Exploration of establishing the evaluation index system of professional and specialized drug inspectors in China

HU Di; DAI Yuemin; DING Ruoyin; ZHU Xin; GE Yuanyuan; CHEN Guiliang; CHEN Yuwen

doi:10.6039/j.issn.1001-0408.2023.08.04

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Exploration of establishing the evaluation index system of professional and specialized drug inspectors in China

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- Exploration of establishing the evaluation index system of professional and specialized drug inspectors in China
- ZHONGGUO YAOFANG Vol. 34, Issue 8, Pages: 911-916(2023)
- 作者机构：
  
  1.沈阳药科大学工商管理学院，沈阳　110016
  2.上海市药品监督管理局，上海　200233
  3.上海药品审评核查中心，上海　201210
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2023.08.04
  CLC： R95
- Published：30 April 2023，
  
  Received：07 October 2022，
  
  Revised：10 March 2023，
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胡迪,戴悦敏,丁若音等.我国药品检查员职业化专业化评价指标体系的构建探索 ^Δ[J].中国药房,2023,34(08):911-916.

HU Di,DAI Yuemin,DING Ruoyin,et al.Exploration of establishing the evaluation index system of professional and specialized drug inspectors in China[J].ZHONGGUO YAOFANG,2023,34(08):911-916.
胡迪,戴悦敏,丁若音等.我国药品检查员职业化专业化评价指标体系的构建探索 ^Δ[J].中国药房,2023,34(08):911-916. DOI： 10.6039/j.issn.1001-0408.2023.08.04.

HU Di,DAI Yuemin,DING Ruoyin,et al.Exploration of establishing the evaluation index system of professional and specialized drug inspectors in China[J].ZHONGGUO YAOFANG,2023,34(08):911-916. DOI： 10.6039/j.issn.1001-0408.2023.08.04.

摘要

目的

为构建我国职业化专业化药品检查员评价指标体系提供科学依据。

方法

结合国内外药品检查实践情况，通过文献调研、小组讨论、行为事件访谈等，对照我国法律法规、部门规章要求，提取、筛选对药品检查员的评价要素；再运用德尔菲法对相关领域的专家进行函询，确定药品检查员评价指标体系。结果与

结论

最终有62位专家完成了两轮匿名网络问卷的填写，其中第1轮函询专家29位，第2轮函询专家33位，问卷回收率分别为96.67%和94.29%，专家权威系数分别为0.81和0.79，说明专家的权威程度较高。经过专家咨询，最终构建了包含5个一级指标（个人特质、职业知识、职业技能、职业行为、职业道德）及其对应的27个二级指标的职业化专业化药品检查员评价指标体系，其中二级指标的重要性平均得分为4.224～4.879，满分比为81.8%～100%，变异系数为0.067～0.177，Kendall’s

为0.643（

＜0.001），表明本体系较为可靠，有望成为推进职业化专业化药品检查员队伍建设及保障药品检查质量的管理工具。

Abstract

OBJECTIVE

To provide scientific basis for establishing the evaluation index system of professional and specialized drug inspectors in China.

METHODS

Through the method of literature research， group discussions and behavioral event interview， combined with the practice situation of drug inspection at home and abroad， in accordance with the requirements of Chinese laws and regulations and department rules， the evaluation indexes for drug inspectors were extracted and screened. In addition， the Delphi method was used to conduct correspondence with experts in relevant fields so as to determine the evaluation index system of drug inspectors.

RESULTS &

CONCLUSIONS

Finally， 62 experts completed two rounds of anonymous online questionnaires， including 29 experts in the first round and 33 experts in the second round. The questionnaire recovery rates were 96.67% and 94.29% respectively， and the expert authority coefficients were 0.81 and 0.79， indicating a high level of authority among experts. After expert consultation， evaluation index system for professional and specialized drug inspectors had been constructed， including five first-level indexes （personal characteristics， professional knowledge， professional skills， professional behavior and professional ethics） and their corresponding 27 second-level indexes. The average score of the importance of second-level indexes was 4.224-4.879， the full score ratio was 81.8%-100%， the coefficient of variation was 0.067-0.177， and Kendall’s

was 0.643 （

＜0.001）. It indicates that this evaluation index system is relatively reliable and is expected to become a management tool for promoting the construction of professional and specialized drug inspector team and ensuring the quality of drug inspection.

关键词

药品检查员职业化专业化评价指标德尔菲法

Keywords

professionalspecializationevaluation indexDelphi method

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