700例药品不良反应报告超说明书用药情况分析

Analysis of Off-label Drug Uses of 700 Cases of Adverse Drug Reaction Reports

关键词:  药品不良反应  超说明书用药

Key words:  adverse drug reactions  off-label drug uses

摘要:

目的 了解药品不良反应（adverse drug reactions，ADR）报告中超说明书用药的情况，为临床合理用药提供参考。方法 对2014年1~12月收集的药品不良反应报告共700例进行回顾性分析，根据药品说明书对超说明书用药情况进行分析。结果 700例ADR报告中，共有医嘱1 605条，有267份超说明书用药报告（38.1%），有416条超说明书医嘱（25.9%），类型主要为超给药频次、超给药剂量和超适应症，超说明书用药构成比居前3位的药物依次为银杏达莫注射液、前列地尔注射液和注射用美洛西林钠。结论 ADR报告中超说明书用药情况普遍存在，需加强监管，促进临床合理用药，减少ADR的发生。

Abstract:

OBJECTIVE To investigate the situation of off-label drug uses of drug adverse reaction reports, and to promote clinical rational drug use. METHODS A retrospective analysis was conducted on 700 cases of adverse drug reactions reported in our hospital in 2014, according to the drug instructions. RESULTS A total of 1 605 drug prescriptions was recorded in 700 cases of ADR reports, 267 ADR reports involved off-label drug uses(38.1%), 416 drug prescriptions involved off-label drug uses(25.9%). The top three types of off-label uses were off-label administration frequency, overdose, and off-indication use; and the top three drugs were Ginkgo Dipyidamolum, Alprostadil injection, and mezlocillin sodium for injection. CONCLUSION Off-label drug uses are common in ADR reports in our hospital. It is important to tighten monitoring on the off-label drug uses and to promote clinical rational drug uses so as to reduce the incidence of ADR.