Dose standardisation of intravenous anticancer drugs: Risk analysis and implementation in a French cancer centre

ObjectiveImplementation of a Standard Doses (SD) workflow is a big challenge for pharmacists, in order to optimize the organization of chemotherapy preparation and support in day hospital activity. The objective is to map and determine the feasibility of a SD routine and to identify eligible molecules with and corresponding SD.MethodsA Preliminary Risk Analysis (PRA) of the process from prescription to preparation was carried out, with a failure mode and effects critical analysis (FMECA) method. A survey on standard dose concept was distributed to all prescribers. The rules to define eligible dosage of each drugs was an annual production of more than 250 preparations and for each eligible molecule, at least a 70% coverage rate for a maximum of 7 SD. These doses have been rounded up to a maximum of +/- 10% for cytotoxics and antibody-drug conjugates, and +/- 15% for monoclonal antibodies.ResultsAfter medical approval, sixteen molecules were eligible and thirteen are used routinely to date. The PRA highlighted 52 risks over 16 stages of the process. A risk retains a significant criticality after application of control actions: the risk of musculoskeletal disorders (MSD) during preparation.ConclusionThis work enabled us to study the feasibility of setting up a SD workflow in our hospital to optimize the provision of chemotherapy to the patient. Due to persistent MSD risk and limited storage capacity, we decided to prescribe exclusively in SD, pending the automation of our preparation unit in 2025.