Australian consensus guidelines for the safe handling of monoclonal antibodies for cancer treatment by healthcare personnel

Internal Medicine Journal

Volumn 44, Issue 10, 2014, Pages 1018-1026

  Alexander, M ^a   King, J ^b   Bajel, A ^c   Doecke, C ^d,e   Fox, P ^f,g   Lingaratnam, S ^a   Mellor, J D ^a,h   Nicholson, L ⁱ   Roos, I ^j   Saunders, T ^a,k   Wilkes, J ^l,m   Zielinski, R ^f,g   Byrne, J ⁿ   Macmillan, K ^b   Mollo, A ^b   Kirsa, S ^a   Green, M ^o  

^a PETER MACCALLUM CANCER CENTRE   (Australia)

^b Pharmacy Department   (Australia)

^c ROYAL MELBOURNE HOSPITAL   (Australia)

^d ROYAL ADELAIDE HOSPITAL   (Australia)

^e UNIVERSITY OF SOUTH AUSTRALIA   (Australia)

^f Central West Pathology Services   (Australia)

^g UNIVERSITY OF WESTERN SYDNEY   (Australia)

^h Display Pty Ltd   (Australia)

ⁱ ROYAL HOBART HOSPITAL   (Australia)

^j UNIVERSITY OF MELBOURNE   (Australia)

^k Cancer Nurses Society of Australia National Executive Committee   (Australia)

^l View Health Pty Ltd   (Australia)

^m Chemo at home Pty Ltd   (Australia)

ⁿ Western and Central Melbourne Integrated Cancer Services   (Australia)

^o WESTERN HEALTH   (Australia)

more..

Author keywords

Administration; Cancer; Consensus guideline; Manufacturing; Monoclonal antibody; Occupational health and safety

Indexed keywords

MONOCLONAL ANTIBODY; DRUG;

ARTICLE; AUSTRALIA; CANCER IMMUNOTHERAPY; CONSENSUS; HAZARD; HEALTH CARE PERSONNEL; HEALTH CARE SURVEY; HUMAN; MALIGNANT NEOPLASTIC DISEASE; NONHUMAN; OCCUPATIONAL EXPOSURE; OCCUPATIONAL HAZARD; PRACTICE GUIDELINE; PROCESS DEVELOPMENT; WASTE; EPIDEMIOLOGY; FEMALE; MALE; OCCUPATIONAL HEALTH; PREVENTION AND CONTROL; RISK ASSESSMENT; SAFETY; STANDARDS;

ANTIBODIES, MONOCLONAL; AUSTRALIA; CONSENSUS; FEMALE; GUIDELINE ADHERENCE; HEALTH PERSONNEL; HUMANS; MALE; OCCUPATIONAL EXPOSURE; OCCUPATIONAL HEALTH; PHARMACEUTICAL PREPARATIONS; RISK ASSESSMENT; SAFETY MANAGEMENT;

EID: 84913599140     PISSN: 14440903     EISSN: 14455994     Source Type: Journal    
DOI: 10.1111/imj.12564     Document Type: Article

References (43)

1. National Health and Medical Research Council. A Guide to the Development, Implementation and Evaluation of Clinical Practice Guidelines. Canberra: National Health and Medical Research Council (NHMRC); 1998.
2. Turner TJ. Developing evidence-based clinical practice guidelines in hospitals in Australia, Indonesia, Malaysia, the Philippines and Thailand: values, requirements and barriers. BMC Health Serv Res 2009; 9: 235.
3. Alexander M, King J, Lingaratnam S, Byrne J, MacMillan K, Mollo A etal. A survey of manufacturing and handling practices for monoclonal antibodies (MABs) by pharmacy, nursing and medical personnel. J Oncol Pharm Pract 2014; (in press).
4. King J, Alexander M, Byrne J, MacMillan K, Mollo A, Kirsa S etal. A review of the evidence for occupational exposure risks to novel anticancer agents - a focus on monoclonal antibodies. J Oncol Pharm Pract 2014; (in press).
5. National Health and Medical Research Council. Additional Levels of Evidence and Grades for Recommendations for Developers of Guidelines. Canberra: National Health and Medical Research Council (NHMRC); 2008-2009. Stage 2 consultation.
6. National Occupational Health and Safety Commission. Approved Criteria for Classifying Hazardous Substances. Canberra: National Occupational Health and Safety Commission (NOHSC); 2004.
7. National Institute for Occupational Safety and Health. National Institute for Occupational Safety and Health (NIOSH) List of Antineoplastic and Other Hazardous Drugs in Health Care Settings. Ohio: National Institute for Occupational Safety and Health (NIOSH); 2012 [cited 2013 Apr 1]. Available from URL: http://www.cdc.gov/niosh/docs/2012-150/pdfs/2012-150.pdf
8. Berlex Biosciences. Alemtuzumab (Campath) Material Safety Data Sheet (MSDS). Biosciences. 2002.
9. Genzyme Australasia Pty Ltd. Alemtuzumab (MabCampath) TGA Product Information. Australasia Pty Ltd. 2012. [Revision date 2012 Jun 20].
10. Roche Products Pty Ltd. Bevacizumab (Avastin) Material Safety Data Sheet (MSDS). Roche. 2013. [Revision date 2013 Mar 1].
11. Roche Products Pty Ltd. Bevacizumab (Avastin). TGA Product Information. Roche. 2013. [Revision date 2013 May 9].
12. Genentech Inc. Bevacizumab (Avastin). FDA Product Information. Genentech Inc. 2013. [Revision date 2013 Mar].
13. Clearsynth Labs Pvt Ltd. Brentuximab-Vedotin (914088-09-8) Material Safety Data Sheet (MSDS). Clearsynth. 2012.
14. Seattle Genetics. Brentuximab-Vedotin (Adcetris) FDA Product Information. SeattleGenetics. 2012. [Revision date 2012 Jan].
15. ImClone Systems Incorporated. Cetuximab (Erbitux) Material Safety Data Sheet (MSDS). ImClone Systems Incorporated. 2005. [Revision date 2005 Feb].
16. Merck Serono Australia Pty Ltd. Cetuximab (Erbitux) TGA Product Information. Merk Serono. 2013. [Revision date 2013 Feb 26].
17. ImClone LLC. Cetuximab (Erbitux) FDA Product Information. ImClone LLC a wholly-owned subsidiary of Eli Lilly and Company, and Bristol-Myers Squibb Company. 2013. [Revision date 2013 Mar].
18. Amgen Inc. Denosumab (Prolia) Material Safety Data Sheet (MSDS). Amgen. Version 6. 2013. [Revision date 2013 Feb 1].
19. Amgen Inc. Denosumab (Prolia) TGA Product Information. Amgen. 2013. [Revision date 2013 Apr 24].
20. Amgen Inc. Denosumab (Xgeva) Material Safety Data Sheet (MSDS). Amgen. Version 3. 2013. [Revision date 2013 Feb 1].
21. Amgen Inc. Denosumab (Xgeva) Product Information. Amgen. 2013. [Revision date 2013 Mar 5].
22. Bristol-Myers Squibb. Ipilimumab (Yervoy) Material Safety Data Sheet (MSDS). Bristol-Myers Squibb. Version 7.1. 2011. [Revision date 2011 Apr 15].
23. Bristol-Myers Squibb. Ipilimumab (Yervoy). TGA Product Information. Bristol-Myers Squibb. 2013. [Revision date 2013 May 16].
24. Bristol-Myers Squibb. Ipilimumab (Yervoy). FDA Product Information. Bristol-MyersSquibb. 2013. [Revision date 2013 May].
25. GlaxoSmithKline. Ofatumumab (Arzerra) Material Safety Data Sheet (MSDS). GlaxoSmithKline. Version 4. 131072. 2009. [Revision date 2009 Nov 12].
26. GlaxoSmithKline. Ofatumumab (Arzerra) FDA Product Information. GlaxoSmithKline. 2011. [Revision date 2011 Sep].
27. Amgen Inc. Panitumumab (Vectibix) Material Safety Data Sheet (MSDS). Amgen. Version 2. 2008. [Revision date 2008 May 8].
28. Amgen Inc. Panitumumab (Vectibix) TGA Product Information. Amgen. 2013. [Revision date 2013 May 21].
29. Amgen Inc. Panitumumab (Vectibix) FDA Product Information. Amgen. 2013. [Revision date 2013 Mar].
30. Roche Products Pty Ltd. Rituximab (Mabthera) Material Safety Data Sheet (MSDS). Roche. 2009. [Revision date 2009 Oct 22].
31. Genentech Inc. Rituximab (Rituxan) Material Safety Data Sheet (MSDS). Genentech. 2006. [Revision date 2006].
32. Roche Products Pty Ltd. Rituximab (Mabthera). TGA Product Information. Roche. 2013. [Revision date 2013 May 13].
33. Shpilberg O, Jackisch C. Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase. Br J Cancer 2013; 109: 1556-1561.
34. Roche Products Pty Ltd. Trastuzumab (Herceptin) Material Safety Data Sheet (MSDS). Roche. 2013. [Revision date 2013 Mar 1].
35. Roche Products Pty Ltd. Trastuzumab (Herceptin) TGA Product Information. Roche. 2013. [Revision date 2013 Aug 13].
36. Roche Products Pty Ltd. Trastuzumab (Herceptin) FDA Product Information. Roche. 2012. [Revision date 2012 Oct].
37. Roche Products Pty Ltd. Trastuzumab-Emtansine (Kadcyla) Material Safety Data Sheet (MSDS). Roche. 2013. [Revision date 2013 Apr 26].
38. Genentech Inc. Trastuzumab-Emtansine (Kadcyla) FDA Product Information. Genentech. 2013. [Revision date 2013 May].
39. Australian Commission on Safety and Quality in Healthcare. Australian Guidelines for the Prevention and Control of Infection in Healthcare. Canberra: Commonwealth of Australia; 2010.
40. Australian Government Department of Health. Revised Arrangements for the Efficient Funding of Chemotherapy Drugs & Streamlined Authority Data Capture. Canberra: Pharmaceutical Benefits Scheme (PBS); 2013. [cited 2013 Oct 17]. Available from URL: http://www.pbs.gov.au/info/publication/factsheets/shared/revised-arrangements-for-chemotherapy
41. Austin P, Elia M. Improved aseptic technique can reduce variable contamination rates of ward-prepared parenteral doses. J Hosp Infect 2013; 83: 160-163.
42. Thomas M, Sanborn M. R C. I.V. admixture contamination rates: traditional practice site versus a class 1000 cleanroom. Am J Health Syst Pharm 2005; 62: 2386-2392.
43. Clinical Excellence Commission. New South Wales Health. Programs - high risk medicines. 2013. [cited 2013 Oct 16]. Available from URL: http://www.cec.health.nsw.gov.au/programs/high-risk-medicines