省级药物警戒科学决策支持能力分析

Analysis on Scientific Decision Supporting Ability of Provincial Level Pharmacovigilance

药物警戒体系和能力建设,是国家和省级药品安全“十四五”规划主要任务之一。药物警戒与检查、检验、监管科学研究已成为地方药品监管技术支撑力量,需要提升省级药物警戒在风险防控、安全形势研判和质量评价等方面的科学决策能力。基于对省级药物警戒相关的制度文件、监测评价职能、资源现状等分析,本研究采用社会网络分析方法(SNA)分析了省级药品安全“十四五”规划中药物警戒体系、药物警戒能力建设工程项目和风险防控体系等文本的关键词汇网络,分析结果显示:“数据”“技术”“评价”“风险”是药物警戒体系的重要内容,“数据”对于“监测”“评价”的重要作用在药物警戒能力建设工程项目中得到体现,“检查”“监管”“监测”“检验”4项是较重要的风险防控体系内容。同时,本研究构建了监测评价、体系检查、决策支持和基础条件为主要内容的省级药物警戒决策支持指标体系,并提出编制指导原则、监测与评价职能分离、全生命周期管理和组织协调机制等省级药物警戒决策支持能力建设路径。

It is one of the main tasks of the national and provincial drug safety"14th Five-Year Plan"to build the pharmacovigilance system and capacity.Pharmacovigilance is an important drug supervision technical support which combined with the inspection,testing,and regulatory science.It is necessary to improve the scientific decision-making ability of provincial level pharmacovigilance in risk prevention and control,safety situation judgment,quality evaluation,and so on.Based on analysis of the institutional documents,monitoring and evaluation functions,and resource status of the provincial level pharmacovigilance capability,the study analyzed the key words network of the text about pharmacovigilance system,pharmacovigilance capacity building project,and the risk prevention and control system based on the social network analysis(SNA).The analysis results show that"data""technology""evaluation"and"risk"are important contents of the pharmacovigilance system.The important role of"data"in"monitoring"and"evaluation"is reflected in pharmacovigilance capacity building,and"inspection""supervision""monitoring"and"testing"are important contents of the risk prevention and control system.The study built the decision support index including monitoring and evaluation,system inspection,decision support,and basic conditions,which was considered as the main content of provincial level pharmacovigilance.At the same time,the study proposed the building roads of provincial level pharmacovigilance decision support capacity,such as the establishing guidelines,separation of monitoring and evaluation functions,whole lifecycle management,and coordination mechanisms.