Centre for Pharmacoepidemiology and Drug Safety, Division of Pharmacy and Optometry, School of Health Sciences, Manchester Academic Health Science Centre, University of Manchester, UK.
Health Information Technology Department, Faculty of Applied Studies, King Abdul Aziz University, Jeddah, Kingdom of Saudi Arabia.
Br J Clin Pharmacol. 2022 May;88(5):2213-2222. doi: 10.1111/bcp.15150. Epub 2021 Dec 8.
The aim of this study was to assess the incidence, nature, preventability and severity of adverse drug events (ADEs) across three paediatric intensive care units (PICUs) in England.
A prospective observational cohort study was conducted across three PICUs over a three-month period during 2019. Included patients were aged ≤18 years and stayed in PICU for a minimum of 24 hours. Identification of suspected ADEs was performed by trained PICU pharmacists. A multidisciplinary expert panel assessed causality, preventability and severity of events.
A total of 302 patients were included and 62 ADEs were confirmed (definite/probable causality). One in six patients experienced one or more ADEs. The estimated incidence of ADEs were 20.5 per 100 patients (95% CI 15.3-27.5) and 16.7 per 1000 patient-days (95% CI 9.3-29.9). The majority of ADEs were judged preventable by the expert panel (36/62, 58.1%). ADEs were commonly involved with medicines prescribing (29/62, 46.8%) and caused temporary patient harm (42/62, 67.7%). Medications for the central nervous system (14/62, 22.6%), infections (13/62, 20.9%) and cardiovascular system (12/62, 19.4%) were commonly implicated with ADEs. Multivariable analysis revealed that patients who stayed in PICU for ≥7 days (OR 6.29, 95% CI 2.42-16.32) were more likely to experience an ADE compared to patients with a stay of 1-6 days.
ADEs are common in English PICUs and most of them may be preventable. There is a strong association between ADE occurrence and duration of PICU stay, which represents a target for remedial interventions. Exploring contributory factors of preventable ADEs is now necessary to inform preventive policies.
本研究旨在评估英格兰三家儿科重症监护病房（PICU）中不良药物事件（ADE）的发生率、性质、可预防程度和严重程度。
这是一项在 2019 年三个月期间于三家 PICU 中进行的前瞻性观察性队列研究。纳入标准为年龄≤18 岁且在 PICU 中至少停留 24 小时的患者。经培训的 PICU 药师对疑似 ADE 进行识别。一个多学科专家小组评估了事件的因果关系、可预防程度和严重程度。
共纳入 302 例患者，确诊 62 例 ADE（确定/可能的因果关系）。六分之一的患者发生了 1 次或多次 ADE。ADE 的估计发生率为每 100 例患者 20.5 例（95%CI 15.3-27.5）和每 1000 例患者日 16.7 例（95%CI 9.3-29.9）。专家组判断大多数 ADE 是可预防的（36/62，58.1%）。ADE 通常与药物处方有关（29/62，46.8%），并导致患者暂时受到伤害（42/62，67.7%）。与 ADE 相关的药物通常涉及中枢神经系统（14/62，22.6%）、感染（13/62，20.9%）和心血管系统（12/62，19.4%）。多变量分析显示，与住院 1-6 天的患者相比，住院≥7 天（OR 6.29，95%CI 2.42-16.32）的患者更有可能发生 ADE。
ADE 在英国 PICU 中很常见，其中大多数可能是可预防的。ADE 的发生与 PICU 住院时间之间存在很强的关联，这代表了补救干预的目标。现在有必要探索可预防 ADE 的促成因素，以为预防政策提供信息。
