title: Australian consensus guidelines for the safe handling of monoclonal antibodies for cancer treatment by healthcare personnel.
abstract: These consensus guidelines provide recommendations for the safe handling of monoclonal antibodies. Definitive recommendations are given for the minimum safe handling requirements to protect healthcare personnel. The seven recommendations cover: (i) appropriate determinants for evaluating occupational exposure risk; (ii) occupational risk level compared with other hazardous and non-hazardous drugs; (iii) stratification of risk based on healthcare personnel factors; (iv) waste products; (v) interventions and safeguards; (vi) operational and clinical factors and (vii) handling recommendations. The seventh recommendation includes a risk assessment model and flow chart for institutions to consider and evaluate clinical and operational factors unique to individual healthcare services. These guidelines specifically evaluated monoclonal antibodies used in the Australian cancer clinical practice setting; however, the principles may be applicable to monoclonal antibodies used in non-cancer settings. The guidelines are only applicable to parenterally administered agents.
authors.affiliation: Pharmacy Department, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Alexander
authors.forename: J
authors.initials: J
authors.lastname: King
authors.forename: A
authors.initials: A
authors.lastname: Bajel
authors.forename: C
authors.initials: C
authors.lastname: Doecke
authors.forename: P
authors.initials: P
authors.lastname: Fox
authors.forename: S
authors.initials: S
authors.lastname: Lingaratnam
authors.forename: J D
authors.initials: JD
authors.lastname: Mellor
authors.forename: L
authors.initials: L
authors.lastname: Nicholson
authors.forename: I
authors.initials: I
authors.lastname: Roos
authors.forename: T
authors.initials: T
authors.lastname: Saunders
authors.forename: J
authors.initials: J
authors.lastname: Wilkes
authors.forename: R
authors.initials: R
authors.lastname: Zielinski
authors.forename: J
authors.initials: J
authors.lastname: Byrne
authors.forename: K
authors.initials: K
authors.lastname: MacMillan
authors.forename: A
authors.initials: A
authors.lastname: Mollo
authors.forename: S
authors.initials: S
authors.lastname: Kirsa
authors.forename: M
authors.initials: M
authors.lastname: Green
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D001315:Australia / Q000453:epidemiology; D032921:Consensus; D005260:Female; D019983:Guideline Adherence; D006282:Health Personnel; D006801:Humans; D008297:Male; D016273:Occupational Exposure / Q000517:prevention & control*; D016272:Occupational Health / Q000592:standards*; D004364:Pharmaceutical Preparations; D018570:Risk Assessment; D017751:Safety Management / Q000592:standards*
chemical_list: D000911:Antibodies, Monoclonal; D004364:Pharmaceutical Preparations
keywords: administration; cancer; consensus guideline; manufacturing; monoclonal antibody; occupational health and safety