I did spend a bit of time on the garbage-in, garbage-out issue. I actually feel strongly that what we need to be doing is looking at sex and gender at the beginning of the process--that is, what's going on in the clinical trials, what's the notice, what's the review, what's the notice of compliance? And because we're not, I think we need to make sure, as we engage citizens in post-market reviews and contributions through adverse events reporting, that we do some special outreach to women.
That being said, the fact is that if we look at who makes up health care providers, if we look at who makes up unpaid health care providers in families, it's women. Inevitably, then, whether we like it or not, we're going to be doing a lot of this reporting anyway.
An educational campaign and a skills campaign for the Canadian public to engage in so that they understand the differences and the symptoms--that's part of the process. It's tied into the quality of health information that patients get when they're given these drugs. They're often not told that they have a drug that's maybe had 5,000 people in it, or told any of those specific things that would make the consumer sit up, take note, and say, “Well, gee, that doesn't sound like me; I'd better be very careful.”
Doctors don't have the time, and there are very few materials I would trust right now, to provide what I would call the “decision support” tools that are needed. Hence, part of post-market surveillance is really about a health information system in a very different way.