Methods to Reduce Medication Errors in a Clinical Trial of an Investigational Parenteral Medication.
Methods to Reduce Medication Errors in a Clinical Trial of an Investigational Parenteral Medication.
复制标题
减少研究性肠外药物临床试验中用药错误的方法。
DOI：
10.1016/j.conctc.2016.06.005
复制
发表时间：
2016
影响因子：
1.5
通讯作者：
Puder,Mark
中科院分区：
文献类型：
--
作者：
Fell,GillianL;O'Loughlin,AlisonA;Nandivada,Prathima;Potemkin,AlexisK;Mitchell,PaulD;Mahoney,Judith;Gura,KathleenM;Puder,Mark
很少有循证指南来指导复杂临床试验的最佳设计，例如评估每日静脉注射药物的安全性和有效性，每天输注时间超过数小时，治疗持续时间可能长达数年。本研究是对研究药物的住院给药偏离报告的回顾性审查，研究药物每日给药，输注时间为8-24小时，每例患者的治疗持续时间不同。我们报告了2007-2008年进行的研究设计修改，旨在最大限度地减少与机构审查委员会和美国食品药品监督管理局批准的研究药物输注方案的偏差。修改旨在最大限度地减少输注速率错误、剂量错误、患者错误或给药错误。我们发现，采用特定研究设计变更后，研究药物的这些类型给药错误的发生率显著降低。本报告为在住院患者中检测研究药物静脉输注给药的安全性和疗效的临床试验设计提供了指南，以最大限度地减少给药方案偏离并优化患者安全性。
There are few evidence-based guidelines to inform optimal design of complex clinical trials, such as those assessing the safety and efficacy of intravenous drugs administered daily with infusion times over many hours per day and treatment durations that may span years. This study is a retrospective review of inpatient administration deviation reports for an investigational drug that is administered daily with infusion times of 8–24 h, and variable treatment durations for each patient. We report study design modifications made in 2007–2008 aimed at minimizing deviations from an investigational drug infusion protocol approved by an institutional review board and the United States Food and Drug Administration. Modifications were specifically aimed at minimizing errors of infusion rate, incorrect dose, incorrect patient, or wrong drug administered. We found that the rate of these types of administration errors of the study drug was significantly decreased following adoption of the specific study design changes. This report provides guidance in the design of clinical trials testing the safety and efficacy of study drugs administered via intravenous infusion in an inpatient setting so as to minimize drug administration protocol deviations and optimize patient safety.