Background About 6,000 cytotoxic bags per year are produced in the compounding unit of a University Hospital Pharmacy. Each bag is checked by UV-Raman spectrometry. This analytical technique presents many advantages for better efficiency: identification and quantification of results, short time of analyses (2 min) and a minimal volume sample (1 mL).
Purpose To evaluate the quality of cytotoxic bags prepared and analysed over 11 months by this spectrometry tool.
Material and methods All the drugs and solvents were identified and a calibration curve was constructed. Each drug is subject to quality control every week. For eleven months, cytotoxic bags were routinely produced and then checked by UV-Raman spectrometry.
Criteria for acceptance was ±10% error. Tolerance occurred when error was between 10% and 15%. If ±15% error was found status was rejected.
Results 4838 cytotoxic bags were produced and checked in 11 months. 14 cytotoxic drugs were analysed by UV-Raman: carboplatin, cisplatin, cyclophosphamide, dacarbazine, docetaxel, doxorubicin, etoposide, ganciclovir, gemcitabine, ifosfamide, oxaliplatin, paclitaxel, pemetrexed, vinorelbine. 92.1% of cytotoxic bags were in the concentration range of ±10%; 5.2% in the range ±15% and 2.0% with a difference of more ±15%. The preparations presenting most non-compliance were doxorubicin (18.8%), cyclophosphamide (14.3%) and ifosfamide (11.1%). 0.6% of analyses were a misidentification of the molecule.
Conclusion This study makes an assessment of the quality of production of our cytotoxic bags and shows that UV-Raman is a suitable technique for the analysis of drugs. These results highlight defects of preparation of some cytotoxic bags. Awareness-raising activities were undertaken in order that the team be more watchful during the preparation and some protocols have been improved. This approach is subject to a process of continuous improvement of the quality of drug preparations, in our laboratory which was recently ISO900 certified.
References and/or acknowledgements No conflict of interest.
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