基层药品不良反应监测机构标准化建设要点研究

Research on Key Points of Standardization Construction of Primary Adverse Drug Reaction Monitoring Institutions

目的:总结基层药品不良反应监测机构进行标准化建设的要点,为基层药品不良反应监测机构开展标准化建设提供对策。方法:从基层药品不良反应监测机构一线监测人员的角度,运用ISO9001质量管理的理念,分析和探讨基层药品不良反应监测机构标准化建设的过程中引入ISO9001质量管理理念的现实意义及其建设要点。结果和结论:提出了基层药品不良反应监测机构标准化建设的六大要点,为其他地市药品不良反应监测机构开展标准化建设提供了思路和参考。

Objective:To summarize the key points of standardization construction of primary adverse drug reaction monitoring institutions,and to provide countermeasures for the standardization construction of primary adverse drug reaction monitoring institutions.Methods:From the perspective of the front-line monitoring personnel of the primary adverse drug reaction monitoring institutions,the concept of ISO9001 quality management is used to analyze and discuss the practical significance of introducing the ISO9001 quality management concept in the standardization construction of the primary adverse drug reaction monitoring institutions and and key points in the construction.Results and Conclusion:Six key points of the standardization construction of primary adverse drug reaction monitoring institutions are proposed,which provide ideas and references for the standardization construction of adverse drug reaction monitoring institutions in other cities.