The anticipated compounding of injectable anticancer drugs without physician’s prescription: a process study

4 October 2023

T. Melun, E. Marilly, P. Doucey, S. Kalfon, A. Mace, S. Menguy, F. Forges, X. Simoens
Centre Hospitalier Universitaire de Saint-Etienne, France

Background and objectives
The increasing burden of injectable anticancer drugs compounding in the Southern Loire Basin and the organizational difficulties associated with variations in daily or even weekly activity have led to the need for a smoothing system.
This raised the question of carrying out advance preparations independently, without medical approval, using a simpler process than dose banding. The aim of this work is to explore the possibility of integrating this type of process into the current activity.

Materials and methods
In order to select eligible drugs, a number of criteria were defined: fixed dose, sufficient physico-chemical stability, high prescription volume (need for reallocation), order of administration within protocols, storage conditions and technical feasibility.
Preparations made between 2022/09/05 and 2023/03/26 (29 weeks) were analyzed.
A review was carried out based on the scientific databases PubMed, Google Scholar and GERPAC publications relating to the early production of anticancer drugs.

As we were reconstituting proprietary medicinal products, the status of hospital preparations was not taken into account. 9 compounds met the criteria: 5-fluorouracil (4800mg dispenser), vincristine, atezolizumab, nivolumab, durvalumab, rituximab SC, trastuzumab SC, PHESGO® and +/- daratumumab SC. They represent 10% of our weekly business, which is equivalent to approximately 130 preparations per week. Specific points of the process were identified: edition of non-nominative manufacturing sheets (who? when?), manufacturing conditions (when?), labelling rules, storage conditions and location, labelling secondary to the medical prescription (double-checking), dispensing procedures.

Discussion - Conclusion
The candidate drugs represent a sufficient volume to initiate the advance preparation project.
From an organizational point of view, they should be prepared when our activity allows: on weekends, afternoons or at the end of off-peak mornings. Batch sizes covering 14 days would give us sufficient margin to ensure the stability of our preparations and allow us to reallocate them throughout the month.
An a priori FMEA-type risk analysis is necessary, as the integration of an early preparation activity within our unit is delicate. The new organization will have to be assessed in terms of response time, redeployment of staff, and the budgetary consequences if a "batch" were to be non-compliant. The aseptic process will have to be qualified according to the desired shelf life.
This type of anticipation would make it possible to optimize staff time by avoiding some of the fluctuations in manufacturing activity.

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