Risk analysis to support the implementation of Dose Banding circuit in Cancer Centre

Khevin Itoua-Gassaye1, Mallory Friou1, Marion Lafay1, Adeline Cordary2, Laurence Escalup1
1 Pharmacy Department,
2 Quality-Risk Management Department, Institut Curie, 35 Rue Dailly, 92210 Saint-Cloud

Aim of the study
The implementation of a Standard Doses (SD) circuit in our Cancer Centre was initiated at the end of 2020, to optimize the chemotherapy circuit from an organizational and economic point of view. The aim is to establish a risk map of implementation of this new process and to determine its feasibility.

An a priori risk assessment was carried out by a multidisciplinary working group with pharmacists, residents, health manager, and quality manager, according to a methodology proposed by the HAS. [1] The approach began with construction of the future SD circuit, with a description of each process, from determination of SD of chemotherapies to their administration. Potential failure modes have been identified, and ranked according to Frequency (F) of occurrence, Severity (S) and Initial Criticality (Ci). F and S were determined with a 5-level scale. Ci corresponds to the product of F and S, and is quoted with a 3-level scale. Control actions have been considered based on the score obtained and a risk control level (M) is determined with a 5-level scale. The product of Ci and M correspond to the Residual Criticality (Cr), (ranked with a 3-level scale) used to assess the feasibility of the project.

Risk analysis highlighted 50 risks associated with the establishment of a SD circuit, on 15 different processes. Twelve percent of the risks were assessed as major risks, 44% as moderate risk, and 44% as low risk. After determining the risk reduction measures, 1 risk remains highly critical: risk of musculoskeletal disorders within the pharmacy technician team. Twenty three risks keep an intermediate criticality, like storage of finished SD preparations, which would require additional equipment and premises. We decided to postpone the serial production until our new unit with automated equipment, but to apply immediately the prescription in SD.

This work allowed us to identify critical points in our project and demonstrates the feasibility of SD circuit within our Cancer Centre, with a view to optimizing production, organizing flows with non-additional risk. The SD were clinically approved by medical staff for routine application, but we decided to prescribe only in SD and waiting for automatic equipment in 2023 (which would cover amount 57% of the production).

[1] HAUTE AUTORITE DE SANTE, Mettre en œuvre la gestion des risques associés aux soins en établissement de santé, des concepts à la critique. Mars 2012

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