Once again, an analysis of the U.S. system for reporting patient injuries caused by prescription drugs is yielding an unexpected side effect — incomplete information. And a key reason is inconsistent reports filed by drug makers, according to the Institute for Safe Medicines Practices, a nonprofit that tracks drug safety issues.
The Adverse Event Reporting System, which is run by the Food and Drug Administration, is the primary tool for collecting information about side effects that may be caused by medicines. Consumers and physicians may voluntarily report problems to the agency or to a drug maker. But drug makers are required to investigate and then report any side effect that may be attributable to one of their products.
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Does this finding change any of your conclusions in the “Failure to Warn” piece you published last month? It would seem contradictory to tout a finding from a database that you now think it an unreliable set of data.
Hi Sam,
Thanks for the note. The short answer is ‘no.’ And that’s because that earlier piece by a colleague focused on the FDA’s Sentinel Initiative, which looks at
insurance data and medical records to learn about drug risks. That story noted how the effort has so far failed to deliver.
The ISMP analysis looked at a separate database, called FAERS, which consists of reports filed by drug makers, doctors and consumers. This analysis pointed out that drug makers are largely not doing a good job of reporting the basics. And this is a key reason why FAERS is viewed with skepticism, along with concerns that some reports by consumers are off the mark.
Let me know if this helps or, if not, if you have further questions. Always happy to chat.
Best,
ed at pharmalot
Here is an article on reporting trends for two FDA approved medical devices that have subsequently caused serious and even fatal adverse reactions. Patient advocacy has been instrumental in bringing awareness to these problems.
https://www.drugwatch.com/2017/06/20/morcellator-cancer-reports-drop-essure-reports-rise/
Adverse event reporting also covers medical and dental devices in the FDA’s Medwatch system. Yet dental is never mentioned in FDA materials. Patients can now use a convenient app to report drug and device adverse reactions that was developed by a Boston startup, Epidemico. Download at http://www.medwatcher.org.
Given these reported figures – “Aurobindo included this information in 87 percent of nearly 6,000 reports,” the idea that Mylan’s advanced privacy settings could explain their rating of less than 2% is quite …. underwhelming? One must assume our scribe is faithfully reporting what they said but it’s questionable at best.