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Viability of microorganisms in bags of cytotoxic drugs

Pharmacy Department, Centre Régional de Lutte Contre le Cancer Léon Bérard, Lyon, France

Jean François Latour, PharmD

Pharmacy Department, Centre Régional de Lutte Contre le Cancer Léon Bérard, Lyon, France

Christine Fuhrmann, MD

Pharmacy Department, Centre Régional de Lutte Contre le Cancer Léon Bérard, Lyon, France

Objectives. The aim of this report was to study the viability of five microorganisms (Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, S epidermidis and Candida albicans) in chemotherapeutic solutions made up 1-2 days before administration.

Methods. The four preparations studied were 0.5 mg/mL cisplatin, 1.8 mg/mL doxorubicin, 5 mg/mL 5-fluorouracil, and 5 mg/mL cyclophosphamide. All four solutions were tested at a temperature of 258C, and doxorubicin and cyclophosphamide were also tested at 48C. The concentrations of the microorganisms in the preparations were determined 2, 24, 48, 72, and 96 hours after inoculation.

Results. No microbial growth was found; on the contrary, bacterial and fungal growth decreased rapidly and substantially with cisplatin and doxorubicin (by 2log after 24 hours), moderately with 5-fluorouracil, and weakly or not at all with cyclophosphamide. Refrigeration at 48C appeared to slow the decreased growth of the microorganisms when compared with storage at 258C.

Conclusion. As no bacterial or fungal growth was seen in the four solutions of cytotoxic agents tested, the practice of preparing such solutions under a hood with vertical laminar ventilation according to good practice in the preparation of sterile solutions 1 or 2 days before administration to patients is validated. J Oncol Pharm Practice (2001) 6, 167-171.

Key Words: Cytotoxic agent • viability • quality assurance • Escherichia coli • Pseudomonas aeruginosa • Staphylococcus aureus • Staphylococcus epidermidis • Candida albicans

Journal of Oncology Pharmacy Practice, Vol. 6, No. 4, 167-171 (2001)
DOI: 10.1177/107815520100600405


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