中山市坦洲医院15460张超说明书处方的用药分析

Off-label Drug Use in Zhongshan Municipal Tantou Hospital: Analysis of 15 460 Prescriptions

目的:了解广东省中山市坦洲医院(以下简称"我院")门诊超说明书用药情况,促进临床安全、合理用药。方法:2011年1月—2014年7月,每天随机抽查我院一定比例门诊处方,以药品说明书为依据,比较处方中开具药品的适应证、适应人群、给药剂量、给药频次、给药途径、禁忌证、配伍禁忌等与说明书的相符性,不符者即为超说明书用药处方。结果:共抽取64 930张处方,占总处方数的3.36%。超说明书用药处方15 460张,占抽取总处方数的23.81%。超说明书用药类型居前3位者分别是给药频次(67.35%)、适应证(20.66%)和给药途径(11.51%),超说明书用药居前3位的科室分别是小儿内科(42.80%)、急诊科(38.38%)和内科门诊(7.63%)。15 460张超说明书用药中,医护人员不规范操作占79.33%,无大量临床研究数据支持、循证医学证据不足占7.68%,有多中心样本的循证医学证据支持占12.99%。结论:我院超说明书用药比例较高,需制定相应措施,提高规范用药水平。

OBJECTIVE：To investigate the off-label drug use in outpatient prescriptions in Zhongshan Municipal Tanzhou Hospital （hereinafter referred to as ＂ our hospital＂） to promote clinical safe and rational use of drugs. METHODS： From January 2011 to July 2014, a certain ratio of prescriptions per day were randomly sampled from our hospital for evaluation of the conformity between the prescriptions and the package inserts in terms of indications, target population, dosage and frequency of administration, route of administration, contraindications and incompatibility. The prescriptions found to be of inconformity with drug package inserts were regarded as off-label ones. RESULTS： A total of 64 930 prescriptions were sampled, accounting for 3.36% of total. 15 460 were off-label prescriptions, accounting fii^r 23.81% of the total prescriptions sampled. In terms of off-label types, administration frequency （67.35%）, indications （20.66%）, and route of administration （11.51% ） ranked among the top three; in terms of departments, the Department of Pediatrics （42. 80% ）, the Emergency Department （38.38%） and the Department of Internal Medicine （7.63%） dominated the top three places. The off-label use in 79.33% were caused by non-standard operations of physicians and doctors, and in 7.68% caused by lack of support of considerable clinical trial data or lack of evidence-based medicine data; the off-label prescriptions supported by evidence-based medicine data of muhicenter samples accounted for 12.99%. CONCLUSIONS： The off-label use was frequent in our hospital, therefore, it is important for hospitals develop appropriate measures to improve the rational level in dug use.