Electronic Medical Records Aid Reporting of Drug Problems

Researchers at Massachusetts General Hospital (MGH; Boston, USA) and Brigham & Women's Hospital (Boston, MA, USA) conducted a proof-of-concept study of a scalable EHR-based system to automatically send electronic adverse drug events (ADE) reports to the US Food and Drug Administration (FDA) in real time. The study involved 26 clinicians who were given access to EHR-based ADE reporting functionality from December 2008 to May 2009. Outcome measures were the number and content of ADE reports; severity of adverse reactions (clinician and computer algorithm defined); and the results of a clinician survey.

The results showed that the clinicians defined 23% of the ADEs as serious, while a computer algorithm defined only 4% of the ADEs as serious. The most common drug classes were cardiovascular drugs (40%), central nervous system drugs (19%), analgesics (13%), and endocrine drugs (7%). The reports contained information, prefilled from the EHR, about comorbid conditions, concurrent medications, weight, and laboratory data. It took the clinicians a mean of 53 seconds to complete and send the form. Importantly, in the clinician survey, 21 of 23 respondents (91%) said they had submitted zero ADE reports to the FDA in the prior 12 months. The study was published early online on October 11, 2010, in Pharmacoepidemiology and Drug Safety.

"EHR-based, triggered ADE reporting is efficient and acceptable to clinicians, provides detailed clinical information, and has the potential to greatly increase the number and quality of spontaneous reports submitted to the FDA," concluded lead author Jeffrey Linder, MD, MPH, and colleagues.

An ADE is either an undesired side effect (such as injury, toxicity, or sensitivity reaction), or the failure to perform as expected, whether or not determined to be attributable to the drug.

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Massachusetts General Hospital
Brigham & Women's Hospital