Generic placeholder image

Current Pharmaceutical Analysis

Editor-in-Chief

ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

General Research Article

Analytical Protocol for Monitoring Workplace Surface Contamination with Capecitabine

Author(s): Stanila Stoeva* and Petko Marinov

Volume 18, Issue 1, 2022

Published on: 17 December, 2020

Page: [132 - 140] Pages: 9

DOI: 10.2174/1573412917666201217164305

Price: $65

Abstract

Background: The risk of toxicity for the healthy individuals who are chronically exposed to cytostatic drugs was established in 1970s. Since then, many institutions have recommended monitoring occupational exposure to antineoplastic agents. Nevertheless, there is still a lack of analytical procedures for this inspection. The prodrug Capecitabine is an example of a cytostatic drug that has never been analyzed for the purpose of occupational exposure inspection. Thus, the objective of the present study was to develop a suitable protocol for its evaluation on workplace surfaces.

Methods: The determination of the surface residue of Capecitabine has been carried out in a laboratory setting through аn HPLC-UV method, preceded by an appropriate sample preparation procedure,. It was used for the pre-and post-cleaning analysis of wipe samples from several working sites, which are assessed as the most likely ones for the occurrence of dermal contact with the prodrug.

Results: The applied HPLC-UV method was assessed as accurate and precise, with an established limit of quantification of 0.05 μg/mL. The analytical procedure provided a recovery of Capecitabine of more than 90%. During the analytical protocol approbation, one surface sample containing Capecitabine was detected. To determine the efficiency of routine hygiene measures, wipe samples from all tested surfaces were analyzed after a cleaning procedure. However, the cytostatic presence was not determined on any area, including the area that gave a positive result.

Conclusion: The analytical protocol developed here successfully permits, for the first time, to study the surface contamination with the cytotoxic agent, Capecitabine. Due to this, it can be concluded that the proposed method could be useful for institutions where a potential risk of contamination to the prodrug exists.

Keywords: Capecitabine, HPLC-UV, occupational exposure, wipe sample, drugs, cytotoxic complications.

Graphical Abstract
[1]
Erlichman, C.; Moore, M. Cancer Chemotherapy and Biotherapy: Principles and Practice, 2nd ed; Chabner, B.A.; Longo, D.L., Eds.; Lippincott-Raven: Philadelphia, 1996, pp. 45-58;
[2]
Connor, T.H.; McDiarmid, M.A. Preventing occupational exposures to antineoplastic drugs in health care settings. CA Cancer J. Clin., 2006, 56(6), 354-365.
[http://dx.doi.org/10.3322/canjclin.56.6.354] [PMID: 17135692]
[3]
Falck, K.; Gröhn, P.; Sorsa, M.; Vainio, H.; Heinonen, E.; Holsti, L.R. Mutagenicity in urine of nurses handling cytostatic drugs. Lancet, 1979, 1(8128), 1250-1251.
[http://dx.doi.org/10.1016/S0140-6736(79)91939-1] [PMID: 87722]
[4]
Kusnetz, E.; Condon, M. Acute effects from occupational exposure to antineoplastic drugs in a para-professional health care worker. Am. J. Ind. Med., 2003, 44(1), 107-109.
[http://dx.doi.org/10.1002/ajim.10230] [PMID: 12822142]
[5]
Valanis, B.G.; Vollmer, W.M.; Labuhn, K.T.; Glass, A.G. Acute symptoms associated with antineoplastic drug handling among nurses. Cancer Nurs., 1993, 16(4), 288-295.
[http://dx.doi.org/10.1097/00002820-199308000-00005] [PMID: 8402605]
[6]
Pałaszewska-Tkacz, A.; Czerczak, S.; Konieczko, K.; Kupczewska-Dobecka, M. Cytostatics as hazardous chemicals in healthcare workers’ environment. Int. J. Occup. Med. Environ. Health, 2019, 32(2), 141-159.
[http://dx.doi.org/10.13075/ijomeh.1896.01248] [PMID: 30896680]
[7]
Lawson, C.C.; Rocheleau, C.M.; Whelan, E.A.; Lividoti Hibert, E.N.; Grajewski, B.; Spiegelman, D.; Rich-Edwards, J.W. Occupational exposures among nurses and risk of spontaneous abortion. Am. J. Obstet. Gynecol., 2012, 206(4), 327.e1-327.e8.
[http://dx.doi.org/10.1016/j.ajog.2011.12.030] [PMID: 22304790]
[8]
Sessink, P.J.M.; Sewell, G.; Vandenbroucke, J. Preventing occupational exposure to cytotoxic and other hazardous drugs european policy recommendations., 2016.http://www.europeanbiosafetynetwork.eu/wp-content/uploads/2016/05/Exposure-to-Cytotoxic-Drugs_Recommendation_DINA4_10-03-16.pdf
[9]
NIOSH alert: preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health., 2004.https://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf?id=10.26616/NIOSHPUB2004165
[10]
Hoppe-Tichy, T. Current challenges in European oncology pharmacy practice. J. Oncol. Pharm. Pract., 2010, 16(1), 9-18.
[http://dx.doi.org/10.1177/1078155209354346] [PMID: 20015932]
[11]
Wilson, B.E.; Jacob, S.; Yap, M.L.; Ferlay, J.; Bray, F.; Barton, M.B. Estimates of global chemotherapy demands and corresponding physician workforce requirements for 2018 and 2040: a population-based study. Lancet Oncol., 2019, 20(6), 769-780.
[http://dx.doi.org/10.1016/S1470-2045(19)30163-9] [PMID: 31078462]
[12]
International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J. Oncol. Pharm. Pract., 2007, 13(Suppl.), 1-81.
[PMID: 17933809]
[13]
Easty, A.C.; Coakley, N.; Cheng, R.; Cividino, M.; Savage, P.; Tozer, R.; White, R.E. Safe handling of cytotoxics: guideline recommendations. Curr. Oncol., 2015, 22(1), e27-e37.
[http://dx.doi.org/10.3747/co.22.2151] [PMID: 25684994]
[14]
American Society of Health-System Pharmacists ASHP guidelines on handling hazardous drugs. Am. J. Health Syst. Pharm., 2006, 63(12), 1172-1191.
[http://dx.doi.org/10.2146/ajhp050529]
[15]
Occupational and Safety and Health Administration. Guidelines for Cytotoxic (Antineoplastic) Drugs, STD 01-23-001.,, 1986.https://www.osha.gov/enforcement/directives/std-01-23-001
[16]
Lucas, M.A.; Connor, T.H. Hazardous drugs: the silent stalker of healthcare workers? Synergist (Akron), 2015, 26(1), 22-26.
[17]
Safe Handling of Hazardous Chemotherapy Drugs in Limited-Resource Settings; Pan American Health Organization: Washington, DC, 2013. www.paho.org/hq/dmdocuments/2014/safe-handling-chemotherapy-drugs.pdf
[18]
Bernabeu-Martínez, M.A.; Ramos Merino, M.; Santos Gago, J.M.; Álvarez Sabucedo, L.M.; Wanden-Berghe, C.; Sanz-Valero, J. Guidelines for safe handling of hazardous drugs: A systematic review. PLoS One, 2018, 13(5)e0197172
[http://dx.doi.org/10.1371/journal.pone.0197172] [PMID: 29750798]
[19]
Sugiura, S.; Asano, M.; Kinoshita, K.; Tanimura, M.; Nabeshima, T. Risks to health professionals from hazardous drugs in Japan: a pilot study of environmental and biological monitoring of occupational exposure to cyclophosphamide. J. Oncol. Pharm. Pract., 2011, 17(1), 14-19.
[http://dx.doi.org/10.1177/1078155209358632] [PMID: 20179165]
[20]
Viegas, S.; Pádua, M.; Veiga, A.C.; Carolino, E.; Gomes, M. Antineoplastic drugs contamination of workplace surfaces in two Portuguese hospitals. Environ. Monit. Assess., 2014, 186(11), 7807-7818.
[http://dx.doi.org/10.1007/s10661-014-3969-1] [PMID: 25096642]
[21]
Connor, T.H.; DeBord, D.G.; Pretty, J.R.; Oliver, M.S.; Roth, T.S.; Lees, P.S.J.; Krieg, E.F., Jr; Rogers, B.; Escalante, C.P.; Toennis, C.A.; Clark, J.C.; Johnson, B.C.; McDiarmid, M.A. Evaluation of antineoplastic drug exposure of health care workers at three university-based US cancer centers. J. Occup. Environ. Med., 2010, 52(10), 1019-1027.
[http://dx.doi.org/10.1097/JOM.0b013e3181f72b63] [PMID: 20881620]
[22]
[23]
Eitel, A.; Scherrer, M.; Kümmerer, K. Handling Cytostatic Drugs: A Practical Guide., 2000.http://www.escoglobal.com/resources/pdf/zyto20_e.pdf
[24]
Power, L.A.; Coyne, J.W. ASHP Guidelines on Handling Hazardous Drugs. Am. J. Health Syst. Pharm., 2018, 75(24), 1996-2031.
[http://dx.doi.org/10.2146/ajhp180564] [PMID: 30327293]
[25]
Lißner, L.; Kuh, K.; Kauppinen, T.; Uuksulainen, S. Exposure to carcinogens and work-related cancer: A review of assessment methods.European Risk Observatory Report, 2014.https://osha.europa.eu/en/publications/exposure-carcinogens-and-work-related-cancer-review-assessment-methods
[26]
Larson, R.R.; Khazaeli, M.B.; Dillon, H.K. Monitoring method for surface contamination caused by selected antineoplastic agents. Am. J. Health Syst. Pharm., 2002, 59(3), 270-277.
[http://dx.doi.org/10.1093/ajhp/59.3.270] [PMID: 11862639]
[27]
Schmaus, G.; Schierl, R.; Funck, S. Monitoring surface contamination by antineoplastic drugs using gas chromatography-mass spectrometry and voltammetry. Am. J. Health Syst. Pharm., 2002, 59(10), 956-961.
[http://dx.doi.org/10.1093/ajhp/59.10.956] [PMID: 12040735]
[28]
Touzin, K.; Bussières, J.F.; Langlois, E.; Lefebvre, M. Evaluation of surface contamination in a hospital hematology--oncology pharmacy. J. Oncol. Pharm. Pract., 2009, 15(1), 53-61.
[http://dx.doi.org/10.1177/1078155208096904] [PMID: 18772214]
[29]
Siderov, J.; Kirsa, S.; McLauchlan, R. Reducing workplace cytotoxic surface contamination using a closed-system drug transfer device. J. Oncol. Pharm. Pract., 2010, 16(1), 19-25.
[http://dx.doi.org/10.1177/1078155209352543] [PMID: 19965949]
[30]
Kopp, B.; Schierl, R.; Nowak, D. Evaluation of working practices and surface contamination with antineoplastic drugs in outpatient oncology health care settings. Int. Arch. Occup. Environ. Health, 2013, 86(1), 47-55.
[http://dx.doi.org/10.1007/s00420-012-0742-z] [PMID: 22311009]
[31]
Merger, D.; Tanguay, C.; Langlois, E.; Lefebvre, M.; Bussières, J.F. Multicenter study of environmental contamination with antineoplastic drugs in 33 Canadian hospitals. Int. Arch. Occup. Environ. Health, 2014, 87(3), 307-313.
[http://dx.doi.org/10.1007/s00420-013-0862-0] [PMID: 23471647]
[32]
Sottani, C.; Grignani, E.; Oddone, E.; Dezza, B.; Negri, S.; Villani, S.; Cottica, D. Monitoring Surface Contamination by Antineoplastic Drugs in Italian Hospitals: Performance-Based Hygienic Guidance Values (HGVs) Project. Ann. Work Expo. Health, 2017, 61(8), 994-1002.
[http://dx.doi.org/10.1093/annweh/wxx065] [PMID: 29028251]
[33]
Verscheure, E.; Creta, M.; Vanoirbeek, J.; Zakia, M.; Abdesselam, T.; Lebegge, R.; Poels, K.; Duca, R.C.; Godderis, L. Environmental contamination and occupational exposure of algerian hospital workers. Front. Public Health, 2020, 8, 374.
[http://dx.doi.org/10.3389/fpubh.2020.00374] [PMID: 32850596]
[34]
Miwa, M.; Ura, M.; Nishida, M.; Sawada, N.; Ishikawa, T.; Mori, K.; Shimma, N.; Umeda, I.; Ishitsuka, H. Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. Eur. J. Cancer, 1998, 34(8), 1274-1281.
[http://dx.doi.org/10.1016/S0959-8049(98)00058-6] [PMID: 9849491]
[35]
Meulendijks, D.; van Hasselt, J.G.C.; Huitema, A.D.R.; van Tinteren, H.; Deenen, M.J.; Beijnen, J.H.; Cats, A.; Schellens, J.H.M. Renal function, body surface area, and age are associated with risk of early-onset fluoropyrimidine-associated toxicity in patients treated with capecitabine-based anticancer regimens in daily clinical care. Eur. J. Cancer, 2016, 54, 120-130.
[http://dx.doi.org/10.1016/j.ejca.2015.10.013] [PMID: 26761784]
[36]
Kadoyama, K.; Miki, I.; Tamura, T.; Brown, J.B.; Sakaeda, T.; Okuno, Y. Adverse event profiles of 5-fluorouracil and capecitabine: data mining of the public version of the FDA Adverse Event Reporting System, AERS, and reproducibility of clinical observations. Int. J. Med. Sci., 2012, 9(1), 33-39.
[http://dx.doi.org/10.7150/ijms.9.33] [PMID: 22211087]
[37]
Brookhaven National Laboratory: IH75190: Surface Wipe Sampling for Metals. Safety & Health Services Division, Industrial Hygiene Group Upton, NY: Brookhaven National Laboratory,, 2017.https://www.bnl.gov/esh/shsd/sop/pdf/ih_sops/ih75190.pdf
[38]
Zufía, L.; Aldaz, A.; Giráldez, J. Simple determination of capecitabine and its metabolites by liquid chromatography with ultraviolet detection in a single injection. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2004, 809(1), 51-58.
[http://dx.doi.org/10.1016/j.jchromb.2004.06.004] [PMID: 15282093]
[39]
ICH Topic Q 2 (R1). Validation of Analytical Procedures: Text and Methodology. European Medicines Agency,, 1995.https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-2-r1-validation-analytical-procedures-text-methodology-step-5_en.pdf
[40]
Reviewer Guidance: Validation of Chromatographic Methods, Center for Drug Evaluation and Research. Food and Drug Administration, U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, 1994, https://www.fda.gov/media/75643/download
[41]
Łaszcz, M.; Trzcińska, K.; Filip, K.; Szyprowska, A.; Mucha, M.; Krzeczyński, P. Stability studies of capecitabine. J. Therm. Anal. Calorim., 2011, 105(3), 1015-1021.
[http://dx.doi.org/10.1007/s10973-011-1351-x]
[42]
Connor, T.H.; Zock, M.D.; Snow, A.H. Surface wipe sampling for antineoplastic (chemotherapy) and other hazardous drug residue in healthcare settings: Methodology and recommendations. J. Occup. Environ. Hyg., 2016, 13(9), 658-667.
[http://dx.doi.org/10.1080/15459624.2016.1165912] [PMID: 27019141]
[43]
NIOSH Manual of Analytical Methods (NMAMTM), Fourth Edition. Cincinnati, OH: Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health., 1994.https://www.cdc.gov/niosh/docs/96-135/pdf/96-135.pdf
[44]
National Center for Biotechnology Information. PubChem Compound Summary for CID 60953, Capecitabine.. https://pubchem.ncbi.nlm.nih.gov/compound/Capecitabine
[45]
Dhoru, M.; Shah, K.; Detholia, K.; Patel, M. Green chromatography: the eco-friendly and safer concept of green analytical chemistry. IJPSR, 2020, 11(3), 1022-1032.

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy