Chyka P A
Department of Pharmacy Practice and Pharmacoeconomics, University of Tennessee, and Southern Poison Center, Memphis, Tennessee, USA.
Am J Med. 2000 Aug 1;109(2):122-30. doi: 10.1016/s0002-9343(00)00460-5.
The numbers of deaths attributed to adverse drug reactions by death certificates and by the Food and Drug Administration's (FDA) spontaneous postmarketing surveillance system (MedWatch) were compared in order to characterize national mortality statistics.
Mortality statistics related to adverse drug reactions were obtained from national public-use databases of death certificates based on appropriate International Classification of Disease (ICD-9) codes and from MedWatch during 1995. The number of deaths, frequency distributions of sex and age groups, and rankings of drug categories associated with adverse reactions were compared.
During 1995, 206 deaths were attributed to adverse drug reactions on death certificates in the United States, whereas MedWatch tabulated 6,894 fatalities. The proportions of men and women were similar, and the majority of deaths involved persons 60 years of age and older, in both data sets. The rankings of drug categories associated with adverse drug reactions differed in the two data sets.
The numbers of deaths reported in these data sets varied 34-fold and were up to several 100-fold less than values based on extrapolations of surveillance programs. These differences indicate that better and more comprehensive data are needed to develop appropriate health care policies to improve drug safety.
比较死亡证明和美国食品药品监督管理局（FDA）自发上市后监测系统（MedWatch）归因于药物不良反应的死亡人数，以描述国家死亡率统计数据。
从基于适当国际疾病分类（ICD - 9）编码的国家死亡证明公共使用数据库以及1995年期间的MedWatch获取与药物不良反应相关的死亡率统计数据。比较死亡人数、性别和年龄组的频率分布以及与不良反应相关的药物类别排名。
1995年期间，美国死亡证明上归因于药物不良反应的死亡人数为206人，而MedWatch记录的死亡人数为6894人。两个数据集中男性和女性的比例相似，且大多数死亡涉及60岁及以上的人群。两个数据集中与药物不良反应相关的药物类别排名不同。
这些数据集中报告的死亡人数相差34倍，比基于监测项目外推值少高达数百倍。这些差异表明，需要更好、更全面的数据来制定适当的医疗保健政策以提高药物安全性。
