Thank you.
I'm representing PharmaWatch. My name is Colleen Fuller, and my colleague Carol Kushner and I are both going to present.
First of all, thank you very much for inviting PharmaWatch. We're really pleased that the standing committee is looking at post-market surveillance. Of course, we have been following the work of the committee for many years and we are looking forward to your report.
PharmaWatch is a consumer advocacy group. We were founded in 2001, like a lot of other consumer groups, to begin pushing Health Canada to do a stepped-up ADR monitoring. We are focused on adverse drug reaction collection, although we obviously recognize that post-market surveillance has a much broader lens than that. We would take the position that the rest of the responsibility within the marketed health products directorate isn't going to get done if there is no data collection. So we do focus on adverse drug reaction reporting, and we are specifically focused on consumer reporting of adverse drug reactions.
Consumer reporting is a relatively recent development both in Canada and internationally. In Canada it wasn't really until the year 2000 that there was a focus on consumer reporting. Consumers began to be identified as a category or a source of report in 1998. That was the first time there was any ability to know how many reports were actually coming from that source. In 1998 it was estimated that 7.1% of reports were contributed directly by consumers, and by 2006 that had increased to 24.2%. So there has been a significant increase in the number of reports coming directly from consumers.
However, the contribution of consumers to the overall collection of data is very, very low, and what we are mostly focused on is increasing the contribution of consumers to the database. One of the reasons is that both our information and an increasing number of international papers that have been published in the last five years indicate that consumers are really able to make a significant contribution to our knowledge about the safety of medicines that are being prescribed. They are often overlooked as a source of information, or the information they contribute is often downplayed because they're not health professionals and physicians and so forth, but they actually are able to make a significant contribution.
Although the level of consumer reporting has increased in the last four to six years, overall, as I said, the number of consumer reports is quite low. We have conducted in the last three to four years a number of focus groups across the country. What we know is that awareness about Health Canada's ADR program is very, very low in Canada amongst consumers. In fact, if you say the term “adverse drug reaction” to most consumers in Canada, they won't know what you're talking about.
We think this situation really needs to be addressed with dedicated resources and funding by the marketed health products directorate. I concur with Durhane that patient groups, consumer groups, really have to be utilized by Health Canada in a much more significant way than they have done so far. We also believe that the priorities within the health products and food branch are focused on approval of drugs and expedited approvals within 300 days and so on, and that this focus needs to be shifted, obviously not entirely, but there has to be a reorientation and a greater allocation of resources and staffing to the marketed health products directorate.
In the summary I have provided a table comparing the resources and staffing that are allocated between the two directorates, the therapeutic products directorate and the marketed health products directorate. In terms of funding, TPD gets triple the funding that the marketed health products directorate gets and almost four times the staff.
We feel there needs to be a rethinking within the health products and food branch about where their resources and funding are being dedicated.
Finally, in our report I've listed our recommendations. I'm just going to finish by highlighting a few of them.
We make two types of recommendations. One is to increase consumer awareness about ADR reporting, and the other is about the actual collection of consumer ADR reports.
On the awareness side, we think there has to be dedicated funding for community-based promotion of consumer reporting and that there has to be a lot more investment in educational materials and promotion through television, radio, and through the media. We think the toll-free number that consumers can use to report ADRs should be listed on every package insert and every prescription label; that there needs to be a source of government-approved, unbiased information about drug safety and adverse side effects; that there has to be material published and geared towards different literacy skills, because this is a major problem in trying to communicate not only information about the reporting system, but about the risks that are detected in the collection of the ADRs. We also need to think about establishing a national clearing house for patient and consumer information on drug safety that is independent of the pharmaceutical industry.
On the collection side, it's obvious that people need to be trained. When we were first set up, we collected adverse drug reaction reports, and believe me, this is not an easy task for anybody. You have to be trained; you have to be educated.