陕西省化妆品生产企业不良反应监测体系建设调研

Investigation on the Construction of Adverse Cosmetics Reaction Monitoring System for Manufacturing Enterprises in Shaanxi Province

目的为进一步规范化妆品不良反应(ACR)监测工作提供建议。方法以陕西省拥有独立化妆品生产线的生产企业(56家)为研究对象,围绕化妆品生产企业基本情况、委托受托生产情况,受托企业开展不良反应监测情况,ACR组织体系建设情况,ACR管理情况等开展问卷调查,分析省内生产企业在ACR体系建设中的差异。结果共回收有效问卷45份,有效回收率80.36%。共纳入45家企业,以小型企业(20~<300人)为主(60.00%);成立年限>5~10年和>10年的企业均超过总数的1/3。3家(6.67%)委托企业中,仅1家能开展ACR监测、ACR数据搜集等活动;有10家(22.22%)企业受托生产化妆品,其中2家未开展ACR监测活动。拥有ACR监测与上报人员、ACR负责人/质量安全负责人的不同规模或不同成立年限的企业数量差异均不显著(P>0.05);且不同规模或不同成立年限企业ACR负责人/质量安全负责人的最高学历及工作年限差异均不显著(P>0.05)。不同规模企业建立的用于收集ACR报告/投诉渠道,中小型企业在官方网站、微信公众号、投诉电话、电子邮箱方面的建设率显著高于微型企业;企业规模越大,对于ACR搜集分析的信息化平台建设越完善,尤其在不良反应报告的质量评估工具的配备方面(P<0.05)。4家企业(8.89%)未制订任何ACR相关的操作程序,25家企业(55.56%)未建立消费者发生ACR的报告途径或程序。企业规模越大,开展ACR报告填写指南培训的占比越高(P<0.05);不同成立年限企业开展ACR监测系统的使用、ACR报告质量评估、ACR主要类别及关联性评价培训的占比有显著差异(P<0.05)。结论应健全ACR监测体系、落实主体责任,改善ACR人员配比、提高专业素质,完善ACR搜集渠道和信息化平台建设、提升报告水平,以全面提升ACR监测水平。

Objective To provide suggestions for further standardizing the monitoring of adverse cosmetics reactions(ACRs).Methods A questionnaire survey was conducted on 56 cosmetics manufacturing enterprises in Shaanxi Province that had independent production lines around the basic information,commissioning and commissioned production of the enterprises,monitoring of ACRs by commissioned enterprises,construction of ACR organizational system and ACR management,etc.The differences in ACR system construction among manufacturing enterprises in the province were analyzed.Results A total of 45 effective questionnaires were collected,with an effective recovery rate of 80.36%.A total of 45 enterprises were included,mainly small enterprises(20-<300 persons,60.00%);the enterprises with establishment time>5-10 years and>10 years both accounted for more than one-third of the total number.Among the three commissioning enterprises(6.67%),only one could carry out the activities such as ACR monitoring and ACR data collection;there were 10 commissioned enterprises(22.22%),of which two had not carry out ACR monitoring.There was no significant difference in the number of enterprises with different scales or establishment time having ACR monitoring and reporting personnel,ACR directors/quality and safety directors(P>0.05);and there was no significant difference in the highest education and work experience of ACR directors/quality and safety directors in enterprises with different scales or establishment time(P>0.05).The construction rate of collecting ACR reports/complaint channels(including official websites,WeChat official account,complaint telephones,e-mail)of small and medium-scale enterprises was significantly higher than that of micro-enterprises;the larger the scale of the enterprise,the more complete the construction of the information platform for ACR collection and analysis,especially in the construction of quality assessment tool for ACR reports(P<0.05).Four enterprises(8.89%)had not formulated any ACR-related operating procedure,and 25(55.6%)had not constructed a reporting channel or procedure for consumers experiencing ACR.The larger the scale of the enterprise,the higher the proportion of enterprises that conducted ACR report filling guide training(P<0.05);there was a significant difference in the proportion of enterprises with different establishment time that conducted the raining on the use of ACR monitoring system,ACR report quality evaluation,ACR main categories and correlation evaluation(P<0.05).Conclusion It is suggested that we should perfect the ACR monitoring system,implement principal responsibilities,improve the personnel ratio of ACR,enhance professional quality,perfect the ACR collection channels and information platform construction,and improve the reporting level to promote the ACR monitoring.