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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中图分类号 R95；R197.323 文献标志码A 文章编号1001-0408（2025）21-2711-07

DOI 10.6039/j.issn.1001-0408.2025.21.16

ABSTRACTOBJECTIVETo provide practicalbasisand policyrecommendations forimproving the pharmacovigilance（PV） systemconstruction inmedical instutionsacross China.METHODSAquestionnaire survey wasconductedusingamixed samplingstrategyof“onlinerandomsampling+oflinesupplementarysampling”todistributequestionnairesamongpharmaceutical profesionalsintertiarymedicalinstitutionsnationwide.ThequestionnairecoveredaspectssuchastheconstructionofPVsystems， jobpositionsetings，informationsystemsupport，operationalpractices，andmuli-stakeholdercolaboration.Thedata were analyzedusingdescriptivemethodsandSPSS20.0statisticalsoftware.RESULTSAtotalof70validquestionnaires werecolected from 66 medical institutions，primarily Class A tertiary hospitals.The survey found that 90.00% had designated PV personnel and 74.29% routinelyconducted PVactivities.However，there were notable disparities inresource alocationand information system capacity，with less than 50% of the institutions conducting post-marketing drug re-evaluation.PV activities were primarily focused onthecoletionandreportingofadversedrugreactions，withlimitedcapabilitiesinsignaldetectionandriskassessment. CONCLUSIONSAmong thesurveyed tertiaryhospitals，PVsystems have begun totake shape.However，chalengespersist in termsof systemestablishmntresourcealocation，riskassessmentandinter-organzationalcoordination.Policyefortsshould focusonstrengtheningregulatoryframeworks，improving informationsharingmechanisms，enhancingprofessionaltraning，and strengtheningcollaborationbetweenhospitalsandmarketauthorizationholders toensuretheeffectiveimplementationof PVinmedicalinstitutions.

KEYWORDSmedical institutions; pharmacovigilance; adverse drug reactions；market authorization holder；multistakeholderco-governance

国家药品监督管理局自2019年起出台《药物警戒质量管理规范》（GoodPharmacovigilancePractice，GVP）等系列法规文件[-3]，明确药品上市许可持有人（marketingauthorizationholder，MAH）应承担全生命周期药品安全责任，同时也对医疗机构协同履行药物不良反应（adversedrugreaction，ADR）监测与报告义务提出更高要求。（剩余12272字）