Expert consensus on the management of off-label use of novel antineoplastic agents.
10.3724/zdxbyxb-2025-0260
- Collective Name:Pharmaceutical Management Professional Committee of Zhejiang Provincial Hospital Association;Zhejiang Quality Control Center for Hospital Drug Affairs;Clinical Pharmaceutical Management Professional Committee of Shanghai Hospital Association;Hospital Pharmaceutical Management Professional Committee of Jiangsu Provincial Hospital Association;Pharmaceutical Management Professional Committee of Anhui Provincial Hospital Association
- Publication Type:Consensus Development Conference
- Keywords:
Antineoplastic agents;
Expert consensus;
Information sharing platform;
Off-label use management
- MeSH:
Antineoplastic Agents/therapeutic use*;
Humans;
Off-Label Use/standards*;
Consensus;
Evidence-Based Medicine
- From:
Journal of Zhejiang University. Medical sciences
2025;54(5):567-572
- CountryChina
- Language:Chinese
-
Abstract:
To enhance medication safety and rational use, a multidisciplinary expert panel from the Yangtze River Delta region-comprising specialists in pharmacy, clinical medicine, healthcare administration, and evidence-based medicine-was convened to develop this consensus through multiple rounds of Delphi consultation. A management system for the off-label use of novel antineoplastic agents was established, incorporating a tiered management process and a regional information sharing platform. Standardized procedures were implemented to regulate the applications, review, documentation, and dynamic adjustment of off-label use. The regional platform centralizes the collection and evaluation of evidence for off-label usage, facilitating consistent and homogeneous manage-ment across healthcare institutions. The tiered management process and information sharing platform established herein are intended to serve as a practical reference for standardizing the management of off-label use of novel antineoplastic agents in medical institutions.
