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我国66家三级医疗机构药物警戒职能与工作模式调研
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| 篇名： | 我国66家三级医疗机构药物警戒职能与工作模式调研 |
| TITLE： | Survey on pharmacovigilance functions and operational models in 66 tertiary medical institutions in China |
| 摘要： | 目的 为我国医疗机构药物警戒体系建设提供现实依据与政策建议。方法采用问卷调查法，通过“网络随机抽样+线下补充”的混合抽样策略面向全国三级医疗机构药学专业技术人员发放问卷，问卷内容涵盖药物警戒制度建设、岗位设置、信息系统、实际操作及多方协作等。数据通过描述性方法及SPSS20.0统计软件进行分析。结果共回收有效问卷70份，覆盖66家医疗机构（以三级甲等医疗机构为主）。调查发现，本研究覆盖的三级医疗机构中90.00%的机构已设立药物警戒负责人或专员，74.29%的受访者所在机构常规开展药物警戒工作，但资源配置及信息化能力差异显著，药品上市后再评价开展率不足50%。药物警戒活动主要集中于药物不良反应的收集和上报，而信号识别和风险评估能力有限。结论在本研究覆盖的三级医疗机构中，药物警戒体系建设已初具雏形，但在制度建设、资源配备、风险评估及多方协同机制方面仍存在短板。建议从完善制度标准、推动信息共享、强化专业培训、加强药品上市许可持有人与医疗机构联动等方面发力，促进药物警戒职能在医疗机构的有效落地。 |
| 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. |
| 期刊： | 2025年第36卷第21期 |
| 作者： | 孙雪林；钱东方；赵文靖；王春婷；胡欣；张亚同 |
| AUTHORS： | SUN Xuelin，QIAN Dongfang，ZHAO Wenjing，WANG Chunting，HU Xin，ZHANG Yatong |
| 关键字： | 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 |
| KEYWORDS： | medical institutions； pharmacovigilance； |
| 阅读数： | 3 次 |
| 本月下载数： | 0 次 |
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