我国药学人员资质管理的法律法规现状分析
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摘要
目的:为完善我国药学人员资质管理领域的法律法规提供参考。方法:对药品的生产、经营和使用环节中关于药学人员资质要求的现行法律法规进行分类、汇总和分析。结果:目前,我国药学人员资质管理存在部分概念界定不清、缺乏统一标准,药学人员的资质准入要求较低,部分要求较为泛化,现行法律法规中强制性要求具备执业药师比例较少,相关立法有待完善等问题。结论:应概念界定明确,提高药学人员资质准入门槛,加大药学人员中执业药师的比例,完善法律法规。
Objective: To provide references for improving the laws and regulations on qualification management of pharmaceutical personnel in China. Methods: The current laws and regulations on the qualification requirements of pharmaceutical personnel in the production, operation and use of drugs were classified,summarized and analyzed. Results: At present, the problems of the qualification requirements of pharmaceutical personnel in China exist in the following aspects: unclear definition of some concepts, lack of uniform standards,low qualification requirements for pharmaceutical personnel, and the generalization of some requirements. In addition, there is only a small proportion of mandatory requirements for licensed pharmacists in the existing laws and regulations. So the related legislation needs to be improved. Conclusion: It is suggested that the concepts should be clearly defined, the threshold for admission of pharmaceutical personnel should be raised, the proportion of requirements for licensed pharmacists in pharmaceutical personnel should be increased so as to improve laws and regulations.
Objective: To provide references for improving the laws and regulations on qualification management of pharmaceutical personnel in China. Methods: The current laws and regulations on the qualification requirements of pharmaceutical personnel in the production, operation and use of drugs were classified,summarized and analyzed. Results: At present, the problems of the qualification requirements of pharmaceutical personnel in China exist in the following aspects: unclear definition of some concepts, lack of uniform standards,low qualification requirements for pharmaceutical personnel, and the generalization of some requirements. In addition, there is only a small proportion of mandatory requirements for licensed pharmacists in the existing laws and regulations. So the related legislation needs to be improved. Conclusion: It is suggested that the concepts should be clearly defined, the threshold for admission of pharmaceutical personnel should be raised, the proportion of requirements for licensed pharmacists in pharmaceutical personnel should be increased so as to improve laws and regulations.
引文
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[2]胡燕,贾红英.日本、美国和英国执业药师制度对我国的启示[J].医学与社会,2011,24(10):75-77+80.
[3]喻小勇.我国药师立法问题研究[D].南京:南京中医药大学,2016.
[4]侯晓宁.对“执业药师”“从业药师”“药师”三师并存的几点思考[J].中国药师,2004,(5):397-398.
[5]杨世民.中国药事管理学科发展30年:1984~2014年[M].北京:中国医药科技出版社,2014:1-2.
[6]中华人民共和国主席令第45号中华人民共和国药品管理法[S]. 2001.
[7]国家食品药品监督管理局令第14号药品生产监督管理办法[S]. 2004.
[8]国家食品药品监督管理总局.国务院关于印发国家药品安全“十二五”规划的通知[EB/OL].(2012-01-20)[2018-06-28]. http://samr.cfda.gov.cn/WS01/CL0100/.
[9]国家食品药品监督管理总局.国务院关于印发“十三五”国家食品安全规划和“十三五”国家药品安全规划的通知[EB/OL].(2017-02-14)[2018-06-28]. http://samr.cfda.gov.cn/WS01/CL0852/.
[10]中华人民共和国国务院令第360号中华人民共和国药品管理法实施条例[S]. 2002.
[11]马海英,杨悦.医院药学人员管理存在的问题及其对策[J].医药导报,2012,31(3):397-399.
[12]徐晓媛,张凯丽.中美执业药师准入制度研究[J].中国执业药师,2014,11(Z1):64-68.
[13]左根永.执业药师执业资格与评聘职称何时接轨?[N].中国医药报,2017-06-13(007).
[14]陈明颖,陈化.对药学技术人员的职业准入与职称管理的思考[J].中国药房,2008,(22):1692-1693.