[Organization of the pharmaceutical circuit of advanced therapy medicinal products in France. A capacity-based perspective from a national French Society for Oncology Pharmacy (SFPO) survey].

OBJECTIVES: Advanced therapy medicinal products (ATMPs) are complex biological medicines associated with specific constraints related to handling, storage and pharmaceutical circuit security. This study aims to describe the current organization of the hospital pharmaceutical circuit for ATMPs in France and to analyse the human, organizational and capacity-related determinants conditioning its sustainability in a context of rapidly expanding activity.

METHODS: A national observational survey based on a questionnaire was conducted among hospital pharmacists involved in ATMP management. Data collected concerned the types of ATMPs handled, the organization of the pharmaceutical circuit, mobilized human resources, storage modalities, information systems, relationships with manufacturers, and institutional governance.

RESULTS: Forty-four pharmacists responded, mainly from university hospitals. ATMPs are predominantly managed within clinical trials, with a predominance of gene therapies. Activity is rapidly expanding and characterized by marked organizational heterogeneity. The number of preparations per patient varies according to ATMP type, demonstrating that pharmaceutical workload cannot be assessed solely on the basis of patient volume. Organizational thresholds linking patient volumes and dedicated human resources were identified. Cryogenic storage remains a major bottleneck. Inadequate information systems, industrial constraints and insufficient institutional governance were identified as major barriers.

CONCLUSIONS: The pharmaceutical circuit for ATMPs in France has reached a mature phase requiring organizational scale-up based on a structured capacity-based approach and dedicated governance.