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·指南与共识·
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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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(1.上海中医药大学
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附属龙华医院药学部,上海 200032;2.复旦大学附属华山医院药剂科,上海 200040;3.复旦大学附属中山医
院药剂科,上海 200032;4.上海市老年医学中心药剂科,上海 201104)
中图分类号 R952 文献标志码 A 文章编号 1001-0408(2025)01-0001-06
DOI 10.6039/j.issn.1001-0408.2025.01.01
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。
关键词 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
Expert consensus on dispensing management of intravenous infusion drugs for clinical trials in PIVAS
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YANG Xingchen ,FU Wenhuan ,LAO Donghui ,ZHAO Jing ,ZHANG Jianzhong ,Pharmacy Intravenous
Admixture Service Group, Hospital Pharmacy Professional Committee, Shanghai Pharmaceutical Association
(1. Dept. of Pharmacy, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai
200032, China;2. Dept. of Pharmacy, Huashan Hospital, Fudan University, Shanghai 200040, China;3. Dept.
of Pharmacy, Zhongshan Hospital, Fudan University, Shanghai 200032, China;4. Dept. of Pharmacy,
Shanghai Geriatric Medical Center, Shanghai 201104, China)
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,
Δ 基金项目 上 海 市 卫 生 健 康 委 员 会 中 医 药 科 研 项 目(No.
2024QN079) with the aim of achieving standardized and meticulous
*第一作者 主任药师,硕士。研究方向:医院药学、PIVAS 管理。 management of PIVAS’s receipt of clinical trial drugs.
E-mail:star_2002@163.com KEYWORDS
# 通信作者 主任药师。研究方向:临床药学、PIVAS管理。E-mail: PIVAS; intravenous infusion drugs for clinical
zhang.jianzhong@zs-hospital.sh.cn trials; dispensing management; expert consensus
中国药房 2025年第36卷第1期 China Pharmacy 2025 Vol. 36 No. 1 · 1 ·