Development of a flowchart for risk assessment and allocation of preparation of monoclonal antibodies

Abstract

Monoclonal antibodies have expanded as a novel class of therapeutic agents. In contrast to appropriate guidelines for safe handling of cytotoxics, there are no real standards for the safe handling of monoclonal antibodies. Many questions have arisen whether monoclonal antibodies have to be prepared under controlled circumstances or can be prepared on the ward. We developed a flowchart which provides recommendations for the classification of monoclonal antibodies according to their toxicity profile and takes practical and financial issues into account. It allows oncology pharmacists worldwide to define which monoclonal antibodies can/must be prepared in pharmacy aseptic facilities and which monoclonal antibodies can be prepared on the ward.

Keywords: Safe handling; monoclonal antibodies.