Alfaro Lara ER1, Santos-Rubio MD1, Gil Navarro MV1, Pérez-Guerrero C2, Galván Banqueri M1
1 Hospital Universitario Virgen del Rocío. Sevilla (España)
2 Departamento de Farmacología. Facultad de Farmacia. Sevilla (España)
Rev. OFIL 2016, 26;3:161-170
Fecha de recepción: 03/08/2015 – Fecha de aceptación: 01/06/2016
Objectives: To identify the risks in an unit-dose drug distribution system in order to improve the safety of the usual procedures.
Methods: We used the methodology Failure Mode Effect Analysis (FMEA). A multidisciplinary team identified potential failure modes of the procedure through a brainstorming. We assessed the impact associated with each failure mode with the Risk Priority Number (RPN), which involves three variables: occurrence, severity and detectability. Improvement measures were established for all identified failure modes, those with RPN >100 are considered critical. The final RPN (theoretical) that would result from the proposed measures was also calculated and the process was redesigned.
Results: The process was divided in six sub-processes: receiving the prescription, transcription, validation, printing of medical orders and nurse´s forms, filling medication trolleys and realization of treatment changes on them. 40 failure modes, with 34 causes and with varying effects (severity 1-7) were evaluated. The five major failure modes NPR were: not detected allergy, undetected interaction, incorrect regimen, indication absence and incorrect indication, with values of 378, 405, 320, 360 and 360, respectively. The most effective improvement measures were: updating of computer records and expanding the staff dedicated to this sub-process.
Conclusions: The FMEA methodology was a useful tool when applied to an unit-dose drug distribution system. The implementation of improvement actions allow to reduce the risk significantly.
Key Words: Failure mode effect analysis, safety, quality, risk, medication systems.