Abstract

MARTIN DE ROSALES CABRERA, A. M.ª; LOPEZ CABEZAS, C.  and  GARCIA SALOM, P.. Design of a risk matrix to assess sterile formulations at health care facilities. Farm Hosp. [online]. 2014, vol.38, n.3, pp.202-210. ISSN 2171-8695.  https://dx.doi.org/10.7399/FH.2014.38.3.7457.

Objective: To design a matrix allowing classifying sterile formulations prepared at the hospital with different risk levels. Material and methods: i) Literature search and critical appraisal of the model proposed by the European Resolution CM/ResAp (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.

Keywords : Drug preparation; Risk analysis; Risk matrix; Aseptic preparation; Sterile medications; Quality; Patient's safety.

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