Study seeks to improve drug safety

The Food and Drug Administration monitors the safety of prescription drugs in the U.S. But experts say that oversight largely relies on busy doctors who often do not take the time to report problems with medications.

The Food and Drug Administration monitors the safety of prescription drugs in the U.S. But experts say that oversight largely relies on busy doctors who often do not take the time to report problems with medications.

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Doctors complain that the current reporting system is time-consuming and cumbersome. Experts say information about drug side effects regularly gets noted in patient files but often doesn’t make it to the FDA.

Researchers in Boston equipped doctors with a computerized reporting system directly linked to each patient’s electronic health record. Michael Ibara was co-leader of the study, called ASTER.

Ibara: During ASTER, for those same physicians that had reported no adverse events in the previous 12 months, they reported over 200 adverse event reports during the five-month period of the study.

Ibara is a director of information management with drug maker Pfizer. He says the study suggests another way health data and technology can be combined to improve patient safety.

Dr. Jeffrey Linder, with Brigham and Women’s Hospital, was co-leader on the pilot program. He says some research suggests that doctors report less than 1 percent of all the unexpected side effects that they encounter.

Linder: In our, for example, electronic health record, we’re discontinuing medicines all the time, and documenting that patients have had adverse reactions to medicines. So we hit upon the idea of taking the information that’s in our health system servers and sending those right on to the FDA.