医疗机构视角解读新《药品管理法》中使用假劣药的责任  

The responsibility of using counterfeit and inferior drugs in the new drug administration law from the perspective of medical institutions

作　　者：张亮 周秋云[2] 侯文洁[2] 邵蓉[1] ZHANG Liang;ZHOU Qiu-yun;HOU Wen-jie;SHAO Rong(School of International Pharmaceutical Business,China Pharmaceutical University,Jiangsu Nanjing 211198,China;Department of pharmacy,Nanjing Chest Hospital,Jiangsu Nanjing 210029,China)

机构地区：[1]中国药科大学国际医药商学院,江苏南京211198 [2]南京市胸科医院药学部,江苏南京210029

出　　处：《中国医院药学杂志》2020年第15期1679-1683,共5页Chinese Journal of Hospital Pharmacy

基　　金：国家社科基金重大项目(15ZDB167);中国药科大学“双一流”学科创新团队建设项目(CPU2018GY39)。

摘　　要：目的:对新《药品管理法》中涉及医疗机构使用假劣药的责任条款进行剖析,为加强医疗机构的药品质量监管提供参考和依据。方法:对新法的立法背景和执行中可能存在的难点进行分类、汇总和分析。结果:新法对强化医疗机构的药品质量管理有积极作用,但鉴于医疗机构的一些情况,还存在条款宽泛、理解冲突较多,监管主体和法律条款不明确以及法律责任难以落实等问题。结论:新法还需要完善相关细节,尤其要明确医疗机构应承担的法律责任。此外,我们还需要其它相关配套措施,以保障医疗机构的药品质量。OBJECTIVE To analyze the liability clauses of medical institutions involved in the use of counterfeit and inferior drugs in the new Drug Administration Law,and to provide reference and basis for strengthening the drug quality supervision of medical institutions.METHODS The legislative background and difficulties in the implementation of the new law were classified,summarized and analyzed.RESULTS The new law has positive effects on strengthening drug quality supervision in medical institutions.Given some special situations of medical institutions,however,there are still some problems like rules being broadly regulated,many understanding conflicts,ambiguities in the responsibility enforcement and legal terms,together with the difficulty to practice legal liabilities.CONCLUSION The new law still needs improving relevant details,especially regarding the clarification of the legal responsibilities of medical institutions.In addition,we still need other related measures to ensure the quality of medicines in medical institutions.

关 键 词：药品管理法 医疗机构 假劣药 法律责任 

分 类 号：R951[医药卫生—药学]