浅谈制药企业在药品风险管理中的责任  

The Responsibilities of Pharmaceutical Enterprises in Drug Risk Management

作　　者：曹波[1] 王越[2] 徐厚明[2] 邵蓉[1] 

机构地区：[1]中国药科大学国际医药商学院,江苏南京210009 [2]江苏省药品不良反应监测中心,江苏南京210002

出　　处：《中国药物警戒》2008年第3期144-146,154,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的探讨制药企业在药品风险管理中的责任。方法以预防-处理-反馈为主线,结合现状和具体案例,深入剖析制药企业在药品风险管理中应承担的责任。结论制药企业作为药品的供应者,不应只关心产品的销售和利润,还要关注企业与社会的协调发展,关注本企业研发生产的产品的安全性,在药品风险发生之前及时预防风险,在药品风险发生之后主动控制风险,降低损害程度,切实有效地保护消费者的生命安全。Objective To disicuss the responsibilities of pharmaceutical enterprises in drug risk manage ment. Methods With the main line of preventing-handling-feedback, the responsibilities of pharmaceutical enterprises in drug risk management have been deeply analyzed by combining the status with specific cases. Conclusion As drug suppliers, pharmaceutical enterprises should not only concern about product sales and profits, but also concern the coordinated development between the enterprises and society, and the safety of the product that enterprises developed and manufactured. Pharmaceutical enterprises shonld prevent the risks before it occurred timely, and control the risk actively after it occurred, so as to lower the loss coverage and protect the life safety of the consumer effectively.

关 键 词：制药企业 药品风险 风险管理 责任 

分 类 号：R954[医药卫生—药学]