门诊静脉药物超说明书用药调查分析

Investigation and Analysis of Off-Label Use of Intravenous Drugs in Outpatient Department

目的了解门诊静脉药物超说明用药情况。为临床合理用药提供参考依据。方法采用回顾性分析方法,随机抽取某院2013-06-2014-01门诊处方,根据静脉用药的说明书及相关文献资料,分析判断静脉用药超说明书用药情况。结果共抽取门诊静脉用药处方817张,其中超说明书用药处方281张,占34.3%。超说明书用药类型包括：超剂量用药（49.1%）、超溶媒（20.6%）、超给药途径（16.3%）、超适用人群（12.4%）、超适应症（1.42%）。不合理超说明书用药占71.3%,合理用药占28.7%。结论门诊静脉用药超说明书使用普遍存在,虽然有部分超说明书用药有一定合理性,但这些用药易引起法律纠纷和伦理问题,所以对超说明书用药应掌握更多的循证医学证据,才能确定用药安全,对此应引起重视并加以管理和规范。

OBJECTIVE To analyze the off-label use of intravenous drugs in outpatient department of the hospital,and to provide information for rational drug use in clinic. METHODS The outpatient prescriptions,which were randomly sampled from Jun. 2013 to Jan. 2014,were retrospectively reviewed and analyzed according to the drug instructions and other related references. RESULTS A total of 817 outpatient prescriptions with intravenous drugs were selected,in which 281（34. 3%） had off-label drug use. 5 kinds of offlabel drug use of intravenous drugs in outpatient department were as follow,overdose use than the approved label（49. 1%）,improper solvent（20. 6%）,different route of administration（16. 3%）,unsuitable subjects（12. 4%） and improper indications（1. 42%）. In general,71. 3% of those off-label prescriptions were irrational,while others（28. 7%） were rational. CONCLUSION The off-label use of intravenous drugs commonly existing in the outpatient department,although some of which were reasonable,might probable cause legal disputes and ethical issues. More attention should be paid to the management of off-label drug use,and more evidence-based medical evidences should be obtained to ensure the safety of drug use