Abstract
BACKGROUND: The introduction of chimeric antigen receptor (CAR)-T cell therapies to the Belgian market represents a major revolution in patient treatment but also poses a challenge for hospitals to adapt. The medicinal status of CAR-T cells means that hospital pharmacists are legally responsible for managing this drug. In Belgium, due to infrastructure and expertise barriers, the hospital pharmacist's responsibilities are often delegated to the cell therapy units in many hospitals. This delegation of tasks effectively excludes the hospital pharmacist from the CAR-T cell circuit. OBJECTIVE: The aim of the study was to measure the impact of the hospital pharmacist in securing the CAR-T cell circuit using the Failure Mode, Effects and Criticality Analysis (FMECA) method. METHODS: The process map and FMECA were performed by a multidisciplinary team. Criticality indices were calculated before and after the implementation of corrective and preventive actions by the hospital pharmacist. RESULTS: The FMECA identified 114 failure modes. Thirteen (11.5%) failure modes were assessed as high criticality, 47 (41.23%) as moderate criticality and 54 (47.8%) as low criticality. The most critical stages highlighted by this study are pharmacovigilance and tarification. The hospital pharmacy played a central role in ensuring the safety of the circuit, being involved in the implementation of 28 corrective and preventive actions, which represent 53% of the FMECA actions. These actions led to a 77% reduction in high-criticality failure modes and a 49% reduction in moderate-criticality failure modes. CONCLUSIONS: This study enabled us to identify the potential risks of the CAR-T cell circuit at the Jules Bordet Institute. The hospital pharmacy was involved in resolving 54% (62/114) of the failure modes. This confirms the hospital pharmacist's central role in ensuring the safety of the CAR-T cell circuit.