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Study finds growing risk from drug errors
The recent research from Wake Forest University School of Medicine in Winston-Salem, NC, showing an increase in reported drug errors,1 was based on data in the Food and Drug Administration's (FDA's) Adverse Event Reporting System, which has been in place since 1998.
This system collects all voluntary reports of adverse drug events submitted directly to the agency or through drug manufacturers. The researchers analyzed all serious adverse drug events and medication errors in the United States reported to the FDA from 1998 through 2005, finding that serious adverse drug events increased 2.6-fold from 34,966 to 89,842. Fatal adverse drug events increased 2.7-fold from 5,519 to 15,107.
Reported serious events increased four times faster than the total number of outpatient prescriptions during the period. In a subset of drugs with 500 or more cases reported in any year, drugs related to safety withdrawals accounted for 26% of reported events in that group in 1999, declining to less than 1% in 2005. For 13 new biotechnology products, reported serious events grew 15.8-fold, from 580 reported in 1998 to 9,181 in 2005. The increase was influenced by relatively few drugs: 298 of the 1,489 drugs identified (20%) accounted for 407,394 of the 467,809 events (87%).
1. Moore TJ, Cohen MR, Furberg CD. Serious adverse drug events reported to the food and drug administration, 1998-2005. Arch Intern Med 2007; 167:1,752-1,759.
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