:
I call this meeting to order.
Welcome to meeting number 42 of the House of Commons Standing Committee on Health.
Today we meet for two hours with witnesses on our study of over-the-counter pediatric medication.
I see that we have a couple of members participating online who are well aware of the procedures and the fact that the hybrid format is permitted pursuant to the House order of June 23, 2022.
We're going to get right into welcoming the witnesses. We have a panel in front of us today who are quite familiar with the committee, as we are with them.
We have Dr. Stephen Lucas, deputy minister of Health Canada; Dr. Supriya Sharma, chief medical advisor and senior medical advisor in the health products and food branch; Stefania Trombetti, assistant deputy minister, regulatory operations and enforcement branch; Linsey Hollett, director general, health product compliance; and Dr. Kim Godard, director, health product inspection and licensing division, regulatory operations and enforcement branch.
Thank you all for being with us here today.
I understand that Dr. Lucas is going to lead us off.
You have up to five minutes, Doctor. Welcome to the committee. Thanks for being here. You have the floor.
Good morning, and thank you for the opportunity to appear before the Standing Committee on Health today to participate in the discussion on the availability of non-prescription analgesics for infants and children.
As you noted, I am joined by a number of colleagues from Health Canada. They are Dr. Supriya Sharma, Stefania Trombetti, Linsey Hollett and Kim Godard, who will work with me to respond to your questions.
[Translation]
First, I want to emphasize that the shortage of pediatric analgesics is a top priority for Health Canada, and all efforts are being taken to resolve this shortage.
[English]
We share the concerns of everyone in Canada touched by this shortage. We also understand the impact that it is having on children in need of these medications and the stress it has created for parents and caregivers.
With the time that I have for my opening remarks, I would like to share with the committee a quick snapshot of the work that Health Canada has been undertaking to mitigate the effects of this shortage.
Drug shortages are a complex and multi-faceted issue with a range of stakeholders having roles to play. Mitigating and resolving drug shortages require a collective effort of many players. Health Canada’s experience in managing shortages, the regulatory tools at its disposal and well-developed government-to-government networks and stakeholder relationships have provided Canada with a solid foundation to address shortages.
In regard to pediatric analgesics, Health Canada has been actively engaging in bringing together manufacturers, distributors, retailers, provinces and territories, children’s hospitals, the Canadian Pharmacists Association, and industry associations and health care practitioners, including the Canadian Paediatric Society, to assess demand, assess the options for expanding supply and implement measures to limit the effects of the shortage. Our engagement has been constant over many months, with daily interactions with key stakeholders over the last number of months.
Companies who supply the Canadian market, be they large or small, have ramped up their supply. Some manufacturers are now producing these products at record levels in Canada; however, demand continues to outpace supply. Health Canada is using other tools at its disposal to increase the supply, including facilitating the importation of foreign products.
When Health Canada first became aware of supply constraints for these products in the spring, we reached out to the suppliers and made it clear that regulatory flexibilities to permit the exceptional importation of foreign product were available and could be used to increase the supply coming into Canada.
With the information available at that time, the mitigation approach adopted by suppliers was to ramp up domestic production. The department continued to engage multiple players in the supply chain over the following months, but by late summer the unprecedented spike in demand made clear that ramping up production would not be sufficient. Again, the department sought proposals from market authorization holders for the importation and sale of foreign-authorized supply.
In a statement released yesterday by Health Canada, we advised Canadians that we have secured foreign supply of children’s acetaminophen that will be available for sale at retail and in community pharmacies in the coming weeks. The amount to be imported will increase supply available to consumers and will help address the immediate situation. To further increase supply, Health Canada has also approved the exceptional importation of infant and children’s ibuprofen and acetaminophen to supply hospitals in Canada. The importation of ibuprofen has occurred, and distribution has begun.
Each proposal received from a company to import a foreign-authorized product undergoes careful review by Health Canada to confirm that the product was manufactured according to standards of safety, quality and efficacy that are comparable to those for all drug products approved for use in Canada.
[Translation]
For foreign supply of children's analgesics, in addition to meeting the required safety standards, information related to cautions and warnings, dosing directions, ingredients, and other important details will be made available in both English and French to ensure parents and caregivers clearly understand what medication they are using and how to give it to their children.
As foreign product generally does not have important safety information available in both official languages, Health Canada works to ensure this is not an impediment to importation.
[English]
When this involves products at a retail level, this can be done, for example, by providing and visibly posting a QR code, website information and paper printouts in community pharmacies and retail stores where the safety information can be accessed.
Health Canada is continuing to work alongside suppliers to facilitate more product coming into Canada to fill the supply needs. We know that companies are continuing to produce at record levels to meet the needs of Canadians.
In addition, through the exercise of regulatory flexibility, Health Canada has facilitated greater access to these needed medications by temporarily allowing the sale of compounded acetaminophen or ibuprofen without a prescription. Regulations on the safety and quality of these products continue to apply. This measure will be in place until the shortage is resolved.
I will conclude by reaffirming that addressing this issue is a top priority for Health Canada. All possible efforts are being made to mitigate the shortage of pediatric analgesics. The health and well-being of infants and children has been and remains our highest priority. Health Canada has been actively engaged since observing early signals of a potential shortage. We have and will continue to dedicate significant resources to resolving the shortage. As I've noted, we have mobilized, convened and worked with all the players involved to address it as quickly as possible and on a sustained basis over many months.
We will continue to communicate with Canadians, including through the dedicated pediatric analgesics information on our website.
[Translation]
We look forward to today's discussion and will be happy to answer any questions that committee members may have.
[English]
Thank you, Mr. Chair.
:
You're correct. The drugshortagescanada.ca website is a very transparent way to see what drugs are in shortage.
I'll put that into perspective. You're correct that there are other pediatric drugs that are currently in shortage. That does not necessarily mean that there will be a stock outage. At this point, there are about 800 drugs in shortage in Canada. To put that into further perspective, with regard to those that reach the national critical level, at this point we have 22. On a regular basis, we do manage these shortages successfully.
On the other two you mentioned, azithromycin and amoxicillin, when we receive signals, we take them seriously. We look to understand what the situation is with the suppliers, what the supply looks like, what the demand looks like, what the reason for the shortage is and what the anticipated end date of the shortage is. We always look at how we can manage supply that exists and how we can shore up that supply. In some cases, manufacturers are able to ramp up supply or bring in supply that is manufactured in other markets.
I'll speak about one example because you asked about examples.
Caffeine citrate, for example, is another drug that you'll see on that list that is currently at a national critical level. It's used to treat infants and newborns with apnea. In that situation, we have been able to understand early in the shortage what the supply gaps will be and to work with manufacturers to make sure that we have supply coming in that will fill those supply gaps before they are even felt.
:
Well, as you may or may not know, I'm a doctor. I still work a little bit in medicine. Before going into politics, I was an emergency room doctor in Thunder Bay for about 18 years.
I have to say that I kind of disagree with you when you say that Canada has a history of managing drug shortages successfully and that we have a foundation for addressing drug shortages. It didn't start with the Liberal government. I was working in an emergency room from 2003 or 2004 in Canada, and in the hospital we were constantly undergoing shortages, often of important drugs like etomidate, which you need for rapid sequence induction in the emergency room. At times we were out of IV Levaquin, which is the primary go-to drug with community-acquired pneumonia. We were out of pediatric bicarbonate, which is just baking soda and water, and Stemetil, which is, and continues to be, the best IV drug to treat migraines. We haven't been able to get that in Canada for years. This was constantly a source of frustration for me in the emergency room, and I don't blame it all on the federal government. The hospital wasn't interested in addressing this issue. They'd just tell us, “Well, we're out of the drug.”
My understanding of the regulatory process, especially for drugs that are off-patent, is that it's rather onerous. There are a lot of hurdles you have to clear. You have to get a drug product licence and you also have to have an establishment licence. My understanding is that it's easier to import drugs from countries where we have a shared good manufacturing process, but especially with drugs that are off-patent, my understanding is that the profit margin is fairly small, and if, for instance, an Indian or Chinese company wants to get that product into the market in Canada, it has to go through all these hurdles, which are fairly onerous. Given that often the profit margin for some of these drugs is small—that isn't the case for acetaminophen, for which there's a big market—and the market is much more limited and the regulatory process is complex, they don't want to do it, and that's why these products aren't getting to the market in Canada.
That's certainly how I, as a doctor, perceive the problem. I don't know whether that's Health Canada's perception of the problem. As an emergency room doctor, I was really frigging frustrated with constantly having this process with drugs, so how can we address this problem?
:
Mr. Chair, I will start by indicating that Health Canada has taken and continues to take the issue of drug shortages very seriously. We have certainly seen the challenges increase over the past decade. The challenges are of a global nature with supply chains. In some cases, the active pharmaceutical ingredient is coming from just a single supplier. We've been working domestically to strengthen our capability in Health Canada—with Stefania's team and with colleagues here—to have a focused organizational unit and task force working to address it.
There has also been work globally, and Stefania co-chairs an international group of regulators looking at this issue. Certainly, as we saw in the pandemic, the importance of supporting domestic biomanufacturing is a critical priority and one in which the government has invested significantly to attract and support businesses and develop manufacturing operations in Canada.
We routinely work with—and we recently updated, in 2021—regulatory authorities to further facilitate addressing drug shortages. My colleagues can speak to that. As Stefania said, at any point in time we could be having supply challenges with 10% to 15% of drugs, but we work actively with multiple suppliers to avoid, to the greatest extent possible, those having impacts at the clinician and importantly at the patient and care provider/parent level.
As well, we have worked to look at novel ways of addressing it, including, during the pandemic, by establishing a critical drug reserve with provinces and territories.
We are fully engaged in addressing this and in using regulatory flexibilities to help ensure that Canadians get the supply of drugs they need.
The manufacture of pharmaceuticals is absolutely global. It's not unusual to have a pharmaceutical where the active pharmaceutical ingredient comes from one country, the first part of manufacturing happens in another country and then maybe packaging and labelling happens in another country before it would come to the country in which it's sold. That's why it's really important that we have harmonized international standards to make sure that regardless of where those ingredients come from or where the finished drug product comes, they meet the standards for safety, efficacy and quality in Canada.
That's the case no matter where it's manufactured. An incredible amount of work goes on internationally on standards for the places where the manufacturing is happening, through what we call “good manufacturing practices”. That's basically the same everywhere in the world.
As well, there's a lot of work on harmonization of the technical standards of how those medications are looked at. A group called the International Council on Harmonisation involves multiple countries from around the world, along with industry, to put together those technical standards.
Again, because of the global nature, it's really important that we have harmonization and can rely on those medications being safe and effective and of high quality.
:
I want to say something first and then my colleague Ms. Trombetti can answer your question in more detail.
First, there are factors that are unique to Canada. For example, demand has grown much more significantly in Canada, compared to other countries. The increase in demand started in August and has been going on since then.
There are also shortages of drugs elsewhere, such as Adderall in the U.S., that don't exist in Canada right now. So there are challenges in every jurisdiction.
As I said, there are factors today that are unique to Canada, particularly the fact that, for some products, demand has doubled, or even quadrupled.
What is Health Canada's obligation to communicate? There has been a shortage since the spring, and it took the Conservatives tabling a motion in our committee to try to find out what is going on. Despite that, we haven't had any data.
Since you are talking about supply and demand, I will use the example of the announcements that have been made this week on amoxicillin. What I'm hearing from the manufacturers and the people who trade in it is that it has created a panic among parents. In the last few days, the quantities of this drug that have had to be ordered are unprecedented.
What I understand from this, at least as an economist who has contacted the industry, is that the communications from Health Canada are so bad that people learn the bad news at the last minute and panic. You are part of the problem right now. You're contributing to the panic among parents and the abnormal increase in demand, which makes the shortage worse.
I have been paying attention to what the has said since the spring. He has said, among other things, that health funding is futile. Whatever else he has said, he has never alerted Canadians and families. He never reassured them and never explained the processes.
Do you have a job to do communicating with Canadians, or do we really need to drag you in front of a committee, like today, to make you talk?
Through you, Chair, if I could, we're talking about transparency here, and I'm finding it exceedingly difficult to get a transparent answer. Now we're blaming the parents by saying that we didn't want to talk about this to Canadians because we were concerned the parents might buy some more acetaminophen and ibuprofen. That, in my mind, would be almost victim blaming.
Good communication comes down to asking what our plan is. It would occur to me very clearly that the minister was not involved in this for a very, very long time, which is shameful, and that Health Canada had a very, very poor plan in place here, not to mention that I would suggest we should have anticipated that there might be a surge in the fall of the year and taken it much more seriously in April. I think that's shameful.
The second part of that would be that it's exceedingly important to rebuild the trust of Canadians. Part of that is not standing behind the fact that we can't share how many doses are coming, when they're going to get here or when they're going to be distributed. That would be an essential part of the plan of transparency to reassure Canadian parents that you're doing something. To me, standing over there and sitting over there and continuing to refuse to do that is absolutely unconscionable.
I guess my question would be, then, what are you going to do about that? How are you going to reassure Canadian parents that you've done something and that these medications that are essential are going to be on the shelves?
We do have a much bigger and looming problem, which we'll have to bring you back for, because clearly you don't appear to have the competence to do it yourselves. We're going to have to bring you back to talk about amoxicillin and azithromycin as we move into the fall and winter season.
That's a big question. Fill your boots.
:
Mr. Chair, I and Dr. Sharma and perhaps other witnesses will respond, given the range of points that were made.
I will start by indicating, as I noted, that Health Canada, from the earliest indication of potential shortages in the spring, actively engaged manufacturers, of which there are about a dozen supporting the Canadian market, provinces and territories, children's hospitals, pharmacies, retail networks, pharmacists and pediatricians.
We continued to do that encouraging through the spring, based on our plan to increase domestic supply, which happened and is now at record levels. We have given throughout that time the opportunity to import available foreign product as an option, for which we have the regulatory tools, and indeed are now doing just that. We are importing foreign product to address that shortage for Canadians.
We have communicated with Canadians. I'll turn to Dr. Sharma to describe that. As I've explained, we have a drug shortages task force in place and a dedicated team, and we've worked to resolve literally hundreds of drug shortages every year so that there is no impact or visibility to patients. We transparently reported through our drug shortages website and have communicated with a range of stakeholders across the country to address this situation.
A very significant amount of work goes to protect the health and safety of Canadians, and for infants and children there has been a very focused effort since the spring.
I'll turn to Dr. Sharma now to speak to communication, including that which she has participated in to support information for Canadians both directly from Health Canada and through key partners, including pediatricians.
First we would say that we feel for parents and caregivers. Being parents of young children is a difficult enough job. To try to figure out how to source medications to treat them for pain or fever is just adding to the stress. We're obviously dealing with situations with respiratory viruses now, so we understand that it's really challenging.
Health Canada's role really is a convening function to bring people together to make sure we're sharing information. In terms of Health Canada communications, as soon as we got a proposal from manufacturers to allow additional product to come in and that was approved, we communicated. Before that, we worked through our groups, like the Canadian Paediatric Society and the Pharmacists Association, to figure out what should be communicated to patients and who would be best placed to provide that information. When it's advice to parents about what to do about dosing and alternatives, it really is best placed coming from practitioners and people who are doing the health care delivery.
Certainly we can provide additional information about the communication that we did in Health Canada. Really it was a focus on what Canadians needed to know and who was best placed to provide that information to help them through this shortage situation.
:
I have nothing to add to what we look at, but I can address your question around official languages.
When we are looking at a shortage situation, our number one priority is to make sure that critical safety information gets to all the people of Canada in the language of their choice. That is why, when we have a shortage situation, the preference is always to use Canadian-authorized product to address the situation, since by law all information will be in English and French. However, when we have to consider foreign product, as Stefania mentioned, through that process, if the product coming in will not be labelled and contain all of the information in both languages, as Canadian product would, we look at how can we still ensure that the critical information is available to everyone in the language of their choice, English or French.
What we do there is look at a myriad of options. If product is going to hospitals then every unit or every shipment going to a hospital will have information in English and French.
In the situation we're talking about here, which is that there's also product on store shelves, we have multiple options to choose from, and we can implement some or all. When you purchase at a store, you can be given bilingual information. There can be signage on the shelf, a bar code or a code to scan, and as the deputy minister mentioned earlier, there's making sure on public-facing websites that information is available in all languages. When we work with companies with 1-800 numbers or help lines, we make sure that those are serviced in both official languages.
Earlier, my colleague Dr. Powlowski talked a little bit about drug prices. I've been talking to people in the industry recently, including drug distributors. They have told me that Canadian drug pricing regulations may be one of the causes of shortages, particularly because drug inventories are kept low.
If I am not mistaken, there has been deflation in the cost price of drugs in recent years, that is to say that prices have fallen. In the middle of the supply chain are the distributors. Essentially, they resell the drugs at the price they paid for them, but they are paid a fixed proportion of the price.
We have been aware for several years that stocks are getting lower and lower. Therefore, if there is ever an outbreak of respiratory viruses and demand peaks and there is a panic, such as that created by poor communication from the Government of Canada, we are going to find ourselves in a situation where stocks will drop rapidly and we will have fewer drugs.
In this whole issue, what is the responsibility of Canada's drug price regulatory system, particularly with respect to inventory?
:
I call the meeting back to order.
I'd like to welcome our witnesses for the second panel.
I have just a few comments for the benefit of the new witnesses, specifically Dr. Ahmed, who is participating online.
Dr. Ahmed, you have interpretation on your screen. You have the choice of either floor, English or French.
For those in the room, you can use the earpiece to select the desired channel.
[Translation]
Mr. Garon, I can confirm that sound and connection tests have been carried out with Dr. Ahmed and that the sound quality is good.
[English]
I would now like to welcome our next panel of witnesses.
From the Association québécoise des distributeurs en pharmacie, we have Mr. Hugues Mousseau, director general.
From Children's Healthcare Canada, we have Emily Gruenwoldt, president and chief executive officer.
From the Critical Drugs Coalition, we have Dr. Saad Ahmed, physician, appearing by video conference from Vancouver.
Finally, from Food, Health & Consumer Products of Canada, we have Gerry Harrington, senior adviser.
Thanks to all.
Mr. Mousseau, I invite you to begin. You have five minutes for your opening statement. Welcome to the committee, sir.
[Translation]
You have the floor.
:
Thank you, Mr. Chairman.
[Translation]
Members of Parliament, thank you very much for welcoming me here today to discuss an issue as vital as the supply of medication for the children of Quebec and Canada.
My name is Hugues Mousseau and I am the director general of the Quebec Association of Pharmacy Distributors. In this capacity, I represent the distributor-wholesalers in Quebec, who provide more than 16,000 deliveries each week to all hospitals and pharmacies in the province, whether in downtown Montreal, Blanc-Sablon, the North Shore, or even the Magdalen Islands.
As Quebeckers and Canadians, we have made the choice that all our citizens have access to the medicines they need, when they need them, no matter where they live. This is no small decision for a territory with one of the lowest population densities in the world.
For nearly a year, in Quebec, demand for over-the-counter analgesics has remained at nearly double the historical demand for these drugs. Although the major manufacturers have also managed to double their supply to our distribution centres, the strength of demand is preventing us from replenishing pharmacy and warehouse shelves at this time.
In plain English, everything we receive is immediately shipped to hospitals and pharmacies. The imports recently confirmed by Health Canada are welcome, and I would like to confirm at the outset that the issue of the language of labelling on imported products is a false debate. I will come back to this a little later.
Since the drug supply chain is complex, my aim today is to give you a brief overview of its main components, and then to conclude by giving you some possible solutions to better combat drug shortages.
The starting point of the drug supply chain is provided by the active ingredient factories, mainly located in South-East Asia and Eastern Europe. The chemical compounds from these plants are shipped to the drug manufacturers, who also package and market the products.
The wholesalers I represent buy almost all of the manufactured drugs and resell them at cost to pharmacies and hospitals. The wholesalers are paid according to a model set by the provincial governments. In Quebec, this takes the form of a fixed percentage of the list price of each drug.
This funding model applies consistently regardless of the region of drug distribution and regardless of the type of drug, whether it is narcotics from secure storage, refrigerated products, or cytotoxic drugs whose handling parameters are complex and highly specific.
In fact, Quebec and Canada can count on a drug supply chain that is among the safest and most efficient in the world. This is perhaps one of the most overlooked strengths of our health care system.
Six companies manage drug distribution centres in Quebec. Our members alone represent the most important bulwark against drug shortages. With multi-week stockpiles, strategic stockpiling and a keen understanding of market dynamics, our members can continue to meet the needs of Canadians even if a supply disruption occurs upstream in the chain.
However, this bulwark is now under threat. In recent years, extreme downward pressure on drug prices and a lack of predictability regarding market conditions have weakened the drug chain, with the direct consequence of increasing the number, frequency and duration of shortages.
In fact, according to calculations made by our association, the number of prescription drug shortages has quadrupled in five years in Quebec.
Since then, the problems of price cuts and lack of predictability have been compounded by issues related to inflation and the skyrocketing cost of fuel, in addition to the ever-increasing regulatory burden. Faced with this critical situation, wholesalers will have no choice but to consider reducing the number of weeks of drug stock and reducing the frequency of deliveries to pharmacies.
If the government does not act soon, the reform of the Patented Medicine Prices Review Board and the negotiations of the pan-Canadian Pharmaceutical Alliance will lead to further reductions in the list price of drugs, thereby amplifying the shortage problem. Yet viable alternatives have been proposed to the government and the PMPRB for three years.
Let me be very clear: wholesalers are in favour of price cuts for drugs if they do not undermine supply and innovation. In fact, there is already a mechanism in place across the country called listing agreements, which is a viable alternative for achieving savings while isolating the effect on the drug supply chain and shortages.
I would like to conclude my remarks with some additional observations and suggestions in relation to the shortage of pediatric analgesics and other medicines.
In our view, three concrete solutions will better equip us to respond to shortages in the future.
First, we must put an end to successive and unpredictable price cuts by focusing on contractual and financial mechanisms other than a reduction in the list price, such as listing agreements.
Secondly, we need to stop the critical erosion of distribution funding and reinvest in our supply chain to allow wholesalers to play their full role as a bulwark against shortages.
Finally, we need to work with wholesalers to establish national stocking strategies for critical medicines with a view to optimal stock management according to expiry dates.
Thank you.
:
Good afternoon, and thank you for the return invitation.
My name is Emily Gruenwoldt, and I am the CEO of Children's Healthcare Canada and the executive director of the Pediatric Chairs of Canada.
Children's Healthcare Canada is a national association. We represent all 16 of Canada's children's hospitals as well as community hospitals, rehabilitation centres, home care, and palliative centres caring for children and youth. We have a unique systems perspective on the continuum of care for children, a population of eight million and growing. The Pediatric Chairs of Canada are the 17 department heads of the pediatric departments in our medical schools across the country.
I'm pleased today to join you to provide input on how the shortages of children's analgesics are impacting the delivery of health care within our hospital settings and exacerbating strains on emergency departments and entire hospital systems.
It's no secret that a very large number of children across this country are very sick, Whether it is influenza, RSV or even COVID-19, parents and caregivers have their hands full. Typically, these respiratory infections can be managed at home with readily available, over-the-counter pediatric medications, including acetaminophen and ibuprofen. Of course, we know these products are and have been in short supply for several weeks and months.
Parents are struggling to alleviate symptoms at home and are seeking out the assistance of their primary care teams, community pharmacies and, increasingly, emergency departments.
From coast to coast, children's hospitals in particular, but also many regional community hospitals, are experiencing historic volumes of young patients visiting their emergency departments, in part due to the lack of formulations to treat the symptoms of this perfect storm of respiratory illnesses, which shows no sign of abating.
Here's what we are seeing and hearing across the country.
At the Janeway Children's Hospital in St. John's, Newfoundland, their emergency department occupancy topped 200% over the weekend. Their hospital is operating at over 100% capacity.
In Halifax, the IWK emergency department and ICU have declared a code census, which for 14 days reflects severe overcapacity. The IWK emergency department recently registered 200 patients in one 24-hour period, setting a hospital record. Making matters worse, that same day, the IWK saw their highest-ever number of patients triaged as seriously ill and requiring admission. Last week, between 11 and 32 patients left unseen each shift.
In Montreal last week, the emergency department at CHU Sainte-Justine was operating at 300% occupancy, and at Montreal Children's Hospital, it was at 250%.
In-patient occupancy at McMaster Children's Hospital in Hamilton hit 140% on Friday, November 11.
Yesterday, SickKids Hospital reduced surgical activity to focus exclusively on emergency and urgent surgeries to create capacity for critically ill children. Half of the kids in their ICU are on a ventilator.
CHEO, our children's hospital down the street in Ottawa, announced last week that they have opened a second pediatric intensive care unit to care for the most critically ill children. As of Friday, this new ICU reported 280% occupancy.
Ontario has created capacity for most critically ill children by now decanting pediatric patients over the age of 14 to adult facilities.
In Edmonton, wait times at Stollery Children's Hospital have reached 20 hours for care.
Many of our children's hospitals across the country are now activating emergency operation centres to better manage patient access and flow. These are only a few examples, but the story is consistent. Across the country, we are seeing record numbers of children visiting emergency departments, record numbers of admissions, record acuity of patients being admitted, record waits to be admitted, record wait times for time-sensitive surgical interventions, record staff shortages and mounting public frustration.
Beyond exacerbating challenges within the emergency setting, children's and community hospitals commonly rely on analgesics prior to and after surgical interventions to manage pain and also to reduce the use of opioids and reduce the likelihood of developing chronic pain. Some children's hospitals are now evaluating whether or not they can perform essential surgical interventions based on the availability of analgesics to manage patients' care before and after surgery.
As many in the room will know, the Canadian pain task force recently published an action plan for pain management in Canada. A foremost goal was to ensure access to appropriate pain care for all Canadians. The report shared three important recommendations that are relevant to our discussions today.
First, the report shares evidence that reveals that treating pain with analgesics is not only the right thing to do, it also spares the use of opioids. From an access perspective, the report underscores a necessity to ensure appropriate pain management for our most vulnerable populations, including children. Lastly, the report speaks to the moral and financial imperative to prioritize the prevention of chronic pain, which is not only disabling for children, but creates long-term health system challenges.
I think we can agree that the current situation is both unacceptable and unsustainable. Elongated shortages of essential medicines, whether over the counter or prescription, are inexcusable in a country like Canada. While this overnight crisis in pediatrics has been actually decades in the making, there are solutions that will provide much-needed relief, even if just in the short term.
I'd be happy to elaborate on some of these ideas during the question and answer period.
Thank you.
:
Thank you for having me.
Dear honourable members, in the context of the committee's urgent study on the shortage of pediatric acetaminophen formulations, and on behalf of the Critical Drugs Coalition, which is a non-partisan and grassroots coalition of frontline physicians, pharmacists, academics and pharmaceutical industry experts, I'm speaking to provide recommendations for how the federal government can improve the resilience and security of Canada's drug supply chain.
I should note that the Critical Drugs Coalition and I have no conflicts of interest, financial or otherwise. I'm a lecturer with the University of Toronto's Department of Family and Community Medicine. I was also formerly a rural physician, having worked in remote settings all across northern Ontario, from remote indigenous communities in Moose Factory to small but very busy towns, particularly emergency departments in Kenora. I now work at the Vancouver General Hospital's ICU, as well as at the George Pearson Centre, which is a facility for patients with very complex disabilities. I have a breadth of experience. I've collated my personal experience from these settings and my colleagues' ongoing experiences with drug shortages.
I should add that I did have the pleasure of speaking to this committee in May of 2021 in the context of the critical drug shortages that occurred during the peak of the COVID-19 pandemic. At that time, the Critical Drugs Coalition made a number of recommendations to secure our drug supply going forward. Those included better data on the supply of such drugs, the creation of a critical medicines list, and the stockpiling of said critical medicines in a critical drug reserve, especially in anticipation of our respiratory flu seasons and further waves of COVID-19.
This was all included in a public open letter that we had issued to the in August of 2020. It had been supported and co-signed by multiple national bodies, such as the Canadian Medical Association and the Ontario Medical Association.
Our asks were very clear at that time. To reiterate, our asks were three points. We asked for a pan-Canadian critical medications list that the government commits to ensure is always in stock; public support for a generic critical drugs manufacturer to increase redundancy and capacity for said critical drugs; and greater transparency, data and communications to and from the governments and the health sector around the critical drug supply.
We did hear in April of 2021 from the , and there was an announcement around a critical drug reserve. Obviously, Health Canada folks have mentioned that billions have been spent on biomanufacturing.
However, my understanding is that the critical drug reserve has now been wound down. It is unclear to me at this point whether we do have any kind of policy and framework around strategic reserves of critical drugs.
I won't reiterate this, as I do know that we've spoken at length about the causes of the shortages. I will just mention that a cursory review of the drugshortagescanada.ca website for children's acetaminophen formulations states that the 80-milligram-per-millilitre suspension has been short due to manufacturing disruptions, so we've been really relying on the 160-milligram-per-millilitre suspension. From what I've heard from our industry sources, demand is up by about 400%, despite manufacturers having increased their manufacturing by about 200%.
Really, this is a perfect storm of supply strain and domino effects on other drugs. We're hearing about amoxicillin, azithromycin and ibuprofen shortages. It's really taxing our health care system, as we have also heard.
We are importing pediatric formulations and certainly folks have spoken about that. It's interesting because the United States has not experienced any significant shortages of acetaminophen. We've been hearing about people bringing bottles of acetaminophen back in the suitcases and other stopgaps, like going to compounding pharmacies, etc., to try to get some specific formulations made.
I do think that while we have an urgent importation order and a number of solutions for the crisis at hand, we must commit to addressing the root causes of such shortages going forward.
I'd like to reiterate what we said back in May of 2021, which is that we really need better data on the supply of such drugs. How much drug is inside of Canada at one time is something we need to know, as well as where the important components of our drugs are actually made. That's the first thing when it comes to better data.
We need a creation of a critical medicines list. I think people are using the words “critical medicines”, but what does that actually mean? You look at the UN list of essential medicines— there are thousands of them.
We actually truly need to understand what a critical medicine is, and then have policies, such as stockpiling of said critical medicines. It doesn't necessarily have to be physical stockpiling. It could be other sophisticated strategies, such as redundant manufacturing capacity in domestic or friendly countries' manufacturing plants, or strategic reserves of the active pharmaceutical ingredients that create these finished pharmaceutical products.
There are really the three points that we're going to continue to drive home, and something has to be done, because we are seeing rolling shortages of other drugs. People have mentioned azithromycin and amoxicillin. I really do think that if I were to bring it home, I'd say that we need to define “critical drugs”.
I would put in a plug here for a very sharp colleague of mine, Dr. Mina Tadrous, who is a pharmacist and a researcher at the U of T and the Canadian expert on drug shortages. He's been diligently plugging away at measuring the scope of the problem, spending lots of grants to define a critical medication list, and extensively collaborating with researchers in the U.S. where there has been a matter of national security for their drug supply.
They actually defined “critical inputs”, which I'll just end with here. They defined what the critical inputs for hospitals would be very early on and very clearly in the pandemic, and that included things from drugs to PPE to even oxygen.
As I said, something has to be done. We do have a number of points, and I'd be happy to elaborate.
Good afternoon, members of the committee.
My name is Gerry Harrington and I am the senior advisor at Food, Health & Consumer Products of Canada, or FHCP.
[English]
FHCP represents the companies that manufacture and distribute the vast majority of essential products found in Canadian households, including the children's pain relievers we're here to talk about today.
For Canadian families who have endured more than two years of the pandemic with school closures, illness and ongoing disruptions, the shortage of children's pain relievers has added to their anxiety. As a parent, I understand how stressful the situation is. However, I would add that the current shortage of these medicines is an unprecedented event in my 30 years in this sector, as is the level of mobilization across the industry to try to address it.
The major manufacturers of these medicines planned for higher than normal demand for these products in the 2022-2023 cough, cold and flu season. This forecasting was done with various factors considered, such as the severity of the cold and flu season in the southern hemisphere earlier this year, the expected prevalence of COVID in the community as we went into the season and the state of public health measures in place that might influence the spread of infections. Based on those forecasts, the production and allocation for Canada was increased substantially.
However, the infections came early. By late spring, as you've heard previously today, rates of respiratory infections in children were already far ahead of expectations and out of season, putting pressure on inventories just as they were being replenished. In August, a hospital's decision to require prescriptions for children's acetaminophen that had been compounded in their own pharmacy was widely misreported as applying to all such products being sold in community pharmacies. This, of course, caused an understandable degree of stockpiling by anxious parents. Indeed, demand spiked to three or four times above normal levels, quite quickly emptying supply chains and store shelves which, in turn, spurred more panic buying.
This has happened within the context of supply chains already being stressed and business still not being back to normal in our industry. Our member companies continue to face unprecedented and ongoing supply chain disruptions, including complex factors like transportation disruptions and delays, rising costs and shortages of inputs and labour. Despite these challenges, the manufacturers of children's pain relievers have already ramped up production to 30% to 40% above historic highs and plants are operating 24-7 as we speak.
Replenishing empty supply chains on the fly is always challenging, but as you know, the number of respiratory and virus cases has continued to climb through the fall, pushing ERs and pediatric ICUs well beyond their capacities, as you've just heard. Manufacturers will continue to work around the clock as long as this demand level continues.
It's important to understand that this outbreak of respiratory infections is a global phenomenon. Since late winter, sporadic shortages of these medicines have been reported in France, Ireland, Pakistan, Germany, Malaysia and Japan. Since this summer, industry has looked for opportunities, in spite of those pressures, to supplement Canadian production and allocations with new allocations from global supplies, but those supplies are tight.
As early as this summer, Health Canada was signalling to our members that it was prepared to offer regulatory flexibilities that would allow manufacturers to boost production or imports as long as these did not compromise consumer safety. Those flexibilities permitted two proposals for imported products directed to hospitals to be approved last month, as you are all aware, and I'm delighted to note that more recently we've had another proposal approved for a shipment of children's acetaminophen intended for community pharmacies within weeks.
In all three of these cases, the degree of supportive collaboration offered by Health Canada played a critical role in these successful outcomes, and I want to underline that. I want to emphasize that numerous manufacturers continue to explore opportunities to bolster supplies and are in regular contact with Health Canada to that end.
We believe these efforts will result in a marked improvement in access to these medicines in the coming days and weeks. That said, we still have no clear line of sight of the day when the number of these viral cases begins to normalize and demand for these products returns to something resembling normal. That remains, above all, the public health issue for all of us to address collaboratively.
Thank you. I look forward to your questions.
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Sorry; it's going to be me, and I'm going to split with Dr. Ellis.
Thank you, Mr. Chair, and thanks to all the witnesses for being here.
We heard from Health Canada that they actually were aware of this issue in the spring. In their mind, it only really became an issue when it was publicized in August, and basically only after we started bringing it up in question period did we actually see any movement from Health Canada to publicly address this issue.
I know as a parent that the worst thing in the world is having a sick kid. No one wants to bring a sick child to the emergency room just because they have a fever, yet I'm seeing countless reports of that happening because there is no other option, especially in many of our rural and isolated communities that don't have 24-hour compounding pharmacies and the families don't have the capacity of having this medication on hand.
Ms. Gruenwoldt, can you describe how many families are presenting simply with a fever at some of your hospitals just to get Tylenol or Advil and then going home?
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Sure. Some of them are consistent with what we heard Dr. Ahmed, I believe it was, speak to earlier in thinking about how we create a pan-Canadian critical medications list specifically for children.
It's also thinking about how we coordinate education and communications campaigns for parents and caregivers to help them understand at what point they need to seek out urgent or emergent care and what sorts of symptoms they can manage at home safely and how.
As well, it's thinking about how we create a communications response not only for our children's hospitals but also for our community hospitals, and especially those in rural and remote communities, as well as our family health care teams and pediatricians, so that they have a line of sight into where are we today in terms of the shortages and when we can expect additional supply.
Then, lastly, I would say that we really still need a coordinated push on immunizations, generally speaking, whether it's a flu shot campaign or whether it's a COVID-19 booster or original vaccine for children. These are essential measures that we know work, just like we know our masks work.
There are lots of actions that we can take collectively at both the federal and the provincial level—and the local level—and we would like to see those measures put in place as soon as possible.
In the longer term, I think we do need to evaluate the merit of strategic reserves for these essential medications to make sure that we're not caught on our hind feet for shortages like these. I think we would also support a call from the Canadian Paediatric Society to have an expert pediatric pharmacological advisory committee tasked with reviewing these drugs that are in short supply and with considering a list of alternative agents.
There's a misconception that population aging has led to an increase in medication use, and by extension, higher revenues for distributors and wholesalers. That's not true. As you mentioned, the deflation of prices for patented and generic drugs is at play.
The distributor compensation model is based on a percentage of the drug price. Here's a real-life example. In Quebec, the distribution margin is 6.5%, but we have to apply a prompt payment discount, which lowers the actual margin to 4.37%. On a $50 drug, the distributor would get $2.19 no matter where the drug is distributed in Quebec.
Further to the reforms introduced by the Patented Medicine Prices Review Board, or PMPRB, the price of that drug could drop by 10%. Just like that, instead of getting $2.19, distributors would receive $1.97 for the same distribution activities, storage and reshipping.
Deflation translates into lower revenues for wholesalers. As a result, they need to think about the possibility of reducing inventories, because storage is expensive and inflation is high. That's where the problem lies.