中国药事
中國藥事
중국약사
Chinese Pharmaceutical Affairs
2015年
10期
1097-1101
,共5页
药品说明书%超说明书用药%用药风险与用药安全%原因分析
藥品說明書%超說明書用藥%用藥風險與用藥安全%原因分析
약품설명서%초설명서용약%용약풍험여용약안전%원인분석
drug package inserts%off-label drug use%risk and safety of drug use%analysis of cause
目的：加强医务人员对超药品说明书用药的责任和法律意识，为政府部门发布相关法律、法规，以达到安全、有效、合理的用药目的提供建议。方法：查阅超说明书用药的有关文献及规范，简要综述超说明书用药的国内外现状、原因、风险等情况。结果：我国临床超说明书用药现象普遍存在，且发生在儿童上的比例偏高。结论：建议制定超说明书用药的统一判定标准，规范医院用药行为，出台相应的国家政策，使临床超说明书用药更加规范、严格。
目的：加彊醫務人員對超藥品說明書用藥的責任和法律意識，為政府部門髮佈相關法律、法規，以達到安全、有效、閤理的用藥目的提供建議。方法：查閱超說明書用藥的有關文獻及規範，簡要綜述超說明書用藥的國內外現狀、原因、風險等情況。結果：我國臨床超說明書用藥現象普遍存在，且髮生在兒童上的比例偏高。結論：建議製定超說明書用藥的統一判定標準，規範醫院用藥行為，齣檯相應的國傢政策，使臨床超說明書用藥更加規範、嚴格。
목적：가강의무인원대초약품설명서용약적책임화법률의식，위정부부문발포상관법률、법규，이체도안전、유효、합리적용약목적제공건의。방법：사열초설명서용약적유관문헌급규범，간요종술초설명서용약적국내외현상、원인、풍험등정황。결과：아국림상초설명서용약현상보편존재，차발생재인동상적비례편고。결론：건의제정초설명서용약적통일판정표준，규범의원용약행위，출태상응적국가정책，사림상초설명서용약경가규범、엄격。
Objective: To strengthen the responsibility and legal awareness of the medical staff for off-label drug use and put forward suggestions to government departments on issuing relevant laws and regulations to achieve safe, effective and reasonable clinical medicine use.Methods: Through literature review of off-label drug use and regulations, the present situation and relevant speciifcation of the off-label drug use at home and abroad as well as causes, risks and recommendations, etc., were brielfy reviewed.Results: The phenomenon of off-label drug use is prevalent in clinical practice and frequently occurs in children cases.Conclusion: It is recommended to develop uniform drug-label criteria, regulate the behavior of hospital medication and formulate appropriate national policies to achieve more standardized and rigorous off-label drug use.
