36

The reform of the early and expanded access programs (EAP) starting on July 1, 2021 intended to simplify access to innovative treatments for patients. However, it has led to organizational rearrangements within health establishments and is particularly complex due to the multiple possible circuits of request and supply. An assessment of the situation between July 1, 2021 and July 1, 2022 was carried out in our hospital to evaluate the impact of the reform on the organization and the pharmaceutical time dedicated to this activity. The EAP status impacted 198 drugs (51% compassionate access authorization, 31% early access authorization, 12% compassionate access framework, and 6% cohort temporary authorization). Access authorizations are specific to each laboratory or indication (40% of connections to a computing platform required for data collection and/or orders), making access to treatment more complex. Their management mainly involves three sectors of the pharmacy: cancer chemotherapy, retrocessions, and the procurement of drugs. One third of the references concern multi-status drugs for which the duplication of GEF codes is sometimes essential but not without risk (billing error, stock management, indication coding). The amount of pharmaceutical time required varies from case to case, but requires multidisciplinary consultation in order to consider the problems of management, the supply circuit, financial monitoring, and IT configuration. Some one-hundred changes in status have been identified and increase the time hospital pharmacists are required to spend on monitoring, follow-up, and communication with physicians for EAP medicines.