Monoclonal antibodies safety and occupational hazard: Current practice in Australia.

Biological therapies are the mainstay of management for ulcerative colitis and Crohn's disease. These molecules are large and complex and require careful handling to ensure they maintain their potency and integrity during preparation and administration. There have been widespread concerns that some or all of these biological agents, particularly the monoclonal antibodies, may also pose some occupational exposure risks for healthcare workers involved in their preparation or administration. Principally, this has arisen from their initial use to manage forms of malignant disease. Both European and US guidelines for safe handling of hazardous substances have grouped all the monoclonal antibodies together and recommended that they be treated as potentially hazardous. In 2014, the US agency responsible for guidance around hazardous substances, the National Institute for Occupational Safety and Health (NIOSH) removed most monoclonal antibodies from its hazardous substances list. In 2013, the Western Central Melbourne Integrated Cancer Service (WCMICS) agreed to fund a 12-month project, led jointly by Western Health and the Peter MacCallum Cancer Centre, to develop consensus guidelines for the safe handling of monoclonal antibodies used in the treatment of cancer.1 The project used a modified National Health and Medical Research Council (NHMRC) methodology for developing consensus guidelines including an extensive literature review, a survey of clinicians to determine current practices, development of recommendations by a multidisciplinary writing group, voting on the recommendations at a consensus meeting, and endorsement of the guidelines by professional organizations. The guidelines developed make seven recommendations for the safe handling of monoclonal antibodies, which can be used by organizations in developing policies and procedures for local practice. The WCMICS recommendations cover internal exposure risk, risk of cytotoxicity, carcinogenicity, genotoxicity or mutagenicity, teratogenicity, organ toxicity at low doses, and immunogenicity. In addition, recommendations are made for safe handling procedures; stratifying exposure risk according to the role of the healthcare professional (HCP) and health considerations; and waste management. Available safety interventions such as aseptic technique and the use of isolator and cytotoxic drug safety cabinets are also included alongside operational and clinical factors such as vial sharing and preparation complexity and medication errors. Whilst the recommendations developed as part of these WCMICS consensus guidelines were specific to the cancer setting, the guidelines are highly likely to be applicable to non-cancer settings such as for inflammatory bowel disease (IBD) services. Health services should have processes to review these guidelines in a multidisciplinary setting involving pharmacy, nursing, and medical personnel to come to an agreement product by product with respect to where and by whom these products should be prepared and administered.