As an overall patient safety and medicines quality measure, hospital pharmacists in Belgium have mitigated critical risks in the supply chain for chimeric antigen receptor (CAR) T-cell therapies.
Advanced therapy medicinal products (ATMPs), such as CAR T-cell therapies, are innovative biological drugs that demand careful management of complex supply chains. In Belgium, licensing regulations mandate pharmacist oversight of these processes. However, infrastructural limitations and gaps in staff training often lead hospitals to delegate some of these responsibilities to specialised cell therapy units.
This delegation of tasks effectively sidelines the hospital pharmacist from the CAR T treatment pathway. To address these implications, this study evaluated the hospital pharmacist’s impact on managing and securing the CAR T-cell process.
The impact of the hospital pharmacist
Conducted at the Jules Bordet Institute between October 2023 and June 2024, researchers used Failure Modes, Effects and Criticality Analysis (FMECA) to measure the impact of the hospital pharmacist on securing the CAR T-cell circuit.
FMECA is a proactive method to identify and address potential system failures. A process map that systematically assessed each potential risk and assigned criticality scores based on severity, occurrence and detectability, together with FMECA analysis, was performed by a multidisciplinary team. Criticality indices were calculated before and after preventive actions by the hospital pharmacist.
Corrective and preventive actions (CAPAs) were implemented for moderate- and high-criticality risks, and the scores were recalculated to assess improvement.
FMECA-driven analysis identified 114 ‘failure modes’ across 14 steps in the CAR T-cell therapy process. The hospital pharmacy department implemented 28 CAPAs, representing 53% of the FMECA actions, including enhanced collaboration with haematology clinicians to manage severe adverse effects such as cytokine release syndrome and neurotoxicity.
Pharmacists also reorganised responsibilities between the pharmacy and cell therapy units, updating service agreements and procedures and training pharmacists specifically for handling these products.
Reducing CAR T-cell risks
Overall, these hospital pharmacist-driven interventions reduced high-criticality risks by 77% and moderate-criticality risks by 49%.
The authors noted how the legal status of CAR T-cells as medicinal products places critical responsibilities on hospital pharmacists, highlighting the importance of clear role definitions in collaboration with cell therapy laboratories.
They also emphasised how effective partnerships between these departments will help to navigate compliance with relevant regulatory standards going forward.
‘This work demonstrates the key role of pharmacists in securing the CAR T-cell circuit at [the Jules Bordet Institute],’ they said. ‘The prospects for the evolution of ATMPs are numerous, and the hospital pharmacist must be ready to meet these new challenges.’
Reference
Bryla A et al. Involvement of the hospital pharmacist in securing the chimeric antigen receptor (CAR)-T-cell circuit. Eur J Hosp Pharm. 2025 Mar 6:ejhpharm-2024-004454.
