长三角基于药品快速评估的新型抗肿瘤药物临时采购专家共识  

Expert Consensus on Temporary Procurement of Novel Antineoplastic Drugs Based on Rapid Drug Evaluation in the Yangtze River Delta Region

作　　者：《长三角基于药品快速评估的新型抗肿瘤药物临时采购专家共识》专家组 张剑萍[2] 杨全军[2] 陈娟 郭澄[2] 缪丽燕[3] 卢晓阳[4] 姜玲[5] Expert Group of Expert Consensus on Temporary Procurement of Novel Antineoplastic Drugs Based on Rapid Drug Evaluation in the Yangtze River Delta Region

机构地区：[1]不详 [2]上海交通大学医学院附属第六人民医院 [3]苏州大学附属第一医院 [4]浙江大学医学院附属第一医院 [5]中国科学技术大学附属第一医院·安徽省立医院

出　　处：《中国药业》2023年第11期1-8,共8页China Pharmaceuticals

基　　金：国家自然科学基金[82274151];上海市医院协会抗肿瘤药物临床应用管理项目[YS2021001]。

摘　　要：目的加强新型抗肿瘤药物临时采购的管理,提高用药安全性和合理性,为各级医疗机构新型抗肿瘤药物的临时采购提供参考。方法邀请长江三角洲(简称长三角)地区上海市、江苏省、浙江省、安徽省的30位药学专家、临床专家、行政管理专家和卫生技术评估专家,运用德尔菲法,通过2轮专家意见调查和4轮讨论后形成《长三角基于药品快速评估的新型抗肿瘤药物临时采购专家共识》。结果制订了简便、快速的新型抗肿瘤药物临时采购规范化管理流程;建立了新型抗肿瘤药物临时采购申请表、快速评估表和临床用药后评估表。新型抗肿瘤药物临时采购评估采用基于临时采购的必要性,药品的有效性、安全性、经济性、创新性和其他属性6个维度的快速评估方法。推荐必要时开展临床用药后评估,包括药品临床应用有效性、安全性和经济性3个维度。结论通过规范管理流程、明确卫生技术评估方法内容、开展临床用药后评估3个层次,为新型抗肿瘤药物临时采购审批提供了科学的决策依据,形成了用药全程闭环管理,可保障患者的用药权益和用药安全,规范医疗机构的药事管理。Objective To strengthen the management of temporary procurement of novel antineoplastic drugs,to improve the safety and rationality of medication,and to provide a reference for the temporary procurement of novel antineoplastic drugs in medical institutions at all levels.Methods Thirty experts in pharmacy,clinical medicine,administration,and health technology assessment from Shanghai City,Jiangsu Province,Zhejiang Province and Anhui Province in the Yangtze River Delta Region were invited to form the Expert Consensus on Temporary Procurement of Novel Antineoplastic Drugs Based on Rapid Drug Evaluation in the Yangtze River Delta Region after two rounds of expert opinion survey and four rounds of discussion by the Delphi method.Results The standardized management process for the temporary purchase of novel antineoplastic drugs was formulated,which was simple and rapid.The temporary procurement application form,rapid evaluation form and post-medication evaluation form for novel antineoplastic drugs were established.The temporary procurement evaluation of novel antineoplastic drugs adopted a rapid evaluation method based on six dimensions:the necessity of temporary purchase,drug effectiveness,safety,economy,innovation and other attributes.Conclusion By standardizing the management process,clarifying the content of the health technology evaluation method,and carrying out the post-medication evaluation at three levels,a scientific decision-making basis is provided for the temporary procurement and approval of novel antineoplastic drugs,the closed-loop management system of drugs is formed,the patients'medication rights and interests and medication safety are guaranteed,and the pharmaceutical administration work of medical institutions is standardized.

关 键 词：新型抗肿瘤药物 药品临时采购 长江三角洲 药品快速评估 专家共识 

分 类 号：R95[医药卫生—药学] R979.1