Page 7 - 《中国药房》2025年1期
P. 7

·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
                                                                                            Δ

                                                   4 #
                          2
                                          3
                 1*
          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
                                  3
          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
                                                                   3
                         1
                                       2
                                                      3
                                                                                       4
          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 ·
   2   3   4   5   6   7   8   9   10   11   12