ResultsA total of 5366 medication error reports were identified during the time period. Of these, 3660 (68.2%) were classified, from a regulatory perspective (21 CFR 314.80), as serious (causing death, a threat to life, hospitalization, disability, congenital anomaly or requiring intervention to prevent permanent impairment or damage). Death resulted in 528 (9.8%) of these cases. We excluded 59 reports as duplicates or intentional overdoses. A total of 469 deaths were caused by medication errors. These are sorted by the year they were reported to FDA in Figure 1. Of these, 84 reports (18%) were directly reported to FDA by consumers and health care providers via the MedWatch program. Manufacturers reported 385 reports (82%) to FDA. The increase in reports during calendar year 1998 is probably reflective of FDA's decision to capture all medication error reports within one database (AERS) and no longer support a related database, the Drug Quality Reporting System. Figure.Reports of deaths per year received by FDA.Two hundred and seven deaths were assessed as related to an error, 219 as possibly related, and 43 as unrelated.