title: [Failure mode effect analysis applied to preparation of intravenous cytostatics].
abstract: OBJECTIVE
  To proactively identify risks in the preparation of intravenous cytostatic drugs, and to prioritise and establish measures to improve safety procedures.
  
  
  METHODS
  Failure Mode Effect Analysis methodology was used. A multidisciplinary team identified potential failure modes of the procedure through a brainstorming session. The impact associated with each failure mode was assessed with the Risk Priority Number (RPN), which involves three variables: occurrence, severity, and detectability. Improvement measures were established for all identified failure modes, with those with RPN>100 considered critical. The final RPN (theoretical) that would result from the proposed measures was also calculated and the process was redesigned.
  
  
  RESULTS
  A total of 34 failure modes were identified. The initial accumulated RPN was 3022 (range: 3-252), and after recommended actions the final RPN was 1292 (range: 3-189). RPN scores >100 were obtained in 13 failure modes; only the dispensing sub-process was free of critical points (RPN>100). A final reduction of RPN>50% was achieved in 9 failure modes.
  
  
  CONCLUSIONS
  This prospective risk analysis methodology allows the weaknesses of the procedure to be prioritised, optimize use of resources, and a substantial improvement in the safety of the preparation of cytostatic drugs through the introduction of double checking and intermediate product labelling.
authors.affiliation: Unidad de Gestión Clínica de Farmacia Hospitalaria, Hospital Universitario Virgen del Rocío, Sevilla, España. Electronic address: mariad.santos.sspa@juntadeandalucia.es.
authors.forename: M D
authors.initials: MD
authors.lastname: Santos-Rubio
authors.affiliation: Unidad de Gestión Clínica de Farmacia Hospitalaria, Hospital Universitario Virgen del Rocío, Sevilla, España.
authors.forename: R
authors.initials: R
authors.lastname: Marín-Gil
authors.affiliation: Unidad de Gestión Clínica de Farmacia Hospitalaria, Hospital Universitario Virgen del Rocío, Sevilla, España.
authors.forename: R
authors.initials: R
authors.lastname: Muñoz-de la Corte
authors.affiliation: Unidad de Gestión Clínica de Farmacia Hospitalaria, Hospital Universitario Virgen del Rocío, Sevilla, España.
authors.forename: M D
authors.initials: MD
authors.lastname: Velázquez-López
authors.affiliation: Unidad de Gestión Clínica de Farmacia Hospitalaria, Hospital Universitario Virgen del Rocío, Sevilla, España.
authors.forename: M V
authors.initials: MV
authors.lastname: Gil-Navarro
authors.affiliation: Unidad de Gestión Clínica de Farmacia Hospitalaria, Hospital Universitario Virgen del Rocío, Sevilla, España.
authors.forename: F J
authors.initials: FJ
authors.lastname: Bautista-Paloma
mesh_terms: D054697:Cytostatic Agents; D006801:Humans; D011446:Prospective Studies; D018570:Risk Assessment; D012449:Safety
chemical_list: D054697:Cytostatic Agents
keywords: Análisis modal de fallos y efectos; Citostáticos; Cytostatic drugs; Errores de medicación; Failure mode and effect analysis; Gestión de riesgos; Medication errors; Risk management