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Clinical Oncology Society of Australia Position Statement: 2022 update to the safe handling of monoclonal antibodies in healthcare settings

Clinical Oncology Society of Australia Position Statement: 2022 update to the safe handling of... INTRODUCTIONThe first Clinical Oncology Society of Australia (COSA) Safe Handling of Monoclonal Antibodies in Healthcare Settings Position Statement was published in 2013.1 Since then, many new monoclonal antibodies (mABs) have been registered for use. mABs have unique characteristics in terms of chemistry, pharmacology, biological activity, toxicity, and formulation2,3 and may pose an occupational exposure risk to healthcare workers who prepare or administer them or who work in areas where they are administered.1–16Compared to the plethora of guidelines for the safe handling of cytotoxic medication, up‐to‐date guidelines for the safe handling of mABs are lacking. Without an understanding of risks, healthcare workers may have concerns regarding the safe handling of mABs, such as whether they should be prepared under controlled conditions (i.e., from a centralized service such as a pharmacy cleanroom) or can be prepared on the ward.10 These concerns are extrapolated from published studies with cytotoxic medicines which have shown that workplace exposures to hazardous drugs can cause both acute and chronic health effects.In response to these concerns, consensus guidelines on occupational risk with handling mABs in healthcare settings have been published in the past several years. These publications reflect the enthusiasm of organizations in committing their own resources http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Asia-Pacific Journal of Clinical Oncology Wiley

Clinical Oncology Society of Australia Position Statement: 2022 update to the safe handling of monoclonal antibodies in healthcare settings

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Publisher
Wiley
Copyright
© 2023 John Wiley & Sons Australia, Ltd.
ISSN
1743-7555
eISSN
1743-7563
DOI
10.1111/ajco.13943
Publisher site
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Abstract

INTRODUCTIONThe first Clinical Oncology Society of Australia (COSA) Safe Handling of Monoclonal Antibodies in Healthcare Settings Position Statement was published in 2013.1 Since then, many new monoclonal antibodies (mABs) have been registered for use. mABs have unique characteristics in terms of chemistry, pharmacology, biological activity, toxicity, and formulation2,3 and may pose an occupational exposure risk to healthcare workers who prepare or administer them or who work in areas where they are administered.1–16Compared to the plethora of guidelines for the safe handling of cytotoxic medication, up‐to‐date guidelines for the safe handling of mABs are lacking. Without an understanding of risks, healthcare workers may have concerns regarding the safe handling of mABs, such as whether they should be prepared under controlled conditions (i.e., from a centralized service such as a pharmacy cleanroom) or can be prepared on the ward.10 These concerns are extrapolated from published studies with cytotoxic medicines which have shown that workplace exposures to hazardous drugs can cause both acute and chronic health effects.In response to these concerns, consensus guidelines on occupational risk with handling mABs in healthcare settings have been published in the past several years. These publications reflect the enthusiasm of organizations in committing their own resources

Journal

Asia-Pacific Journal of Clinical Oncology – Wiley

Published: Mar 10, 2023

Keywords: cancer services; monoclonal antibodies; oncology; pharmacy; safe handling

References

  • Assessing the risk of handling monoclonal antibodies
    Langford, S; Fradgley, S; Evans, M; Blanks, C
  • Australian consensus guidelines for the safe handling of monoclonal antibodies for cancer treatment by healthcare personnel
    Alexander, M; King, J; Bajel, A
  • A survey of manufacturing and handling practices for monoclonal antibodies by pharmacy, nursing and medical personnel
    Alexander, M; King, J; Lingaratnam, S
  • Staff sensitisation to therapeutic monoclonal antibodies resulting from workplace exposure: a case report
    Barrott, L; Foreman, E
  • . ISOPP standards for the safe handling of cytotoxics
    O'Connor, S; Kerr, K; Chan, A
  • A review of the evidence for occupational exposure risks to novel anticancer agents – a focus on monoclonal antibodies
    King, J; Alexander, M; Byrne, J
  • Development of a flowchart for risk assessment and allocation of preparation of monoclonal antibodies
    Bauters, T; Vandenbroucke, J
  • Safe handling of monoclonal antibodies: too large to be hazardous?
    Lemos, ML; Badry, N; Kletas, V; Fabbro, J; Tew, A
  • Considerations for setting occupational exposure limits for novel pharmaceutical modalities
    Graham, JC; Hillegass, J; Schulze, G
  • New INN nomenclature for monoclonal antibodies
    Balocco, R; Kock, S; Thorpe, R; Weisser, K; Malan, S
  • Assessment of unintended volume loss of six closed system transfer devices
    Kulju, S; McIntosh, BA; Fuller, HJ; Arnold, T; Gunnar, W
  • Evaluating six commercially available closed‐system drug‐transfer devices against NIOSH's 2015 draft vapor protocol
    Halloush, S; Reveles, IA; Koeller, J
  • Frequency and component analysis of contaminants generated in preparation of anticancer agents using closed system drug transfer devices (CSTDs)
    Sumikawa, S; Yakushijin, Y; Aogi, K
  • Challenges of using closed system transfer devices with biological drug products: an industry perspective
    Sreedhara, A; Zamiri, C; Goswami, S
  • A systematic approach to evaluating closed system drug‐transfer devices during drug product development
    Patke, S; Gaillat, EN; Calero‐Rubio, C
  • The United States Pharmacopeia, 43rd rev., and The National Formulary
  • The 500 Dalton rule for the skin penetration of chemical compounds and drugs
    Bos, JD; Meinardi, MMHM
  • Assessing the risk to health care staff from long‐term exposure to anticancer drugs ‐ the case of monoclonal antibodies
    Halsen, G; Krämer, I
  • The clinical pharmacology of therapeutic monoclonal antibodies
    Roskos, LK; Davis, CG; Schwab, GM
  • Effect of topically applied anti‐CD4 monoclonal antibodies on orthotopic corneal allografts in a rat model
    Pleyer, U; Milani, JK; Dukes, A
  • Efficacy of antibody delivery to the retina and optic nerve by topical administration
    Hu, S; Koevary, S
  • The airways, a novel route for delivering monoclonal antibodies to treat lung tumors
    Maillet, A; Guilleminault, L; Lemarié, E
  • Bioavailability of therapeutic proteins by inhalation—worker safety aspects
    Pfister, T; Dolan, D; Bercu, J
  • Aerodynamical, immunological and pharmacological properties of the anticancer antibody cetuximab following nebulization
    Maillet, A; Congy‐Jolivet, N; Le Guellec, S
  • The thermal stability of immunoglobulin: unfolding and aggregation of a multi‐domain protein
    Vermeer, AW; Norde, W
  • Development of an analytical method to assess the occupational health risk of therapeutic monoclonal antibodies using LC‐HRMS
    Reinders, LMH; Klassen, MD; Jaeger, M; Teutenberg, T; Tuerk, J
  • . SHPA Guidelines for medicines prepared in Australian Hospital Pharmacy Departments
  • Surface contamination of cytotoxic chemotherapy preparation areas in australian hospital pharmacy departments
    Siderov, J; Kirsa, S; McLauchlan, R
  • Guidelines for the safe handling of hazardous drugs: consensus recommendations
    Chaffee, BW; Armitstead, JA; Benjamin, BE