Commentary on "Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting" by Linder et al.

For the past four decades, voluntary spontaneous reporting of suspected adverse drug reactions has been the cornerstone of postmarketing drug safety surveillance in many countries. The key to this system is the recognition, at the point of care, that an untoward sign or symptom may be the result of a medicine. This suspicion, which is no less important for medical care than it is for drug safety surveillance, only fulfills the goals of the latter system if the practitioner or patient takes the time to submit a report to the drug regulatory authority, national pharmacovigilance center, or the product’s manufacturer that provides a summary of the medical facts surrounding the suspected adverse drug reaction. These reports are useful to drug safety specialists only if they contain sufficient information for an independent assessment of the relationship between the medicine and the adverse event. Such reports need not be long, though they generally should contain a narrative of the event that includes its time course, clinical features, any treatments administered, and its outcome. To put the event in context, medical history, concomitant medication use, relevant laboratory and imaging data, and pertinent histopathological data should be included. What are the barriers today to effective voluntary reporting of suspected adverse drug reactions? In the United States, there are no general requirements that practitioners submit reports either to the US Food and Drug Administration (FDA) or to the drug’s manufacturer. Thus, busy practitioners often do not think of submitting a report; many, in fact, are unaware of this system. To compound this general lack of awareness, completing a MedWatch form requires an estimated 36minutes, time that busy practitioners almost always do not have. Finally, many reports are often submitted with insufficient clinical details to allow for an independent assessment of the relationship between the medicine and the adverse event. Can modern technology help improve awareness of reporting suspected adverse drug reactions, simplify the reporting process for practitioners, and improve the quality of reports? In this issue of Pharmacoepidemiology and Drug Safety, Linder and colleagues describe a pilot project within the Partners Healthcare System to test an alternative, semi-automated method for reporting adverse events. Partners uses a Longitudinal Medical Record (LMR) system that specifically codes adverse drug events, which allowed the researchers to identify 26 physicians who had discontinued a medication due to an adverse event in the year prior to the pilot program. These physicians were given access to ASTER, a remotely hosted central aggregator of reports that interfaced with the LMR. When a physician noted in the LMR that a medicine had been discontinued due to an adverse event, the LMR triggered ASTER, which then collected data from the LMR, populated an ADE reporting form, and made pharmacoepidemiology and drug safety 2010; 19: 1216–1217 Published online 28 October 2010 in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/pds.2050