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).
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.