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药品零售企业远程药学服务风险分析 被引量:1

Risk Analysis of Remote Pharmaceutical Care in Pharmaceutical Retail Enterprises
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摘要 目的:通过研究药品零售企业远程药学服务的风险,为相关法规标准的制定提供研究基础,助力实现药品零售企业远程药学服务事前事中事后的科学监管、智慧监管。方法:以层次分析法为主线,建立层次结构模型,采用德尔菲法进行专家问卷咨询,实现模糊定量研究。结果:本文将权重在0.1以上的指标项定义为重要风险,其中包括执业药师监管风险(14.56%)、处方监管风险(14.10%)和法律缺陷风险(11.80%),需要重点分析考虑;连锁自建远程药学服务平台总风险大小为0.505,第三方远程药学服务平台总风险大小为0.495。结论:药品零售企业远程药学服务作为一种新模式、新业态,其关键风险点在于缺少配套的监管政策及法规的引导与约束。因此,建议监管部门进一步通过科学的监管手段,有效引导行业规范、合理、健康地发展。 Objective:By studying the risk of remote pharmaceutical care in pharmaceutical retail enterprises,this paper aims to provide research basis for the establishment of relevant regulations and standards,and help to realize the scientific regulation and intelligent regulation before,during and after the remote pharmaceutical care for pharmaceutical retail enterprises.Methods:The hierarchical structure model was established by taking analytic hierarchy process as the main line,and the Delphi method was used for expert questionnaire consultation to achieve fuzzy quantitative research.Results:The indicators with weights above 0.1 are defined as important risks,including licensed pharmacist regulatory risk(14.56%),prescription regulatory risk(14.10%)and legal defect risk(11.80%),which need to be analyzed and considered emphatically.The total risk of the chain self-established remote pharmaceutical care platform(hereinafter referred to as the chain self-established platform)is 0.505,and the total risk of the third-party remote pharmaceutical care platform(hereinafter referred to as the third-party platform)is 0.495.Conclusions:Remote pharmaceutical care in pharmaceutical retail enterprises is a new mode and new format,and the key risk point lies in the lack of guidance and constraints from supporting regulatory policies and provisions.It is suggested that the regulatory authorities should further adopt scientific regulatory means to effectively guide the standardized,reasonable and healthy development of the industry.
作者 宋英杰 陈丽芳 宋申猛 臧恒昌 王凤山 SONG Ying-jie;CHEN Li-fang;SONG Shen-meng;ZANG Heng-chang;WANG Feng-shan(School of Pharmaceutical Science,Shandong University;Institute of Regulatory Science for Medical Products,Shandong University;SDU-ZB Biomedical Research&Development Institute;Institute of Regulatory Science for Medical Products,Shandong University National Glycoengineering Research Center)
出处 《中国食品药品监管》 2022年第9期126-137,共12页 China Food & Drug Administration Magazine
基金 2021年中国药品监督管理研究会课题:零售药店执业药师互联网药学服务风险分析及监管策略研究。
关键词 药品零售企业 远程药学服务 风险分析 监管策略 pharmaceutical retail enterprises remote pharmaceutical care risk analysis regulatory strategies
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