Daratumumab subcutaneous formulation : impact of its stability period on a dispensation and administration process

Mbouyou A.1, Kerr G.1, Lecoutre A.1, Courtin J.1, Pinturaud M.1, Vasseur M.1,2, Odou P.1,2
1 Institut de Pharmacie, CHU de Lille, Lille, France
2 Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA), Centre Hospitalier Universitaire de Lille, Lille, France

Background
In March 2021, access to the subcutaneous formulation of daratumumab (SD) was granted to French hospitals by regulating authorities. SD allows for shorter infusion times and is approved in the same indications as intraveinous daratumumab (ID) in multiple myeloma; thus causing a shift in prescriptions in our hematology departments. However, its 4-hour stability once drawn up into a syringe impacts the running of our centralized cytotoxic compounding unit (CCCU).
The aim of our work was to set up - pending new stability studies-, an alternative dispensation process for SD, and evaluate its impact on hematology care units (HCU).

Materials and methods
A risk assessment of a decentralized preparation of SD syringes process was completed. Both microbial and chemical contamination hazards of the preparation, the environment and the participants were taken into account; as well as safety, cost-effectiveness and planning.
A survey based on 1-5 rating scales was then conducted among nurses in HCU. It inquired about the impact of the new process on patient quality of care (QC), planning and personnel.

Results
A specific dispensation process for SD was launched in April 2021. Each vial is assigned to a patient via a unique number, after a prescription validation process. Vials are dispensed under the supervision of a pharmacist. Trained nurses (TN) then draw the product up into syringes, using closed transfer devices (Chemolock® ICU Medical), hence reducing contamination hazards. Overall dispensation and administration process safety is guaranteed through a full traceability ensured by CCCU.
In June 2021, ID dispensations dropped to 3 per week as opposed to 31 in March. Per contra, SD dispensation rates are at 26 per week versus 1 per month in March.
The survey among 10 TN in 2 HCU shows an overall satisfaction in the new process; with a mean of 4.1/5 and a betterment in patient QC mean of 4/5. The new process’ impact on planning is assessed through: the impact on appointments scheduling rated at 4/5, the impact on the handling of unadministered vials returns to CCCU rated 2.2/5, and the impact on appointment cancellation rates graded 0/1. TN rated their satisfaction and trust in closed transfer device use at 4.3/5 and 4.6/5 respectively. 86% noticed an increase in their workload.

Discussion
The spread of SD as a standard of care has a positive impact of patient QC. The SD specific dispensation process is an effective tool albeit intended to remain temporary. The resulting increase in TN workload and the impossibility to transpose this process in care units remote from CCCU or to in-home care patients, shows the need to revert to a centralized preparation as soon as new studies regarding SD stability in syringes are made available.

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