CAJ | 학술논문

目的：探讨我国政府推动执业药师制度改革的举措及其初步效果,为制度的顶层设计提供参考。方法采用内容分析法,对我国政府推动执业药师制度改革的思路、举措等进行归纳分析；采用实证分析的方法,对国家食品药品监督管理总局(CFDA)执业药师资格认证中心最新数据和相关文献数据进行分析、比较,从执业药师人数和每万人口执业药师数量增长、执业药师注册率变化、注册岗位分布趋向等方面,探讨执业药师制度改革的初步效果。结果与结论《国家药品安全“十二五”规划》提出的目标任务为执业药师制度改革指明了方向；新版《药品经营质量管理规范》(GSP)的刚性规定对执业药师制度改革起到了强力促进作用；CFDA 的高频率系列工作加快了执业药师制度改革的步伐。制度改革效应在2013年凸显。其中,执业药师人数增长幅度显著提高,2013年同比提高22.95%；2014年上半年国内每万人口执业药师数量增至0.94个,≥1人的省份从2013年的5个增加至13个；执业药师注册率2014年6月底增至45.75%,本月注册人数月环比增长4.58%；执业药师注册领域分布趋向合理,药品零售企业注册的执业药师比例持续增加,2014年6月底达73.9%。建议政府在推动执业药师制度改革的进程中,应统一协调相关部门关系,以优化政府顶层设计；引入内部服务质量理念,以激发体系内生动力；加大制度改革宣传力度,以寻求公众认知和支持。
목적：탐토아국정부추동집업약사제도개혁적거조급기초보효과,위제도적정층설계제공삼고。방법채용내용분석법,대아국정부추동집업약사제도개혁적사로、거조등진행귀납분석；채용실증분석적방법,대국가식품약품감독관리총국(CFDA)집업약사자격인증중심최신수거화상관문헌수거진행분석、비교,종집업약사인수화매만인구집업약사수량증장、집업약사주책솔변화、주책강위분포추향등방면,탐토집업약사제도개혁적초보효과。결과여결론《국가약품안전“십이오”규화》제출적목표임무위집업약사제도개혁지명료방향；신판《약품경영질량관리규범》(GSP)적강성규정대집업약사제도개혁기도료강력촉진작용；CFDA 적고빈솔계렬공작가쾌료집업약사제도개혁적보벌。제도개혁효응재2013년철현。기중,집업약사인수증장폭도현저제고,2013년동비제고22.95%；2014년상반년국내매만인구집업약사수량증지0.94개,≥1인적성빈종2013년적5개증가지13개；집업약사주책솔2014년6월저증지45.75%,본월주책인수월배비증장4.58%；집업약사주책영역분포추향합리,약품령수기업주책적집업약사비례지속증가,2014년6월저체73.9%。건의정부재추동집업약사제도개혁적진정중,응통일협조상관부문관계,이우화정부정층설계；인입내부복무질량이념,이격발체계내생동력；가대제도개혁선전력도,이심구공음인지화지지。
Objective To explore the measures and preliminary results of licensed pharmacists system reform,and provide a reference for the top-level design of licensed pharmacists system.Methods The content analysis method was used to analyze the ideas and measures of licensed pharmacists system reform promoted by the government.Using the method of empirical analysis of the CFDA Center for Qualification of Licensed Pharmacists,analysis and comparison were made on the latest data and related literature.The preliminary effect of licensed pharmacist system reform was discussed in aspects of the number of licensed pharmacists and per million population increase in the number of licensed pharmacists,the change rate of the registration of licensed pharmacist,registered post distribution trend,etc.Results The goal put forward by the national drug safety "twelfth five-year" plan pointed out the direction for the reform of licensed pharmacists system;the rigid rules of new GSP strongly reinforced the reform effect;the high frequency of CFDA series accelerated the pace of reform.The reform effect began to show in year 2013. For instance,the number of licensed pharmacists increased significantly,at a rate of 22.95% in 2013;the number of licensed pharmacist per 10 000 population increased to 0.94 in the first half of 2014,with 13 provinces ≥ 1;licensed pharmacist registration rate increased to 45.75% at the end of June 2014.Conclusion In order to promote the process of licensed pharmacist system reform,it was suggested that the government should coordinate the relationship between the relevant departments,optimize the government top-level design,introduce the concept of internal service quality,and promote the publicity of the system reform,so as to seek the public recognition and support.