PIVAS临床试验用静脉输液类药品调配管理专家共识
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篇名: PIVAS临床试验用静脉输液类药品调配管理专家共识
TITLE: Expert consensus on dispensing management of intravenous infusion drugs for clinical trials in PIVAS
摘要: 目的 进一步规范医疗机构临床试验用静脉输液类药品在静脉用药调配中心(PIVAS)的调配管理标准,为医疗机构提供高质量药学服务提供参考。方法上海市药学会医院药学专委会PIVAS学组发起,上海中医药大学附属龙华医院、上海市老年医学中心共同牵头,组织多个医疗机构的PIVAS专家成立编写组,就临床试验用静脉输液类药品在PIVAS调配管理中的基本要求、调配过程等重点内容进行研讨,由牵头单位专家对意见进行整理、归纳、分析、反馈、修订,最终召开定稿会形成《PIVAS临床试验用静脉输液类药品调配管理专家共识》。结果与结论本共识主要内容包括PIVAS临床试验用静脉输液类药品的信息化管理、操作流程、经费管理以及文档管理等要点。本共识建立了规范的PIVAS临床试验用静脉输液类药品调配管理模式,通过规范临床试验药品管理操作流程,准确记录、保存药品相关信息,使PIVAS接收临床试验药品的管理能达到规范化、精细化的结果。
ABSTRACT: OBJECTIVE To further standardize the dispensing management standard of intravenous infusion drugs for clinical trials in pharmacy intravenous admixture services (PIVAS), and provide reference for medical institutions to provide high-quality pharmaceutical services. METHODS Initiated by PIVAS Group, Hospital Pharmacy Professional Committee, Shanghai Pharmaceutical Association, jointly led by Longhua Hospital, Shanghai University of Traditional Chinese Medicine and Shanghai Geriatric Medical Center, a writing group was established by PIVAS experts from multiple medical institutions to discuss the basic requirements and dispensing process of intravenous infusion drugs for clinical trials in PIVAS. The experts from the leading unit sorted out, summarized, analyzed, fed back and revised the opinions, and finally reached Expert Consensus on Dispensing Management of Intravenous Infusion Drugs for Clinical Trials in PIVAS. RESULTS & CONCLUSIONS The main contents of this consensus include information management, operation process, fund management and document management of intravenous infusion drugs for clinical trials in PIVAS. This consensus establishes a more standardized model for dispensing management of intravenous infusion drugs for clinical trials in PIVAS, by standardizing clinical trail drug management operational procedures, accurately recording and preserving drug-related information, with the aim of achieving standardized and meticulous management of PIVAS’s receipt of clinical trial drugs.
期刊: 2025年第36卷第01期
作者: 杨星辰;付文焕;老东辉;赵婧;张建中;上海市药学会医院药学专委会PIVAS学组
AUTHORS: YANG Xingchen,FU Wenhuan,LAO Donghui,ZHAO Jing,ZHANG Jianzhong,Pharmacy Intravenous Admixture Service Group,Hospital Pharmacy Professional Committee,Shanghai Pharmaceutical Association
关键字: 静脉用药调配中心;临床试验用静脉输液类药品;调配管理;专家共识
KEYWORDS: PIVAS; intravenous infusion drugs for clinical
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