中国药房2016，Vol.27Issue(31)：4400-4402,3.DOI:10.6039/j.issn.1001-0408.2016.31.24
基于HACCP的我院药品质量风险管理实践
Practice of Drug Quality Risk Management in Our Hospital Based on HACCP
宋菲 1董迪 1甄健存1
作者信息
- 1. 北京积水潭医院药学部，北京 100035
- 折叠
摘要
Abstract
OBJECTIVE:To strengthen comprehensive management and control of drug quality risk so as to guarantee the safe-ty of drug use. METHODS:The steps and effects of drug quality risk management in our hospital were introduced according to haz-ard analysis and critical control point(HACCP). RESULTS:Our hospital started with the establishment of working team,drew out drug flow plot and formulated the plan according to HACCP [including hazard analysis,confirming critical control point (CCP) and establishing critical limit(CL),monitoring system,correcting measures,confirmation procedure and quality record]. Ultimate-ly,4 CCPs were determined,which were temperature and humidity dissatisfaction of drug storing environment,disorder of drug storing or unclear label,expired drugs arrayed on pharmacy storage or nurse station and use of unqualified drug. The implementa-tion of above management obtained effective management and control of every link. There was no hazardous accident and complaint caused by drug quality problem in our hospital in 3 years after HACCP implemented. By comparison,10 accidents involving CCPs were recorded in 6 years before HACCP implemented. CONCLUSIONS:Reasonable application of HACCP can effectively control drug quality risk and promote the safety of drug use in patients.关键词
危害分析和关键控制点法/医院药品/药品质量/风险管理/关键控制点/用药安全Key words
Hazard analysis and critical control point/Hospital drug/Drug quality/Risk management/Critical control point/Safety of drug use分类
医药卫生引用本文复制引用
宋菲,董迪,甄健存..基于HACCP的我院药品质量风险管理实践[J].中国药房,2016,27(31):4400-4402,3.
