美国处理药品短缺问题的经验及其对我国的启示  

Experiences of American in Dealing with the Drug Shortage Problem and Its' Implication for China

作　　者：杨悦[1] 黄果[2] 初智铭[1] 罗玉晶[1] 林琳[1] 

机构地区：[1]沈阳药科大学,沈阳市110016 [2]国家食品药品监督管理局,北京市100810

出　　处：《中国药房》2008年第28期2173-2176,共4页China Pharmacy

摘　　要：目的:借鉴美国处理药品短缺问题的经验,为我国处理药品短缺问题提出建议。方法:采用文献研究方法和案例研究方法进行研究。结果:美国食品与药品管理局(FDA)建立了由药品评价与研究中心(CDER)和法规事务办公室(ORA)负责的处理药品短缺问题的程序,可以处理不同类型的短缺问题。结论:我国政府应明确一个部门负责处理药品短缺问题,重点解决医疗必需药品短缺,当务之急是摸清药品短缺的情况。OBJECTIVE： To provide suggestions for China in dealing with the drug shortage problem by drawing experiences from USA. METHODS： The study was done by reiviewing literature and cases study. RESULTS： The FDA in USA has established procedures for the Center of Drug Evaluation and Organization of Regulation Affairs to resolve all kinds of drug shortage problems. CONCLUSIONS： A specific department should be set up to be responsible for resolving drug shortage problems in China with an emphasis on the shortage of medical necessary drugs, and it is urgent to get the information of drug shortage.

关 键 词：中国 美国 药品 短缺 医疗必需 

分 类 号：R95[医药卫生—药学]