Pronovost Lauds Patient Reporting of Adverse Events via FDA Site

Cheryl Clark, October 24, 2013

The FDA apparently isn't satisfied that doctors and hospitals are reporting all they know about drug errors and harm from medical devices. A top physician and safety advocate says enabling patients to report events is a welcome "paradigm shift."

Peter Pronovost, MD

Peter Pronovost, MD

When patient safety rock star Peter Pronovost, MD, learned that the U.S. Food and Drug Administration is now urging patients to report drug and medical device adverse events directly to the agency, bypassing hospitals and doctors, he got so excited he rushed to create a podcast.

"This is fantastic," he effuses. The FDA's Safety Information and Adverse Event Reporting Program's consumer component is "long overdue, and it finally gives patients a voice to say 'here's my experience with these medications.' And now it's our job to take what they submit and make sure we use it to reduce harm from them."

For too long, the Johns Hopkins intensivist says, the model was that "physicians know it all and we don't need the voice of the patient, either because they're not sophisticated enough, or don't know the medicine, or they're going to give us wrong information. And we see now that was a mistake. Yes, we need to work together; patients have an important voice that needs to be heard."

The FDA apparently isn't satisfied that doctors and hospitals are reporting all that they know, as Pronovost's colleague, surgeon Marty Makary, MD, recently documented in a report about the underreporting of surgical mishaps caused by the Da Vinci robot.



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