儿童重症患者超说明书用药情况分析

Investigation of Off-Label Drug Use in Pediatric Intensive Care Unit

目的:调查儿童重症患者超说明书用药现状,分析可能的超说明书用药危险因素,为促进儿科重症监护病区合理用药提供参考。方法:分层随机抽取西北妇女儿童医院2019年儿科重症监护病区的医嘱,根据药品说明书,判断是否为超说明书用药。分析不同年龄段、不同科室、不同级别医师、不同种类药品的超说明书用药发生率。分析超说明书用药与患儿基本信息(年龄、性别)、医师级别和药品信息(基本药物、高警示药物)的相关性。结果:共纳入患儿864例,医嘱13 926条,药品200种,超说明书用药发生率分别为87.27%、53.02%和56.00%。新生儿、女性患儿、高职称医师、基本药物、高警示药物存在较高的超说明书用药风险(P<0.05)。结论:儿童重症患者超说明书用药情况普遍存在,新生儿、女性患儿、高职称医师、基本药物、高警示药物为超说明用药的危险因素。药师需发挥用药指导作用,协助医师规避风险用药,促进重症患儿用药安全合理。

Objective: To investigate the application status of off-label drug use in children from pediatric intensive care unit(PICU), and to analyze the risk factors of off-label drug use, so as to provide reference for promoting the rational drug use in PICU. Methods: Medical orders were selected from the PICU of Northwest Women’s and Children’s Hospital in 2019 through the proportionate stratified random sampling method, and off-label drug use was judged according to the drug instructions. The incidences of off-label drug use in different age groups, departments, levels of clinicians and different kinds of drugs were analyzed. Correlation between off-label drug use and children’s basic information(age, gender), levels of clinicians and drug information(essential drugs, high-alert drugs) was analyzed. Results: A total of 864 children were enrolled, including 13,926 medical orders and 200 kinds of drugs. The incidence of off-label drug use was respectively 87.27%, 53.02% and 56.00%. Newborns, female children, clinicians with high professional titles, essential drugs and high-alert drugs had higher risks of off-label drug use(P<0.05). Conclusion: Off-label drug use is widespread in children from PICU. Newborns, female children, clinicians with high professional titles, essential drugs and high-alert drugs are risk factors of off-label drug use. Pharmacists are supposed to play a role in guiding rational drug use, assisting clinicians in avoiding drug use risks and promoting the safe and rational drug use in critically ill children.