A review of the evidence for occupational exposure risks to novel anticancer agents-A focus on monoclonal antibodies

Journal of Oncology Pharmacy Practice

Volumn 22, Issue 1, 2016, Pages 121-134

  King, Julie ^a   Alexander, Marliese ^b   Byrne, Jenny ^c   MacMillan, Kent ^a   Mollo, Adele ^a   Kirsa, Sue ^b   Green, Michael ^a  

^a WESTERN HEALTH   (Australia)

^b PETER MACCALLUM CANCER CENTRE   (Australia)

^c Western and Central Melbourne Integrated Cancer Service   (Australia)

Author keywords

Cancer; Guidelines; Monoclonal antibodies; Occupational exposure

Indexed keywords

ANTINEOPLASTIC AGENT; CYTOTOXIC AGENT; HYBRID PROTEIN; LIVE VACCINE; MONOCLONAL ANTIBODY;

CARCINOGENICITY; CYTOTOXICITY; GENE THERAPY; HUMAN; IMMUNOGENICITY; MOLECULAR WEIGHT; MUTAGENICITY; OCCUPATIONAL EXPOSURE; OCCUPATIONAL HAZARD; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; TERATOGENICITY; ADVERSE EFFECTS; HEALTH CARE PERSONNEL; SAFETY;

ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; HEALTH PERSONNEL; HUMANS; OCCUPATIONAL EXPOSURE; RISK ASSESSMENT; SAFETY;

EID: 84960863312     PISSN: 10781552     EISSN: 1477092X     Source Type: Journal    
DOI: 10.1177/1078155214550729     Document Type: Review

References (124)

1. National Institute for Occupational Safety and Health (NIOSH). List of antineoplastic and other hazardous drugs in health care settings. Ohio: Author, 2012.
2. National Occupational Health and Safety Commission (NOHSC). Approved criteria for classifying hazardous substances [NOHSC:1008(2004)]. Australian National Standard. 3rd revision. Canberra: Author, 2004.
3. Commission Directive 2001/59/EC of 6 August 2001 adapting to technical progress for the 28th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Off J Eur Commun, No. L225 (21 August 2001).
4. EC Council Directive 67/548/EEC on the approximation of the laws RAAPRTTC, packaging and labelling of dangerous substances. Off J Eur Commun, No. L196 (16 August 1967).
5. TM (Bortezomib). Canc Investig 2004; 22: 304-311.
6. Australian Register of Therapeutic Goods (ARTG). Therapeutic goods administration (TGA), www.ebs.tga. gov.au/(accessed 30 September 2013)
7. US Food and Drug Administration (FDA). Hematology/oncology (cancer) approvals & safety notifications, http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm279174.htm (accessed 30 September 2013).
8. Moreau P, Richardson P, Cavo M, et al. Proteasome inhibitors in multiple myeloma: 10 years later. Blood 2012; 120: 947-959.
9. Bortezomib (Velcade) material safety data sheet (MSDS). Johnson and Johnson. Version 2.0. Issue date 20 March 2012 (A317L).
10. SHPA. Standards of practice for the safe handling of cytotoxic drugs in pharmacy departments. J Pharm Pract Res 2004; 35: 44-52.
11. Lamm DL, Thor DE, Harris SC, et al. Bacillus Calmette-Guerin immunotherapy of superficial bladder cancer. J Urol 1980; 124: 38-40.
12. Bacillus Calmette and Guerin (Oncotice) TGA product information. Merck Sharp & Dohme. Revision date: 1 September 2012.
13. Ginn SL, Alexander IE, Edelstein ML, et al. Gene therapy clinical trials worldwide to 2012-an update. J Gene Med 2013; 15: 65-77.
14. Bamford KB, Wood S and Shaw RJ. Standards for gene therapy clinical trials based on pro-active risk assessment in a LondonNHSteachinghospitaltrust.QJM 2005; 98: 75-86.
15. Gene Technology Act 2000. Act No. 169/2000 as amended. Compilation prepared on 24 January 2012 taking into account amendments up to Act No. 58 of 2011.
16. SHPA. Guidelines for medicines prepared in Australian hospital pharmacy departments. J Pharm Pract Res 2010; 40: 133-143.
17. Connor T, McLauchlan R and Vandenbroucke J. ISOPP standards of practice-cytotoxics. J Oncol Pharm Pract 2007; 13: 13-81.
18. The scientific advisory committee on genetic modification (SACGM) compendium of guidance. Part 6: guidance on the use of genetically modified microorganisms in a clinical setting. Health and Safety Executive (HSE), First published January 2007.
19. Liossis S-NC and Tsokos GC. Monoclonal antibodies and fusion proteins in medicine. J Allergy Clin Immunol 2005; 116: 721-729.
20. Guideline for the preparation or manipulation of monoclonal antibodies (MABs) and related compounds such as fusion proteins, used in the treatment of cancer. Version 2.0. Pan Birmingham cancer network, 2012.
21. Clinical oncology society of Australia. Cancer pharmacists group position statement. Safe handling of monoclonal antibodies in healthcare settings. Melbourne: Clinical Oncology Society of Australia, 2013.
22. Etanercept (Enbrel) Material Safety Data Sheet (MSDS). Amgen. Revision number 3. Issue date 12 February 2013.
23. Abatacept Material Safety Data Sheet (MSDS). Bristol-Myers Squibb. Version 1.6. Issue date 4 June 2007.
24. Andrady C, Chester KA and Sharma SK. Antibody-enzyme fusion proteins for cancer therapy. Immunotherapy 2011; 3: 193-211.
25. Mascelli MA, Zhou H, Sweet R, et al. Molecular, biologic, and pharmacokinetic properties of monoclonal antibodies: impact of these parameters on early clinical development. J Clin Pharmacol 2007; 47: 553-565.
26. Mellor JD, Brown MP, Irving HR, et al. A critical review of the role of Fc gamma receptor polymorphisms in the response to monoclonal antibodies in cancer. J Hematol Oncol 2013; 6: 1-10.
27. Guidance for industry S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals (ICH S6). International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH), 1997.
28. Maibach H and Conant M. Contact urticaria to a cor-ticosteroid cream: polysorbate 60. Contact Dermatitis 2006; 3: 350-351.
29. Kerwin BA. Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: structure and degradation pathways. J Pharmaceut Sci 2008; 97: 2924-2935.
30. Overdijk MB, Verploegen S, van den Brakel JH, et al. Epidermal growth factor receptor (EGFR) antibody-induced antibody-dependent cellular cytotoxicity plays a prominent role in inhibiting tumorigenesis, even of tumor cells insensitive to EGFR signaling inhibition. J Immunol (Baltimore, Md: 1950) 2011; 187: 3383-3390.
31. Ueda N, Tsukamoto H, Mitoma H, et al. The cytotoxic effects of certolizumab pegol and golimumab mediated by transmembrane tumor necrosis factor a. Inflamm Bowel Dis 2013; 19: 1224-1231.
32. Monoclonal antibodies risk management for Northern Sydney Local Health District (NSLHD). Document No. PR2013-001. Department of Oncology, Division of Medicine, Northern Sydney Local Health District Hospitals, 2013.
33. Halsen G and Kramer I. Assessing the risk to health care staff from long-term exposure to anticancer drugs-the case of monoclonal antibodies. J Oncol Pharm Pract 2011; 17: 68-80.
34. Langford S, Fradgley S, Evans M, et al. Assessing the risk of handling monoclonal antibodies. Hospital Pharmacist 2008; 15: 60-64.
35. Connor TH and MacKenzie BA. Should monoclonal antibodies and their conjugates be considered occupational hazards. In: Kurt E and Goodman N (eds) Safety Considerations in Oncology Pharmacy Fall. Ohio: National Institute for Occupational Safety and Health, 2011, pp.13-16.
36. Moss GP, Dearden JC, Patel H, et al. Quantitative structure-permeability relationships (QSPRs) for percutaneous absorption. Toxicol Vitro 2002; 16: 299-317.
37. Bos JD and Meinardi MM. The 500 Dalton rule for the skin penetration of chemical compounds and drugs. Exp Dermatol 2000; 9: 165-169.
38. Dostalek M, Gardner I, Gurbaxani BM, et al. Pharmacokinetics, pharmacodynamics and physiologically-based pharmacokinetic modelling of monoclonal antibodies. Clin Pharmacokinet 2013; 52: 83-124.
39. Blink R. Concepts of occupational exposure to monoclonal antibodies [unpublished work]. Appendix in BioPharma environmental health and safety (EHS) group public correspondence to NIOSH, http://www.cdc.gov/niosh/docket/archive/pdfs/NIOSH-105/0105-092007-treanor-sub.pdf (2007, accessed 22 August 2013).
40. Kaestli L, Fonzo-Christe C, Bonfillon C, et al. Development of a standardised method to recommend protective measures to handle hazardous drugs in hospitals. Eur J Hosp Pharm 2013; 20: 100-105.
41. Lightwood D, O'Dowd V, Carrington B, et al. The discovery, engineering and characterisation of a highly potent anti-human IL-13 fab fragment designed for administration by inhalation. J Mol Biol 2013; 425: 577-593.
42. Maillet A, Congy-Jolivet N, Le Guellec S, et al. Aerodynamical, immunological and pharmacological properties of the anticancer antibody cetuximab following nebulization. Pharmaceut Res 2008; 25: 1318-1326.
43. Kim S. Low inhalation bioavailability of MABs [unpublished work]. Appendix in correspondence from BioPharma EHS Forum to NIOSH, http://wwwcdcgov/niosh/docket/archive/pdfs/NIOSH-105/0105-092007-treanor-subpdf (2007, accessed 1 April 2013).
44. Saltzman WM, Sherwood JK, Adams DR, et al. Long-term vaginal antibody delivery: delivery systems and bio-distribution. Biotechnol Bioeng 2000; 67: 253-264.
45. Samson G, Garcia de la Calera A, Dupuis-Girod S, et al. Ex vivo study of bevacizumab transport through porcine nasal mucosa. Eur J Pharm Biopharm 2012; 80: 465-469.
46. Falero-Diaz G, Challacombe S, Rahman D, et al. Transmission of IgA and IgG monoclonal antibodies to mucosal fluids following intranasal or parenteral delivery. Int Arch Allergy Immunol 2000; 122: 143-150.
47. Pleyer U, Milani JK, Dukes A, et al. Effect of topically applied anti-CD4 monoclonal antibodies on orthotopic corneal allografts in a rat model. Investig Ophthalmol Vis Sci 1995; 36: 52-61.
48. Ochi H, Abraham M, Ishikawa H, et al. Oral CD3-spe-cific antibody suppresses autoimmune encephalomyelitis by inducing CD4+ CD25-LAP+ T cells. Nat Med 2006; 12: 627-635.
49. Petschow BW and Talbott RD. Reduction in virus-neutralizing activity of a bovine colostrum immuno-globulin concentrate by gastric acid and digestive enzymes. J Pediatr Gastroenterol Nutr 1994; 19: 228-235.
50. Tacket CO, Losonsky G, Link H, et al. Protection by milk immunoglobulin concentrate against oral challenge with enterotoxigenic Escherichia coli. N Engl J Med 1988; 318: 1240-1243.
51. Vermeer AW and Norde W. The thermal stability of immunoglobulin: unfolding and aggregation of a multi-domain protein. Biophys J 2000; 78: 394-404.
52. Chu W, Hon C-Y, Danyluk Q, et al. Pilot assessment of the antineoplastic drug contamination levels in British Columbian hospitals pre-and post-cleaning. J Oncol Pharm Pract 2012; 18: 46-51.
53. Fransman W, Vermeulen R and Kromhout H. Occupational dermal exposure to cyclophosphamide in Dutch hospitals: a pilot study. Ann Occup Hyg 2004; 48: 237-244.
54. Gandre B and Kramer I. Cytotoxic surface contamination in a robotic system compared with manual preparation. Eur J Hosp Pharm 2012; 19: 151.
55. Hon C-Y, Teschke K, Chu W, et al. Antineoplastic drug contamination of surfaces throughout the hospital medication system in Canadian hospitals. J Occup Environ Hyg 2013; 10: 374-383.
56. Kiffmeyer TK, Kube C, Opiolka S, et al. Vapour pressures, evaporation behaviour and airborne concentrations of hazardous drugs: implications for occupational safety. Pharmaceut J 2002; 268: 33.
57. Siderov J, Kirsa S and RM. Surface contamination of cytotoxic chemotherapy preparation areas in Australian hospital pharmacy departments. J Pharm Pract Res 2009; 39: 117-121.
58. Australian and New Zealand Standard. AS/NZS 1716:2012. Respiratory protective devices, 7th ed. New Zealand: Standards Australia Limited/Standards New Zealand, Melbourne.
59. Australian and New Zealand Standard. AS/NZS 1715:2009. Selection, use and maintenance of respiratory protective equipment. New Zealand: Standards Australia Limited/Standards.
60. Allwood M, Stanley A and Wright P (eds) The cytotoxics handbook, 4th ed. Abingdon, UK: Radcliffe Medical Press, 2002.
61. Harrison B and Kloos M. Penetration and splash protection of six disposable gown materials against fifteen anti-neoplastic drugs. J Oncol Pharm Pract 1999; 5: 61-66.
62. Jorgenson J, Spivey S, Canann D, et al. Contamination comparison of transfer devices intended for handling hazardous drugs. Hosp Pharm 2008; 43: 723-727.
63. Harrison B, Peters B and Bing M. Comparison of surface contamination with cyclophosphamide and fluorouracil using a closed-system drug transfer device versus standard preparation techniques. Am J Health-Syst Pharm 2006; 63: 1736-1744.
64. McMichael D, Jefferson D, Carey E, et al. Utility of the PhaSeal closed system drug transfer device. Am J Pharm Benefits 2011; 3: 9-16.
65. Sessink P, Rolf M and Ryden N. Evaluation of the PhaSeal hazardous drug containment system. Hosp Pharm 1999; 34: 1311-1317.
66. Siderov J, Kirsa S and McLauchlan R.Reducing workplace cytotoxic surface contamination usinga closed-system drug transfer device. J Oncol Pharm Pract 2010; 16: 19-25.
67. Spivey S and Connor T. Determining sources of workplace contamination with antineoplastic drugs and comparing conventional IV preparation with a closed system. Hosp Pharm 2003; 38: 135-139.
68. Biron AD, Lavoie-Tremblay M and Loiselle CG. Characteristics of work interruptions during medication administration. J Nurs Scholarsh 2009; 41: 330-336.
69. Raban MZ and Westbrook JI. Are interventions to reduce interruptions and errors during medication administration effective? A systematic review. BMJ Qual Saf 2013. DOI:10.1136/bmjqs-2013-002118.
70. Kiese S, Papppenberger A, Friess W, et al. Shaken, not stirred: mechanical stress testing of an IgG1 antibody. J Pharmaceut Sci 2008; 97: 4347-4366.
71. Sreedhara A, Glover ZK, Piros N, et al. Stability of IgG1 monoclonal antibodies in intravenous infusion bags under clinical in-use conditions. J Pharmaceut Sci 2012; 101: 21-30.
72. Wang W, Singh S, Zeng D, et al. Antibody structure, instability and formulation. J Pharmaceut Sci 2007; 96: 1-26.
73. Austin P and Elia M. Improved aseptic technique can reduce variable contamination rates of ward-prepared parenteral doses. J Hosp Infect 2013; 83: 160-163.
74. Thomas M, Sanborn M and Couldry R. I.V. admixture contamination rates: traditional practice site versus a class 1000 cleanroom. Am J Health Syst Pharm 2005; 62: 2386-2392.
75. Trissel L, Gentempo J, Anderson R, et al. Using a medium-fill simulation to evaluate the microbial contamination rate for USP medium-risk-level compounding. Am J Health Syst Pharm 2005; 62: 285-288.
76. Mattner F and Gastmeier P. Bacterial contamination of multiple-dose vials: a prevalence study. Am J Infect Contr 2004; 32: 12-16.
77. Pricing of PBS medicine. Average rates payable for extemporaneous items. Medicare, Australian government department of human services, https://www.medicareaus tralia.gov.au/provider/pbs/pharmacists/pricing.jsp# N102DE (accessed 8 May 2013).
78. Bortezomib (Velcade) product information. Jannsen. Revision date: 20 November 2012.
79. Denosumab (Xgeva) product information. Amgen. Revision date: 5 March 2013.
80. Shpilberg O and Jackisch C. Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase. Br J Canc 2013; 109: 1556-1561.
81. Cisplatin (cas 15663-27-1) material safety data sheet (MSDS). GuideChem.
82. National Institute for Occupational Safety and Health (NIOSH). List of antineoplastic and other hazardous drugs in healthcare settings: proposed additions and deletions to the NIOSH hazardous drug list-charge to reviewers. Ohio: Author, 2012.
83. Brentuximab-Vedotin (Adcetris) FDA product information. SeattleGenetics. Revision date: January 2012.
84. Trastuzumab-Emtansine (Kadcyla) FDA product information. Genentech. Revision date: May 2013.
85. Aflibercept (Eylea) material safety data sheet (MSDS). Bayer Australia Ltd. Version 1.0. Revision date: 22 September 2011.
86. Aflibercept (Eylea) product information. Bayer Australia Ltd. Revision date: 5 April 2013.
87. Alemtuzumab (Campath) material safety data sheet (MSDS). Berlex Biosciences. Revision date: 4 June 2002.
88. Alemtuzumab (Campath) FDA product information. Genzyme Corporation. Revision date: 19 September 2007.
89. Alemtuzumab (MabCampath) TGA product information. Genzyme Australasia Pty Ltd. Revision date: 20 June 2012.
90. Bacillus Calmette-Guerin (OncoTICE) material safety data sheet (MSDS). MSD, Merck & Co, Inc. Revision date: 4 April 2011.
91. Bevacizumab (Avastin) material safety data sheet (MSDS). Roche. Revision date: 1 March 2013.
92. Bevacizumab (Avastin) FDA product information. Roche. Revision date: March 2013.
93. Bevacizumab (Avastin) TGA product information. Roche. Revision date: 9 May 2013.
94. SeattleGenetics. Brentuximab-Vedotin (914088-09-8) material safety data sheet (MSDS). Clearsynth, 2012.
95. Cetuximab (Erbitux) material safety data sheet (MSDS). ImClone Systems Incorporated. Revision date: February 2005.
96. Cetuximab (Erbitux) TGA product information. Merk Serono. Revision date: 14 May 2013.
97. Denosumab (Xgeva) material safety data sheet (MSDS). Amgen. Version 3. Revision date: 1 February 2013.
98. Denosumab (Prolia) material safety data sheet (MSDS). Amgen. Version 6. Revision date: 1 February 2013.
99. Denosumab (Prolia) product information. Amgen. Revision date: 24 May 2013.
100. Ipilimumab (Yervoy) FDA product information. Bristol-MyersSquibb. Revision date: May 2013.
101. Ipilimumab (Yervoy) TGA product information. Bristol-Myers Squibb. Revision date: 16 May 2013.
102. Ipilimumab (Yervoy) material safety data sheet (MSDS). Bristol-Myers Squibb. Version 7.1. Revision date: 15 April 2011.
103. Ofatumumab (Arzerra) material safety data sheet (MSDS). GlaxoSmithKline. Version 4. Revision date: 12 November 2009 (131072).
104. Ofatumumab (Arzerra) FDA product information. GlaxoSmithKline. Revision date: September 2011.
105. Panitumumab (Vectibix) FDA product information. Amgen. Revision date: March 2013.
106. Panitumumab (Vectibix) material safety data sheet (MSDS). Amgen. Version 2. Revision date: 8 May 2008.
107. Panitumumab (Vectibix) TGA product information. Amgen. Revision date: 21 May 2013.
108. Rituximab (Mabthera) TGA product information. Roche. Revision date: 13 May 2013.
109. Rituximab (Mabthera) material safety data sheet (MSDS). Roche. Revision date: 22 October 2009.
110. Trastuzumab (Herceptin) FDA product information. Roche. Revision date: October 2012.
111. Trastuzumab (Herceptin) TGA product information. Roche. Revision date: 13 August 2012.
112. Trastuzumab (Herceptin) material safety data sheet (MSDS). Roche. Revision date: 1 March 2013.
113. Trastuzumab-Emtansine (Kadcyla) material safety data sheet (MSDS). Roche. Revision date: 26 April 2013.
114. Dangerous Goods Act. Act No. 10189/1985. Version No. 081, www.austlii.edu.au (1985, accessed 25 August 2014).
115. Dangerous Goods (Storage and Handling) Regulations (Victoria). SR No. 132/2012, 2012.
116. Occupational Health and Safety Act. Act No. 10190/1985. Version No. 061, 1985.
117. Victorian Government. Occupational health and safety regulations. SR No. 54/2007. Version No. 001, 2007.
118. Workplace exposure standards for airborne contaminants. Safe work Australia, April 2013.
119. WorkSafe Victoria. Handling cytotoxic drugs in the workplace. Melbourne: WorkSafe Victoria, State Government of Victoria, 2003.
120. The handling of hazardous drugs and related wastes in South Australian health services. Policy-public health and clinical systems. Approved 2 April 2012, http://www.sahealth.sa.gov.au/wps/wcm/connect/f99069004b3 f738aa4ddade79043faf0/HandlingOfHazardousDrugs RelatedWastesinSADirective-PHCS-PSS-1205.pdf? MOD=AJPERES&CACHEID=f99069004b3f738aa4d dade79043faf0 (accessed 31 May 2013).
121. Safe handling of cytotoxic drugs and related wastes: guidelines for South Australian health services. Approved 2 February 2012, www.sahealth.sa.gov.au/wps/wcm/connect/f8aa68004b3f6cf6a340afe79043faf0/SafeHandlingOfCytotoxicDrugsRelatedWastesGuideline-PHCS-120515.pdf?MOD=AJPERES (2012, accessed 31 May 2013).
122. American Society of Clinical Oncology/Oncology Nursing Society. Chemotherapy administration: safety standards. Alexandria: Author, 2012.
123. World Health Organisation (WHO). Good manufacturing practices for pharmaceutical products containing hazardous substances. WHO, 2010.
124. National Health Service (NHS). Guidance on the safe handling of monoclonal antibody (MAB) products. 4th ed. London: Author, 2008.