The pharmaceutical circuit of Advanced Therapy Medicinal Products-guidelines of the French Society for Oncology Pharmacy.

Abstract

Advanced Therapy Medicinal Products (ATMPs) represent a new generation of biological medicines, which are very challenging for hospital pharmacists. Given their complexity, ATMPs require a robust and standardized hospital circuit to ensure safety, traceability and optimal patient care. Pharmacists play a crucial role in managing these products, from reception and storage to reconstitution and administration. However, existing guidelines remain fragmented and do not comprehensively address the full ATMP circuit across all therapeutic areas. The French Society for Oncology Pharmacy (SFPO) has therefore developed new recommendations to update and expand upon previous guidelines established in 2015, incorporating recent regulatory and scientific advancements. The SFPO guidelines were developed using a formalized consensus approach, involving a multidisciplinary panel of experts in hospital pharmacy and ATMP management. The process followed a four-phase methodology, including a review of existing regulations and guidelines, drafting an initial version, peer review by 59 specialists, and final validation through expert consensus. Each recommendation was rated on a numerical scale (1-9) to assess its appropriateness, with a median score of 7 or above required for inclusion. The resulting guidelines consist into 30 recommendations organized in 13 sections cover all stages of the hospital ATMP circuit. One hundred percent of recommendations obtained a median agreement value of 9 and then all were judged appropriate. These new SFPO guidelines are unique in that they provide the first comprehensive framework addressing the entire hospital circuit for ATMPs, including oncology and nononcology applications. Recommendations encompass a broader scope, including containment strategies, waste management and pharmaceutical responsibilities. These guidelines provide a comprehensive, structured and evidence-based framework for managing ATMPs within hospital settings. By addressing both clinical and logistical challenges, they aim to improve patient safety, ensure regulatory compliance and enhance the efficiency of ATMP workflows.