Utilization of “ready-to-use” (RTU) gemcitabine and irinotecan bags: anticipating change
4 October 2023M. Robert, R. Meghnagi, O. Giuly, D. Sankhare, I. Madelaine, N. Jourdan
APHP, Hôpital Saint-Louis, Paris, France
For the past 2 years, our centralized preparation of cytotoxic unit has been experiencing difficulties in recruiting hospital pharmacy preparators. After analyzing consumption and in order to relieve and fluidify the activity, RTU bags from the pharmaceutical company SunPharma® were referenced in March 2022: 5 gemcitabine dosages (every 200 mg from 1400 to 2200mg), and 3 irinotecan dosages (270, 300 and 330mg). The aim of this study is to describe problems encountered in the implementation of the circuit and the solutions applied.
Materials and methods
The referencing of these 2 new products required a revision of standard doses (SD). For irinotecan, the SD were different to the RTU doses: 240, 280 and 340mg (in NaCl). For gemcitabine, the SD were identical to the 6 RTU doses. A retrospective study (from 06/01/22 to 06/03/22) was carried out on prescribed doses (PD) to estimate the impact of the new SD. In addition, the adaptation of the informatic tool (Chimio® v5.9 and SD module), the modification of the solvent and stability duration, and the securing of attributions/reattributions had to be anticipated. An Excel® extraction of the number of destruction events was carried out over 2 periods (January-March 2022 and 2023).
The gap between PD and SD was smaller with RTU for irinotecan (5.4% vs. 8.8%) and unchanged for gemcitabine. For 37 patients on irinotecan (50% of the cohort), the PD were modified with the physicians’ agreement. A procedure for anticipating orders and monitoring stocks was established (direct ordering). Orders were based on estimated consumption: 50% of total irinotecan production vs. 46.1% in reality, and 84.6% vs. 75.8% for gemcitabine. A specific RTU storage area has been created. Chimio® v.5.9 doesn’t allow the creation of products with different concentrations for the same INN (e.g. irinotecan: [vial] = 20mg/mL vs [RTU] = 1.5mg/mL): an adaptation of the fictitious volumes (reconstitution and to-be-added) enabled the creation of products. The solvent was changed to Glucose 5% for all irinotecan bags. The difference in stability between RTUs and magistral preparations (7 days after percutting in a safety cabinet vs. 28 days) leads to a difference in traceability of reattributions, with an impact on the number of bags destroyed (2022: 4.4%; 2023: 37%). As for RTU attribution, this stage was secured by a double visual check of the INN, dosage, batch and final volume.
RTUs cover the majority of gemcitabine preparations, and a considerable proportion of irinotecan preparations. This new circuit is based on the pre-existing hospital preparation circuit. After 1 year of use, the RTU circuit has become perfectly established in our unit. A more adapted version of the software would make this circuit even more secure.