Pharmalot: What prompted your organization to look at side effects so closely? Cohen: We've collected medication error reports for many years, actually, starting in the 1970s. If you went to our website, you'd see a lit of what we call high alert drugs, where outcomes are generally more serious. We've done surveys and some research and maintain a list of drugs most likely to injure patients. We've been an organization that collects med errors from practitioners who want to tell us their stories. So we collect anedoctal reports and we publish them along with prevention strategies that are peer-reviewed, and we have a newsletter that goes to every hospital every two weeks, another that goes to nurses every month and one for consumers. We've been doing this for years, and it's had an impact...Sometimes, these are product related - a device with some flaw. Some errors are due to names that sound or look alike, and were later changed. Some are practice-related - a doctor's handwriting or a nurse checking an arm band...But it's always anecdotal reports that prove things are happening and you don't want to see them repeated. So you publish and hope they don't keep happening.
But we aren't an organization that collects thousands and thousands of reports and runs large databases. We've always been a practitioner reporting program. But the FDA's database has many more reports than we would ever hope to attract, and we thought we should look to see what's there. So we made software modifications to extract some info and see what's getting reported most frequently - which drugs and categories asociated most with patient harm. And what we've done is not necessarily an accurate count of something happening out there and we've included those caveats in our articles. Anyway, we started that last year.
Pharmalot: Why the focus on Chantix? Cohen: That is the one we saw most frequently causing harm. That's just what showed up. As we tried to include in the (most recent) report, there are many factors out there that include events with Chantix. Fentanyl was second most frequently noted drug. But the reaction went beyond what we expected. We attempted to make contact with Pfizer and let the FDA know and had drug safety exprets look at it before it was published. We didn't hear back from Pfizer. But there's been no argument as far as the count (of adverse events).
I certainly understand why Pfizer would be concerned that we may have stoked some reports from our first report earlier, but I don't think enough attention was paid to accident and sudden loss of consciousness as we did. The Federal Aviation Administration brought a lot of attntion to this, and since then, addtionol actions by the Department of Defense - for people handle missile launching devices - and the Department of Transportation with drivers. I think that was a good move. For people who control a vehicle, you want to know if these occur and are reported. And this hasn't been denied. The FDA confirmed accidents in the database and are looking into it now. It wasn't clearly delineated in product labeling, although it did say use caution when driving. But we had a hard time finding the driving language...
But we're not just going to focus on Chantix in every report. We're looking to see what kind of problems are reported to the FDA Medwatch database. If we see other drugs, we might focus attention there.. We're a little concerned with the number of reports with Fentanyl, which is being abused and leading to adverse events that are leading to overdosing. We don't know if we'll look into that for sure.
Pharmalot: If you use the FDA database, why is ISMP is the first to release this kind of data? Cohen: I guess were the only ones who have done this so far. I don't know why the FDA hasn't done this on a regular basis. Maybe they have good reasons. They did release a quarterly report that listed 20 drugs that they are paying special attention to, but it didn't have any quantitative data. I don't know what kind of software they have that allows them to look at the Adverse Event reporting system. In any event, I think it's good to have an outside organization doing this.
Pharmalot: Has the problem of side effects gotten bigger because more people are taking more meds, or is it that you found a new way to pay attention? Cohen: I think some reports come from doctors and some from patients... We always have concerns that side-effect reports are increased by different factors, including publicity given the news media, but we have no way to control that... We have a lot of drugs and categories that weren't even available several years ago. Now, a lot of good has come from that, but at the same time, there are more adverse effects. We're not saying drug therapy is bad, but when we recognize there are serious problems, it's important to follow up... We hope people understand this. We're trying to provide a public service.
With Chantix, there's a balance. It's important to get it in the labeling and make people aware of the side effects, like driving or operating machinery while you're taking the drug may not be a good idea. By the same token, it is a drug that can help a certain number of patients stop smoking...I think people just weren't aware of the downside, and with almost every medication, there's an up side and a down side. And that's what we're seeing here.