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Evaluation of a new quality-control system for cytotoxics based on UV-visible spectrophotometry (DrugLog®)


F. Feutry1,2, A. Exquis2,3, L. Falaschi2, N. Guichard2,3, P. Odou1, P. Bonnabry2,3, S. Fleury2
1 UDSL, EA GRITA, Univ Lille, 3 rue du Professeur Laguesse, F-59000, Lille, France
2 Pharmacy, Geneva University Hospitals, 4 Rue Gabrielle-Perret-Gentil CH-1211 Geneva 14, Switzerland
3 Section of pharmaceutical sciences, University of Geneva, University of Lausanne, Geneva, Switzerland

Introduction

A new quality control system - DrugLog® (Pharmacolog, Uppsala, Sweden) - was tested on cytotoxics produced by the hospital pharmacy. Identification and quantification of antineoplastic drugs were based on the UV-visible spectrophotometry

Materials and methods

Drugs and concentration ranges were selected in function of clinical use, diluents (saline or 5% dextrose) and chemical characteristics (similar structures, UV-visible absorption potential).

Analytical validation was performed according to the accuracy profile methodology. For each drug, three series of calibration points (in duplicate) and validation points (in triplicate) were prepared with an automatic micropipette.

Then, system was introduced in the cytotoxic compounding unit to control real patients bags with a sample volume of 0.5 mL (from 12 to 21 samples depending on the cytotoxic).

Results

Three out of the thirteen drugs were excluded of the study because of the lack of UV absorption below 225 nm (cisplatin, ifosfamide, cyclofosfamide). For the other compounds (5FU, doxorubicin, carboplatin, docetaxel, irinotecan, oxaliplatin, gemcitabine, paclitaxel, epirubicin and etoposide phosphate), maximum total error was under 10% during the validation step. One hundred and fifty-nine patient bags were analysed in the compounding unit with a mean error between 2.05% (gemcitabine) and 9.72% (docetaxel). Rate of non-compliance was 1.3% (two identification errors).

Discussion and conclusion

Excluding disadvantages of the technology used (sampling method, limited to UV-visible absorbent drugs), DrugLog® system has permitted quick (less than 1 min) and accurate control of selected chemotherapies prepared in the compounding unit.

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