[Expert consensus on the management of off-label use of novel antineoplastic agents].

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 off-label use applications, review, documentation, and dynamic adjustment. The regional platform centralizes the collection and evaluation of evidence for off-label usage, facilitating consistent and homogeneous management 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.