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The Troubles With Adverse Event Reporting

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According to the September/October edition of the Impact Report released by the Tufts Center for the Study of Drug Development (CSDD), the reporting of adverse events (AEs) by healthcare professionals is inadequate. In particular, regulatory submissions are an issue due to the lack of critical information provided on submission forms, which can inadvertently alter prescribing practices, or worse, result in products being withdrawn from the market. The report also indicates that physicians and nurses are less likely than pharmacists to report AEs, and that patients are more thorough in their own submissions. 

While it’s possible that those in the medical community are reluctant to report adverse events because they’re unsure an event is caused by a certain drug, patients can always take matters into their own hands. As I wrote in a blog post several months ago, patients, at the very least, can submit AE reports via the FDA’s MedWatch Form. They can also use sites, such as Patients Like Me, Iodine, and Smart Patients, to see if others have had similar experiences.

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Eugene Sefanov

Director, Industry and Regional Marketing

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