[Risks associated with the implementation of a nominative unit-dose dispensing robotic system: Analysis after ten years of use within a hospital pharmacy department].

Objectives: Our hospital pharmaceutical department acquired an automated drug dispensive system to secure the medication management, from the dispensation to the administration process. The aim of our study was to secure the new circuit by identifying the risks associated with the implementation of the robotic system.

Methods: A working-group was set-up and the use of the Failure Modes, Effects and Criticality Analysis (FMECA) method was decided. FMECA is a proactive risk assessment tool that allows the identification of all potential failures. It relies on the identification of failure modes and their severity, frequency and detectability. The product of the three ratings determines the criticality of the failure mode and allows to rank the failure modes according to the criticality: from low, to intermediate and high.

Results: The process was delimited from drug analysis to medication delivery to the wards. Six steps and 33 sub-steps were identified. In all, 75 failure modes were identified, 67% of which could lead to a medication error. The working-group identified and prioritised corrective measures to implement. It was decided to focus on the failure modes with a high and intermediate criticality index.

Conclusions: This analysis allowed us to highlight weaknesses is the new process created with the implementation of the robotic system. The sub-steps the more at risk are prescription analysis and pillboxes' manually addings. FMECA is an effective tool easy to implement that allows the pooling of ideas and to be exhaustive in the identification of failure modes.