超说明书用药与司法评判冲突的现状及对策

发布时间：2018-03-23 22:10

本文选题：超说明书用药　切入点：医疗纠纷　出处：《中国药房》2017年28期

【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。
[Abstract]:Objective: to put forward some suggestions for standardizing and guaranteeing the use of hyper-instruction drugs. Methods: through field interviews with pharmacists and lawyers, this paper analyzes the current situation of drug use in the judicial practice at home and abroad, and puts forward the relevant countermeasures. Results and conclusions: at present, China's laws and regulations have not established a mechanism for over-prescribing drugs; there are only "special circumstances" in sporadic clauses, but there is also a lack of explanation. In judicial practice of medical disputes, judges refer to all kinds of references. Such as the authority department to compile the diagnosis and treatment routine and the guide, compiles the medical teaching material, the clinical path, the medical organization internal rule and so on the legitimacy existence different confirmation; The judicial environment in which surrogates are examined also prevents the administration of superprescriptions from being fairly adjudicated. Six countries, including the United States, have legislated to allow reasonable drug use in excess of the specification. FDA requires that the drug should be used for the benefit of patients rather than for clinical trials and to safeguard it. Patients' right to know. Our country should establish the authority standard of over-instruction medicine, The establishment of scientific identification procedures and legislation to ensure the informed consent of patients medical institutions should formulate corresponding management systems and procedures to regulate medical behavior so as to ensure that over-specification of medication is in the interests of both doctors and patients.
【作者单位】：中山大学附属第一医院药学部;广东经纶律师事务所;
【基金】：广东省医学科研基金(No.A2015300)
【分类号】：R95

【相似文献】