INCIDENCE OF ADVERSE DRUG EVENTS AND POTENTIAL ADVERSE DRUG EVENTS - IMPLICATIONS FOR PREVENTION
INCIDENCE OF ADVERSE DRUG EVENTS AND POTENTIAL ADVERSE DRUG EVENTS - IMPLICATIONS FOR PREVENTION
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DOI：
10.1001/jama.274.1.29
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发表时间：
1995-07-05
影响因子：
120.7
通讯作者：
LEAPE, LL
中科院分区：
文献类型：
--
作者：
BATES, DW;CULLEN, DJ;LEAPE, LL
目标。评估药物不良事件（ADE）和潜在ADE的发生率和可预防性。分析可预防的事件，以制定预防策略。设计。前瞻性队列研究。内裤。-所有4031成人入院的分层随机抽样的11个内科和外科单位在两个三级保健医院超过6个月的时间。单位包括两个内科和三个外科重症监护病房和四个内科和两个外科普通护理病房。不良药物事件和潜在的ADE。通过护士和药剂师的刺激自我报告以及护士调查员对所有图表的日常审查来检测事件。事件随后由两名独立评审员进行分类，以确定它们是否代表ADE或潜在ADE以及严重程度和可预防性。在6个月内，确定了247起ADE和194起潜在ADE。外推的事件发生率为每100例非产科住院患者中有6.5例ADE和5.5例潜在ADE，每家医院每年的平均数量约为1900例ADE和1600例潜在ADE。在所有ADE中，1%为致命性（不可预防），12%危及生命，30%严重，57%显著。28%被认为是可以预防的。在危及生命和严重的ADE中，42%是可预防的，相比之下，18%的重大ADE，导致可预防ADE的错误最常发生在订购（56%）和给药（34%）阶段;转录（6%）和分发错误（4%）不太常见。如果错误发生在过程的早期，错误更有可能被拦截：在订购阶段为48%，在管理阶段为0%，结论。药物不良事件很常见，通常是可以预防的;严重的ADE更有可能是可以预防的。大多数是由于订购阶段的错误造成的，但也有许多发生在管理阶段。预防战略应针对药物输送过程的两个阶段。
Objectives.-To assess incidence and preventability of adverse drug events (ADEs) and potential ADEs. To analyze preventable events to develop prevention strategies.Design.-Prospective cohort study.Participants.-All 4031 adult admissions to a stratified random sample of 11 medical and surgical units in two tertiary care hospitals over a 6-month period. Units included two medical and three surgical intensive care units and four medical and two surgical general care units.Main Outcome Measures.-Adverse drug events and potential ADEs.Methods.-Incidents were detected by stimulated self-report by nurses and pharmacists and by daily review of all charts by nurse investigators. Incidents were subsequently classified by two independent reviewers as to whether they represented ADEs or potential ADEs and as to severity and preventability.Results.-Over 6 months, 247 ADEs and 194 potential ADEs were identified. Extrapolated event rates were 6.5 ADEs and 5.5 potential ADEs per 100 nonobstetrical admissions, for mean numbers per hospital per year of approximately 1900 ADEs and 1600 potential ADEs. Of all ADEs, 1% were fatal (none preventable), 12% life-threatening, 30% serious, and 57% significant. Twenty-eight percent were judged preventable. Of the life-threatening and serious ADEs, 42% were preventable, compared with 18% of significant ADEs, Errors resulting in preventable ADEs occurred most often at the stages of ordering (56%) and administration (34%); transcription (6%) and dispensing errors (4%) were less common. Errors were much more likely to be intercepted if the error occurred earlier in the process: 48% at the ordering stage vs 0% at the administration stage,Conclusion.-Adverse drug events were common and often preventable; serious ADEs were more likely to be preventable. Most resulted from errors at the ordering stage, but many also occurred at the administration stage. Prevention strategies should target both stages of the drug delivery process.