This study shows that the surface of Japanese CP vials was contaminated and that it was probable that healthcare workers were exposed to CP. CP absorption by the pharmacist was probably due to dermal uptake while dispensing. Washing the vial is considered effective to avoid CP exposure. Manufacturers should be more proactive to prevent contamination and healthcare workers should comply with exposure prevention rules. Cytotoxic drugs should be included in institution monitoring lists.

The residual-related volume was marked in its low preparation volume. In water-soluble drugs, the residual volume of PhaSeal was lowest of the devices in this study, but in viscous drugs, such as etoposide, the residual volume of PhaSeal was almost identical to Chemo CLAVE; that is, the residual volume of these devices was affected by the solution property. The residual-related volume in the devices will lead to errors; therefore, residual-related errors need to be considered in the use of these devices.

No abstract

日本における抗がん薬の調製・投与における職 業的曝露の問題は，日本病院薬剤師会学術小委員 会第 3 小委員会を中心とした取り組み以降，様々 な研究や調査が行われている． 1-18) 抗がん薬の調製時の職業的曝露を回避するため のデバイスの使用については，平成 22( 2010) 年の診療報酬改定により，無菌製剤処理料として 閉鎖式接続器具の使用を評価する項目の新設に よって算定が可能となりその必要性が認められ た．病院内での CP を指標とした環境拭き取り調 査により，院内環境が複数の施設で，抗がん薬で 汚染されていることはすでに報告されている． 7，19) しかしながら，日本において複数の抗がん薬曝露 対策を総合的かつ継続的に実施することで，それ らが総合的に抗がん薬曝露の減少に有用であるか を評価した報告は見あたらない． ＊ 兵庫県神戸市中央区港島南町2-1-1 医療薬学 39(12) 700-710 (2013)

In the Japanese Pharmacopoeia, there are no criteria for multiple uses, such as multidose vials, for rubber stoppers (RS), which may cause bacteriological contamination. To resolve this problem we would like to suggest the use of a closed system (CS), while considering the structure. However, multidose vials are not always kept in an aseptic environment. Hence, it is necessary to assess CS contamination and metal needles, so we compared the microbiological contamination level using Bacillus subtilis between the PhaSeal system (PS) and metal needles.On the RS of a vial containing distilled water and the top of PS-P21＇s membrane, 3.0 × 10 4 spores were prepared (＂Bacillus-vial＂ and ＂Bacillus-P21＂). An unused P21 was attached to the Bacillus-vial (Sample1). A metal needle was vertically inserted into the Bacillus-vial, and each of the puncture and vial inversion operations was carried out once, 5 times, and 10 times (Sample 2-1, 2-5, 2-10). Furthermore, Bacillus-P21 was attached to the Bacillus-vial, and PS-N35 was attached to Bacillus-P21. Each puncture was carried out once, 5 times, and 10 times (Sample 3-1, 3-5, 3-10). Viable bacterial cells were counted using the pour plate method. Bacterial cells were detected in all samples; however, bacterial cells were not detected from control vials that were not administered prepared spores. The B. sublitis contamination rates of Sample 1/2-1/2-5/2-10/3-1/3-5/3-10 were 0.7/1.4/3.1/1.9/0.1/3.2/5.0 ％, respectively. This study suggests that PS is almost equivalent to metal needles at up to 5 punctures in terms of microbiological contamination when PS is used multiple times for multidose preparation under preparation conditions where the vials are susceptible to bacterial contamination.