Evidence of meeting #38 for Health in the 41st Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was shortages.

A recording is available from Parliament.

On the agenda

MPs speaking

Also speaking

  • Brian O'Rourke  President and Chief Executive Officer, Canadian Agency for Drugs and Technologies in Health
  • Jeff Poston  Executive Director, Canadian Pharmacists Association
  • Joel Lexchin  Professor, School of Health Policy and Management, York University, As an Individual
  • Jeff Morrison  Director, Government Relations and Public Affairs, Canadian Pharmacists Association
  • Paul Glover  Assistant Deputy Minister, Health Products and Food Branch, Department of Health

8:45 a.m.


The Chair Joy Smith

Go ahead, Ms. Davies.

8:45 a.m.


Libby Davies Vancouver East, BC

Just to be clear, that was my original motion. On the advice of the clerk, it was shortened to this.

I have no problem with that; if your amendment basically follows the wording of what the original decision was, there's no problem. That's what we want to report, our study and the testimony of our witnesses.

I would consider that a friendly amendment; I'm happy to include it. I did originally, actually, so it's no problem.

8:50 a.m.


The Chair Joy Smith

This is very good. We'll vote on the amendment first and then the motion, and we can do that now.

8:50 a.m.


Libby Davies Vancouver East, BC

I'm willing to just incorporate it into the motion.

8:50 a.m.


The Chair Joy Smith

You're willing to just incorporate it in the motion?

8:50 a.m.


Libby Davies Vancouver East, BC


8:50 a.m.


The Chair Joy Smith

That's great. That's wonderful cooperation. I'm very proud of you guys.

(Motion agreed to [see Minutes of Proceedings])

Thank you, Ms. Davies and Mr. Strahl.

We're now going to go to panel one. In our panel we have the Canadian Agency for Drugs and Technologies in Health, represented by Dr. Brian O'Rourke, president and chief executive officer; we have Dr. Jeff Poston and Mr. Jeff Morrison from the Canadian Pharmacists Association; and we have, as an individual, Dr. Joel Lexchin, professor in the School of Health Policy and Management at York University.

We're going to begin with the Canadian Agency for Drugs and Technologies in Health. Dr. Brian O'Rourke, please go ahead.

April 3rd, 2012 / 8:50 a.m.

Dr. Brian O'Rourke President and Chief Executive Officer, Canadian Agency for Drugs and Technologies in Health

Thank you, Madam Chair.

Thank you for inviting me to appear before the committee.

CADTH is a not-for-profit corporation funded primarily by Health Canada and all the provinces and territories, with the exception of Quebec.

We are a health technology assessment agency. This means that we provide independent evidence-based assessments of the clinical effectiveness and cost-effectiveness of pharmaceuticals, diagnostics, and medical, dental, and surgical devices and procedures. We do not make the final decisions on what technologies will be funded by health ministries; however, our work informs technology-related decision-making.

The Canadian Agency for Drugs and Technologies in Health, CADTH, provides a range of services to support the effective management of pharmaceuticals and other health technologies in Canada.

The common drug review program supports coverage decisions by 18 of the 19 publicly funded drug plans in Canada. We do therapeutic class reviews on pharmaceuticals and conduct optimal use projects that encourage the appropriate prescribing and utilization of drugs and other health technologies.

CADTH's Rapid Response Service addresses urgent jurisdictional needs for information that informs policy and practice decisions about drug and non-drug technologies.

The agency also does large health technology assessments when warranted. For example, last year, we did a major review of robot-assisted surgery.

Finally, our horizon scanning products alert decision-makers to new and emerging health technologies that are likely to have an impact on the delivery of health care in Canada. As part of this service, CADTH also provides environmental scans of different health care issues, practices, processes, and protocols inside and outside of Canada.

That brings me to why the committee asked me to appear today. In March 2011 CADTH published an environmental scan on drug supply disruptions. The scope of this report is a bit beyond our normal mandate, as CADTH is not involved in pharmaceutical procurement or the drug supply chain. However, as the drug shortage issue was becoming more prominent, Health Canada asked us to provide them with some background information on this issue. The report we produced is publicly available on our website, and a copy of the report has been distributed to committee members. This document was referenced in the House of Commons on March 12 during the emergency debate on drug shortages.

I will now provide a brief overview of our findings on drug supply disruptions as presented in that report.

First, I want to be clear that CADTH's environmental scans are not comprehensive, systematic reviews. Typically they are very time sensitive, so the information is based on limited literature searches and personal communications. They are meant to be informative, but are intended to be considered along with other types of information.

Many factors can influence the occurrence and severity of drug shortages.

Shortages of the raw materials required to make drugs contribute to drug shortages and are believed to be particularly problematic when an active ingredient is obtained from a single raw material supplier.

Manufacturing issues may create or contribute to drug shortages; for example, quite often multiple products are produced on the same equipment, which means that an increase in production of one product will result in a delay in production of another. There can also be temporary or permanent discontinuation of products as manufacturers shift production or reallocate resources. There can be numerous other problems associated with production.

Business decisions by manufacturers can also lead to drug shortages. For example, company mergers can be a way to create internal efficiencies in response to economic downturns, patent expirations, or a lack of new products in the pipeline; however, when companies merge, less profitable product lines are often reduced or discontinued, and sometimes manufacturing facilities are closed. Mergers of companies with similar product lines can lead to product consolidation, possibly resulting in changing a multi-source product into a single-source product, and single-source products are the most vulnerable to shortages.

Another major factor is the reluctance by manufacturers to provide advance warning of potential disruptions. This can magnify the impact of a shortage.

Purchasing and distribution issues can also play a role in drug shortages. For example, the use of just-in-time inventory control practices that involve keeping minimal supplies of drugs in stock at all levels of the supply chain can result in an overall reduction of readily available drug inventories.

Strict enforcement of good manufacturing practices and other related regulations by drug regulatory bodies can also play a role in drug shortages.

Madam Chair, these are just some of the many factors that contribute to drug supply disruptions identified in CADTH's environmental scan.

The causes of drug shortages in Canada are believed to be multifactorial. It is difficult to determine the extent of drug shortages in Canada because manufacturers are not required to report disruptions in drug supply and because there is no single accountable Canadian organization that provides system-wide drug distribution oversight.

The current drug supply issues underscore the need for greater transparency in the system as well as for strategies at every level of the drug supply chain that help minimize disruptions to patient care.

Let me now briefly present a potential option for CADTH, should we be invited by the provinces and territories to play a role in managing future drug shortages.

CADTH is both a producer and a broker of evidence-based assessments of health technology. We are a credible and independent source of information. We have the skills and processes available to produce drug substitution advice, and we can broker such advice created by others. Because of our skills in searching, accessing, analyzing, and publishing evidence-based clinical information, we have an ability to be a central source of information relevant to a drug shortage.

The role that CADTH might be able to play could best be summarized as a clearinghouse of shortage information and relevant substitution advice, and perhaps to provide a link to currently available databases and information sources. Information from CADTH could be used to supplement local efforts and to support clinical decision-making at the patient-clinician interface.

We are currently exploring this potential role with our board of directors, with senior federal, provincial, and territorial officials, and with other stakeholders.

Madam Chair, thank you for allowing me to present to you today. I welcome any questions that you may have.

8:55 a.m.


The Chair Joy Smith

Thank you very much for your presentation. It's very much appreciated.

Now we have Dr. Jeff Poston, from the Canadian Pharmacists Association.

8:55 a.m.

Dr. Jeff Poston Executive Director, Canadian Pharmacists Association

Thank you, Madam Chair, and thank you for the invitation to appear today.

The Canadian Pharmacists Association is the national association that represents individual pharmacists. Our members work in community, hospital, industry, and academia.

We are pleased that the committee has agreed to hold hearings into drug shortages. We suggested to the committee a year ago that such hearings be held and, in fact, the committee had scheduled hearings in March 2011, but the fall of the government and the subsequent election resulted in the cancellation of those hearings.

Although there's been a great deal of attention paid to drug shortages over the past months owing to the Sandoz situation, the fact is that drug shortages have been a serious problem for health practitioners and Canadians for at least two years.

CPhA identified the scope of this problem in a survey of our members that we conducted, and we released the report in December 2010. This work was prompted by reports that we'd been receiving as early as March 2010 about shortages. We've provided copies of this report for your information.

In the survey, you will note that 94% of pharmacists reported not being able to fill at least one prescription in the past week, with the average number of drugs in short supply being 10. At least half an hour per shift was being spent on drug shortages, although we heard reports of many hours per shift being spent addressing some significant problems. Most importantly, 70% of pharmacists reported their patients' health was adversely affected, and over 90% reported that patients had been significantly inconvenienced.

It's important to point out that dealing with shortages consumes a lot of pharmacist and physician time that should be available for direct patient care. It's only the diligent work by front-line health care professionals that's been able to limit the impact of shortages on the population.

Although it is difficult to say whether drug shortages have increased or decreased in scope or duration since that time, the fact remains that drug shortages are a source of serious concern for the Canadian health care system. The events related to the Sandoz shutdown are just the latest manifestation of what has been a major concern for some time.

As an association we've worked with government, industry, other pharmacy groups, and other health practitioners to look at responses and solutions to this problem. In the fall of 2010 we held meetings with industry groups, wholesalers, and other stakeholders to better understand the causes of the problem. That prompted us, later that year, to release our guide to addressing drug shortages to our members as one tool available for pharmacists to deal with shortages when they occur.

There are many aspects of the problem, including causes that we could discuss today—and Dr. O'Rourke has mentioned a number of the causes—but given the time constraints, I'd like to take a few moments to outline a number of the solutions and recommendations that we feel are needed to address not just the Sandoz-related shortages, but the full range of shortages that are plaguing our health care system.

First, we were pleased to see the House of Commons unanimously adopt a motion on March 14 that called for the development of a national strategy to address the long-term issue of drug shortages. We applaud parliamentarians for recognizing this need and would encourage the minister to take the lead on the development of a national strategy.

Second, in response to the Sandoz shutdown, we have welcomed Health Canada's efforts at sourcing alternative supplies and expediting approvals of equivalent or alternative drugs. However, this proactive approach to sourcing supply in the event of a shortage should not be restricted to drugs impacted by Sandoz. This is a role that we believe Health Canada could and should be playing at all times to proactively address shortages. This is the role that the Food and Drug Administration plays in the United States, and we would argue Health Canada could be doing the same.

We would also like to see an increase in effective collaboration between Health Canada and the FDA on drug regulatory aspects related to drug shortages.

Third, governments and large purchasing bodies need to be aware of the risks associated with tendering systems that result in sole-sourcing. Although it is true that sole-sourcing, which is often associated with bulk purchasing, can lead to lower prices, the fact is that when problems are encountered by that sole-source producer, shortages can and will be the result.

Sandoz, which supplies approximately 50% of Canada's injectable pharmaceuticals, is a perfect example.

We understand that HealthPRO announced before this committee last week that they have introduced a new policy whereby they will seek secondary suppliers for hospital drugs when alternative suppliers exist. This is a very welcome development, and one we would encourage other group purchasing organizations and provinces to adopt. However, we wish to point out that in many existing contractual agreements, clauses exist to impose a penalty in the face of failure to supply, yet it is our understanding that these clauses are seldom implemented.

Fourth, in order to ensure that health practitioners and the general public have the most up-to-date information possible, the Canadian Pharmacists Association established in March 2011 a stakeholder working group on drug shortages to develop a voluntary drug shortages reporting system.

Today I'm joined by my colleague Jeff Morrison, who's been the chair of that working group.

An initial version of that reporting system went live in November 2011. Information populating the system is being fed by member companies of Rx&D and the Canadian Generic Pharmaceutical Association. It was announced just last week that this information is now being collated on one centralized website, at www.drugshortages.ca.

The working group is now working on a more robust system that would, we hope, contain therapeutic alternative information and that would allow health practitioners to report directly into the system to validate a shortage. While the industry associations have committed $200,000 towards the establishment of this system, we need to put in place a sustainable funding model to ensure continuity of this reporting system.

Fifth, this is not just a Canadian problem. It is a global problem, and therefore requires global attention. Last fall we were successful in getting the council of the International Pharmaceutical Federation to issue a statement calling for global action on drug shortages.

We strongly recommend that the Minister of Health request that the World Health Organization and the Organisation for Economic Co-operation and Development add this issue to their agendas and immediately look into the global causes and solutions to drug shortages from an international perspective.

Lastly, we need a forum to bring together all stakeholders, particularly manufacturers and regulators, to identify the root causes of drug shortages, provide more information to the discussion, and then, more importantly, identify what solutions can be implemented to alleviate shortages. Reporting on shortages and dealing with them when they occur is all fine and good, but our goal should be nothing less than to prevent any shortage before it can interfere in the care of even one Canadian patient.

In closing, I would like to emphasize that is not only an access to care issue but also a patient safety issue. The uncertainty and inconvenience created through having to manage a lack of supply can result in patients receiving less than optimal treatment and increases the risk of error. Shortages also take up a lot of time on the part of pharmacists and other health care providers, time that would be better spent in treating and caring for our patients.

Thank you, Madam Chair. We'll be happy to take questions

9:05 a.m.


The Chair Joy Smith

Thank you very much.

We'll now go to Dr. Joel Lexchin, professor in the school of health policy, as an individual.

9:05 a.m.

Dr. Joel Lexchin Professor, School of Health Policy and Management, York University, As an Individual

Thank you very much, Madam Chair, for the invitation to appear here.

I have a couple of roles. First of all, I work as an emergency physician in downtown Toronto, and secondly, I teach health policy at York University. Moreover, I've been studying pharmaceutical policy issues for about 30 years now.

With regard to the first role, just yesterday we were discussing drug shortages in the emergency department at the University Health Network. We've had to modify certain practices because of these shortages. I'm well aware of the impact that drug shortages can have on doctors' prescriptions and patient care, which is what we're all concerned about.

I think drug shortages have been on the horizon for a number of years now. We've certainly been aware of them in the emergency department for a few years. It should not come as any surprise that we're now in more of a crisis situation. All it took was a fire to create a crisis.

What we need is proactive planning to avoid any similar situation in the future. Merely approving other generic manufacturers that are able to produce drugs is not really proactive planning. We need to go beyond that, and in that context I have a number of suggestions.

I believe that Health Canada should convene an expert committee to identify off-patent drugs. Most of the products we're concerned about are generics, off-patent, that are supplied by only one or two companies. They are considered critical to medical care. Examples of these critical products might be chemotherapeutic agents, morphine, anesthetic agents, or drugs to treat epilepsy.

Once these critical drugs have been identified, Health Canada should proactively identify possible alternative sources of these products and determine whether the companies making them are prepared to supply Canada in the event of an emergency. Contingency contracts could then be negotiated with interested suppliers.

In the future, any company marketing one of these critical drugs in Canada should be required to give Health Canada a minimum of six months' notice before they stop supplying the product, and Health Canada should maintain a list of these drugs and post it publicly.

One of the conditions for granting a notice of compliance to sell one of these critical drugs in Canada should be a commitment by the company to guarantee the availability of the drug for a minimum of three years. We already go beyond what's required in the Food and Drugs Act when we approve drugs or give them a notice of compliance; we now invoke patent issues, so asking for a commitment to supply the drug doesn't really break any new ground.

Finally, if we do have another crisis similar to the one we have now, we need to avoid any possibility that companies can take advantage of the situation by charging a premium for their products. In that regard, I think the federal government should consider establishing a publicly owned generic drug company to manufacture some of these drugs to ensure that the drugs will not only be available, but will be available at a reasonable price.

Thank you very much for your attention, and I welcome the chance to answer any questions.

9:10 a.m.


The Chair Joy Smith

Thank you.

Go ahead, Ms. Davies.

9:10 a.m.


Libby Davies Vancouver East, BC

Thank you, Madam Chair.

Thank you to the witnesses for being here today. You've really helped illuminate not only the problem but also what we need to do. I really appreciate that. I want to jump right in and focus on what we can do.

There's something in the pharmacists' report from December 2010 that you distributed that you didn't exactly say today, but it's very clear in your report, and I'd like to quote from it. On page 11, under “causes”, you say:

What is missing in the drug supply chain is any organization or party that holds accountability for the supply chain from a system-wide perspective. Neither government nor any third party has an oversight function for the drug distribution system, and therefore drug supply is dictated in large measure by the market.

You go on from there to spell that out a little more.

I think this is a very telling comment, because everybody is saying from varying perspectives that there is no oversight, no mechanism to do this. We're completely reliant or dependent on, or held captive to—however you want to put it—what's going on in the marketplace.

I would also comment that in the brief that was just presented by the Canadian Agency for Drug and Technologies in Health, you also point out that the drug shortages are often difficult. You mention the mergers and the reluctance to share details of the shortages, again for business case reasons.

There are two questions that I would like to get at and have you answer. First of all, Mr. O'Rourke, you suggested that your organization might be able to fulfill that function as an independent overseer of information and in looking for substitutes. I'd like you to spell out how you could take that on and how quickly. I'd like others to comment on whether or not that is feasible.

Dr. Lexchin, in your brief you speak about establishing a publicly owned company. I was very interested to read in your brief that in the mid-1980s there actually was such a publicly owned company, called Connaught Laboratories. I don't recall that myself, but I wonder if you can speak a little bit more about this. I think your recommendations are great. This additional one about having a publicly owned company to ensure that some of the essential medications are there and that we won't have to face these kinds of shortages is a very brilliant suggestion.

I'd like you to speak a little more on how Connaught Laboratories worked, if you have that information. I don't know what happened to it, why it went under, or whether it was just done out of business by the government. Then I'd like the others to address the question of what kind of independent agency we need to provide this oversight.

9:15 a.m.


The Chair Joy Smith

Who would like to take that question?