以儿科驻科药师为核心的儿童超说明书用药:安全管理模式探索与实践OA
Exploration and practice of establishing a safety management mode for off-label drug use for children with pediatric resident pharmacists
目的 探索以儿科驻科药师为核心的儿童超说明书用药安全管理新模式,建立一套符合我院实际、科学规范且具落地的标准化管理流程.方法 围绕超说明书 用药全流程,明确驻科药师主导职责:用药启动前,负责循证评价、协同备案、审方规则修订及处方集更新;用药过程中,参与药学会诊、提供用药说明与咨询、协助签署知情同意书,并开展中国医院药物警戒系统主动监测与上报;用药实施后,开展真实世界研究、构建药学监护路径、专项点评评估及动态调整备案目录.形成"启动前—过程中—实施后"闭环管理机制.结果 累计完成35种药物的规范化评估,建立个性化审方规则,完善药学监护路径.2025年(2025年1月1日至12月31日)开展药学监护500例次,其中超说明书专项监护330例次,较2024年增长70％;开展超说明书药学会诊132次,增长30％;专项点评240例,动态调整3个药物风险管理等级.不良反应主动监测系统覆盖品种扩大.该模式已成功推广至我院肾内科、肿瘤科及风湿免疫科等,形成跨学科协同管理.结论 该模式通过构建基于证据等级的风险分级制度,有效凸显了儿科药学服务的专业价值,为推动我院儿科超说明书用药的精细化管理提供了有力支撑.
Objective To explore a new safety management model for off-label drugs in children with pediatric resident pharmacists as the core,and to establish a standardized management process that conforms to the actual,scientific and standardized conditions of our hospital.Methods Focusing on the whole process of off-label medication,the leading responsibilities of the resident pharmacist were clarified:before initiation of medication,be responsible for evidence-based evaluation,collaborative filing,revision of prescription review rules and update of formulary;participate in pharmaceutical consultation,provide medication instructions and consultation,assist in signing informed consent forms,and carry out Chinese Hospital Pharmacovigilance System active monitoring and reporting;after implementation of medication,carry out real-world research,construct pharmaceutical care paths,evaluate special comments and dynamically adjust the filing catalogue.Form a closed-loop management mechanism of"before launch-during process-after implementation".Results A total of 35 drugs have completed standardized evaluation,personalized prescription review rules have been established,and pharmaceutical monitoring paths have been improved.In 2025(January 1 to December 31),500 pharmaceutical care services were provided,including 330 off-label medication-specific services,a 70％increase from 2024.A total of 132 off-label medication consultations were completed,an increase of 30％;240 targeted reviews were performed;and three management levels were dynamically adjusted.The active monitoring system for adverse reactions has expanded its coverage of varieties.This model has been successfully extended to our hospital's departments of nephrology,oncology,and rheumatology and immunology,forming interdisciplinary collaborative management.Conclusion This model effectively highlights the professional value of pediatric pharmaceutical services by building a risk grading system based on evidence levels,and provides strong support for promoting the refined management of off-label pediatric medication in our hospital.
李燕慈;许巧霞;许桂媛;徐丽;刘建芳;邬丽玲
日照市人民医院药学部,山东日照 276800日照市人民医院药学部,山东日照 276800日照市人民医院药学部,山东日照 276800日照市人民医院药学部,山东日照 276800日照市人民医院药学部,山东日照 276800日照市人民医院药学部,山东日照 276800
医药卫生
儿科驻科药师超说明书用药安全管理模式闭环管理药学监护
pediatric resident pharmacistoff-label medicationsafety management modelclosed-loop managementpharmaceutical care
《中国临床药理学杂志》 2026 (14)
2061-2067,7
北京医卫健康公益基金会基金资助项目(B20288AN)
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