微生物学的見地による抗がん剤バイアル製剤の分割使用の検討と診療報酬算定方法に基づいた薬剤経費削減効果の試算

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Though the use of residual anticancer-agents in vials reduces drug costs, the vials may be subject to bacterial contamination. With this in mind, we examined the extent of bacterial contamination in reused vials and estimated the resulting reduction in drug costs. The anticancer agent vial formulations studied were those of Etoposide (ETP), Paclitaxel (PTX), Irinotecan (CPT-11), Vinorelbine (VNR), Cisplatin (CDDP), and Carboplatin (CBDCA). Vials containing residual anticancer agents were placed in sterilized ointment containers in a safety cabinet and then stored at room temperature for 14 days outside a safety cabinet. We then performed sterility tests based on the methods specified in the Japanese Pharmacopoeia to test for the presence of bacterial contamination. Furthermore, in order to simulate actual contamination, we added E. coli, P. aeruginosa, S. aureus, A. niger, and C. albicans to the vials, and performed preservative efficacy tests. All vials tested negative in the sterility tests, and no bacterial contamination was observed. In the antimicrobial preservative efficacy tests, except for CPT-11 when C. albicans was added and VNR when A. niger was added, viable bacteria counts decreased to zero or were reduced to less than 1/1000 of the inoculated level. Most of the tested anticancer agents were therefore considered to possess antimicrobial properties. Between January and December 2007, for 2,313 preparations of ETP, PTX, CDDP and CBDCA, we estimated the extent of the reduction in medical costs when they were used as residual drugs, and found there was a saving of 2,549 yen per preparation. These agents were selected as they are considered to be appropriate for residual drug use due to their preservative properties. The results of this study indicate that residual drug use is possible for ETP, PTX, CDDP and CBDCA if stored under specific conditions, and that such use will reduce drug costs.
日本医療薬学会の論文
2009-01-10

微生物学的見地による抗がん剤バイアル製剤の分割使用の検討と診療報酬算定方法に基づいた薬剤経費削減効果の試算

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