated medically, for the benefit of the vast majority of patients. Drugs are no longer just one of those things that are there as an optional extra.
I turn it back from the patient's point of view and say that the constitutional debate, the funding debate, the financing debate between health boards, provinces, and the national group has not informed them. It has not made them feel comfortable. It has not made them feel as though things are moving in the right direction. Finger pointing and blame....
You need to learn from case studies, and where you stand on that depends on where you sit, quite frankly.
As Rick Hillier, another Newfoundlander, said, no good crisis should go to waste. The one good thing that could come out of this is that we can do it a hell of a lot better next time and we won't end up in this pickle in the future. If that requires that the feds and the provinces and the territories sit down together and actually talk to each other, is that such a bad thing?
Our examination of shortages—which we had already begun a year ago—revealed that more than 43% of shortages had to do with manufacturing quality, so products that did not meet either Health Canada or FDA standards. So there is a significant responsibility at all levels.
The current crisis has prompted us to adopt a different outlook, one where we do not point the finger at those who came before. When we saw shortages in the early 2000s, they did not last long, generally speaking. Now, they are longer. We are being told they will last three or six months. That is a new reality.
Legislation is adapted in response to new needs of patients and the public, and new problems. We are facing a new problem. Thirty years ago, no one would have ever thought there would be a need for legislation on counterfeit drugs or Internet pharmacies. But that is where we are heading, where countries all over the world are heading.
The drug shortage problem falls in that same category. It is a global problem whose repercussions have not necessarily been felt, a problem caused by globalization, the worldwide concentration of the pharmaceutical industry—both ingredient suppliers and drug manufacturers—and distribution methods, among other things. As you can see, all those areas need to be addressed.
Clearly, we have certain needs that have yet to be met. We used to rely solely on the good faith of organizations, which did not necessarily act in bad faith. They were simply caught in a historical context that dictated a certain way of doing things. It is now time to realize that we must do things differently. And to make these organizations do things differently, legislation is needed, because this is an area where people want to protect certain markets, or could eventually do so.