基于多维管理工具的药品不良事件管理体系构建与实践

Construction and Practice of Adverse Drug Event Management System Based on Multi-Dimension Management Tool

目的探讨多维管理工具在药品不良事件(ADE)管理体系构建中的应用效果。方法采用失效模式与效应分析(FMEA)法对ADE管理体系进行前瞻性评估,寻找矫正失效因子,并采取相应的改进措施;基于时效性的管理模式,采用PDCA循环法进一步完善ADE管理体系;采用根本原因(RCA)法进行回顾性查因,收集主观、客观资料,分析近端、远端原因,并进行系统性分析。结果ADE相关概念知晓率由42.74%升至96.35%,ADE上报及时率由35.75%升至89.50%,ADE处理及时率由38.25%升至97.25%,ADE上报完整率由49.50%升至96.75%,且差异均显著(P<0.001)。结论多维管理工具在ADE管理体系构建中具有重要意义。

Objective To investigate the application effect of multi-dimensional management tools in the construction of adverse drug event(ADE)management system.Methods The failure mode and effects analysis(FMEA)method was used to conduct a prospective evaluation of the ADE management system,identify corrective failure factors,and take corresponding improvement measures.Based on the timeliness management model,the PDCA cycle method was used to further improve the ADE management system.The root cause analysis(RCA)method was used for retrospective investigation,collecting subjective and objective data,analyzing the proximal and distal causes,and conducting systematic analysis.Results The awareness rate of the concepts related to ADE increased from 42.74%to 96.35%,the timely reporting rate of ADE increased from 35.75%to 89.50%,the timely processing rate of ADE increased from 38.25%to 97.25%,and the integrity reporting rate of ADE increased from 49.50%to 96.75%,with significant differences(P<0.001).Conclusion Multi-dimensional management tools are of great significance in the construction of the ADE management system.