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基于HACCP的我院药品质量风险管理实践
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| 篇名： | 基于HACCP的我院药品质量风险管理实践 |
| TITLE： | |
| 摘要： | 目的：加强药品质量风险的全面管控，保障患者用药安全。方法：介绍我院根据危害分析和关键控制点法（HACCP）实施药品质量风险管理的步骤和效果。结果：我院从建立工作组入手，绘制药品流程图，根据HACCP原则制订计划[包括危害分析，确定关键控制点（CCP），建立关键限值（CL）、监测体系、纠偏措施、确认程序和质量记录档案]，确定4个CCP即库房及调剂部门储存环境温湿度不达标、药品混放或标识不清、货位存放过期药品、护士站存放过期药品及使用质量存在问题的药品。通过上述管理的实施实现了对药品使用各个环节的有效管控，实施HACCP管理的3年内因药品质量问题引发的危害事故与投诉已降为零，而在实施之前的6年内相关事件发生10起。结论：将HACCP科学地运用于医院药品使用环节的管理，可以有效控制药品质量风险，促进患者的用药安全。 |
| ABSTRACT： | OBJECTIVE： To strengthen comprehensive management and control of drug quality risk so as to guarantee the safety of drug use. METHODS： The steps and effects of drug quality risk management in our hospital were introduced according to hazard 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]. Ultimately， 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 implementation 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. |
| 期刊： | 2016年第27卷第31期 |
| 作者： | 宋菲，董迪，甄健存 |
| AUTHORS： | SONG Fei，DONG Di，ZHEN Jiancun |
| 关键字： | 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 |
| KEYWORDS： | Hazard analysis and critical control point； Hospital drug； Drug quality； Risk management； Critical control point； Safety of drug use |
| 阅读数： | 268 次 |
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