本文選題：超說明書用藥　切入點：醫(yī)療糾紛　出處：《中國藥房》2017年28期

【摘要】：目的:為規(guī)范和保障超說明書用藥提出建議。方法:通過實地采訪藥師和律師團(tuán)隊,分析超說明書用藥在國內(nèi)外司法實踐中的現(xiàn)狀,并提出相關(guān)對策。結(jié)果與結(jié)論:目前,我國的法律法規(guī)并未建立超說明書用藥的機(jī)制;僅在零星條款中有"特殊情況"的表述,但也缺乏解釋;醫(yī)療糾紛司法實踐中,法官對各類參考依據(jù),如權(quán)威部門編寫的診療常規(guī)和指南、統(tǒng)編醫(yī)學(xué)教材、臨床路徑、醫(yī)療機(jī)構(gòu)內(nèi)部規(guī)章等的合法性存在不同認(rèn)定;以鑒代審的司法環(huán)境也令超說明書用藥不能被公正裁決。美國等6國立法允許合理的超說明書用藥,FDA要求超說明書用藥必須是為了患者利益而非臨床試驗并保障患者知情權(quán)。我國應(yīng)確立超說明書用藥的權(quán)威規(guī)范、規(guī)定科學(xué)的鑒定程序、立法保障患者的知情同意,醫(yī)療機(jī)構(gòu)應(yīng)制訂相應(yīng)管理制度和流程來規(guī)范醫(yī)療行為,從而保障超說明書用藥符合醫(yī)患雙方利益。
[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.
【作者單位】： 中山大學(xué)附屬第一醫(yī)院藥學(xué)部;廣東經(jīng)綸律師事務(wù)所;
【基金】：廣東省醫(yī)學(xué)科研基金(No.A2015300)
【分類號】：R95

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