摘要
目的:探索建设湖北省的职业化药品检查员队伍,提高我省药品检查的质量和有效性,降低监管风险,保障人民用药安全。方法:解读国家法规和政策对检查员队伍的要求,选取上海药品审评核查中心职业化药品检查员队伍的建设体系进行对比研究,分析我省药品检查员队伍建设现状及存在的问题,找到湖北省职业化检查员队伍的建设方法。结果:以现有的药品检查员队伍为基础,构建药品检查员选拔、培训、考评、分级等管理的标准化体系,逐步完成我省职业化药品检查员队伍的建设。结论:我省可以逐步建立职业药品检查员队伍,先从目前的"兼主专辅"过渡到"专兼并重",然后"专主兼辅",一直到最终实现全部职业化药品检查员。
Objective： To explore the ways to build a team of professional drug inspectors in Hubei province in oder to improve the quality and effectiveness of drug inspections in our province,reduce the risk of supervision,and ensure the safety of people＇s drug use.Methods： The requirements of national regulations and policies for the inspectors were interpreted,the construction system of professional drug inspectors in Shanghai drug review and verification center was selected as comparison,the current situation and existing problems of the construction of drug inspectors in our province were analyzed,and the construction methods of professional inspectors in Hubei province were found out. Results： On the basis of the existing team of drug inspectors,a standardized system for selection,training,evaluation and grading of drug inspectors should be established,and the establishment of a team of professional drug inspectors in our province should be gradually completed. Conclusion： Our province can gradually establish a team of professional drug inspectors,firstly from the current＂main part-time assisted by full-time＂to ＂lay equal stress on part-time and full-time＂,and then to＂main full-time assisted by part-time＂,till the final realization of all professional drug inspectors.
作者
孙煜
张喻
魏晓翠
张雪慧
吕思伊
陈慧
Sun Yu;Zhang Yu;Wei Xiaocui;Zhang Xuehui;Lv Siyi;Chen Hui(Center for Evaluation and Inspection of Hubei Food and Drug Administration,Wuhan 430071,China)
出处
《中国药师》
CAS
2018年第10期1835-1837,共3页
China Pharmacist
关键词
药品检查
检查员
职业化
Drug inspection
Inspectors
Professionalization
