According to the findings of a new study, many nationwide drug recalls go largely unnoticed by doctors and patients, with federal health regulators failing to warn of serious and potentially life-threatening problems associated with widely prescribed medications. The problem appears to be with the U.S. Food & Drug Administration’s notification system for ‘Class I’ drug recalls, which is the most serious category reserved for medications with problems that are likely to cause severe injury or death if used. In response to the study’s findings, FDA officials have indicated that they are currently working on improving their drug recall reporting systems.
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What’s the problem?
For the study, which was published in the Archives of Internal Medicine, researchers investigated 1,700 drug recalls issued between 2004 and 2011. They found about one major recall per month, and determined that 91 of those were Class I recalls, but not all were reported.
Of the 91 Class I recalls, the Recall Alert System only issued notices for 55 of them. The MedWatch reporting system did slightly better, issuing notices for 18 of the remaining Class I recalls. That leaves another 18 – approximately 20% – that were not reported by any FDA system.
The researchers went on to state that not only is incompleteness of reporting a huge problem, but that doctors may have difficulty determining which recalls are important and which are not, due to the fact that both systems attempt to report every drug recall. For example, veterinary drug recalls are reported in exactly the same manner as Class I drugs, which may be life-threatening for humans.
“Equally problematic, the Class I recalls that are communicated through the Recall Alert System become buried in a system that is also used for recalls that have little or no bearing on patient care,” the researchers determined. “It may be difficult for providers who subscribe to and rely on these alerting systems to identify those recalls that are of particular importance.”
After assessing the results of their study, the researchers proposed a comprehensive new strategy for ensuring that healthcare providers are promptly notified when there are clinically important nationwide drug recalls.
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