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我国医疗卫生机构药品不良反应上报指标研究
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| 篇名： | 我国医疗卫生机构药品不良反应上报指标研究 |
| TITLE： | |
| 摘要： | 目的：为评价我国医疗卫生机构药品不良反应（ADR）上报指标提供参考。方法：8名药学专家以焦点组访谈法初拟我国医疗卫生机构ADR上报指标，后采用系统评价法对初拟的ADR上报指标进行循证分析，再采用德尔菲法调查确定ADR上报指标的上报要求、计算公式、含义、意义及参考值，并评价结果的可信度。结果：初拟指标包括ADR上报率、ADR报告合格率和严重的、新的ADR构成比。系统评价共纳入30篇文献（管理规范文件15篇、文献研究15篇），均提出ADR上报的必要性及上报要求，但均未提及ADR上报指标的计算公式、含义及意义。德尔菲法调查确定，ADR上报率参考值范围为≥0.01％，ADR报告合格率参考值范围为≥90％，严重的、新的ADR构成比参考值范围为≥1％；总体评价结果可信。结论：ADR上报指标及其参考下限值的确定可督促医疗卫生机构积极上报ADR，提高上报质量，并加强医疗卫生机构对严重的、新的ADR的重视。 |
| ABSTRACT： | OBJECTIVE： To evaluate the indicators of ADR reporting by medical institutions in China. METHODS： The indicators of ADR reporting by medical institutions in China were presented primarily by 8 pharmacy experts with focus group interview method. System assessment method was used for evidence-based analysis of primary ADR indicators. Delphi method was used to confirm the requirement， calculation formula， definition， evaluation meaning and reference value of ADR indicators. The reliability was assessed. RESULTS： Primary indicators included the rate of ADR reporting， the rate of qualified ADR， constituent ratio of severe and new ADR. A total of 30 literatures were included （15 documents of management standard， 15 literature research） in system evaluation， all of which indicated the necessity and requirement of ADR reporting. But the calculation formula， definition and evaluation meaning of ADR indicators were not mentioned. By investigation with Delphi method， the range of reference value was confirmed as follows that the rate of ADR reporting was≥0.01％； the rate of qualified ADR was≥90％； the constituent ratio of severe and new ADR was≥1％. The evaluation result was reliable. CONCLUSIONS： The indicators of ADR reporting and reference lower limit value can urge medical and health institutions to report ADR actively， improve the quality of ADR reporting and strengthen the attention of medical and health institutions to severe and new ADR. |
| 期刊： | 2018年第29卷第6期 |
| 作者： | 黄蕊，杨春松，熊堉，林芸竹 |
| AUTHORS： | HUANG Rui，YANG Chunsong，XIONG Yu，LIN Yunzhu |
| 关键字： | 药品不良反应；上报指标；焦点组访谈法；系统评价法；德尔菲法 |
| KEYWORDS： | ADR；Reporting indicator；Focus group interview；System evaluation；Delphi method |
| 阅读数： | 1748 次 |
| 本月下载数： | 25 次 |
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