超说明书用药与司法评判冲突的现状及对策  

Present Situation and Countermeasures of Conflict between Off-label Drug Use and Judicial Evaluation

作　　者：邓斌[1] 韦炳华[1] 洪晓丹[1] 唐蕾[1] 符忠 

机构地区：[1]中山大学附属第一医院药学部,广州510080 [2]广东经纶律师事务所,广州510620

出　　处：《中国药房》2017年第28期3892-3895,共4页China Pharmacy

基　　金：广东省医学科研基金(No.A2015300)

摘　　要：目的:为规范和保障超说明书用药提出建议。方法:通过实地采访药师和律师团队,分析超说明书用药在国内外司法实践中的现状,并提出相关对策。结果与结论:目前,我国的法律法规并未建立超说明书用药的机制;仅在零星条款中有"特殊情况"的表述,但也缺乏解释;医疗纠纷司法实践中,法官对各类参考依据,如权威部门编写的诊疗常规和指南、统编医学教材、临床路径、医疗机构内部规章等的合法性存在不同认定;以鉴代审的司法环境也令超说明书用药不能被公正裁决。美国等6国立法允许合理的超说明书用药,FDA要求超说明书用药必须是为了患者利益而非临床试验并保障患者知情权。我国应确立超说明书用药的权威规范、规定科学的鉴定程序、立法保障患者的知情同意,医疗机构应制订相应管理制度和流程来规范医疗行为,从而保障超说明书用药符合医患双方利益。OBJECTIVE：To provide suggestions for standardizing and protecting the off-label drug use. METHODS：Accord-ing to the field interviews with pharmacists and lawyers,the present situation of off-label drug use in judicial practice at home and abroad,and relevant countermeasures were put forward. RESULTS ＆ CONCLUSIONS：At present,there was no mechanism for off-label drug use in the laws and regulations in China;there was only＂special circumstances＂statement in sporadic terms,while lacking explanation. In judicial practice of medical disputes,judges had different identifications in various references,such as the le-gality of routine and guidelines,teaching medical materials,clinical pathways,and internal regulations of medical institutions pre-pared by authoritative departments. Meanwhile,the judicial environment of hearing cases by identification made the off-label drug use had impartial adjudication. Legislation in 6 countries,including America,allows reasonable off-label drug use;FDA required off-label drug use must be for the benefit of patients rather than clinical trials,and it also should protect the patient＇s right to know. China should establish the authority specification of off-label drug use,providing scientific identification procedures,protect the patient ＇s informed consent by law. Medical institutions should develop relevant management system and processes to regulate medical prac-tices and ensure off-label drug use in line with the interests of doctors and patients.

关 键 词：超说明书用药 医疗纠纷 司法实践 

分 类 号：R95[医药卫生—药学]