著者

中山 季昭 内田 礼人 片山 明香 嶋崎 幸也

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.44, no.11, pp.575-581, 2018-11-10 (Released:2019-11-10)

参考文献数

9

被引用文献数

2

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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).

著者

中山 季昭 塩月 篤史 春山 修一 須藤 欣三 辻 佳紀

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.39, no.5, pp.276-285, 2013-05-10 (Released:2014-05-10)

参考文献数

12

被引用文献数

3

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The preparation of anticancer drugs necessitates careful work because it can involve the handling of hazardous drugs. In actual clinical settings, liquid leakage can occur if the same rubber stopper is penetrated with injection needles multiple times; special attention should be paid to the fact that the first penetration mark can serve as a site of leakage to increase risk.Hence, we conducted a confirmatory study to detect air leakage, which can be detected with greater sensitivity than liquid leakage, using a number of methods of penetration with a focus on the viscoelasticity of rubber stoppers. In the second penetration, when the bevel was oriented perpendicularly to the first penetration (AB method), a leakage rate of 100% (30/30) was obtained with an 18 G regular-bevel needle penetrating the rubber stopper at a short depth of 0.5 mm from the first penetration mark. When the bevel orientation was changed under otherwise the same conditions (CB method), the leakage rate decreased to 37% (11/30). When the bevel orientation was completely aligned to the orientation of the first penetration (BB method), the leakage rate further decreased to 0% (0/30). Another important factor was the depth of penetration; under all conditions examined, lower leakage rates were obtained with a 1.0 mm depth than with 0.5 mm.As a result, in clinical settings involving two occurrences of penetration, two distinct cases were revealed depending on needle bevel positioning: spills and other forms of leakage prevented by the viscoelasticity of the rubber stopper and those promoted by the same.