Verification of External Surface Contamination of Japanese 5-fluorouracil Vials and Removal of Contamination by Washing the Vials

Hama, Koji; Hashida, Tohru; Kataoka, Kazusaburo

doi:10.5649/jjphcs.39.451

Cited by 6 publications

(1 citation statement)

References 16 publications

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“…[6][7][8] In addition to these sources of contamination, several studies have shown that the external surfaces of vials supplied by pharmaceutical companies contain cytotoxic drugs on the external parts of the vials. [9][10][11][12][13][14][15][16] As a result, despite safety-controlled conditions, handling cytotoxic drugs still runs the risk of genotoxic, adverse reproductive and cytotoxic effects for occupationally exposed professionals. 1 2 16 To limit such a risk, some pharmaceutical companies have set up additional cleaning steps in their process to limit contamination from the external surface.…”

Section: Introductionmentioning

confidence: 99%

External contamination of antineoplastic drug vials: an occupational risk to consider

et al. 2020

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Risk management for workers involved in the handling and preparation of cytotoxic drugs is challenging. This study aims to investigate drug contamination of the exterior surfaces of cytotoxic drug vials. Two batches of commercially available cytotoxic drugs in unprotected vials (ifosfamide, etoposide phosphate and cyclophosphamide) and plastic shrink wrap vials (doxorubicin, cytarabine and busulfan) were tested without removing the flip-off cap or the plastic wrap, and without prewashing. The results showed significant trace amounts of cytotoxic drugs on the exterior surfaces in both unprotected (eg, cyclophosphamide, ifosfamide) and protected plastic shrink wrap vials (eg, cytarabine), indicating that the secondary packaging of protected vials does not systematically prevent exposure to the handlers. These results focus on the need for guidelines to prevent cytotoxic vial contamination and safety recommendations for staff in the handling and storage of these vials.

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Section: Introductionmentioning

confidence: 99%

External contamination of antineoplastic drug vials: an occupational risk to consider

et al. 2020

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An Assessment of Surface Contamination and Dermal Exposure to 5-Fluorouracil in Healthcare Settings by UPLC-MS/MS Using a New Atmospheric Pressure Ionization Source

Creta,

Verscheure,

Tans

et al. 2024

Toxics

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5-Fluorouracil (5-FU) is a well-known cytostatic drug, which is often used in cancer treatments. Yet, it is also a very dangerous compound for people who are occupationally exposed to it for a long time, such as pharmacy employees, nurses and cleaning staff. We aimed to improve and implement a LC-MS/MS method for 5-FU quantification on surface contamination samples collected with swabs in a pharmacy department and outpatient nursing station of a university hospital. To improve the existing methods to quantify 5-FU, we compared a LC-MS/MS method using the frequently applied electrospray ionization source (ESI) with a UniSpray ionization source (USI). To determine the contamination of 5-FU in a pharmacy department preparing 5-FU infusion bags, which are then given to patients in the outpatient nursing stations, we collected multiple surface swabs of the laminar flow cabinets and frequently touched objects, before the preparation and administration of 5-FU and afterwards. Furthermore, we sampled the protective gloves and the bare hands of employees of the pharmacy department, involved in the preparation of the infusion bags. Using the USI source, we were able to reach the lowest limit of quantification (LOQ). With this technique, we were able to detect 5-FU contamination on the laminar flow cabinets and frequently used objects in the pharmacy department and the outpatient nursing station in the very low ng/cm2 range. This contamination was mostly higher after preparation or administration than before. While we also found 5-FU on the protective gloves, we almost found no 5-FU on the skin of the pharmacy technicians preparing the 5-FU infusion bags. In conclusion, our method was able to detect very low concentrations of 5-FU contamination, but the contamination we found is very unlikely to result in any issues for the personnel working in these areas.

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The Evaluation of Comprehensive Countermeasures to Reduce Occupational Exposure to Anticancer Drugs during Preparation and Administration

Hama¹,

Hirabatake²,

Nakanishi³

et al. 2013

Jpn. J. Pharm. Health Care Sci.

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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)

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Verification of External Surface Contamination of Japanese 5-fluorouracil Vials and Removal of Contamination by Washing the Vials

Cited by 6 publications

References 16 publications

External contamination of antineoplastic drug vials: an occupational risk to consider

External contamination of antineoplastic drug vials: an occupational risk to consider

An Assessment of Surface Contamination and Dermal Exposure to 5-Fluorouracil in Healthcare Settings by UPLC-MS/MS Using a New Atmospheric Pressure Ionization Source

The Evaluation of Comprehensive Countermeasures to Reduce Occupational Exposure to Anticancer Drugs during Preparation and Administration

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