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
March 29th, 2012 / 8:50 a.m.
The Chair Joy Smith
Good morning to you, and welcome to the health committee.
I want to make a special welcome to our witnesses who've taken the time and effort to get here. You think we don't notice who you are or what you say sometimes, because you see us talking, but we do. We meticulously go over everything you say and we value everything you say.
Libby Davies Vancouver East, BC
Madam Chair, I have a point of order.
The Chair Joy Smith
Already, Madam Davies? Okay, go ahead.
Libby Davies Vancouver East, BC
Just very briefly, I notice we actually haven't had a motion to make sure that the study we're doing on drug shortages, which is very important, is reported to the House. So I have a motion that in relation to its study of the role of government and industry in determining drug—
The Chair Joy Smith
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.
Dr. Richard Chisholm President, Canadian Anesthesiologists' Society
Thank you very much.
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.
The Chair Joy Smith
Dr. Chisholm, you made a very profound presentation. I want to thank you for that. We heard it loudly and clearly.
We're going to listen to our other witnesses, and after that we'll have a question and answer period, so I hope you can stay for that. Can you? Thank you, Doctor.
President, Canadian Anesthesiologists' Society
Thank you very much.
The Chair Joy Smith
We'll now go to the Canadian Medical Association, with Dr. Haggie.
Dr. John Haggie President, Canadian Medical Association
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.
The Chair Joy Smith
Thank you so much, Dr. Haggie. We appreciate your testimony today.
We're now going to the Best Medicines Coalition. Ms. Attara is the one who's going to give the presentation.
Could you begin, please? Thank you.
Gail Attara Chair of Operations Committee, President and Chief Executive Officer, Gastrointestinal Society, Best Medicines Coalition
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?
The Chair Joy Smith
Suzanne Nurse Representative, Best Medicines Coalition
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.
Chair of Operations Committee, President and Chief Executive Officer, Gastrointestinal Society, Best Medicines Coalition
Thanks for that.
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.