Evidence of meeting #10 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was product.
A recording is available from Parliament.
Director, Pharmacovigilance, Apotex Inc., Canadian Generic Pharmaceutical Association
Underreporting is a known phenomenon, not only in drugs but in other events that are subject to surveillance.
Conservative
David Tilson Conservative Dufferin—Caledon, ON
So what should the pharmaceutical companies do? How can they be more proactive?
That's terrible, quite frankly. Ten percent is not a good statistic.
Director, Pharmacovigilance, Apotex Inc., Canadian Generic Pharmaceutical Association
The pharmaceutical companies are already required to report everything. It seems to me the challenge is to have the people of Canada, generally, and the health care professionals practising in Canada be stimulated to report, and then from a public policy standpoint, you can use the classical approach of carrot and stick. You start off with carrots. We encourage you to report, we promote you to report, we legislate you to report, and then finally, we fine you if you don't report. So from a public policy standpoint, go through the four-step progression.
Conservative
David Tilson Conservative Dufferin—Caledon, ON
Last week, we had Ms. Meena Ballantyne, who is the assistant deputy minister, come, and she said:
It is the responsibility of a manufacturer to report serious adverse reactions. Health Canada also encourages
—I emphasize the word “encourages”—
reporting from health care professionals and patients.
It seems to me that the load of the reporting is on the manufacturers, and yet only 10% is reported. That's what we're told.
Director, Pharmacovigilance, Apotex Inc., Canadian Generic Pharmaceutical Association
If I may respond, I will use a practical example. The load is on the manufacturer to report what the manufacturer is aware of. If the manufacturer is not aware of something, the manufacturer, clearly, can't make up a report and pass it on.
That said, we were looking in my department yesterday at a particular product that I shall choose not to name, and we compared reports in our database to what was in the Health Canada database for reports in Canada. We had 19 in our database, and there were 11 in the Health Canada database, of which two were common, i.e., two were similar. This is why I made a recommendation to Health Canada, and to the committee today, to encourage Health Canada to share their information with manufacturers: because there is increased granularity of nine reports that I was not able to see respecting privacy law. I could see only what's up on the website, something that all of you in the committee can also see, which was not a lot of detailed information.
Conservative
David Tilson Conservative Dufferin—Caledon, ON
Does anybody else have any comment on this? I'm troubled by this 10%.
Consultant, Regulatory Affairs, Canada's Research-Based Pharmaceutical Companies (Rx&D)
I certainly agree with my colleague that we are regulated in a very stringent manner with respect to our reporting obligations under the Food and Drugs Act. We report what is known, either through the literature or from reports of physicians, patients, or pharmacists.
Now, Health Canada regulates the manufacturers but does not regulate the medical or pharmaceutical profession, so the equality of the data or the 100% reporting is something we cannot enforce.
I certainly indicated earlier that we spend a considerable amount of resources and effort to educate physicians on their obligation to report, but it's an effort of education and of partnership.
Conservative
David Tilson Conservative Dufferin—Caledon, ON
If I take a drug, if I'm prescribed a drug, and there's a problem--I'm ill or there's something wrong with me--I'm not going to call up the manufacturers. I don't even know who the manufacturer is. I'm just a guy. I'm going to call up my doc.
Consultant, Regulatory Affairs, Canada's Research-Based Pharmaceutical Companies (Rx&D)
Exactly.
Conservative
David Tilson Conservative Dufferin—Caledon, ON
But he or she doesn't have to do anything. They can say, “Oh, well, we better get you off that and get you onto something else”. Meanwhile, the drug's being prescribed to other people. There's a problem there.
Conservative
The Chair Conservative Joy Smith
Could you just wrap that up? We're out of time.
Mr. Skinner, would you like to make a comment on that?
President, NDMAC
I will just add something very quickly.
I'm always intrigued by the 10% number, because if you know that 10 in 100 are reported, you must have known that there were 100 to begin with. So the number itself is not that meaningful to me, other than the fact that it is underreported.
For self-care health products, all of ours come in original packaging. Having a 1-800 number and manufacturer contact information...we have an awful lot of consumers actually calling directly to manufacturers. But I think one of the biggest tools is an education so that patients have an appreciation for the idea that when they do get a side effect, an adverse event, and they have a concern about it, they talk to their doctors and ask their doctors to report it. If the patient isn't getting to the doctor, the doctor's not getting it. Then if they go and they don't ask their doctor to report, it may not get reported.
Conservative
The Chair Conservative Joy Smith
Thank you so much, Mr. Skinner.
We're now going to go into our second round. I would just remind committee members that we have now five minutes per question and answer.
Mr. Thibault, would you start the questioning, please?
Liberal
Robert Thibault Liberal West Nova, NS
Thank you all for appearing and informing the committee.
I understand that with 10% being reported, the other 90% would be an estimate, because of the fact that people aren't required to report, either pharmacists or MDs.
I'm also a little concerned about the definition--if you're looking at serious adverse effects as opposed to adverse effects. You could have adverse effects that, if repeated over time, can become quite serious for the individual patient. At one moment, it might not require hospitalization, but it could weaken the patient and he could require hospitalization or suffer serious health effects because of other matters.
That could happen because of the improper use of a drug or the mixed use of different drugs, including self-help drugs.
I just want you to consider those things and how we capture that. I know it's not easy because we're always caught in the dilemma--where I'm sure everybody is caught--which is to make drugs available. If I have the illness, and especially if it's critical, then I'll try anything. If I'm going to die otherwise, I'll try anything. I'd like to have the drug available.
I applaud the use of off-label, but I worry that because the use of off-label isn't regulated too well, the critical events or the adverse events aren't being reported. There is no real way to report them or to share it with other professionals in the industry who may be using them off-label.
But I want to come back to the current definition. If you require hospitalization, is the hospital required to report it to Health Canada or the manufacturer at the current time?
Consultant, Regulatory Affairs, Canada's Research-Based Pharmaceutical Companies (Rx&D)
The treating physician should be reporting that event.
Consultant, Regulatory Affairs, Canada's Research-Based Pharmaceutical Companies (Rx&D)
At the present time, it's not obligatory.
Liberal
Robert Thibault Liberal West Nova, NS
I'd like to see us find a way that you can do that, but I understand the shortage of physicians out there and I understand the burden of paperwork on them. They have to file for unemployment, for Canada Pension Plan, for insurance, and they are becoming more bureaucratic than clinical. In certain instances, you wouldn't want to raise that level too much.
But you'd think, with the electronic databases of the hospitals and all those things, that you'd be able to have a very efficient way of reporting these incidents to Health Canada and to the manufacturer.
Is any work being done on that?
Consultant, Regulatory Affairs, Canada's Research-Based Pharmaceutical Companies (Rx&D)
Yes. The reporting can also be done electronically, and again, I think we have to encourage patients to report any event.
We, the manufacturer, through the source, have to report both serious and non-serious adverse events, especially the ones that are called “unexpected”, which are not in the labelling.
But I believe that at the present time the system is more efficient. I think we've also seen an improvement in the quality of reporting, as per some audits that were conducted by Health Canada over the last four or five years. So there is a certain level of compliance overall.
Underreporting is not only a Canadian problem; it's a problem in the United States, and even the FDA is wrestling with that aspect of reporting.
However, I must say that numbers are not really the only important aspect; it's the quality of these reports. As I mentioned, to make a scientific assessment of the relationship between the drug and the effect, you have to have quality data.
Your colleague mentioned earlier that some people may be reluctant to communicate this information because they do not want to lose their privacy. However, quality reporting doesn't involve the identification of the patient. You can just put initials. But you certainly need the age, you need to know the background, the terms of co-morbidity, you need to know the--
Liberal
Liberal
Robert Thibault Liberal West Nova, NS
Okay.
You were giving the example of 19 cases of adverse effects. I remember what I think were called beta blockers that were used to treat people with severe arthritic pain, and then there were some adverse reactions--some people had heart problems--and all of a sudden these drugs were removed from the market. I might have the term wrong. It might not have been beta blockers; it might be another drug.
The counter to all of this information being out there is that you can send out a false fear to people. If you have 19 adverse reactions out of 300,000 users, it might not warrant the other people worrying and not benefiting from the good use of these drugs. Before you send the message out to all pharmacists and all doctors and put the thing in the magazine, how do you keep that gate...not scaring people but giving them proper information?
Director, Pharmacovigilance, Apotex Inc., Canadian Generic Pharmaceutical Association
First and foremost, the assumption is that one receives quality data. Typically when a case is received by a drug safety associate who is a health care professional by background, the quality of the data received is peer-reviewed, medically reviewed, and management reviewed, and then submitted as per the regulatory timelines, either 7 or 15 days for the serious expeditable or in the periodic report format that my colleague, Dr. Fontana, alluded to.
Before we can make any public communication, we invariably end up in a discussion with the regulator, no matter what jurisdiction we're in, to agree on the format of the communication and the quality of the signal or the issue we have seen. As recently as December 2007, Health Canada signed a data exchange agreement with the EMEA. They do sit in on monthly calls, so it's their forum to share information with the other regulators. This is where we don't want to clutter the system, as Dr. Fontana alluded to, with duplicate reports going in, because you falsely attribute things, which is the very point I think you were trying to make.
Conservative
Patrick Brown Conservative Barrie, ON
I want to touch upon progressive licensing. Perhaps I could get some comments in terms of your association's position on it. Also, perhaps you could discuss the phase 4 clinical trials and the more stringent safety and monitoring it may have on the marketplace and the cost that would be involved for your association.