| 摘要: |
| 新修订《中华人民共和国药品管理法》确立"药物警戒制度"。对药物警戒制度知识体系的梳理和设计，有利于实现药品不良反应（adverse drug reaction，ADR）监测方式的转型升级和提升药物警戒真实世界证据应用水平。基于国内外药物警戒实践经验、相关制度逻辑关系等分析，本文提出了药物警戒分品种、分部门和分渠道的技术科学知识体系框架，以凸显具有中国特色的传统中医药和现代医学相并存的医疗卫生服务特征和信息化时代要求。药物警戒制度知识体系的应用场景包括ADR监测方式转变、药物警戒信息机制建设、社会共治和专业协会决策支持等。 |
| 关键词: 药物警戒 知识体系 药品不良反应 技术科学 |
| DOI：10.13748/j.cnki.issn1007-7693.2022.13.015 |
| 分类号:R951 |
| 基金项目:浙江省哲学社会科学规划课题项目（20NDJC221YB） |
|
| Research on Knowledge System of Pharmacovigilance System |
|
WANG Guangping
|
|
Shanghai Center for Adverse Drug and Medical Device Reaction Monitoring, Shanghai 200040, China
|
| Abstract: |
| The pharmacovigilance system were proposed in the newly revised Drug Administration Law. The combing and designing of the pharmacovigilance knowledge system is conducive to transform and upgrade adverse drug reaction(ADR) monitoring methods, and improve the pharmacovigilance application level of the real-world evidence. Based on the analysis of the practical experience and the logical relationship between the related supervision systems, this study puts forward the technical scientific knowledge framework of the pharmacovigilance sub-species, sub-sectors and sub-channels. The pharmacovigilance knowledge system highlights the coexisting health service characteristics between traditional Chinese medicine and modern medicine, and adapts the information requirements of the information age. The application scenario and design path of pharmacovigilance knowledge system includes several fields, such as the ADR monitoring approach transforming, pharmacovigilance information mechanism constructing, social co-management participating, and the professional association decision supporting, et al. |
| Key words: pharmacovigilance knowledge system adverse drug reaction technical science |
