实用药物与临床
實用藥物與臨床
실용약물여림상
Practical Pharmacy and Clinical Remedies
2015年
9期
1136-1139
,共4页
药品说明书%超说明书用药%医疗投诉%分析和对策%知情同意
藥品說明書%超說明書用藥%醫療投訴%分析和對策%知情同意
약품설명서%초설명서용약%의료투소%분석화대책%지정동의
Package insert%Off-label use of drugs%Medical complaint%Analysis and countermeasure%Informed and consent
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.
目的 規範醫院超說明書用藥管理,為促進臨床安全閤理用藥提供參攷. 方法 對本院髮生的4例因超說明書用藥引起的醫療投訴實例進行瞭迴顧,包括:註射用纖溶酶超療程使用、鹽痠氨溴索註射液超劑量使用、白芍總苷膠囊和註射用左卡尼汀超適應證用藥,對引起醫療投訴的原因進行瞭分析. 結果 超說明書用藥在臨床上有一定的普遍性,但多數併無有效性和安全性的證據,有一定的醫療風險,容易引起爭議和醫療糾紛.結論 臨床應噹慎重對待超說明書用藥,醫院應製定超說明書用藥的管理辦法和規定,規範超說明書用藥管理,臨床超說明書用藥應有充分的依據和理由,遵循患者知情同意的原則,促進臨床閤理用藥,規避醫療風險.
목적 규범의원초설명서용약관리,위촉진림상안전합리용약제공삼고. 방법 대본원발생적4례인초설명서용약인기적의료투소실례진행료회고,포괄:주사용섬용매초료정사용、염산안추색주사액초제량사용、백작총감효낭화주사용좌잡니정초괄응증용약,대인기의료투소적원인진행료분석. 결과 초설명서용약재림상상유일정적보편성,단다수병무유효성화안전성적증거,유일정적의료풍험,용역인기쟁의화의료규분.결론 림상응당신중대대초설명서용약,의원응제정초설명서용약적관리판법화규정,규범초설명서용약관리,림상초설명서용약응유충분적의거화이유,준순환자지정동의적원칙,촉진림상합리용약,규피의료풍험.
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.
