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Monitoring surface contamination for thirty antineoplastic drugs: a new proposal for surface exposure levels (SELs)

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Dugheri S., Mucci N., Bucaletti E., Squillaci D., Cappelli G., Trevisani L., Bonari A., Cecchi M., Mini E., Ghiori A., Tognoni D., Berti N., Alderighi F., Li Vigni N., Orlandi I., Arcangeli G.
Medycyna Pracy
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2022
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vol. 73
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issue 5
383-396
EN
Background Chemotherapy drugs are widely used to treat cancer, but their active compounds represent a danger for workers who could be exposed to them. However, they aren’t yet included in directive CE No. 1272/2008 and the European Biosafety Network has only recommended a limit value of 100 pg/cm2 for surface contamination. Thus, it is crucial to assess surface contaminations in healthcare environments. Currently, the technique of choice is surface wipe test combined with liquid chromatography tandem mass spectrometry to achieve high sensibility. Material and Methods A campaign involving Careggi University Hospital (Florence, Italy) was performed from January 2020 to December 2021, collecting 1449 wipe samples between administration units, preparation unit, and personnel gloves. From the obtained data, the 90th percentile was calculated for 30 antiblastic drugs and proposed as surface exposure levels (SELs); while from data concerning personnel glove contamination, weekly contamination was estimated. Results In the 2-year period only 417 wipe samples were found positive (28.8%), the majority of which regard samples coming from administration unit bathrooms. The proposed SELs are almost all <100 pg/cm2, except for few drugs which produce higher contamination on bathroom surfaces. Also, the estimation of pharmacy personnel’s glove contamination highlighted very low results (ng/week). Conclusions Deeply established protocols and procedures for safe handling of ADs allow for obtaining excellent cleaning results and thus a safer work environment, however, the risk of cytostatic contaminations cannot be avoided in healthcare workplaces, and thus a harmonization of classification and labeling of chemotherapy drugs throughout the European Union should be done.
2
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Occupational exposure to antineoplastic drugs in hospital environments: potential risk associated with contact with cyclophosphamide- and ifosfamide-contaminated surfaces

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Mucci N., Dugheri S., Farioli† A., Garzaro G., Rapisarda V., Campagna M., Bonari A., Arcangeli G.
Medycyna Pracy
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2020
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vol. 71
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issue 5
519-529
EN
BackgroundCyclophosphamide (CP) and ifosfamide (IP) contaminations have been detected in hospital environments. This study was conducted to determine if there was any contamination in the spaces (floors and door handles) between the hospital exit and the antineoplastic drugs (ADs) preparation and administration units. At the same time, the authors proposed a new automation of the analytical procedure to considerably decrease the time needed for sample preparation and analysis.Material and MethodsTo evaluate the ADs contamination of surfaces, 829 wipe tests were performed in a campaign involving 3 hospitals located in Italy. Sampling was performed using an innovative kit. The levels of ADs were measured in each wipe sample using liquid chromatography/triple quadrupole.ResultsOn-line solid-phase extraction guarantees the construction of a robust and reproducible analytical method. The CP and IP recoveries from stainless steel, polycarbonate and polyvinyl chloride ranged >80%, and the wipe holders and the automation tested ensured desorption efficiencies close to 100% for both the ADs. Of the 552 wipes taken on the spaces between the hospital exit and the preparation, administration and pharmacy warehouse units, 22 were greater than or equal to the limit of quantification, all adjacent to the administration units.ConclusionsThis study provides an insight into the exposure situation against ADs residues. In order to improve environmental monitoring programs, the authors propose to evaluate the ADs contamination also outside the preparation, administration and pharmacy warehouse units.
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Analytical strategies for assessing occupational exposure to antineoplastic drugs in healthcare workplaces

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Dugheri S., Bonari A., Pompilio I., Boccalon P., Tognoni D., Cecchi M., Ughi M., Mucci N., Arcangeli G.
Medycyna Pracy
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2018
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vol. 69
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issue 6
589-604
EN
Background Cytotoxic antineoplastic drugs (ADs), widely used in treating cancer, are considered hazardous in the workplace and thus require safe handling practices. An analytical protocol for environmental and biological AD monitoring in the healthcare environment has been developed, since Europe lacks clear guidelines and regulations for cytostatic preparation and handling. Material and Methods Liquid chromatography-tandem mass spectrometry (LC-MS/MS) was used for measuring contemporaneously 20 multi-class cytostatic compounds and urinary α-fluoro-β-alanine, whereas platinum was detected by inductively coupled plasma mass spectrometry (ICP-MS). Sampling procedures and analytical conditions were optimized and the assays were validated. Environmental AD monitoring data, collected in 2009–2017, for a total of 3749 wipe tests and 57 720 determinations, was evaluated. Results The proportion of positive samples gradually decreased from 11.7% in 2010 to 1% in 2017, however, 2266 determinations were positive. No urine sample had detectable concentrations of any of the 4 drugs considered (0/398 samples). Conclusions These improvements are so large that the key role played by the new, more stringent rules for preparing and administering ADs is evident. Hence, the analytical method involving multi-element determinations allows for a more thorough and complete investigation into the AD contamination of work environments. Med Pr 2018;69(6):589–604
4
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Metotreksat – genotoksyczny i teratogenny dla personelu medycznego onkologicznych oddziałów szpitalnych?

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Kupczewska-Dobecka M.
Medycyna Pracy
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2015
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vol. 66
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issue 2
265-275
EN
Methotrexate (MTX) is one of the most widely used cytostatic drugs belonging to the folic acid antagonists. It is a substance non-classified as a carcinogen in the European Union and by the International Agency for Research on Cancer (IARC) as there is no evidence of its carcinogenicity to humans and animals. Nevertheless, MTX has been placed on the list of dangerous drugs used in chemotherapy, mainly due to genotoxic and teratogenic effects, causing developmental toxicity and reproductive toxicity. Methotrexate was determined in the hospital ward air during the preparation of a medicament at a level of 0.3 mg/m³, as well as on protective gloves and preparatory room surfaces. In most research projects MTX was identified in the urine of health care workers, pharmacists and nursing staff. The highest cumulative concentration of MTX in 112 urine samples was 1416 mg in workers preparing infusions for patients. Studies carried out in pharmacies revealed the presence of MTX in 60% of tests, and the maximum concentration of 15 ng/cm² surface of the tray to count tablets. Legal exposure limit values for MTX in the work environment have not yet been established. Occupational exposure limits have been established by some manufacturers at the level of 0.0003–0.0025 mg/m³. There is an urgent need to establish normative values. It should also be emphasized that MTX is absorbed through the skin, which may significantly increase the exposure and measuring its concentration in the work environment may not be sufficient to estimate the actual exposure. Med Pr 2015;66(2):265–275
PL
Jednym z najczęściej stosowanych leków cytostatycznych jest metotreksat (MTX) należący do antagonistów kwasu foliowego. Jest to substancja w Unii Europejskiej niezaklasyfikowana jako rakotwórcza, a Międzynarodowa Agencja Badań nad Rakiem (International Agency for Research on Cancer – IARC) oceniła, że nie ma dowodów na jej oddziaływanie rakotwórcze u ludzi i zwierząt. Mimo to MTX znalazł się na listach leków niebezpiecznych stosowanych w chemioterapii, głównie ze względu na właściwości genotoksyczne oraz działanie teratogenne, powodowanie toksyczności rozwojowej i szkodliwy wpływ na rozrodczość. Metotreksat wykryto w powietrzu oddziału szpitalnego podczas przygotowywania leku, na poziomie 0,3 μg/m³, a także na rękawicach ochronnych oraz czyszczonych powierzchniach pokoi przygotowawczych. Stężenie MTX na polietylenowym pokryciu wyciągu wentylacyjnego wynosiło 645 μg/m². W większości prowadzonych projektów badawczych zidentyfikowano MTX w moczu pracowników opieki medycznej, farmaceutów i personelu pielęgniarskiego, a także pracowników służby zdrowia, którzy byli narażeni w wyniku wtórnego zanieczyszczenia powierzchni roboczych, odzieży czy pojemników. Najwyższe skumulowane stężenie MTX w 112 próbkach moczu wynosiło 1416 μg u pracowników podłączających i przygotowujących wlewy u pacjentów. Badania przeprowadzone w aptekach wykazały obecność MTX w 60% pobranych prób, a jego maksymalne stężenie wynosiło 15 ng/cm² powierzchni tacy do odliczania tabletek. Dotychczas nie zostały ustalone obowiązujące prawnie wartości najwyższych dopuszczalnych stężeń (NDS) metotreksatu w środowisku pracy. Dopuszczalne poziomy narażenia zawodowego niektórzy producenci MTX ustalili w granicach 0,0003–0,0025 mg/m³. Naglącą potrzebą jest ustalenie wartości normatywnych. Należy podkreślić, że substancja wchłania się przez skórę, co może istotnie zwiększać narażenie, a pomiar jej stężenia w środowisku pracy może nie wystarczać do oszacowania rzeczywistego narażenia.Med. Pr. 2015;66(2):265–275
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