化妆品不良反应报告质量评估方法研究

Study on Quality Assessment Method of Adverse Reactions Reports of Cosmetics

目的建立化妆品不良反应报告质量评估方法,为化妆品不良反应报告和监测工作提供参考。方法参考世界卫生组织乌普萨拉监测中心(UMC)药品不良反应报告质量评估的警戒分级法,结合我国化妆品不良反应报告表和报告系统,分个例报告质量评估和报告整体质量评估两部分。设置时效性、规范性和附加项3个评估维度,分必填项和非必填项,按重要性不同,赋予50%,30%,10%的加减分比例,以乘法连续运算。整体质量评估以化妆品不良反应报告质量评估的平均值为标准。结果与现行药品不良反应、医疗器械不良事件报告质量评估方法相比,参考警戒分级法制订的化妆品不良反应报告质量评估方法,更能真实地反映报告质量。结论基于警戒分级法制订的化妆品不良反应报告评估方法,能迅速查找报告质量缺陷,评估结果更客观,更接近真实水平,可信度更高。

Objective To establish a quality assessment method of adverse reaction reports of cosmetics, and to provide reference for reporting and monitoring the adverse reaction of cosmetics.Methods With reference to the Adverse Drug Reaction Report Quality Assessment(vigiGrade) of World Health Organization(WHO) Uppsala Monitoring Center(UMC),combined with cosmetics adverse reaction reports form and the reporting system in China, the assessment system was divided into individual case report quality assessment and overall report quality assessment.Three assessment dimensions were set up: timeliness, standardization and additional items, which were divided into the required item and non-essential item.According to the importance of different assessment projects,given 50%,30%,10% of addition and subtraction ratio, and then multiplied by continuous operation.The overall quality assessment was based on the average of individual case report scores.Results Compared with the current quality assessment method of adverse drug reactions reports and adverse event reports of medical devices,the quality assessment method of cosmetics adverse reaction reports defined by vigiGrade can reflect the quality of the reports more truly.Conclusion The assessment method of cosmetic adverse reaction reports based on vigiGrade can quickly find the quality defects of cosmetic adverse reaction reports,and the results are more objective and closer to the true level,and the reliability is higher.