Comments on: Adverse Drug Reactions Are A Big Killer: Study http://www.pharmalot.com/2008/03/adverse-drug-reactions-are-a-big-killer-study/ News, Comment and Conversation Mon, 15 Mar 2010 15:20:34 +0000 http://wordpress.org/?v=2.6.2 By: Carol http://www.pharmalot.com/2008/03/adverse-drug-reactions-are-a-big-killer-study/#comment-250720 Carol Thu, 03 Apr 2008 20:26:11 +0000 http://www.pharmalot.com/2008/03/adverse-drug-reactions-are-a-big-killer-study/#comment-250720 Bob -- I agree that e-prescribing adds its own value today. I used to work for such a company and I truly see the worth. Having said that, the big opportunity will come at the "great convergence", when new surveillance methods, emerging clinical / biological knowledge, new-age predictive engines and personal health information all meet up. The e-prescribing tools will alert in real-time that adding a particular medication would likely create an adverse drug reaction in a particular person. I'm NOT talking about today's ultra-false-positive DURs. It's about something wholly new. A girl can dream, eh? More than that, a girl can start to create some of these pieces. Wish me luck. !! Bob — I agree that e-prescribing adds its own value today. I used to work for such a company and I truly see the worth.

Having said that, the big opportunity will come at the “great convergence”, when new surveillance methods, emerging clinical / biological knowledge, new-age predictive engines and personal health information all meet up. The e-prescribing tools will alert in real-time that adding a particular medication would likely create an adverse drug reaction in a particular person.

I’m NOT talking about today’s ultra-false-positive DURs. It’s about something wholly new.

A girl can dream, eh? More than that, a girl can start to create some of these pieces. Wish me luck. !!

]]> By: Melody http://www.pharmalot.com/2008/03/adverse-drug-reactions-are-a-big-killer-study/#comment-233949 Melody Sat, 29 Mar 2008 16:43:09 +0000 http://www.pharmalot.com/2008/03/adverse-drug-reactions-are-a-big-killer-study/#comment-233949 FYI, FDA recent held a workshop. Topic: "Maximizing the Public Health Benefit of Adverse Event Collection Throughout hte Productive Life Cycle." Event was held 1/29/2008, and transcript is now posted at: http://www.fda.gov/ohrms/dockets/dockets/07n0480/FDA-2007-N-0000-TR-(07N-0480).pdf All I can add, after reading is . . . it's a beginning. FYI, FDA recent held a workshop. Topic: “Maximizing the Public Health Benefit of Adverse Event Collection Throughout hte Productive Life Cycle.” Event was held 1/29/2008, and transcript is now posted at:

http://www.fda.gov/ohrms/dockets/dockets/07n0480/FDA-2007-N-0000-TR-(07N-0480).pdf

All I can add, after reading is . . . it’s a beginning.

]]> By: Bob Freeman http://www.pharmalot.com/2008/03/adverse-drug-reactions-are-a-big-killer-study/#comment-233902 Bob Freeman Sat, 29 Mar 2008 16:11:21 +0000 http://www.pharmalot.com/2008/03/adverse-drug-reactions-are-a-big-killer-study/#comment-233902 Carol, I think you've presented an excellent case. To add to your point, clinical trials are conducted on relatively uncomplicated patients simply through the patient inclusion criteria. To your exact point, when the drug is used on real patients who may have signficant co-morbidities and associated poly-pharma regimines, the ADEs start being observed. Throw in OTC and supplements used by the patient and not recorded and you've got a real mess. I've always been amazed at the number of drugs prescribed just to manage the side effects of other drugs. To the other point, e-prescribing offers advantages, certainly as long as the patient frequents one community pharmacy. Carol, I think you’ve presented an excellent case. To add to your point, clinical trials are conducted on relatively uncomplicated patients simply through the patient inclusion criteria. To your exact point, when the drug is used on real patients who may have signficant co-morbidities and associated poly-pharma regimines, the ADEs start being observed. Throw in OTC and supplements used by the patient and not recorded and you’ve got a real mess. I’ve always been amazed at the number of drugs prescribed just to manage the side effects of other drugs.

To the other point, e-prescribing offers advantages, certainly as long as the patient frequents one community pharmacy.

]]> By: Carol http://www.pharmalot.com/2008/03/adverse-drug-reactions-are-a-big-killer-study/#comment-233871 Carol Sat, 29 Mar 2008 15:40:52 +0000 http://www.pharmalot.com/2008/03/adverse-drug-reactions-are-a-big-killer-study/#comment-233871 All the e-prescribing in the world won't stop ADRs. E-prescribing can reduce errors. ADRs are about bad things happening even though drugs are prescribed and used according to FDA guidelines. The fact is, given the way phase 3 clinical trials are conducted, many of the chemical interactions and their biological consequences are simply not discovered until drugs are launched into the real world. There are ways to find and know these, but that requires a different approach to post-marketing surveillance. All the e-prescribing in the world won’t stop ADRs. E-prescribing can reduce errors. ADRs are about bad things happening even though drugs are prescribed and used according to FDA guidelines. The fact is, given the way phase 3 clinical trials are conducted, many of the chemical interactions and their biological consequences are simply not discovered until drugs are launched into the real world. There are ways to find and know these, but that requires a different approach to post-marketing surveillance.

]]> By: Jack2 http://www.pharmalot.com/2008/03/adverse-drug-reactions-are-a-big-killer-study/#comment-215646 Jack2 Tue, 18 Mar 2008 21:09:05 +0000 http://www.pharmalot.com/2008/03/adverse-drug-reactions-are-a-big-killer-study/#comment-215646 electronic prescribing. I don't think all the phase 4 monitoring possible would improve drug safety as much as electronic prescribing. And electronic prescribing would cost a lot less too. electronic prescribing.

I don’t think all the phase 4 monitoring possible would improve drug safety as much as electronic prescribing. And electronic prescribing would cost a lot less too.

]]> By: Justice in Michigan http://www.pharmalot.com/2008/03/adverse-drug-reactions-are-a-big-killer-study/#comment-215636 Justice in Michigan Tue, 18 Mar 2008 20:52:57 +0000 http://www.pharmalot.com/2008/03/adverse-drug-reactions-are-a-big-killer-study/#comment-215636 As I recall, there was a 1998 study in JAMA which had the relative proportions even higher in the U.S.. AEs were estimated to between the 4th and 6th leading cause of death. JAMA wrote an editorial, "Now is the Time to Act on Drug Safety," in which were included essentially the same proposals that we have seen from the IOM, GAO, etc. reports. The editorial notes the same proposals go back to the 1970s. Virtually all of them remain unimplemented. As I recall, there was a 1998 study in JAMA which had the relative proportions even higher in the U.S.. AEs were estimated to between the 4th and 6th leading cause of death.

JAMA wrote an editorial, “Now is the Time to Act on Drug Safety,” in which were included essentially the same proposals that we have seen from the IOM, GAO, etc. reports. The editorial notes the same proposals go back to the 1970s.

Virtually all of them remain unimplemented.

]]> By: Ken Thomas, RN http://www.pharmalot.com/2008/03/adverse-drug-reactions-are-a-big-killer-study/#comment-215544 Ken Thomas, RN Tue, 18 Mar 2008 19:10:49 +0000 http://www.pharmalot.com/2008/03/adverse-drug-reactions-are-a-big-killer-study/#comment-215544 I think more research will reveal that the adverse effects are a compilation of several side effects interacting from the polypharmacy most patients experience. We don't really know what's going on until something manifests itself when a person is taking three or more drugs simultaneously. Hard to study what side effects to expect when you study them and then prescribe them in the presence of multiple drugs in the real world. I think more research will reveal that the adverse effects are a compilation of several side effects interacting from the polypharmacy most patients experience. We don’t really know what’s going on until something manifests itself when a person is taking three or more drugs simultaneously. Hard to study what side effects to expect when you study them and then prescribe them in the presence of multiple drugs in the real world.

]]> By: Dan http://www.pharmalot.com/2008/03/adverse-drug-reactions-are-a-big-killer-study/#comment-215525 Dan Tue, 18 Mar 2008 18:52:03 +0000 http://www.pharmalot.com/2008/03/adverse-drug-reactions-are-a-big-killer-study/#comment-215525 If something is a drug, it has a side effect. It's a fact of nature. An adverse effect, however is harmful, instead of just being undesirable, such as a side effect. Some feel side effects and adverse effects are synonomous with each other. This is something that should be analyzed more thoroughly as a drug works its way through the approval process. If something is a drug, it has a side effect. It’s a fact of nature. An adverse effect, however is harmful, instead of just being undesirable, such as a side effect. Some feel side effects and adverse effects are synonomous with each other.

This is something that should be analyzed more thoroughly as a drug works its way through the approval process.

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