Prospective risk analysis in a retrocession unit: Focus on drug dispensation process

Objectives. - Failure mode effect analysis (FMEA) improves safety in the drug life cycle. As the drug dispensation by hospital's pharmacy can be at risk, the FMEA tool has been used to evaluate and enhance the process. Methods. - After detailing the process, a first FMEA has been run in 2015. Corrective actions were implemented every time criticality indexes (CI) were above 15. One year later, we have evaluated potential impacts of these actions by running a new FMEA. Results. - In 2015, 11 failure modes were prioritized (CI > 15) and the total CI for the overall process was 397. Corrective actions were implemented and one year later this amount has decreased by 14% (340) with 6 failure modes still prioritized. Thus, thanks to the FMEA, risks could be identified in year "y", they were taken into account and corrected and then effectively reassessed in year "y + 1". Conclusion. - This study showed us the interest of performing FMEA analysis in the drug dispensation process by hospital. The renewal of this risk analysis after a year helped us to monitor corrective actions, to evaluate their effectiveness and to improve safety. Finally, FMEA seems to be an effective way to steer the drug dispensation process. (C) 2019 Academie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.