Guidance Values for Surface Monitoring of Antineoplastic Drugs in German Pharmacies

Schierl, Rudolf; Böhlandt, Antje; Nowak, Dennis

doi:10.1093/annhyg/mep050

Cited by 70 publications

(50 citation statements)

References 30 publications

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“…However, as no occupational exposure limits have been established, we recommend that North American researchers and/or occupational hygienists consider developing suitable hygienic guidance values based on surface contamination levels that have been recently obtained from Canadian and American healthcare facilities. Such hygienic guidance values have previously been proposed in two European countries—one for Germany [63] and another set of values for Sweden [39] . Given the potential difference in practices and training regimens, the hygienic guidance values developed in Europe may not be practical or suitable to North American facilities.…”

Section: Discussionmentioning

confidence: 99%

Identification of Knowledge Gaps Regarding Healthcare Workers' Exposure to Antineoplastic Drugs: Review of Literature, North America versus Europe

Hon

Barzan

Astrakianakis

2014

Safety and Health at Work

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We have been examining the issue of healthcare workers' exposure to antineoplastic drugs for nearly a decade and have observed that there appears to be more publications on the subject matter originating from Europe than from North America. The concern is that findings from Europe may not be generalizable to North America because of differences in handling practices, regulatory requirements, and training. Our objective was to perform a literature review to confirm our observation and, in turn, identify gaps in knowledge that warrants addressing in North America. Using select keywords, we searched for publications in PubMed and Web of Science. All papers were initially classified according to the originating continent and then categorized into one or more subject categories (analytical methods, biological monitoring, occupational exposure, surface contamination, and probability of risk/exposure). Our review identified 16 papers originating from North America and 55 papers from Europe with surface contamination being the subject matter most often studied overall. Based on our results, we are of the opinion that North American researchers need to further conduct dermal and/or urinary drug contamination studies as well as assess the exposure risk faced by healthcare workers who handle antineoplastic drugs. Trends in exposure levels should also be explored.

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Section: Discussionmentioning

confidence: 99%

Identification of Knowledge Gaps Regarding Healthcare Workers' Exposure to Antineoplastic Drugs: Review of Literature, North America versus Europe

Hon

Barzan

Astrakianakis

2014

Safety and Health at Work

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“…The high number of positive biological samples found by Yoshida et al [11] demonstrates the need to adopt more sensitive analytical techniques; the FBAL determination method proposed by the Japanese research group, a modification of that proposed by Rubino et al [33], using gas chromatography coupled with high-resolution MS, allowed for a lower order of magnitude of sensitivity than other methodologies. No critical issues with Pt were noticed by us; Schierl et al [10] found that nearly all Pt samples were above the detection limit (0.025 pg/cm 2 ). The significant reduction in surface contamination from ADs found in 2009-2017 in Careggi University Hospital is attributable to: ■ training and re-training of the staff, ■ the use of closed systems to prevent any escape of hazardous drugs, ■ the development of a new cleaning technique for floors and work surfaces.…”

Section: Discussionmentioning

confidence: 83%

“…That list was recently updated in 2016 to include drugs newly approved by the U.S. Food and Drug Administration (FDA) [9]; slightly more than a half of these hazardous drugs are classified as antineoplastic/cytotoxic agents. Despite the NIOSH guidelines, studies continue to document ongoing exposure to antineoplastic drugs (ADs), in part because compliance has been voluntary and irregular, and in part since contamination is not being regularly monitored at the ward level [10][11][12][13][14][15][16].…”

Section: Introductionmentioning

confidence: 99%

“…Kiffmeyer et al [19], instead, produced a substance-independent guideline based on the 90th percentile values of the 8 chemotherapy drugs found in the highest concentrations in a large-scale German study. Stricter threshold guidance values for platinum (Pt) and 5-fluorouracil (5-FU), such as the 50th or 75th percentile, were suggested by a German research group [10,20]. In addition, Hedmer et al [21] reported hygienic guidance values (HGVs) for CP and ifosfamide (IP) in different categories of surfaces for hospital workplaces.…”

Section: Introductionmentioning

confidence: 99%

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Analytical strategies for assessing occupational exposure to antineoplastic drugs in healthcare workplaces

Dugheri¹,

Bonari²,

Pompilio³

et al. 2018

Med Pr

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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.

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“…The United States Occupational Safety and Health Administration has set threshold limit values for platinum salts in workplace air. 22) Some studies have centered on workplace contamination and occupational exposure to anticancer drugs. [3][4][5][6][7] Occupational exposure to an anticancer drug is affected by its chemical properties such as volatility, molecular weight, and liposolubility.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Contamination Levels on the Exterior Surfaces of Vials Containing Platinum Anticancer Drugs in Japan

Naito

Ôsawa

Suzuki

et al. 2012

Biological & Pharmaceutical Bulletin

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Contamination of the external surface of anticancer drug vials supplied to hospital pharmacies has been recognized as a potential health hazard. The aim of this study was to investigate the levels of contamination on the exterior surface of vials containing platinum anticancer drugs in Japan. Platinum contamination on the exterior surface of vials containing cisplatin or carboplatin was examined using products commercially available in Japan. Cisplatin vials from 42 batches (2 drug contents, 10 products and 5 manufacturers) and carboplatin vials from 28 batches (3 drug contents, 7 products and 3 manufacturers) were used. Five vials were randomly sampled from each batch. Exterior contamination levels of 0.070-144 ng/vial as cisplatin and 0.21-1630 ng/vial as carboplatin were detected. Significant differences in the levels of contamination among the batch numbers were observed in 6 of 10 cisplatin products and 6 of 7 carboplatin products. Significant differences in the levels of contamination were observed in 3 cisplatin products with different contents of drug within the vials and 1 carboplatin product with different contents of drug within the vials. Significant differences in the contamination levels among the cisplatin manufacturers but not carboplatin manufacturers were observed. The degree of contamination of the carboplatin products was significantly higher than that of the cisplatin products. In conclusion, external contamination was confirmed in all cisplatin and carboplatin vials tested. The degree of contamination was different among different batch numbers, drug contents, manufacturers, and platinum anticancer drug.

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Guidance Values for Surface Monitoring of Antineoplastic Drugs in German Pharmacies

Abstract: The introduction of TGVs helps to reduce occupational exposure and allows pharmacy personnel to benchmark their own contamination levels. This provides a basis for improvement in occupational safety precautions and for regular contamination controls.

Cited by 70 publications

References 30 publications

Identification of Knowledge Gaps Regarding Healthcare Workers' Exposure to Antineoplastic Drugs: Review of Literature, North America versus Europe

Identification of Knowledge Gaps Regarding Healthcare Workers' Exposure to Antineoplastic Drugs: Review of Literature, North America versus Europe

Analytical strategies for assessing occupational exposure to antineoplastic drugs in healthcare workplaces

Comparison of Contamination Levels on the Exterior Surfaces of Vials Containing Platinum Anticancer Drugs in Japan

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