Quarter Watch: 2008 Quarter 1 : QUARTER WATCH PROJECT TEAM

EXECUTIVE SUMMARY A record number of deaths and serious injuries associated with drug therapy were reported to the US Food and Drug Administration (FDA) in the first quarter of 2008. Serious injuries associated with drug therapy reached a total of 20,745 new cases; there were a total of 4,824 reported deaths, a 2.6-fold increase from the previous quarter. In addition, varenicline (Chantix, Champix), an aid to smoking cessation, accounted for more reported serious injuries than any other prescription drug for a second quarter, with a total of 1,001 new cases and including 50 additional deaths. Varenicline was the subject of a previ ous Quarter Watch Special Report and a separate FDA Public Health Alert about psychiatric adverse events. Ranked second in reported serious injuries was heparin, a drug that helps prevent injury from blood clots. Heparin was the subject of a major product recall after a potentially lethal contaminant was identified and traced to suppliers in China. In the first quarter of 2008, the FDA received reports of 779 cases of serious injury in which heparin was the principal suspect drug. These findings come from a program being developed by the Institute for Safe Medication Practices (ISMP) for improvement of patient safety through increasing understanding of how and why drugrelated injuries and medication errors occur. The results are from analyses of new adverse drug event reports submitted to the FDA. The agency releases computer excerpts of these reports for research use after personal-identifying information has been removed. However, the results of this monitoring program should be interpreted with caution because of the known limitations of these data and the nature of the overall system through which adverse events are monitored in the United States. Because reporting is voluntary, only a small fraction of adverse drug events that occur are ever reported to the FDA or to drug manufacturers who then investigate and forward reports to the agency. Although the sum totals of reported adverse event reports usually provide an accurate overall adverse event profile for a drug, the individual reports themselves do not prove that the drug caused the event described. Trends in Reported Cases Serious injuries and deaths associated with drug therapy were reported for a record total of 20,745 persons in the first quarter of 2008. The total was 38% higher than the average for the previous 4 quarters and the highest for any quarter. Reported deaths totaled 4,824 cases, a 2.6-fold increase over the previous quarter and the highest number of deaths in a calendar quarter since 2004. Fatal cases also accounted for a larger share of all serious cases, 23% of those in the first quarter of 2008 compared with an historical average of 16%. Identifiable medication errors accounted for 7.1% (1,464) of all cases of serious injury. The largest numbers of cases were divided evenly between errors of administration (wrong drug, wrong dose, or wrong route of administration) and overdoses (both accidental and intentional). Most drugs in medical use produced only a small number of reports of serious injury or death. One-half the 773 identifiable drugs tracked in the most recent quarter had 6 or fewer serious adverse events reported. Only 50 drugs accounted for 100 or more reported serious injuries. Hospital Pharmacy Volume 44, Number 1, pp 47–56 2009 Wolters Kluwer Health, Inc.

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