中国药物警戒 ›› 2013, Vol. 10 ›› Issue (6): 344-347.

• 政策与法规研究 • 上一篇    下一篇

基于Delphi 法的药品生产企业人员对药品安全性监测认知度评估指标体系构建研究

高菁1,田克仁2*,余超1,周鹃1,徐瑾1,万凯化1,李穗1   

  1. 1.江西省药品不良反应监测中心,江西南昌330046；
    2.江西省食品药品监督管理局,江西南昌330029
  • 收稿日期:2013-03-05 修回日期:2016-03-09 出版日期:2013-06-08 发布日期:2016-03-09
  • 通讯作者: 田克仁,男,硕士,药品安全监测。E-mail：gaojing1209@163.com
  • 作者简介:高菁,女,主任药师,药事管理。
  • 基金资助:
    江西省软科学研究计划项目（20122BBA10109）。

A Study o f Drug Safety Monitoring Awareness Assessment Index System for Drug-producing Enterprises Staff Based on Delphi Method

GAO Jing1 ,TIAN Ke-ren2* ,YU Chao1, ZHOU Juan1, XU Jin1 ,WAN Kai-hua1, LI Sui1   

  1. 1.Jiangxi Medicine Adverse Reaction Monitoring Center, Jiangxi Nanchang 330046, China;
    2.Jiangxi Food and Drug Administration, Jiangxi Nanchang 330046, China
  • Received:2013-03-05 Revised:2016-03-09 Online:2013-06-08 Published:2016-03-09

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摘要： 目的 建立一套统一、规范、可行的药品生产企业人员对药品安全性监测认知的评估体系。方法 在前期文献检索、政府相关文件分析及专家访谈的基础上,构建药品生产企业药品安全性监测认知评估的初步框架,采用改良德尔菲（Delphi）法分析、筛选和确定认知度评估指标体系。结果 ①专家咨询的权威系数为0.81,判断系数为0.75,熟悉程度为0.86。②最终确定的药品生产企业认知度评估指标体系包括一级指标5项,二级指标18 项,三级指标19 项,其专家接受度均＞80%。③两轮专家咨询的Kendall 协调系数分别为0.383 和0.467,均具有统计学意义（ ＜0.05）。结论 用Delphi 法构建的药品生产企业药品安全性监测认知度评估指标体系具有较高的科学性和可靠性,能为评估药品生产企业药品安全性监测认知现状提供科学依据。

关键词: 药品生产企业, 药品安全性监测, 认知度评估, 德尔菲法

Abstract: Objective To establish an unified, standardized, and feasible drug safety monitoring awareness assessment index system for drug-producing enterprises staff. Methods On the basis of literature search, government documents review and expert interviews, we constructed the framework of drug safety monitoring awareness assessment for drug -producing enterprises. Then,a modified Delphi method was used to analyze, screen and determine indicators in the framework. Results The authoritative coefficient, determination coefficient and familiarity coefficient was 0.81, 0.75 and 0.86, respectively.于The indicator system consisted of 5 first-dimensions, 18 second-dimensions and 19 third -dimensions.The Kendall coordination coefficients of experts for two times consulting were 0.383 and 0.467, respectively, which had statisticcal significance. Conclusion The drug safety monitoring awareness assessment index system for drug-producing enterprises has higher scientificity and reliability, which can provide the scientific evidences for an assessment of the situation about drug safety monitoring among drug-producing enterprises.

Key words: drug-producing enterprises, drug safety monitoring, awareness assessment, Delphi method

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