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Emerging Safety Science: Workshop Summary
voluntary reports of adverse events when an active surveillance network encompassing 100 million people is available. DuMouchel explained that while he is enthusiastic about the idea of an active surveillance network, he believes choosing the correct outcomes to monitor will be challenging. When data are reported to the AERS, a qualified health care provider has already decided that the event is important and should be explored. DuMouchel cautioned that without spontaneous reports, data could be entered into the system without undergoing such scrutiny, and therefore important outcomes could be missed. Although the AERS has a number of limitations as described earlier, until confidence in the ability of an active surveillance system to match the sensitivity of the AERS is established, spontaneous reports should not be abandoned. Platt agreed that spontaneous reports will be needed for the foreseeable future.
Almenoff suggested that an ideal way to approach this issue would be to include in electronic medical records a box that could be checked to indicate that the health care provider believed the occurrence was an adverse event, thereby flagging the event. Responding to this suggestion, Platt said his group is experimenting with “elicited surveillance,” an electronic medical record system including a field designed to prompt clinicians to indicate when an event has occurred (diagnosis or laboratory result) that would not be expected. Using vaccines, this method was tested through comparison with the baseline reporting of the AERS. A five- to six-fold increase in the number of reported events was seen when clinicians were told that they had entered a diagnosis that would be unexpected for an individual who had recently been immunized, and asked whether this might be an adverse event for which they wanted to submit an AERS report. Though Platt believes this might be a good way of soliciting such information from clinicians, he expressed concern that many clinicians are hesitant to attribute unexpected outcomes to drugs, and therefore events could be missed.