2016年至2017年某院儿科住院患儿超说明书用药调查分析

Investigation and Analysis of Off-Label Drug Use for Hospitalized Children in the Department of Pediatrics in a Hospital from 2016 to 2017

目的促进儿童合理用药。方法随机抽取某院2016年7月至2017年6月儿科住院患儿病历300份,参照最新版药品说明书、中国国家处方集(2013年儿童版)等,对超说明书用药情况进行统计与分析。结果住院患儿超说明书用药病例占比83.33%,其中用药医嘱超说明书用药占比33.57%;儿童阶段(2~11岁)发生超说明书用药的患儿占比及超说明书用药医嘱占比均居第1,分别为55.60%和55.41%;婴幼儿阶段(28 d至23个月)超说明书用药的比例及超说明书用药医嘱占比分别为34.00%和31.53%;超说明书用药发生率较高的疾病有肺炎、急性支气管炎、急性咽炎;超说明书用药类型排名前5名的为未提及儿童用药信息(35.46%)、超适应证(23.10%)、超适应人群(9.74%)、疗程不当(7.37%)、给药剂量不当(6.49%)。发生超说明书用药的药品种类排名前3的为抗菌药物(16.49%)、呼吸系统药物(13.46%)、中药制剂(12.66%)。结论该院儿科住院患儿超说明书用药情况较普遍,其结果可能为患儿病情起到治疗作用,但也可能导致不良反应,甚至引起医疗纠纷。临床药师需加大循证医学证据收集力度,分析超说明书用药导致患儿发生的不良反应,保障患儿用药安全、有效,同时降低医务人员的法律风险。

Objective To promote the rational drug use for children. Methods Totally 300 medical records of hospitalized children in the Department of Pediatrics in a hospital fi＇om July 2016 to June 2017 were randomly selected, and off-label drug use was statistically analyzed referring to the latest version of the drug instructions, China＇s National Prescription Collection（2013 Children＇s Edition）. Results The off-label drug use for hospitalized children accounted for 83.00%, among them, the off-label drug use of medication orders accounted for 33.57%. The proportion of children（aged 2 to 11） with off-label drug use and the proportion of medication orders were the number one, which was 55.60% and 55.41%. Secondly, for infants and children（28 d-23 months）, the proportion of off-label drug use and the proportion of medication orders were 34.00% and 31.53%.The diseases with high incidence rates of off-label drug use were pneumonia, acute bronchitis, acute phat^yngitis. The top 5 types of off-label drug use were no mention ofchildren＇ s information （35.46%）, super - indication （23.10% ）, super - adaptation （9.74%）, improper course of treatment （7.37 % ） and improper dosage（6. 49% ）.The top 3 drugs with off-label drug use in the drug category were antimicrobial agents（16.49% ）, respiratory system drugs（13.46% ） and traditional Chinese medicine preparation（12. 66% ）. Conclusion The off＇-label drug use of hospitalized children in the Department of Pediatric is common, the results may play a therapeutic role for the condition of children, but also may lead to adverse reactions, and even cause medical disputes. Clinical pharmacists should strengthen evidence- based medical evidence collection, analyze adverse reactions caused by off- label drug use, ensure the safety and eft）ctiveness of medication for children, and reduce the legal risks of medical staff.