Evaluation of the surface chemical contamination of gemcitabine bags: ready-to-use versus hospital compounded bags

5 October 2023

P. Chennell1, J. Claves2, M. Yessaad2, Y. Bouattour1, V. Sautou1
1 Université Clermont Auvergne, CHU Clermont Ferrand, Clermont Auvergne INP, CNRS, ICCF, F-63000 Clermont-Ferrand, France
2 CHU Clermont-Ferrand, Pôle Pharmacie, F-63003 Clermont-Ferrand, France

Ready-to-infuse (RTI) gemcitabine bags are commercially available, but as they are provided without an extension line, some anticancer units connect this device to the bags inside their compounding isolator, thus potentially contaminating them with antineoplastic agents. The objective of this study was to evaluate the surface chemical contamination of RTI gemcitabine bags versus hospital compounded (HC) gemcitabine bags.

Materials and methods
The surface contamination of gemcitabine bags (front and back sides) was investigated in two settings (n = 10 for each setting): (A) HC gemcitabine bags (2200 mg / 250 mL, 180 cm2 per side), prepared according to current hospital practices, with the extension line inserted and purged inside an anticancer drug compounding unit isolator; (B) RTI gemcitabine bags (2200 mg / 220 mL, 150 cm2 per side) with the extension line inserted and purged inside the same isolator. The bags were prepared over 10 days (1 bag per setting per day). A baseline evaluation (before any manipulations) of the contamination of the materials (RTI gemcitabine bags and 0.9% saline solution IV-bags) was also performed (n = 3). The sampling was performed using kits provided by Cytoxlab. A total of 23 antineoplastic drugs where researched and quantified in the samples by LC-MS/MS1. All results are presented as the total amount (ng) quantified per side.

Before any manipulations, the 0.9% saline solution IV-bags were devoid of any detectable contamination, but the sides of all the RTI gemcitabine bags were contaminated with gemcitabine (min 32, max 186 ng). For setting A, 3 bags (5 sides) were contaminated: 3 sides where contaminated with 5-fluorouracile (5FU) (min 34, max 339 ng) and for the third bag gemcitabine was detected on both sides but not quantifiable. For setting B, the 10 bags (9 sides) were contaminated with quantifiable gemcitabine (min 1 max 350 ng), and two bags (3 sides) presented an additional contamination with 5FU (2 sides: 5FU detected but not quantifiable, 1 side: 287 ng). No other antineoplastic agents were detected with certitude during the study.

Discussion and Conclusion
This study indicates that industrially produced RTI gemcitabine bags are contaminated with low quantities of gemcitabine, and that introducing them into an anticancer drug compounding unit isolator in order to insert the extension line can induce a cross contamination with other antineoplastic agents (such as 5FU, which is this study was also found on the HC gemcitabine bags). As the environmental contamination by hazardous drugs like antineoplastic agents must be as limited as possible, the decision to introduce RTI bags into anticancer compounding isolators should be carefully evaluated as this could add extra contamination to the bags’ surfaces.

1 Guichard et al. Eur J Hosp Pharm. 2021 Mar;28(2):94-99.

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