Centre for Quality Management of Medicines, Faculty of Pharmacy, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300, Kuala Lumpur, Malaysia.
Drug Saf. 2022 Dec;45(12):1457-1476. doi: 10.1007/s40264-022-01236-6. Epub 2022 Oct 3.
Neonates are at greater risk of preventable adverse drug events as compared to children and adults.
This study aimed to estimate and critically appraise the evidence on the prevalence, causes and severity of medication administration errors (MAEs) amongst neonates in Neonatal Intensive Care Units (NICUs).
A systematic review and meta-analysis was conducted by searching nine electronic databases and the grey literature for studies, without language and publication date restrictions. The pooled prevalence of MAEs was estimated using a random-effects model. Data on error causation were synthesised using Reason's model of accident causation.
Twenty unique studies were included. Amongst direct observation studies reporting total opportunity for errors as the denominator for MAEs, the pooled prevalence was 59.3% (95% confidence interval [CI] 35.4-81.3, I = 99.5%). Whereas, the non-direct observation studies reporting medication error reports as the denominator yielded a pooled prevalence of 64.8% (95% CI 46.6-81.1, I = 98.2%). The common reported causes were error-provoking environments (five studies), while active failures were reported by three studies. Only three studies examined the severity of MAEs, and each utilised a different method of assessment.
This is the first comprehensive systematic review and meta-analysis estimating the prevalence, causes and severity of MAEs amongst neonates. There is a need to improve the quality and reporting of studies to produce a better estimate of the prevalence of MAEs amongst neonates. Important targets such as wrong administration-technique, wrong drug-preparation and wrong time errors have been identified to guide the implementation of remedial measures.
与儿童和成人相比,新生儿面临更大的可预防药物不良事件风险。
本研究旨在评估和批判性地评价新生儿重症监护病房(NICU)中新生儿用药错误(MAE)的发生率、原因和严重程度的证据。
通过检索九个电子数据库和灰色文献,对无语言和出版日期限制的研究进行了系统评价和荟萃分析。使用随机效应模型估计 MAE 的总发生率。使用Reason 事故原因模型综合错误原因数据。
共纳入 20 项研究。在直接观察研究中,以总机会错误作为 MAE 的分母进行报告,MAE 的总发生率为 59.3%(95%置信区间 35.4-81.3,I = 99.5%)。而非直接观察研究以药物错误报告作为分母,得出的总发生率为 64.8%(95%置信区间 46.6-81.1,I = 98.2%)。常见的报告原因是易出错的环境(五项研究),而三项研究报告了主动失误。只有三项研究检查了 MAE 的严重程度,每项研究都使用了不同的评估方法。
这是第一项全面的系统评价和荟萃分析,估计了新生儿 MAE 的发生率、原因和严重程度。需要提高研究的质量和报告水平,以更好地估计新生儿 MAE 的发生率。已经确定了重要的目标,如错误的给药技术、错误的药物准备和错误的时间错误,以指导补救措施的实施。