Evidence of meeting #14 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was information.
A recording is available from Parliament.
Regional Supervising Coroner for Eastern Ontario, Office of the Chief Coroner, Ontario Ministry of Community Safety and Correctional Services
Madam Chair, I completely agree with Dr. Haggie's comments. I would say it's important that the committee recognize the temporal difference between peer-reviewed literature--expert use of drugs, which emerges very quickly--and regulatory response. There will be a gap at times.
I think the committee ought to use the term “inappropriate” off-label prescribing as its major interest as opposed to just off-label prescribing, because there certainly is appropriate off-label prescribing as well.
Christiane Gagnon Bloc Québec, QC
You must admit, however, that it is a concern. I would like to get an answer from you. How can we be more vigilant? What kind of action is required to monitor both marketing and regulations? There appears to be a vacuum at this time, which means that labelling may pave the way to other types of uses. What kind of action is required? Would it not be appropriate to test these drugs on more people, including children? Children are often administered drugs that were not developed for use in children.
Chair, Board Working Group on Pharmaceutical Issues, Canadian Medical Association
You're right, there is a huge knowledge gap. The bulk of the information about pharmaceutical agents that the average practitioner receives comes from the pharmaceutical industry directly just because of ease and convenience. That's what the drug companies do. That's how they operate.
Our proposal incorporates moving away from that, to provide unbiased, impartial, peer-reviewed material available to a physician when he or she has a clinical problem in front of them and wishes to write a prescription. We provide excellent training for undergraduates in pharmacology and for residents in internal medicine and a whole variety of specialities in pharmacology. Those resources, with a little adaptation, could be made available to physicians who have been in practice for 20 years and haven't crossed the threshold of a medical school in that period.
So the work is there; it is how you deliver this. You can do it on an educational basis. Whilst we don't have a mandate as an association to do that, continuing education for our members is a vital interest. Dr. Shortt here is our new director and assistant secretary general of knowledge transfer, and that's going to be his mandate over the coming years.
In terms of actually writing a prescription in day-to-day office work, you need real-time electronic database access to something as simple in the electronic record as an Agilent. If you write a particular medication electronically for a patient who is, say, under three years old or over 80, and that is not appropriate...and there are such things as the Beers list. The list itemizes and updates the drugs that are inappropriate for the elderly, for example.
So by just incorporating that simple list, if you wrote a prescription for a patient over the age of 80 for a medication on that list, it would stop you at that point and say, “This is worth reconsidering. Is there a better drug you can use?” Perhaps it would even list some better drugs.
These are decision support tools. The pharmaceutical industry, or rather the pharmacists, have gone a long way to providing that network for their members at the dispensing stage, which is really a very appropriate and very easy point to do that. But a vast majority of clinicians in this country still use a paper and pen. Until you get around that and move to a system akin to the pharmacists', and that will speak to the pharmacists, you're kind of stuck with--
Conservative
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Thank you, Madam Chairperson. Thanks to all of you for very informative presentations.
Of course I'm tempted to ask especially the doctors and nurses what their reaction is to the federal budget, which didn't mention the shortage of doctors and nurses in our country today, but I won't.
I will, though, start my questioning—and if you want to skip it , feel free. I will reference the federal budget in this context of post-market surveillance. We saw in the budget what I would consider a rather piddling amount for health product and food safety, $113 million. I'm not even sure if that includes pharmaceuticals at all. I raise that in the context of the adequacy of our system now to ensure safety of products.
I reference the CMA's brief, where you make a very excellent point about...and I'll just quote from you because I think it is well worth putting on the record time and time again: “A strengthened post-market surveillance system should not be used as justification for lowering approval standards”.
I also reference the Men in Nursing brief, which says that “Ensuring that Canadians are informed of any pharmaceutical product approval and non-approval in an open–access system...” is absolutely critical.
I want to get at two big issues. One is to get your comments about the present system with respect to pre-market approvals and what's needed, from the CMA's point of view, to ensure we aren't condoning any attempt by the government to fast-track drugs by participating in this and making recommendations, follow what it would call the business transformation program, and do everything on the basis of pressure from the big brand-name pharmaceutical companies to get drugs through quickly without adequate testing. I want to know your reaction to that, what needs to be done.
Secondly, what mechanism would you put in place to ensure accountability and transparency in terms of drug information? Both of you and the others have mentioned this as well.
We've had a number of different suggestions. One is for the government being required to put everything on its web page in terms of all the studies and adverse effects that researchers and others have identified for every drug approved or not approved, and as well, to have an independent advisory board to offer advice and evaluate prescription drug safety.
I raise those two issues. I think you're all right in terms of suggesting that too much emphasis on mandatory adverse drug reporting leads us down a path where we will ignore the big issues. I'd like some advice around both the pre-market approval process and the transparent and accountable system you have in mind.
Does anybody want to start?
Vice President and Director of Finance, Canadian Men in Nursing Group
I can comment about the findings you mentioned about information we have available.
It is true we have a lot of information available over the Internet about different drugs, but sadly, most of that information is not evidence based. A lot of patients in my practice go to the Internet and look at different medications. They are obviously concerned about their health and the health of their loved ones, so they read this information and ask questions about one website saying one thing and another website saying the total opposite, and they're wondering which one they should believe.
I think government can do a lot about that. We can have just one system; we can have information available on web pages, some kind of e-learning tool that we proposed in our recommendations. It would have comprehensive information about the drugs. The patients don't have to look around for information that is not evidence based.
In this age of information technology, information is everywhere, but we need to try to promote the right kind of information that will be helpful to our patients and will help solve their concerns and current medical status. If they get that information, then they know the right questions to ask or who to approach for that information.
Conservative
The Chair Conservative Joy Smith
Mr. Shortt, would you like to comment on this for Ms. Wasylycia-Leis as well?
Dr. Samuel Shortt Director, Knowledge Transfer and Practice Policy, Canadian Medical Association
Yes, thank you, Madam Chair.
We've seen nothing in the materials provided by Health Canada to suggest that the barrier is in any way going to be lowered for access to market for new drugs by adding a post-surveillance component. Health Canada has consulted as recently as February 15 with the health professions and has overtly stated that the current regulatory regime for market approval will not be changed.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Let me ask you, the CMA, and others a question. I'm still searching for answers around the proper process to ensure the access to information and transparency of information that you've all espoused, especially from the drug companies, which are a problem by all accounts. I'm sure you're not going to disagree with that. Some of the recommendations include an open-access website that would have all drug approvals and non-approvals on it, as well as a summary of and the rationale behind the decision; a complete review of all clinical trial data used to reach a decision made available to the academic community; and finally, an independent board to provide oversight of the regulatory process and keep it accountable.
Are there any objections to any of those three suggestions?
Conservative
Chair, Board Working Group on Pharmaceutical Issues, Canadian Medical Association
No. We as an association think that is a nice outline of the system. We see the post-marketing surveillance very much as part of a process that begins with initial clinical trials and evaluation and the licensing of drugs, and then moves through the product cycle to keep an eye on what happens once these things are out there. And more importantly, or equally importantly, we see it as a feedback loop so that the physicians who use these drugs have access to what is going on with them in the real world as it happens, in a way that they can use.
The difficulty we've had with some of the current mechanisms, again, as far as post-market surveillance and adverse reporting are concerned, is that they are concentrated simply on adverse reporting. There isn't really anything else that we've seen. The clinicians who use these drugs are baffled by the process. The definitions of what they're supposed to report on aren't clear always. The process by which they are reported has been improved of late but still is something of a black box. Once you send the form in, you don't really know what happens afterwards. There is the great fear that in some way they are, by reporting these adverse reactions, either wasting someone's time with something that's trivial or potentially putting themselves in a situation where a torrent of paperwork is going to be unleashed on them, in addition to whatever else is going on at the time.
The current process really needs a lot of attention to make it into the sort of Cadillac version that we've suggested, and it needs attention from all directions.
NDP
Conservative
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Okay, very quickly then, many physicians...and I'm sure members of your association have talked about the problems with the present approval system for drugs. In fact, Dr. James Wright says, “At present, the system for reviewing and monitoring prescription drugs in Canada has serious deficiencies and often fails to consider patients as the primary focus.”
Others have reported on how drug regulations in Canada are shrouded in secrecy. Even the names of the drugs in the approval process are not disclosed. Any information that industry submits, including clinical trial data on safety and effectiveness, is deemed confidential and can only be released under access to information requests.
We have numerous problems, whether we're talking about pre- or post-approval surveillance. We have serious problems in terms of drug safety. Now, we can go into reams of information about side effects and adverse reactions. We can talk about Propulsid and the Ontario coroner's inquest. Surely you can't sit here today and say that the system, as it is, is effective.
Conservative
The Chair Conservative Joy Smith
The time is up, Ms. Wasylycia-Leis. Sorry.
Could we have Mr. Tilson, please.
Conservative
David Tilson Conservative Dufferin—Caledon, ON
Thank you very much.
Thank you all very much for coming and providing your expertise.
I was listening to Madame Gagnon asking a question on the number of deaths in the United States. I expect it's not as high, but it's pretty bad in Canada as well. That's why we're holding these hearings as to how this can be improved.
I look at the issues, most of which you've addressed, which are whether reporting should be mandatory or voluntary, reporting serious reactions versus all reactions, and who's to do the reporting. Should everybody be involved: medical practitioners, nurses, pharmacists? I think the only mandatory reporting is with the pharmaceutical companies. I think we're talking about hospitals now.
And you get to the question where someone dies or has a very serious reaction, and there's a lawsuit. Everybody gets sued. Health Canada, the pharmaceutical company, the doctor that prescribed it. They don't know; no one knows. I think you gave an example of a drug that may have been prescribed for a hip and someone took it for a knee. So you don't know these things.
It would be useful if the committee had statistics as to the amount of litigation in this country on all these issues. Does anybody have any statistics? If there are only some for Ontario, that would be useful.
There are all kinds of causes. There are errors in prescriptions or that the drug should or should not have been approved. There's a patient who takes increased medication, or not enough; in other words, they broke the rules that the practitioner was recommending. There are genetic issues, the issue that Dr. Haggie raised about something that is good for one part of the body but not for another part. Are there statistics out there that could help us?.
Conservative
The Chair Conservative Joy Smith
Who would like to take on that question?
Dr. Shortt, would you like to start?
Director, Knowledge Transfer and Practice Policy, Canadian Medical Association
Sure.
The statistics would at best be impressionistic. I would suggest that probably the best source to consult would be the Canadian Medical Protective Association, which is aware of litigation involving physicians.
However, I would caution you that the American literature is quite informative. If you look at litigation for malpractice generally, and not specifically focused on drug reactions, you'll find that the vast majority of these cases are not because there was an issue of negligence or inappropriate practice, but because of the outcome that the patient didn't particularly like. Malpractice litigation is a bad reflector of bad medical practice. Turning that around, and this is important, the vast majority of people who do experience negligent care never bring suit. So the American system is not a good indicator.
Conservative
David Tilson Conservative Dufferin—Caledon, ON
I understand that.
You all have similar backgrounds, but from different angles. I think the figure Madame Gagnon gave was 200,000 in the United States a year. Does anyone know what it is in Canada? It's pretty high, I'll bet. Does anyone know?
Chair, Board Working Group on Pharmaceutical Issues, Canadian Medical Association
The answer is that at the moment, the data doesn't exist in any usable way for this country.
One of the things our proposal might do is to address that in terms of getting proper prevalence data. We would see the post-market surveillance system with reporting from physicians as a trigger, which would then be taken by centres of excellence to do proper epidemiological studies. If you rely on a reporting system, whether it's voluntary or mandatory, your figures are going to be inaccurate.
Conservative
David Tilson Conservative Dufferin—Caledon, ON
I understand that. You could have some senior person go into a hospital and have the wrong drug, but they're old and they're going to die anyway. I hate to be so crass about it, but there could be all kinds of reasons that have absolutely nothing to do with errors by doctors or drug people or whoever. I'm just saying that to properly assess this issue it would be most useful if we had some stats. I gather that all of you are saying there really aren't any stats, and if there are, be cautious on how you look at them.
Is that your message?