从系列药品不良反应事件的原因分析浅谈加强医院制剂管理

Experience on Management of Hospital Preparation by Analyzing the Cause for a Set of ADR Events

目的:为医疗机构加强医院制剂的质量管理提供参考。方法:对"亮菌甲素事件"、"欣弗事件"、"甲氨蝶呤事件"、"刺五加事件"系列药品不良反应事件发生的原因与药品生产之间的关系进行探讨,并结合医院制剂的质量管理现状进行分析。结果与结论:上述药品不良反应事件的发生与药品生产中的质量管理具有紧密关系,提示医院制剂应建立与制剂配制相适应的质量管理体系,加强对制剂配制全过程的管理,确保医院制剂的质量安全。

OBJECTIVE： To provide reference for the quality management of hospital preparation in medical institution. METHODS： The relationship between the cause for some typical ADR events such as ＂Armillarisin A Injury＂, ＂Xinfu Injury＂, ＂Methotrexate Injury＂, ＂Aesculus Witsonii Rehd Injury＂ and drug production were discussed and analyzed by combining with status quo of preparation management in hospital. RESULTS ＆ CONCLUSIONS： Above ADR events were connected with quality management in drug production closely. The quality management system of hospital preparation should be established to strengthen management of whole preparation process and guarantee the safety of hospital preparation.