摘要
目的探讨某省级哨点医院化妆品不良反应监测工作改进成效。方法以《化妆品不良反应监测管理办法》的实施时间2022年10月1日为时间节点,从完善自身化妆品不良反应监测制度体系,建立高效多方联动机制、培养监测团队,优化化妆品不良反应监测上报流程,加大公众科普宣传力度方面对化妆品不良反应监测工作进行干预。从国家化妆品不良反应监测系统提取某省级哨点医院2021年10月至2023年10月上报的化妆品不良反应监测报告,比较干预前后的监测数据。结果制订了适用于该医院的监测制度,包括《化妆品不良反应监测与报告制度》《化妆品不良反应报表填写规范》等;化妆品不良反应报告数量由17例升至76例(升高3.47倍),报告平均得分由101.53分升至104.65分(升高3.07%);化妆品不良反应报告来源增加了个人上报(3例),男性上报化妆品不良反应数量大幅增加(由1例升至8例),年龄分布扩大(由16~48岁扩大至15~80岁),医师例均填报时间缩短(由20 min缩短至5 min),化妆品初步诊断范围扩大(增加了化妆品皮肤色素异常、化妆品唇炎、化妆品毛发损害),化妆品不良反应中位潜伏期大幅缩短(由48 h缩短至24 h)。结论通过完善监测体系、优化工作模式,可有效提升哨点医院化妆品不良反应监测工作能力。
Objective To investigate the improving effect of cosmetic adverse reactions(CARs)monitoring system in a provincial sentinel hospital.Methods Taking the implementation date of the Management Measures for Cosmetic Adverse Reactions Monitoring on October 1,2022 as the time node,the CARs monitoring was intervened from the aspects of improving internal CARs monitoring system,establishing an efficient multi-party linkage mechanism,cultivating monitoring teams,optimizing the process of CARs monitoring and reporting,and strengthening the science popularization and publicity to public.The CARs monitoring reports in the National Adverse Reaction Monitoring System for Cosmetics submitted by a provincial sentinel hospital from October 2021 to October 2023 were extracted,the monitoring data before and after intervention were compared.Results Some monitoring system applicable to the hospital were formulated,such as the Cosmetic Adverse Reaction Monitoring and Reporting System and Cosmetic Adverse Reaction Report Filling Standards;the CARs reports increased from 17 to 76(increased by 3.47 times),and the average score of the reports increased from 10153 points to 10465 points(increased by 3.07%);the CARs sources increased(adding individual reports,three cases),the males reporting CAR significantly increased(from one case to eight cases),the age of patients reporting CAR significantly expanded(from 16-48 to 15-80 years),the reporting time of each case for physicians shortened(from 20 min to 5 min),the preliminary diagnosis scope of cosmetics expanded(adding abnormal skin pigmentation,lip inflammation,and hair damage induced by cosmetics),and the median latency of CAR significantly shortened(from 48 h to 24 h).Conclusion By improving the monitoring system and optimizing the work mode,the CARs monitoring ability of sentinel hospitals can be effectively improved.
作者
彭晶
李莉
李庆德
林燕芬
魏雪芳
陈华龙
姜丽君
冯波
PENG Jing;LI Li;LI Qingde;LIN Yanfen;WEI Xuefang;CHEN Hualong;JIANG Lijun;FENG Bo(The Yuebei People's Hospital Affiliated of Medical College of Shantou University,Shaoguan,Guangdong,China 512026;Center for ADR Moni-toring of Guangdong,Guangzhou,Guangdong,China 510080;Center for ADR Monitoring and Reevaluation of Shaoguan,Shaoguan,Guangdong,China 512028)
出处
《中国药业》
2025年第4期19-22,共4页
China Pharmaceuticals
基金
广东省药品不良反应监测中心项目[2022195]
广东省韶关市社会发展科技协同创新体系建设项目[230330218036739]。
关键词
化妆品不良反应
哨点医院
监测体系
监测能力
cosmetic adverse reaction
sentinel hospital
monitoring system
monitoring capability
