医药导报2023，Vol.42Issue(12)：1737-1751,15.DOI:10.3870/j.issn.1004-0781.2023.12.001
国家重点监控药品超说明书临床合理应用专家共识
National Key Monitoring Drugs(the Second Batch)Expert Consensus on Rational Clinical Application for Off-label Drug Uses
摘要
Abstract
Objective To provide medical institutions with expert recommendations for the rational off-label use of key monitored drugs and to guide healthcare professionals in further standardizing the application of national monitored drugs.Methods The research design for reaching expert consensus on the rational clinical use of national monitored drugs beyond their approved indications followed the guidelines of the World Health Organization(WHO).A systematic search was conducted to extensively collect common issues related to the off-label use of the second batch of national monitored drugs in various provinces.The Delphi method was used to survey experts and identify common off-label use items for the key monitored drugs.Literature research and expert experience were utilized to collate and form relevant body of evidence,and quality evaluation was carried out in accordance with the GRADE approach.Consensus was reached again through the Delphi method regarding the recommended advice and evidence level,which ultimately led to the formation of the"Expert Consensus on the Rational Clinical Use of Nationally Monitored Drugs Beyond Their Approved Indications."Results A survey questionnaire was conducted among 60 experts through an online survey,and a consensus on off-label use items was reached using the Delphi method,covering drug categories such as proton pump inhibitors,antibiotics,glucocorticoids,and other medications.A total of 37 clinical issues were identified,resulting in a total of 38 recommended pieces of advice.Conclusion This consensus provides a reference and supplement for medical institutions to develop clinical application norms and prescription(medical order)review rules for national monitored drugs,to ensure the effectiveness and safety of their use.It further improves the quality of medical services,reduces the risk of adverse events related to national monitored drugs,promotes rational drug use.关键词
重点监控药品/超说明书用药/合理用药/适应证/专家共识Key words
Key monitored drugs/Off-label drug use/Rational drug use/Indications/Expert consensus分类
医药卫生引用本文复制引用
四川省医学科学院·四川省人民医院,个体化药物治疗四川省重点实验室,电子科技大学医学院,中华医学会临床药学分会,中国药学会药物流行病学专委会,四川省药学会药物流行病学专委会,童荣生,边原..国家重点监控药品超说明书临床合理应用专家共识[J].医药导报,2023,42(12):1737-1751,15.基金项目
国家重点研发计划(2020YFC2005500) （2020YFC2005500）
四川省科技厅自然科学基金资助项目(2022NSFSC0818) （2022NSFSC0818）
个体化药物治疗四川省重点实验室开放课题(2021ZD01,2021YB10). （2021ZD01,2021YB10）
