Pronovost Lauds Patient Reporting of Adverse Events via FDA Site

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."

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.

Pronovost, who directs the Johns Hopkins Armstrong Institute for Patient Safety and Quality, tells me that the FDA effort represents "a whole new paradigm shift, that patients have valuable input and information." The FDA site actually says, "Wanted: Consumers to Report Problems."

Why now? I asked. What was the FDA's tipping point?

"I don't know for sure," Pronovost replied. "But physician reporting [of adverse events from devices and drugs] is pretty low. It's like most medical mistakes. Only a small fraction of what goes wrong really gets reported. I think the FDA probably realized they were missing a whole piece of the story, one they were just closing their eyes to.

"If you think about how so many devices have gone wrong, like pacemakers and [artificial] hips. Who is going to be both most interested and most knowledgeable that an event occurred? By far it's the patient. It doesn't mean the patient is going to know all the facts about it, but boy, they're sure going to know when something happened and what went wrong. That information could trigger further investigations."

He gave me four reasons why reporting from the usual suspects, hospitals and doctors and device manufacturers, has been lackluster.

1. Event reporting requires that providers "see the event as a preventable rather than inevitable. Too often in healthcare, we just assume stuff goes wrong, that things break down or sometimes don't work, and that's just the way things go," he says.

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.

"But a lot of the feedback we got from the physicians was, 'Well, I can give them their prescriptions, but I really don't have time to talk to them.' Like, that's not my job, or it's really not that important.

"And what the FDA did is recognize that if we are going to have patient-centered care, we should not throw away this valuable information that they have…that we've been throwing vast amounts of away by not engaging them. Now we're actually putting structures in place to make that happen."

At Johns Hopkins, inpatients are already urged to report anything they see that doesn't look right, or which they think may be a medical error. In a video that's shown in a loop on the hospital system's TVs to every new patient, Pronovost says in so many words:

Welcome to Johns Hopkins. Your safety is our top priority. And here are things you can watch out for, like if you see someone not washing their hands, we want to know. And here are ways you can let us know.

Pronovost would like to see direct patient and consumer reporting go even further, perhaps with special websites where patients could log in their experiences, or tell their stories. "The public could say 'I was harmed here, in a nursing home, or there, at the hospital' "and that maybe that would make hospitals and doctors take patient safety more seriously than they do today.

Imagine then, he says, "you'd see summary data, 30,000 people harmed today from healthcare, or 40,000. It would be hard for policymakers, the public, and providers not to say, OK. Enough. Now we have to do something about this."