抗がん薬分割使用時における曝露リスクに関する検討

抄録

Recently, drug vial optimization (DVO) for anti-cancer drugs has been recommended as one of the concrete measures to decrease medical costs. DVO enables us to use single-dose vials for more than one patient to minimize unused drug waste to save on medical costs. Multiple needle punctures of the rubber stopper of the vial, however, could potentially increase the leakage of anti-cancer drugs raising concerns for worker exposure risk during the dose formulation preparation. Thus, we evaluated the relationship between the preparation procedure and leakage of anti-cancer drugs to determine an adequate preparation procedure for multiple use with a low risk of worker exposure.

No significant increase in leakage of anti-cancer drugs was observed with the adequate preparation procedure following the preparation manual of each anti-cancer drug together with replacing the device between preparation intervals for multiple use, irrespective of the presence or absence of a closed system drug transfer device (CSTD). In contrast, the preparation procedure with deviations from the preparation manual resulted in a significant increase in drug leakage. These results indicate that CSTD is not mandatory to reduce the risk of worker exposure during the preparation for multiple use although it has been generally recommended. To perform the adequate preparation for multiple use without CSTD, however, replacing the syringe and needle for every single preparation should be mandatory in addition to adequate procedures consistent with the preparation manual such as creating a slight negative pressure and adequate needle puncture (including adequate location and direction).