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住院患者中可预防的药物不良事件:重症监护病房与普通病房的对比研究

Preventable adverse drug events in hospitalized patients: a comparative study of intensive care and general care units.

作者信息

Cullen D J, Sweitzer B J, Bates D W, Burdick E, Edmondson A, Leape L L

机构信息

Department of Anaesthesia, Massachusetts General Hospital and Harvard Medical School, Boston, USA.

出版信息

Crit Care Med. 1997 Aug;25(8):1289-97. doi: 10.1097/00003246-199708000-00014.

Abstract

OBJECTIVES

To compare the frequency and preventability of adverse drug events and potential adverse drug events in intensive care units (ICUs) and non-ICUs. To evaluate systems factors involving the individual caregivers, care unit teams, and patients involved in each adverse drug event by comparing ICUs with non-ICUs and medical ICUs with surgical ICUs.

DESIGN

Prospective cohort study. Participants included all 4,031 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 ICUs and four medical and two surgical general care units.

SETTING

Two tertiary care hospitals: Eleven medical and surgical units, including two medical and three surgical ICUs.

PATIENTS

Adult admissions (n = 4,031).

INTERVENTIONS

None.

MEASUREMENTS AND MAIN RESULTS

Rate of preventable adverse drug events and potential adverse drug events, length of stay, charges, costs, and measures of the unit's environment. 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 adverse drug events or potential adverse drug events and as to severity and preventability. Those individuals involved in the preventable adverse drug event and potential adverse drug event underwent detailed interviews by peer case-investigators. The rate of preventable adverse drug events and potential adverse drug events in ICUs was 19 events per 1000 patient days, nearly twice that rate of non-ICUs (p <.01). The medical ICU rate (25 events per 1000 patient days) was significantly (p <.05) higher than the surgical ICU rate (14 events per 1000 patient days). When adjusted for the number of drugs used in the previous 24 hrs or ordered since admission, there were no differences in rates between ICUs and non-ICUs. ICU acuity, length of stay, and severity of the adverse drug event were greater in ICUs than non-ICUs, but there were no differences between medical ICU and surgical ICU patients. Structured interviews indicated almost no differences between ICUs and non-ICUs for many characteristics of the patient, patient care team, systems, and individual caregivers.

CONCLUSIONS

The rate of preventable and potential adverse drug events was twice as high in ICUs compared with non-ICUs. However, when adjusted for the number of drugs ordered, there was no greater likelihood for preventable adverse drug events and potential adverse drug events to occur in ICUs than in non-ICUs. Preventable adverse drug events and potential adverse drug events occurred in units that functioned normally and involved caregivers who were working under reasonably normal circumstances, not at the extremes of workload, stress, or a difficult environment.

摘要

目的

比较重症监护病房(ICU)和非ICU中药物不良事件及潜在药物不良事件的发生频率和可预防性。通过对比ICU与非ICU、内科ICU与外科ICU,评估涉及个体护理人员、护理单元团队及参与每一药物不良事件的患者的系统因素。

设计

前瞻性队列研究。研究对象包括两家三级医疗医院11个内科和外科科室分层随机抽取的4031例成年住院患者,为期6个月。这些科室包括两个内科ICU、三个外科ICU、四个内科普通护理单元和两个外科普通护理单元。

地点

两家三级医疗医院:11个内科和外科科室,包括两个内科ICU和三个外科ICU。

患者

成年住院患者(n = 4031)。

干预措施

无。

测量指标及主要结果

可预防性药物不良事件和潜在药物不良事件的发生率、住院时间、费用、成本以及护理单元环境指标。事件通过护士和药剂师的模拟自我报告以及护士调查员对所有病历的每日审查得以发现。随后,两名独立评审员对事件进行分类,确定其是否为药物不良事件或潜在药物不良事件,以及严重程度和可预防性。参与可预防性药物不良事件和潜在药物不良事件的个体接受同行病例调查员的详细访谈。ICU中可预防性药物不良事件和潜在药物不良事件的发生率为每1000患者日19起,几乎是非ICU发生率的两倍(p <.01)。内科ICU的发生率(每1000患者日25起)显著高于外科ICU的发生率(每1000患者日14起)(p <.05)。在对前24小时使用的药物数量或入院后医嘱的药物数量进行调整后,ICU与非ICU的发生率无差异。ICU患者的病情严重程度、住院时间及药物不良事件的严重程度均高于非ICU患者,但内科ICU患者与外科ICU患者之间无差异。结构化访谈表明,在患者、患者护理团队、系统及个体护理人员的许多特征方面,ICU与非ICU之间几乎没有差异。

结论

与非ICU相比,ICU中可预防性和潜在药物不良事件的发生率高出一倍。然而,在对医嘱药物数量进行调整后,ICU中发生可预防性药物不良事件和潜在药物不良事件的可能性并不高于非ICU。可预防性药物不良事件和潜在药物不良事件发生在正常运转的科室,涉及的护理人员工作环境基本正常,并非处于工作量极大、压力极大或环境恶劣的极端情况。

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