Medication Safety

Hospital, Drug-Maker Team Up to Test New Error Reporting System

By Douglas Page

Pilot program will determine if EHRs can be used to improve physician reporting

Using electronic health records to automatically report adverse drug events to the Food & Drug Administration improves drug safety monitoring. However, the concept also raises broader questions for hospital administrators.

Late last year, Brigham & Women’s Hospital in Boston, along with the pharmaceutical company Pfizer, launched a pilot program called ASTER (Adverse Drug Event Spontaneous Triggered Electronic Reporting) to evaluate whether an EHR can alert the FDA to potential drug side effects.

“Patient safety is currently a core measure across the industry, and hospitals will not be able to operate without this type of reporting in the future,” says Todd Cozzens, CEO of Picis, a health care IT provider.

At the same time, hospital CEOs must consider whether legal time bombs lurk in these types of reporting systems. “If more adverse drug events are suddenly being reported, physicians and drug companies may be asked why these events weren’t discovered and prevented earlier,” says Kevin Carr, M.D., associate chief medical officer at BearingPoint, a management and

consulting firm.

Currently, when physicians discover side effects they must locate a lengthy FDA form, fill it out and fax it. Because reporting is voluntary in the United States, the process is often overlooked.

“Side effects are vastly underreported via voluntary reporting,” Carr says. A recent Oxford University study found that adverse drug events were four times less likely to be reported on long forms than noted in patient charts.

The Brigham & Women’s system simplifies adverse drug event reporting. “The goal is that physicians be able to report side effects through the EHR in 30 seconds or less,” says Jeffery Linder, M.D., the program lead.

Under ASTER, when physicians discontinue a medicine because of an adverse reaction, ancillary information (e.g., drug, reaction, other medications, patient demographics, etc.) is collected in a special window on the computer in about 20 seconds. Once the report is reviewed, it can be sent off with a click.

“We’ve made reporting adverse drug events easy,” Linder says.

Ultimately, the success of ASTER-like reporting will hinge on deploying the EHR across many hospitals and clinics in a way that doctors find useful, and not something to avoid or fear.

“Without correct processes in place, the EHR could begin to resemble a Big Brother surveillance program rather than a system that facilitates better clinical care,” says Mark Probst, chief information officer of Intermountain Healthcare.

This article first appeared in the May 2009 issue of H&HN magazine.

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