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A Simpler Way to Report Drug Side Effects

Taking advantage of electronic health records.
January 5, 2009

Harmful side effects from drugs are notoriously underreported: in an increasingly time-crunched environment, what doctor has time to fill out lengthy reports for the Food and Drug Administration (FDA)? But accurate reporting of these effects is crucial to enabling the FDA to quickly recognize when a new drug has unexpected consequences.

A new collaboration between pharma giant Pfizer and two Boston hospitals will test whether computerized patient records can boost reporting, making it a routine part of filling out electronic patient charts. According to a report in the Wall Street Journal, Massachusetts General and Brigham and Women’s hospitals will test the program on 30 physicians. Results so far sound promising.

Martin P. Solomon, another Brigham and Women’s internist, said he had submitted only a half dozen reports in 32 years of seeing patients because the reports took so long to fill out and send. Since the study began Dec. 9, Dr. Solomon estimates he has filed at least a dozen.

Now when Dr. Solomon notes in a patient’s computerized chart that he has dropped a drug because of a side effect, a window pops up on his computer asking for the severity of the reaction and a few additional details. Then he clicks a submit button.

The process takes Dr. Solomon 30 seconds at most. “It’s a blink,” he said.

Criticism over lack of post-approval drug-safety monitoring has grown in recent years, especially after the 2004 Viox debacle.

Some drug-safety specialists described the pilot as a promising and innovative answer to the problem of low reporting rates. But they said its success would hinge on making sure the FDA received valuable new data, and the reports would still need to be complemented with vigorous searches for signs of dangerous side effects.

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