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EN
Cytostatics not only induce significant side-effects in patients treated oncologically but also pose a threat to the health of occupationally exposed healthcare workers: pharmacists, physicians, nurses and other personnel. Since the 1970s numerous reports from various countries have documented the contamination of working areas with cytostatics and the presence of drugs/metabolites in the urine or blood of healthcare employees, which directly indicates the occurrence of occupational exposure to these drugs. In Poland the significant scale of occupational exposure to cytostatics is also confirmed by the data collected in the central register of occupational carcinogens/mutagens kept by the Nofer Institute of Occupational Medicine. The assessment of occupational exposure to cytostatics and health risks constitutes employers’ obligation. Unfortunately, the assessment of occupational risk resulting from exposure to cytostatics raises a number of concerns. Provisions governing the problem of workers’ health protection are not unequivocal because they derive from a variety of law areas, especially in a matter of hazard classification and safety data sheets for cytostatics. Moreover, no legally binding occupational exposure limits have been set for cytostatics or their active compounds, and analytical methods for these substances airborne and biological concentrations are lacking. Consequently, the correct assessment of occupational exposure to cytostatics, the evaluation of health hazards and the development of the proper preventive strategy appear difficult. The authors of this article described and discussed the amendments to the European provisions concerning chemicals in the light of employers’ obligations in the field of employees’ heath protection against the consequences of exposure to cytostatics. Some modifications aimed at a more effective health protection of workers occupationally exposed to cytostatics were also proposed. Int J Occup Med Environ Health. 2019;32(2):141–59
EN
Objectives The objective of the work was to determine the resistance of selected protective clothing and glove materials to permeation of cytostatics such as docetaxel, fluorouracil, and doxorubicin. Material and Methods The following glove materials were used: natural rubber latex (code A), acrylonitrile-butadiene rubber (code B) and chloroprene rubber (code C). In addition, we tested a layered material composed of a non-woven polyester (PES), a polypropylene (PP) film, and a non-woven PP used for protective coats (code D). The cytostatics were analyzed by liquid chromatography with diode array detection. The tested samples were placed in a purpose-built permeation cell modified to be different from that specified in the standard EN 6529:2001. Results The tested materials were characterized by good resistance to solutions containing 2 out of the 3 selected cytostatics: doxorubicin and 5-fluorouracil, as indicated by a breakthrough time of over 480 min. Equally high resistance to permeation of the third cytostatic (docetaxel) was exhibited by natural rubber latex, acrylonitrile-butadiene rubber, and chloroprene rubber. However, docetaxel permeated much more readily through the clothing layered material, compromising its barrier properties. Conclusions It was found that the presence of additional components in cytostatic preparations accelerated permeation through material samples, thus deteriorating their barrier properties. Int J Occup Med Environ Health 2018;31(3):341–350
EN
The employers responsibilities for the assessment of occupational exposure to cytostatics in the workplace were analyzed in the light of existing legal regulations. Cytostatics may pose a threat to health and life of workers taking care of patients treated oncologically, i.e., pharmacists, physicians, nurses and other personnel. The significant scale of occupational exposure to cytostatics in Poland is confirmed by the data collected in the Central Register of Data on Exposure to Carcinogenic or Mutagenic Substances, Mixtures, Agents or Technological Processes, maintained by the Nofer Institute of Occupational Medicine, Łódź, Poland. The issue of occupational risk assessment of exposure to cytostatics gives raise to numerous concerns. Polish regulations concerning health protection of employees occupationally exposed to cytostatics are not unequivocal, as they are derived from different areas of the law, especially those applying to hazard classification, labeling and preparation of safety data sheets for cytostatics. There are neither binding occupational exposure limits legally set for active compounds of antineoplastic drugs nor methods for monitoring of these substances concentrations in a worker’s breathing zone and biological material. This prevents the employer to carry out the correct assessment of occupational exposure, the results of which are the basis for preparing the proper preventive strategy. In this article the consequences of amendments to the European chemical legislation for employers responsible for adequate protection of health and life of employees exposed to cytostatics, were discussed, as well as some legal changes aimed at a better health and life protection of workers exposed to cytostatics in a workplace were proposed. Med Pr 2018;69(1):77–92
PL
W publikacji przeanalizowano obowiązki pracodawców w zakresie oceny narażenia zawodowego na cytostatyki w miejscu pracy w świetle obowiązujących regulacji prawnych. Leki cytostatyczne mogą stanowić zagrożenie dla zdrowia i życia pracowników sprawujących opiekę nad chorym onkologicznym (tj. farmaceutów, lekarzy, pielęgniarek i pozostałego personelu pomocniczego) oraz pracowników lecznic weterynaryjnych. Dużą skalę narażenia zawodowego na cytostatyki w Polsce potwierdzają dane gromadzone w Centralnym Rejestrze Danych o Narażeniu na Substancje Chemiczne, Ich Mieszaniny, Czynniki lub Procesy Technologiczne o Działaniu Rakotwórczym lub Mutagennym, prowadzonym przez Instytut Medycyny Pracy im. prof. J. Nofera w Łodzi. Problem oceny ryzyka zawodowego związanego z narażeniem na cytostatyki budzi wiele wątpliwości. Przepisy regulujące w Polsce kwestie ochrony zdrowia pracowników zawodowo narażonych na leki cytostatyczne wywodzą się z różnych obszarów prawa i nie są jednoznaczne ani spójne (szczególnie w kwestii klasyfikacji cytostatyków pod kątem stwarzanych zagrożeń, ich oznakowania i sporządzania dla nich kart charakterystyki). Nie są ustalone prawnie wartości najwyższych dopuszczalnych stężeń substancji czynnych leków przeciwnowotworowych w środowisku pracy oraz brakuje metod ich monitorowania w strefie oddychania pracownika i w materiale biologicznym. Uniemożliwia to przeprowadzanie prawidłowej oceny narażenia zawodowego, której wyniki są podstawą do podejmowania przez pracodawcę odpowiednich działań profilaktycznych. W pracy omówiono skutki nowelizacji prawa europejskiego w obszarze chemikaliów dla pracodawców, którzy odpowiadają za właściwą ochronę zdrowia i życia pracowników zatrudnionych w narażeniu na leki cytostatyczne. Przedstawiono także propozycje zmian w prawie zmierzające do lepszej ochrony pracowników narażonych na oddziaływanie cytostatyków w środowisku pracy. Med. Pr. 2018;69(1):77–92
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