超说明书用药致医疗投诉实例分析与对策

Cases analysis and countermeasures of medical complaints induced by off-label use of drugs

目的规范医院超说明书用药管理,为促进临床安全合理用药提供参考。方法对本院发生的4例因超说明书用药引起的医疗投诉实例进行了回顾,包括:注射用纤溶酶超疗程使用、盐酸氨溴索注射液超剂量使用、白芍总苷胶囊和注射用左卡尼汀超适应证用药,对引起医疗投诉的原因进行了分析。结果超说明书用药在临床上有一定的普遍性,但多数并无有效性和安全性的证据,有一定的医疗风险,容易引起争议和医疗纠纷。结论临床应当慎重对待超说明书用药,医院应制定超说明书用药的管理办法和规定,规范超说明书用药管理,临床超说明书用药应有充分的依据和理由,遵循患者知情同意的原则,促进临床合理用药,规避医疗风险。

Objective To provide reference for regulation of off-label drug use and promote rational safe drug use in hospital. Methods Four cases of medical complaints caused by off-label use of drugs were reviewed,which in-cluding super course of injective plasmin,super dose of ambroxol hydrochloride injection,super indication of total glu-cosides of paeony capsule and injective levocarnitine,the causes of medical complaints were analyzed. Results Off-la-bel use of drugs had certain universality in clinical,but most of them had no evidence of effectiveness and safety. There were certain risks,easy to cause controversal and medical disputes. Conclusion Off-label use of drugs should be man-aged cautiously,management measure and regulation of off-label use of drugs should be established in hospital. Clinical off-label use of drugs should be used under basis and reasons,and following the principle of informed and consent of patients,promoting rational drug use in clinical practice,and avoiding medical risks.