An analysis of 10.2 million adverse report records filed with the FDA along with survey of 123 health professionals by Tufts CSDD, found voluntary adverse drug event (ADE) reporting in the United States is incomplete, inaccurate, and inefficient.
Key findings from the studies, reported in the September/October Tufts CSDD Impact Report, included the following:
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Pharmacists are more aggressive about ADE reporting, compared to nurses and physicians.
ADE reports submitted by patients tend to be more complete than reports submitted by health care professionals.
Completeness and accuracy of ADE reports vary by therapeutic area, with those for CNS drugs posting the highest drug name accuracy and some of the lowest lot number completion rates.
