中国药房2025，Vol.36Issue(21)：2711-2717,7.DOI:10.6039/j.issn.1001-0408.2025.21.16
我国66家三级医疗机构药物警戒职能与工作模式调研
Survey on pharmacovigilance functions and operational models in 66 tertiary medical institutions in China
摘要
Abstract
OBJECTIVE To provide practical basis and policy recommendations for improving the pharmacovigilance(PV)system construction in medical institutions across China.METHODS A questionnaire survey was conducted using a mixed sampling strategy of"online random sampling+offline supplementary sampling"to distribute questionnaires among pharmaceutical professionals in tertiary medical institutions nationwide.The questionnaire covered aspects such as the construction of PV systems,job position settings,information system support,operational practices,and multi-stakeholder collaboration.The data were analyzed using descriptive methods and SPSS 20.0 statistical software.RESULTS A total of 70 valid questionnaires were collected from 66 medical institutions,primarily Class A tertiary hospitals.The survey found that 90.00%had designated PV personnel and 74.29%routinely conducted PV activities.However,there were notable disparities in resource allocation and information system capacity,with less than 50%of the institutions conducting post-marketing drug re-evaluation.PV activities were primarily focused on the collection and reporting of adverse drug reactions,with limited capabilities in signal detection and risk assessment.CONCLUSIONS Among the surveyed tertiary hospitals,PV systems have begun to take shape.However,challenges persist in terms of system establishment,resource allocation,risk assessment,and inter-organizational coordination.Policy efforts should focus on strengthening regulatory frameworks,improving information sharing mechanisms,enhancing professional training,and strengthening collaboration between hospitals and market authorization holders to ensure the effective implementation of PV in medical institutions.关键词
医疗机构/药物警戒/药品不良反应/药品上市许可持有人/多主体共治Key words
medical institutions/pharmacovigilance/adverse drug reactions/market authorization holder/multi-stakeholder co-governance分类
药学引用本文复制引用
孙雪林,钱东方,赵文靖,王春婷,胡欣,张亚同..我国66家三级医疗机构药物警戒职能与工作模式调研[J].中国药房,2025,36(21):2711-2717,7.基金项目
国家药品监督管理局药品评价中心课题 （）
