云南省医疗机构超药品说明书适应证用药专家共识

Expert Consensus on the Off-label Indication Usage of Medication Use in Medical Institutions of Yunnan Province

目的为科学规范云南省医疗机构超药品说明书适应证用药,为决策者提供参考,依据最新法规、学科进展,构建了超药品说明书适应证用药管理、评价方法和目录。方法采用德尔菲专家咨询法征求专家意见,建立了超药品说明书适应证用药管理共识及评价标准。标准参考了灾害脆弱性分析及品管圈531评分法,从证据来源的可靠程度、药品的安全性、超说明书用药的有效性及备案使用的必要性4个维度进行评价,并使用该标准对35家医疗机构的368个超药品说明书适应证用药进行了评价。结果专家组形成了云南省超药品说明书适应证用药管理建议和目录。目录中超药品说明书适应证用药推荐意见分为强烈推荐、推荐、谨慎推荐和暂不推荐。结论以调研为基础,需求为导向,形成了《云南省医疗机构超药品说明书适应证用药专家共识》,为超药品说明书适应证的合理用药及管理提供了依据。

Objective To manage off-label medication use scientifically and standardizedly in Yunnan province,to provide reference for decision-makers in medical institutions,and to construct the evaluation methods,catalogs and management plan for off-label medication use according to the latest regulations and discipline progress.Methods Using the Delphi methodology to solicit expert opinions,the panel established a consensus,evaluation standards.And 368 off-label medication use of 35 medical institutions were evaluated by the standards from four dimensions:the reliability of evidence sources,safety,effectiveness and the necessity.Results The panel formed the recommendations and catalogue for the management of off-label medication use in Yunnan Province.The recommendations in the catalogue are divided into strong recommendation,recommendation,cautious recommendation and temporary dis-recommendation.Conclusion Based on the research and demand-oriented study,the Expert Consensus on the Off-label Meddication Use in Medical Institutions of Yunnan Province was formed,which provided a basis for the rational use and management off-label medication use.