CAJ | 학술논문

目的：对当前全国基层药品不良反应监测机构现状进行分析，旨在为各级食品药品监督管理部门促进药品不良反应监测体系建设提供参考，更好地服务药品、医疗器械、化妆品上市后安全性监管工作大局。方法通过问卷调研的方式对我国目前基层药品不良反应监测体系建设现状进行了调研。结果与结论通过现状分析，讨论了基层药品不良反应监测技术机构存在的普遍问题，如改革进程尚未完成、机构职责还不健全、机构设置多未独立、人员队伍建设尚需加强等，并对未来全国基层药品不良反应监测体系建设提出了愿景，对各级监管部门完善监测体系建设工作提出了建设性的意见。
목적：대당전전국기층약품불량반응감측궤구현상진행분석，지재위각급식품약품감독관리부문촉진약품불량반응감측체계건설제공삼고，경호지복무약품、의료기계、화장품상시후안전성감관공작대국。방법통과문권조연적방식대아국목전기층약품불량반응감측체계건설현상진행료조연。결과여결론통과현상분석，토론료기층약품불량반응감측기술궤구존재적보편문제，여개혁진정상미완성、궤구직책환불건전、궤구설치다미독립、인원대오건설상수가강등，병대미래전국기층약품불량반응감측체계건설제출료원경，대각급감관부문완선감측체계건설공작제출료건설성적의견。
Objective Through analyzing researches on the current status of the grassroots adverse drug reaction (ADR) monitoring organization in the country, to provide reference for the food and medicine monitoring organizations at different levels to develop ADR monitoring system, so as to better serve the overall safety monitoring of the medicine, medical device and cosmetic product. Methods Questionnaire survey was used to conduct research on the current status of the local adverse drug reaction monitoring system in our country. Results and Conclusion Through analyzing current status, common issues of the grassroots ADR monitoring organizations are discussed. These issues include incomplete reform progress, insufficient organization functions, most of the organizations not being independent, personnel team needing improvement, etc. The author makes proposals to the future local adverse drug reaction monitoring system development in the country and gives constructive advices to all levels of the monitoring departments to improve the monitoring system development.