Verification of surface contamination of Japanese cyclophosphamide vials and an example of exposure by handling

Hama, Koji; Fukushima, Koichi; Hirabatake, Masaki; Hashida, Tohru; Kataoka, Kazusaburo

doi:10.1177/1078155211419543

Cited by 28 publications

(15 citation statements)

References 18 publications

(21 reference statements)

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“…In contrast, some other studies have found traces of hazardous drugs in the urine of healthcare workers. [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44] Some of these studies have reported high proportions of workers with such contamination. For example, Hon et al 26 determined the concentration of cyclophosphamide after 24-h urine collection by 103 healthcare workers (201 samples) in six British Columbia hospitals from 2010 to 2011.…”

Section: Discussionmentioning

confidence: 99%

Quantification of healthcare workers’ exposure to cyclophosphamide, ifosfamide, methotrexate, and 5-fluorouracil by 24-h urine assay: A descriptive pilot study

Palamini

Dufour

Therrien

et al. 2020

J Oncol Pharm Pract

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The objective of this pilot study was to determine the frequency of urination and the concentration of four hazardous drugs (cyclophosphamide, ifosfamide, methotrexate, and fluorouracil) in workers' 24-h urine samples in relation to exposure to traces with hazardous drugs. Methods: The study was conducted in three healthcare centers in the region of Montr eal, Quebec, Canada. We recruited healthcare workers (nurses and pharmacy technicians) assigned to the hematology-oncology department. Each participant was asked to collect all urine voided during a 24-h period, to fill out an activity journal documenting tasks performed and to document the use of personal protective equipment. Samples were analyzed for cyclophosphamide, ifosfamide, methotrexate, and alpha-fluoro-beta-alanine (FBAL, the main urinary metabolite of 5-fluorouracil). Drugs were quantified by ultraperformance liquid chromatography-tandem mass spectrometry (positive electrospray MRM mode). Results: Eighteen healthcare workers (10 nurses and 8 technicians) were recruited and provided consent to participate. Urine samples were obtained between 1 September and 30 September 2019. The number of urinations over the 24-h collection period ranged from 3 to 11 per participant. A total of 128 urine samples were analyzed for the 18 workers. All urine samples were negative for the four antineoplastics tested. Conclusion: No traces of cyclophosphamide, ifosfamide, methotrexate, or FBAL were found in the 24-h urine samples of 18 healthcare workers practicing in three healthcare facilities in Quebec. Although it was feasible to collect 24-h urine samples in this research project, it appears unrealistic to do so recurrently as part of a large-scale surveillance program.

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Section: Discussionmentioning

confidence: 99%

Quantification of healthcare workers’ exposure to cyclophosphamide, ifosfamide, methotrexate, and 5-fluorouracil by 24-h urine assay: A descriptive pilot study

Palamini

Dufour

Therrien

et al. 2020

J Oncol Pharm Pract

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“…(1)(2)(3)(4)(5) Drug residues are still found on various surfaces in and around the drug preparation area of (hospital) pharmacies and oncology wards, even on assumedly "clean" surfaces (6)(7)(8)(9)(10)(11)(12)(13)(14) and on the outside of vials. (15)(16)(17)(18)(19)(20)(21)(22)(23) Dermal contact followed by transdermal absorption is suggested to be the major route of incorporation in occupational settings. (24)(25)(26)(27) Apart from preventive measures, efficient cleaning strategies for decontamination of workstation surfaces must be consequently focused in terms of minimizing the risk of exposure to drug residues.…”

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confidence: 99%

Cleaning Efficiencies of Three Cleaning Agents on Four Different Surfaces after Contamination by Gemcitabine and 5-fluorouracile

Böhlandt

Groeneveld

Fischer

et al. 2015

Journal of Occupational and Environmental Hygiene

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Occupational exposure to antineoplastic drugs has been documented for decades showing widespread contamination in preparation and administration areas. Apart from preventive measures, efficient cleaning of surfaces is indispensable to minimize the exposure risk. The aim of this study was to evaluate the efficiency of three cleaning agents after intentional contamination by gemcitabine (GEM) and 5-fluorouracile (5-FU) on four different surface types usually installed in healthcare settings. Glass, stainless steel, polyvinylchloride (PVC), and laminated wood plates were contaminated with 20 ng/μl GEM and 2 ng/μl 5-FU solutions. Wipe samples were analyzed for drug residues after cleaning with a) distilled water, b) aqueous solution containing sodium dodecyl sulfate (10 mM) and 2-propanol (SDS-2P), and c) Incides N (pre-soaked) alcoholic wipes. Quantification was performed by high-performance liquid chromatography (HPLC) for GEM and gas chromato-graphy-tandem mass spectrometry (GCMS/MS) for 5-FU. Recovery was determined and cleaning efficiency was calculated for each scenario. Mean recoveries were 77-89% for GEM and 24-77% for 5-FU and calculated cleaning efficiencies ranged between 95 and 100% and 89 and 100%, respectively. Residual drug amounts were detected in the range nd (not detected) - 84 ng GEM/sample and nd - 6.6 ng 5-FU/sample depending on surface type and cleaning agent. Distilled water and SDS-2P had better decontamination outcomes than Incides N wipes on nearly all surface types, especially for GEM. Regarding 5-FU, the overall cleaning efficiency was lower with highest residues on laminated wood surfaces. The tested cleaning procedures are shown to clean glass, stainless steel, PVC, and laminated wood with an efficiency of 89-100% after contamination with GEM and 5-FU. Nevertheless, drug residues could be verified by wipe samples. Pure distilled water and SDS in an alcoholic-aqueous solution expressed an efficient cleaning performance, especially with respect to GEM. The study results demonstrate the need to adapt cleaning procedures to the variety of drugs and surface types to develop effective decontamination strategies.

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“…A total of 24 studies from 11 countries were included (Germany (n=3 studies), Australia (n=1), Belgium (n=3), Canada (n=6), the USA (n=2), France (n=2), Japan (n=3), the Netherlands (n=2), the UK (n=1), Sweden (n=2), Switzerland (n=1)) (online supplementary appendix 1). 4 5 10–31 Sampling was done by wiping the containers (n=20) or by immersion (n=3). Liquid chromatography tandem-mass spectrometry (n=15) and gas chromatography tandem-mass spectrometry (n=15) were mostly used to quantify the drugs.…”

Section: Resultsmentioning

confidence: 99%

External contamination of commercial containers by antineoplastic agents: a literature review

2019

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The aim of this study was to review the literature regarding the external contamination of commercial vials by antineoplastic drugs. A PubMed and CINAHL searches from 1 January 1990 to 1 May 2018 was performed with the terms: « antineoplastic agents », « environmental monitoring », « drug packaging », « vials » and « contamination ». Articles that presented results on the external contamination of commercial vials were included. Twenty-four articles were identified from 11 countries. A total of 4248 vials were sampled from 28 manufacturers. Traces were found on 56% (2379/4248) of vials. A maximum of 150 000 ng was measured on a glass vial of fluorouracil. This literature review showed that the exterior of the majority of commercial antineoplastic vials was contaminated. Manufacturers should limit this contamination. Centres are also encouraged to clean the vials on receipt. Personal protection equipment should be worn at all steps of the drug-use process.

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Verification of surface contamination of Japanese cyclophosphamide vials and an example of exposure by handling

Cited by 28 publications

References 18 publications

Quantification of healthcare workers’ exposure to cyclophosphamide, ifosfamide, methotrexate, and 5-fluorouracil by 24-h urine assay: A descriptive pilot study

Quantification of healthcare workers’ exposure to cyclophosphamide, ifosfamide, methotrexate, and 5-fluorouracil by 24-h urine assay: A descriptive pilot study

Cleaning Efficiencies of Three Cleaning Agents on Four Different Surfaces after Contamination by Gemcitabine and 5-fluorouracile

External contamination of commercial containers by antineoplastic agents: a literature review

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