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.

ISOPP Standards for the Safe Handling of Cytotoxics

“…[34][35][36][37][38] A Cochrane review on CSTD with safe handling vs safe handling was released in 2018. 39 The review makes reference to a number of studies that examined the effects on workplace contamination with the introduction of a CSTD, whilst a limited number attempted to address operator exposure by measuring urine levels of cytotoxic drugs. As discussed in Section 10 and 26 and common Occupational Health and Safety practice, current evidence does not suggest there is a safe level of cytotoxic exposure, and therefore exposure must be limited using CSTD until there is sufficient evidence to prove that practice without CSTD is safe for operators.…”

“…A number of studies have measured airborne concentrations of antineoplastic drugs in healthcare settings. 6,7,13,30,[34][35][36][37][38][39][40][41] In most cases, the percentage of air samples containing measurable airborne concentrations of cytotoxic drugs was low, as were the concentrations of the drugs found. These results may reflect the inefficiency of sampling and analytical techniques used, including the use of glass fiber or paper filters to capture airborne particulates.…”

“…Most recently, Bauters and Vandenbroucke 39 developed a flowchart for risk assessment and allocation of preparation of MABs. It provides recommendations for the classification of MABs according to their toxicity profile and takes practical and financial issues into account.…”

“…As cytotoxic based cancer treatments have evolved and survivors live longer, secondary malignancies have emerged to be a significant impact of this therapy. 38 In the 1970s, Falck et al 39 indicated that unprotected nurses who worked in environments where hazardous drugs were prepared and administered had higher levels of mutagenic substances in their urine than non-exposed workers. This suggested that nursing personnel were being occupationally exposed to cytotoxic drugs, many of which were mutagenic.…”

Developing a flowchart to evaluate the use of Closed System Drug-Transfer Devices with monoclonal antibodies: Focus on the clinical trial setting

“…Therefore, MABs are not expected to be carcinogenic, mutagenic, or teratogenic in the patient themselves, nor in personnel handling the drugs correctly. 1,7…”