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

Abstract

AimThe aims were to (a) review the scientific literature on occupational risk, including exposure mechanisms and risk assessment, with regards to handling monoclonal antibodies (mABs) in healthcare settings; and (b) update the recommendations in the Clinical Oncology Society of Australia (COSA) safe handling of monoclonal antibodies in healthcare settings position statement, published in 2013.MethodsA literature search was conducted between April 24, 2022, and July 3, 2022, to identify evidence relating to occupational exposure and handling of mABs in healthcare settings. Evidence in the literature was compared to the Position Statement published in 2013, and any potential additions, deletions, or revisions were discussed by the authors, and then agreed changes were made.ResultsThirty‐nine references were included in this update, comprising of the 2013 Position Statement itself and 10 of its references, as well as 28 new references. The risks to healthcare workers in the preparation and administration of mABs arise from four distinct exposure mechanisms: dermal, mucosal, inhalation, and oral. Updates included recommendations on using protective eyewear during the preparation and administration of mABs, developing a local institutional risk assessment tool and handling recommendations, considerations for using closed system transfer devices, and to have awareness of the nomenclature change from 2021 for new mABs.ConclusionPractitioners should follow the 14 recommendations to lower occupational risk when handling mABs. Another Position Statement update should occur in 5–10 years to ensure the currency of recommendations.

A Human Skin Explant Test as a Novel In Vitro Assay for the Detection of Skin Sensitization to Aggregated Monoclonal Antibodies

“…For example, one study investigating the instability of antibodies during aerosolization of lung mucosa in mice found the development of aggregates, which led to pro-inflammatory and cytotoxic effects [16]. The Clinical Oncology Society of Australia Position Statement [17] also reviews the safe handling of monoclonal antibodies in the health care setting where distinct exposure mechanisms, dermal, mucosal, inhalation, and oral, were discussed with regard to health risk, e.g., dermatitis and skin sensitization.…”