Antiblastic drugs manipulation in oncological departments: environmental contamination levels, exposure risks, formation/information role and possible consequences

Background: Many cytostatic drugs commonly used in anticancer therapies are classified as potentially carcinogenic, mutagenic or teratogenic to humans. While the appearance of toxic effects could be considered “acceptable” in patients in view of therapeutic effects, the onset of primary tumours in healthy subjects handling them during working activities cannot be acceptable. Aims: The present study is aimed i) to present Environmental Monitoring (EM) data for evaluating the occupational exposure to cyclophosphamide (CP), ifosfamide (IF), 5-fluorouracil (5-FU), doxorubicin (Dox) and epyrubicin (Epy) in different Oncological Departments (OD) of South Italy; ii) to highlight possible causes of contamination and the crucial role of personnel information/formation in order to improve working modalities. Methods: EM was carried out in 7 OD of 6 different hospitals between 2004 and 2008. Information about working organization were collected by administering a detailed questionnaire to personnel. More than 800 wipe-samples were collected on different surfaces of the cytostatics preparation rooms. Analytes were extracted with diatomaceous earths (CP, IF, 5-FU) or SPE (Dox, Epy) and quantified by GC/MSMS (CP, IP) and HPLC/UV (5-FU) or FL (Dox, Epy). Analytical methods were fully validated according to Food and Drug Administration Guidelines. The measured contamination levels were analysed (χ2 tests and Spearman correlation) with respect to sampled surfaces and amount of analytes daily handled. Results: The actual working practices differed from the Italian Guideline statements in all OD. The measured analytes concentrations showed wide range of values, 1000 higher than those reported in literature (µg/dm2 vs. ng/dm2). Diffuse contamination throughout drug preparation rooms was found, with workbenches as the most polluted sites. Analytes were detected also when they were not handled. Answers to questionnaires administered to nurses put in evidence grave lacks in personnel formation: in most cases nurses employed in cytostatics manipulation attended a formation course more than five years before, while Italian Guidelines state that it must be performed annually, or they were not formed at all. As a consequence, nurses appeared to be poorly aware of the risks related to working activities – in some cases they didn’t know about the carcinogenicity of some cytostatics. This can also be considered the primary reason of the inadequate drugs manipulation, but also of the incorrect drugs storage, usage of personal protective equipment (when they were not used at all), surfaces and floor cleaning procedures and waste disposal (as for contaminated gauzes and drug flacons). Conclusions: Data from environmental contamination levels and information about working modalities suggest that the poor awareness of the risks related to antiblastic drugs manipulation and organizational/structural deficiencies can be considered the major “sources of contamination”. Performing personnel information/formation courses and planning monitoring campaigns annually appeared to be critical in order to improve working modalities and to adopt risk management strategies to decrease the occupational exposure to cytostatics.