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Pronovost Lauds Patient Reporting of Adverse Events via FDA Site

Cheryl Clark, for HealthLeaders Media, October 24, 2013

2. The "bystander effect, a phenomenon that emerged in the 1960s after a New York woman named Kitty Genovese was stabbed to death in front of hundreds of people, none of whom, despite her pleas, came to help. "What [sociologists] realized was that when no one is assigned responsibility or accountability, everyone just assumes someone else will do it.

"In device or drug adverse event reporting, if you're a physician, you might say, 'I'm just one doctor, out of thousands, that is seeing this," Pronovost explains.

3. Often doctors and hospitals lack awareness that they should report or don't know how to report.

4. They don't have time, or aren't savvy about the FDA's MedWatch Website.

Pronovost, perhaps best known for his checklist that has reduced central line-associated bloodstream infection (CLABSI) rates to zero at some hospitals, believes the FDA's red carpet for consumers to report these serious adverse events directly is an important leap for advancing the concept of "patient-centered" care.

"We talk a lot about 'patient engagement' and 'patient-centered care,'" he explains. But in physician culture, "though we use those words, much of what we do in practice doesn't reflect that we really believe in patient engagement at all."

He gave an example. In one of his care improvement projects, he and his team are helping physicians improve their patients' blood pressure control, an intervention that requires physicians to activate and talk with their patients.

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