某三甲妇儿医院门诊超说明书用药调查分析

Survey and analysis on off-label drug use in outpatients of a maternity and child health hospital

目的为了解我国妇女、儿童超说明书用药现状和制订医疗机构超说明书用药管理规范提供数据。方法回顾性调查2016年厦门市妇幼保健院门诊超说明书用药情况。分层随机抽取该院儿科、妇产科门诊处方,依据药品说明书,判断其用药医嘱是否存在超说明书用药,以及计算各年龄段儿童中超说明书用药的发生率,分析各超说明书用药类型以及超说明书药品品种情况。结果共抽取门诊处方12 766张,分析处方用药医嘱23 567条,涉及药品423种。按处方、用药医嘱计,超说明书用药发生率分别为23.51%、18.00%。儿童超说明书用药发生率居前3位的年龄段依次为新生儿(45.99%)、婴儿期(27.45%)和青春期(18.01%)。超说明书用药类型方面,儿科主要包括超适用人群(46.74%),超剂量、频次、疗程等(39.04%);妇产科主要为超适应证(52.22%)和超给药途径(28.44%)。超说明书用药种类居前3位,在儿科依次为呼吸系统用药(45.96%)、抗感染药(11.80%)和中成药(10.98%),而妇产科为激素类(42.83%),调节水、电解质平衡类(31.89%)和抗肿瘤类(8.50%)。结论 2016年我院门诊超说明书用药情况较为普遍,医疗机构可通过规范管理,有目的防范用药风险,保障医疗安全。

AIM To investigate the off-label drug use status in outpatients of Xiamen Maternity and Child Health Hospital within consecutive 6 weeks in 2016, and provide the data for the analysis and policy making of off- label drug use in Chinese women and children. METHODS The outpatient prescriptions of pediatrics, gynecolo- gy and obstetrics were collected by stratified random sampling and off-label prescribing was determined according to the drug instructions. The comprehensive analysis of off-label drug use was performed in the following aspects： the age distribution of pediatrics, the category of off-label drug use and category of drugs. RESULTS Totally 12 766 outpatient prescriptions including 23 567 medical advices and involving 423 drugs were collected. The incidence rate of off-label prescribing was 23.51% , 18% and 29.55% respectively by prescriptions, medical advices and drugs. The top 3 highest incidence rates of off-label drug use were 45.99% , 27.45% and 18.01% respectively in newborn, infancy and adolescence. Off-label prescribing in pediatric outpatients occurred mainly in patient popula- tion （46.74%） and dosage/frequency/duration （39.04%）, while occurred mostly in indication （52.22%） and route of administration （28.44%） in gynecology and obstetrics. In addition, this study found that most off-label drugs used in children were respiratory system agents （45.96%）, anti-infectives （11.80%）, Chinese patent drugs （10.98%）, and in gynecology and obstetrics were hormonal agents （42.83%）, solutions affecting water and electrolyte balance （31.89%）, antineoplastic agents （8.50%）. CONCLUSION This study suggests that off-label drug use in outpatients remains common in our hospital. It is urgent for medical institutions to improve management regulating off-label drug use so as to prevent drug-related risks and ensure medication safety.