THE INCIDENT REPORTING SYSTEM DOES NOT DETECT ADVERSE DRUG EVENTS - A PROBLEM FOR QUALITY IMPROVEMENT
THE INCIDENT REPORTING SYSTEM DOES NOT DETECT ADVERSE DRUG EVENTS - A PROBLEM FOR QUALITY IMPROVEMENT
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DOI：
10.1016/s1070-3241(16)30180-8
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发表时间：
1995-10-01
期刊：
影响因子：
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通讯作者：
LEAPE, LL
中科院分区：
文献类型：
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作者：
CULLEN, DJ;BATES, DW;LEAPE, LL
目的：本研究的目的是：1）确定住院患者中药物不良事件导致事件报告（IR）的频率; 2）确定质量保证管理人员、质量保证护士长和护士之间是否存在差异，即是否应该或将要为每个药物不良事件提交事件报告。研究对象为1993年2月至7月在一所三级医院的5个监护病房（1个内科重症监护病房、2个外科重症监护病房和2个内科普通监护病房）住院的所有患者。主要结局指标为药物不良事件（ADE）和IR。共识投票是由医院的高级管理人员，护理领导，护士，以确定是否应报告的药物不良事件，并已reported.Results：54药物不良事件的研究确定，只有3例（6%）有相应的事件报告提交给医院的质量保证计划或呼吁到药房热线。通过IR而非ADE研究确定了另外1起ADE。在55起ADE中，15起是可以预防的，26起是严重或危及生命的，但26起中只有2起导致了事件报告。三个投票组一致认为，大多数ADE合理的IR，但判断，在实际操作中，IR将很少有filed.Conclusions：自愿报告确定只有一小部分ADE。使用IR进行质量保证/质量改进将在评估护理质量时导致显著偏倚。
Objectives: The objectives of this study were 1) to determine the frequency with which adverse drug events result in an incident report (IR) in hospitalized patients; and 2) to determine if there were differences between quality assurance administrators, nurse leaders in quality assurance, and staff nurses as to whether an incident report should or would be filed for each adverse drug event.Study design: All patient admitted to five patient care units (one medical intensive care unit, two surgical intensive care units, and two medical general care units) in one academic tertiary care hospital were studied between February and July 1993.The main outcome measures used were adverse drug events (ADEs) and IRs. Consensus voting was used by senior hospital administrators, nursing leaders, and staff nurses to determine whether an adverse drug event should have been reported and would have been reported.Results: Of 54 adverse drug events identified by the study, only 3 patients (6%) had a corresponding incident report submitted to the hospital's quality assurance program or called into the pharmacy hotline. One additional ADE was identified by an IR, but not by the ADE study. Of the 55 ADEs, 15 were preventable, and 26 were serious or life-threatening, yet only 2 of the 26 led to an incident report. The three voting groups agreed that most ADEs justified an IR, but judged that in actual practice, an IR would infrequently have been filed.Conclusions: Voluntary reporting identified only a small fraction of ADEs. Using IRs for quality assurance/quality improvement will lead to significant bias when assessing quality of care.