Digital Records Spot Side Effects

Computerized patient records could be used to improve lax reporting of serious drug side effects, the results of a small study suggest. The study, at Massachusetts General and Brigham & Women's hospitals in Boston and sponsored by Pfizer Inc., showed a large increase in reporting of adverse events to the Food and Drug Administration once doctors used an automated tool.

Over five months in 2008 and 2009, 26 doctors at the two hospitals reported 217 side effects to regulators, compared with zero reports in the same group in the previous year, according to the study, published online Monday in the medical journal Pharmacoepidemiology and Drug Safety. When one of the doctors in the study recorded discontinuing a medicine because a patient experienced an adverse event, the hospital's electronic patient record system generated an alert. The system asked the doctor whether the side effect was serious and submitted a report to regulators. About one in five of the reports involved serious side effects, such as hospitalizations, said Jeffrey Linder, a Brigham & Women's internist who led the study. Dr. Linder said the tool might need to be tweaked to reduce reporting of nonserious effects, though he said it is helpful to learn about less-serious events if they turn out to affect large numbers of people.