YANG Xingchen,FU Wenhuan,LAO Donghui,et al.Expert consensus on dispensing management of intravenous infusion drugs for clinical trials in PIVAS[J].ZHONGGUO YAOFANG,2025,36(01):1-6.
YANG Xingchen,FU Wenhuan,LAO Donghui,et al.Expert consensus on dispensing management of intravenous infusion drugs for clinical trials in PIVAS[J].ZHONGGUO YAOFANG,2025,36(01):1-6. DOI: 10.6039/j.issn.1001-0408.2025.01.01.
Expert consensus on dispensing management of intravenous infusion drugs for clinical trials in PIVAS
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
2
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
2
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.
LU J Y , LI Y Q , XING H . Analysis on the development trend of clinical trials of innovative biological products in China [J ] . Pharm Today , 2023 , 33 ( 6 ): 476 - 480 .
National Medical Products Administration Drug Review Center . Annual report on the progress of clinical trials for new drug registration in China:2021 [EB/OL ] .( 2022-06-07 )[ 2024-05-15 ] . https://www.cde.org.cn/main/news/viewInfoCommon/1839a2c931e1ed43eb4cc7049e189cb0 https://www.cde.org.cn/main/news/viewInfoCommon/1839a2c931e1ed43eb4cc7049e189cb0 .
TONG L H , ZHANG F , SUN T L , et al . Analysis and thinking on the reform of clinical trial data supervision in China [J ] . World Clin Drug , 2023 , 44 ( 8 ): 882 - 890 .
National Food and Drug Administration . Good clinical practice [EB/OL ] .( 2020-04-23 )[ 2024-05-15 ] . https://www.gov.cn/gongbao/content/2020/content_5525106.htm https://www.gov.cn/gongbao/content/2020/content_5525106.htm .
National Health Commission . Guidelines for construction and management of intravenous medication dispensing centers:trial [EB/OL ] .( 2021-12-20 )[ 2024-05-15 ] . http://www.nhc.gov.cn/yzygj/s7659/202112/6fc8ae699c1f4fefb-9e80a80d4f4fa55.shtml http://www.nhc.gov.cn/yzygj/s7659/202112/6fc8ae699c1f4fefb-9e80a80d4f4fa55.shtml .
LIU Y , LU M Y , ZHANG T X , et al . Management mode investigation of drugs used for clinical trials [J ] . Chin J New Drugs Clin Remedies , 2017 , 36 ( 9 ): 522 - 525 .
QIU J W , YU Z L , ZENG X H , et al . Discussion of GCP trial drug dispensing workflow in PIVAS of daytime chemotherapy center [J ] . China Pharm , 2021 , 32 ( 16 ): 2039 - 2043 .
WANG J Q , XU C M , WANG W C . Exploring the road to GCP pharmacy construction and development [J ] . Chin J New Drugs , 2019 , 28 ( 24 ): 3001 - 3003 .
XU W F , YU X , HE D , et al . Design and application of drug clinical trial information management system based on hospital information system platform [J ] . Shanxi Med J , 2021 , 50 ( 19 ): 2739 - 2741 .
DAI Y F , XIANG J , GUO Y J , et al . Design and application of GCP pharmacy based on the hospital information system [J ] . China Digit Med , 2022 , 17 ( 6 ): 41 - 45 .
GUO X N , YU C Z , YUAN M K , et al . Management of Investigational products in clinical trials of PIVAS in ho- spital [J ] . J Nongken Med , 2019 , 41 ( 5 ): 467 - 471 .
CUI L , LYU L , DAI Z L , et al . Several problems about drug management in drug clinical trial process [J ] . China Pharm , 2010 , 21 ( 9 ): 820 - 821 .
QIU J W , WANG L H , ZENG X H , et al . Discussion on the core allocation of cytotoxic drugs configuration [J ] . Pharm Today , 2019 , 29 ( 11 ): 773 - 776 .
XIANG Z J , ZENG M Z , SONG X Q , et al . Analysis on the causes of quality issues of pharmacy intravenous admixture services(PIVAS) finished infusions and on the intervention effects [J ] . Anti Tumor Pharm , 2019 , 9 ( 2 ): 329 - 333 .
KOU Y Y , FENG J F . Scientific management of clinical trial drugs of antineoplastic drugs and its significance [J ] . Chin J Clin Ration Drug Use , 2015 , 8 ( 2 ): 18 - 19 .
BLACK L , KULKARNI D . Perspectives of oncology nursing and investigational pharmacy in oncology research [J ] . Semin Oncol Nurs , 2020 , 36 ( 2 ): 151004 .
ALLEN L . Compounding for investigational and clinical studies [J ] . Int J Pharm Compd , 2022 , 26 ( 3 ): 201 - 209 .
Chinese expert consensus for therapeutic drug monitoring of meropenem
Expert consensus on quality control of home-based pharmaceutical services in the close-knit regional medical community of Sichuan and Chongqing
Study of the evaluation methods for evidence and recommendation in Chinese expert consensus on off-label use of drugs
Expert consensus on perioperative rational use and comprehensive clinical evaluation of NSAIDs inShandong Province
Expert consensus on drug therapy for gastric cancer
Related Author
Society of Therapeutic Drug Monitoring Pharmacists of Chinese Pharmacists Association
Writing Group of the Chinese Expert Consensus for Therapeutic Drug Monitoring of Meropenem
the Compilation Group for the Expert Consensus on Quality Control of Home-based Pharmaceutical Services in the Close-knit Regional Medical Community of Sichuan and Chongqing
Chongqing Pharmaceutical Administration Quality Control Center
Chongqing Medical Association
XU Ling
BAI Zhenggang
LIN Likai
Related Institution
School of Pharmacy, Henan University of Chinese Medicine
Dept. of Pharmacy, People’s Hospital of Henan University of Chinese Medicine/People’s Hospital of Zhengzhou
Evidence-based Research Center of Social Science & Health, Nanjing University of Science and Technology
Hospital Management Institute, Wuhan University
Dept. of Pharmacy, Harbin Medical University Cancer Hospital