Galván-Banqueri M, Santos-Rubio MD, Espejo-Gutiérrez de Tena E, Espinosa-Bosch M, Vega-Coca MD, Alfaro-Lara ER
Unidad de Gestión Clínica de Farmacia. Hospital Universitario Virgen del Rocío. Sevilla (España)
Rev. OFIL 2016, 26;2:95-100
Fecha de recepción: 09/09/2015 – Fecha de aceptación: 22/02/2016
Objectives: To identify the risks in the magistral preparation 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: reception and interpretation of the prescription, documentation, preparation of the data-processing, material preparation, magistral preparation and conditioning (packaging and labelling) and storage. 24 failure modes, with 38 cases and with varying effects (severity 6-2) were evaluated. The sub-processes with more failure modes with NPR >100 was the conditioning and storage. The most effective improvement measures were: implemented reinforcement training, train, train and stability in the post personnel and discard all magistral unidentified.
Conclusions: The FMEA methodology was a useful tool when applied to magistral preparation. It allowed us to reduce the risk significantly.
Key Words: Failure mode effect analysis, safety, quality, risk, master formulas.
Mercedes Galván Banqueri
C/ Manila, 2 – bloque 13, 5ºa
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Download PDF: Análisis modal de fallos y sus efectos aplicado a la elaboración de fórmulas magistrales