title: [Design of a risk matrix to assess sterile formulations at health care facilities].
abstract: OBJECTIVE
  To design a matrix allowing classifying sterile formulations prepared at the hospital with different risk levels.
  
  
  METHODS
  i) Literature search and critical appraisal of the model proposed by the European Resolution CM/Res Ap(2011)1, ii) Identification of the risk associated to the elaboration process by means of the AMFE methodology (Modal Analysis of Failures and Effects), iii) estimation of the severity associated to the risks detected. After initially trying a model of numeric scoring, the classification matrix was changed to an alphabetical classification, grading each criterion from A to D.Each preparation assessed is given a 6-letter combination with three possible risk levels: low, intermediate, and high. This model was easier for risk assignment, and more reproducible.
  
  
  RESULTS
  The final model designed analyzes 6 criteria: formulation process, administration route, the drug's safety profile, amount prepared, distribution, and susceptibility for microbiological contamination.The risk level obtained will condition the requirements of the formulation area, validity time, and storing conditions.
  
  
  CONCLUSIONS
  The matrix model proposed may help health care institutions to better assess the risk of sterile formulations prepared,and provides information about the acceptable validity time according to the storing conditions and the manufacturing area. Its use will increase the safety level of this procedure as well as help in resources planning and distribution.
authors.affiliation: Servicio de Farmacia. Hospital Universitario Fundación Alcorcón. Madrid. Grupo de Trabajo de Farmacotecnia de la Sociedad Española de Farmacia Hospitalaria.. annamariamrc@gmail.com.
authors.forename: A M
authors.initials: AM
authors.lastname: Martín de Rosales Cabrera
authors.affiliation: Servicio de Farmacia. Hospital Clínic. Grupo de Trabajo de Farmacotecnia de la Sociedad Española de Farmacia Hospitalaria. Barcelona. España.. mclopez1@clinic.ub.es.
authors.forename: C
authors.initials: C
authors.lastname: López Cabezas
authors.affiliation: Hospital Vega Baja. Sociedad Española de Farmacia Hospitalaria. Orihuela. Alicante. España.. garcia_ped@gva.es.
authors.forename: P
authors.initials: P
authors.lastname: García Salom
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000592:standards*; D006268:Health Facilities / Q000592:standards*; D006801:Humans; D008962:Models, Theoretical; D061214:Patient Safety; D004364:Pharmaceutical Preparations / Q000592:standards*; D018570:Risk Assessment; D013242:Sterilization / Q000592:standards*
chemical_list: D004364:Pharmaceutical Preparations