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Greg Webb
Greg Webb
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Class I Drug Recalls Effectively Reaching Public?

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We know that the U.S. Consumer Product Safety Commission recalls faulty and dangerous products, furniture, toys, and more. We know that the U.S. Food and Drug Administration (FDA) has the power to recall food that has been found to be contaminated or that is not properly inspected or is mislabeled, but what about bad or contaminated drugs that get to the marketplace—is there a procedure for drug recalls? FDA recalls drugs and, lately, at least once a month. Unfortunately, there is some concern about how well physicians and patients are notified of the drug recalls. Occasionally, one might see a sign above an empty space in a drugstore or supermarket where the recalled over-the-counter drug has been noted and removed. But what about prescription drugs?

Class I recalls are issued for drugs that, if taken by patients, possible serious adverse health events and/or death could occur. A Reuters article appearing on the FoxNews website, June 5, 2012, noted that in 2008 contamination of the anticoagulant, heparin, was the subject of a class I recall issued by FDA. Unfortunately, some patients who took the contaminated heparin died or had serious reactions to it.

Between 2004 and 2011, research scientists from Brigham and Women’s Hospital in Boston, Massachusetts, tallied 1,700 drug recalls—some 91 of which were Class I type drug recalls. The FDA has a Recall Alert System and is to "notify subscribers of recalled drugs and products." But, of the 91 drugs which were Class I recalls, subscribers received notifications for only 55 of the Class I recalled drugs by the FDA. So one might conclude, the system doesn’t work. FDA has another system called MedWatch, which apparently sent alerts for 18 of the remaining (almost 40) recalled drugs mentioned above and apparently some class I drug recalls were never notified at all by that system, so perhaps MedWatch doesn’t touch all the bases either.

At this point, researcher Joshua Gagne’ of Brigham and Women’s Hospital indicated there is no way to know if the lack of notification in the case of the failed Class I drug recall alerts (by either system) caused patients harm. As health care data becomes more digitized, one can only hope that the FDA will develop an efficient system of notifying all pharmacies and physicians of drug recalls that might affect their patients – we the people.

I would like to think that at this moment, Secretary Sebelius is having a face-to-face, sit-down talk with the Administrator of the FDA and the Director of the Center for Drug Evaluation and Research or whoever is responsible for the notification systems… but probably not. How much responsibility, then, does the manufacturer have for notification? Hopefully, you will not have to find out the answer to this question.