2019 年第 8 期 第 14 卷

超药品说明书用药的风险与防范管理措施分析

Risk and preventive measures of off-label medication

作者：宋文利

英文作者：

单位：730050兰州市第一人民医院药剂科

英文单位：

关键词：超说明书用药；用药安全

英文关键词：

• 摘要：

• 【摘要】目的    探讨超说明书用药的风险及防范管理措施，规范医疗机构超说明书用药行为，提升合理用药水平。方法    通过合理用药监测系统随机抽取兰州市某医院2018年1—10月的门急诊处方1 602份，分析不合理处方数及所占比例、发生超说明书用药的药品类别、处方点评具体问题。结果    随机抽取的1 602份处方中合理处方1 303份（81.3%），不合理处方299份（18.7%），其中不规范处方19份（6.4%），超说明书用药处方280份（93.6%），未见超常处方。在280份超说明书用药处方中，用药药品涉及12个不同类别，其中循环系统用药19种、消化系统用药7种、抗感染药及抗菌药物6种、呼吸系统用药5种、妇科用药4种、内分泌系统用药3种、眼科用药3种、神经系统用药2种、泌尿系统用药2种、骨科用药1种、镇痛药1种、外用药1种。299份不合理处方中具体存在问题10项，其中占比前3项的问题分别为用法、用量不适宜149份（49.8%）、适应证不适宜85份（28.4%）、药品剂型或给药途径不适宜35份（11.7%）。结论    超说明书用药存在潜在风险，应完善超说明书用药的管理规定，规范临床超说明书用药的审批及实施流程，减少临床不合理用药，增加用药安全性。

• 【Abstract】Objective    To explore the risk and preventive measures of off-label medication; to standardize the clinical behavior of off-label medication and improve rational drug use. Methods    Through rational drug use monitoring system, 1 602 outpatient and emergency prescriptions of a Hospital in Lanzhou from January to October 2018 were randomly selected. Unreasonable prescriptions, types of off-label drugs and specific problems in medication were analyzed. Results    Among 1 602 prescriptions, 1 303(81.3%) were rational and 299 (18.7%) were not; 19(6.4%) prescriptions were not accordance with criterion; 280（93.6%） prescriptions were off-label; no extraordinary prescriptions were noticed. Among 280 off-label prescriptions, there were 12 different categories of drugs, including 19 for circulatory system, 7 for digestive system, 6 for anti-infective drugs and antibiotics, 5 for respiratory system, 4 for gynecology, 3 for endocrinology, 3 for ophthalmology, 2 for nervous system, 2 for urology urinary system, 1 for orthopedics, 1 for analgesics and 1 for external use. Among 299 unreasonable prescriptions, there were 10 specific problems and the top three were inappropriate usage and dosage［149(49.8%)］, inappropriate indication［85(28.4%)］ and inappropriate form of drug or route of administration［35(11.7%)］. Conclusions    There are potential risks in off-label drug use. It is necessary to improve the management regulations, standardize the approval and implementation processes, reduce irrational medication and enhance the safety.