Risk analysis of the chemotherapy circuit produced in standard doses

N. Cornillet1, R. Vazquez1, M-N. Guerrault1, A-C. Lagrave1
1 Pharmacie, Centre Hospitalier Intercommunal de Poissy/Saint-Germain-en-Laye, 10 rue du champ Gaillard 78300 Poissy

Currently, more and more chemotherapy treatments are performed in day hospitalization. Faced with this strong demand, the cytotoxic preparation unit uses two manufacturing processes. The first is to prepare extemporaneously for a given patient one or more chemotherapies. For the second, it is to prepare in series and in advance injectable cytotoxic (hospital preparations), so-called "standard doses".

Following errors in the dispensing of standard doses, an internal review of nonconformities plotted over one year was carried out and a risk analysis was carried out.
To do this, we used the FMECA (Failure Modes, Effects and Criticality Analysis) and a multidisciplinary working group of 6 people developed a risk map to identify risks and calculate the risks criticality indices.
Over the entire process, 47 failure modes were identified. We identified 11 priority failure modes with an average criticality of 124. An action plan including the establishment of a double discharge control, a weekly inventory and a reorganization of the storage made it possible to obtain a residual average criticality of 39.

This analysis shows that the dispensing and storage of these preparations are the most critical stages of the circuit. We favored simple, concrete measures that can be put in place quickly in order to control risks. In addition, this work has raised the awareness of the entire team on risk management.

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