探讨药品生产企业如何建立药物警戒体系  

How Drug Manufacturers to Establish Pharmacovigilance System

作　　者：彭丽丽[1] 范燕[1] 刘巍[1] 郭雪[1] 胡军[1] 

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100045

出　　处：《中国药物警戒》2017年第11期666-670,共5页Chinese Journal of Pharmacovigilance

摘　　要：目的通过探讨建立药品生产企业药物警戒体系的必要性和相关要素,为构建和完善我国药品生产企业药物警戒体系提供参考和帮助。方法通过借鉴全面质量管理理论中的"人、机、料、法、环"五个主要影响因素,提出我国药品生产企业建立药物警戒体系,至少应具备专职的人员和机构、收集足够的安全性信息、全面切实的文件质量管理体系、及时和高效处理的数据系统及充满"患者安全第一"的企业环境。结果与结论随着科技和社会的进步以及人们对生活质量要求的不断提高,全球对药品安全问题越来越关注,药品生产企业作为"药品安全第一责任人",开展药物警戒工作责无旁贷,药品生产企业应当进一步加强对药物警戒的认识和理解,设置专门的机构和人员负责药物警戒工作,构建全面的质量管理体系并加强企业内部的培训宣传工作,建立一个高效的警戒体系,为药物警戒工作的开展提供必要的保障。Objective Through discussing the necessity and factors of drug manufacturers＇ pharmacovigilance（PV）system, to provide reference and help in building and improving their pharmacovigilance system. Methods By referring the four elements of ＂human resource, machine, material, law and process＂ in quality management theory,the drug manufacturers are proposed on how to set up the pharmacovigilance system, at least they should have full-time staff and PV function, enough safety information collection, comprehensive and practical quality management system of documentation, efficient data processing system, and enterprise environment full of ＂patient safety first＂. Results and Conclusion With the development of science and technology of society and the continuous improvement of people＇s living quality requirements, the problem of drug safety are getting more and more attention from us. Drug manufacturers should strengthen their works to commit ＂the primary responsibility of drug safety＂ actively. They should strengthen their cognition and understanding of the pharmacovigilance, and establish the Quality Management System, set up PV specific function and full-time personnel to be responsible for the ADR monitoring work, and at the same time increase their internal PV training to establish an efficient PV system and ultimately provide the necessary guarantee for the development of the pharmacovigilance work.

关 键 词：药品生产企业 药物警戒 警戒体系 

分 类 号：R951[医药卫生—药学]