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目的:建立北京市药品安全绩效评价指标体系,为政府合理评价药品监管部门工作质量和评价药品市场安全水平提供参 考。方法:采用文献研究、专家头脑风暴法、最大差异化法,遴选出北京市药品安全绩效评价体系的具体指标,并借助SSI Web 软 件对20 名监管者进行网络问卷调查,分析各指标的权重。结果与结论:共遴选出可直接反映药品市场安全性的药品抽验结果 (Oc),可衡量基本药物质量的药品专项抽验结果(So),可衡量各项药品抽验工作能否按流程、按计划完成的药品抽验操作规范性 (Na),可确保抽验进度合理及保证各类药品抽样具有代表性的药品抽验过程合理性(Ra)4 个因素共27 个指标,经专家讨论最终 确定为20 个指标。4 个因素的权重分别为21%、14%、40%、25%。本研究所建立的药品安全绩效考核体系能够达到量化考核药 品监管部门工作的目的,解决目前在药品安全绩效考核过程中主观因素过大、无客观统一标准可循、只针对结果进行考核等问题, 可为其他省、市、自治区药品安全方面绩效考核指标的制订提供参考。
OBJECTIVE:To establish drug safety performance indicator system in Beijing,and to provide reference for evaluating work quality of administration department and drug market safety reasonably. METHODS:Through literature survey,expert brainstorming and maximum difference scaling,the indicators of drug safety performance evaluation system in Beijing were selected, and internet questionnaire survey was conducted among 20 regulators by using SSI Web software. The weight of each indicator was analyzed. RESULTS & CONCLUSIONS:4 factors of drug safety performance have been selected involving 27 indicators,ig. results of drug sampling test(Oc)which reflect drug market safety directly;results of special drug sampling test(So)which measure the quality of essential medicine;drug sampling operation standard(Na)which measure the completion of drug sampling by procedure or plan;rationality of drug sampling(Ra)which guarantee the rationality of sampling procedure and representativeness of sampled drugs. Finally,20 indicators are identified by experts. The weight of 4 factors are 21%,14%,40% and 25%,respectively. Established drug safety performance evaluation system can achieve quantitative check of drug supervision departments,and dispose several problems as rely on subjective factor greatly,lack of objective and uniform standard,only check the results. It provides reference for the formulation of drug safety performance evaluation indicators in other provinces,cities and municipalities.
药品安全指标体系绩效考核最大差异化法
Drug safetyIndicator systemPerformance evaluationMaximum difference scaling
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