中国临床药理学杂志2026，Vol.42Issue(14)：2061-2067,7.DOI:10.13699/j.cnki.1001-6821.2026.14.017
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
Exploration and practice of establishing a safety management mode for off-label drug use for children with pediatric resident pharmacists
摘要
Abstract
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.关键词
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Key words
pediatric resident pharmacist/off-label medication/safety management model/closed-loop management/pharmaceutical care分类
医药卫生引用本文复制引用
李燕慈,许巧霞,许桂媛,徐丽,刘建芳,邬丽玲..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[J].中国临床药理学杂志,2026,42(14):2061-2067,7.基金项目
北京医卫健康公益基金会基金资助项目(B20288AN) （B20288AN）
