Design of a risk matrix to assess sterile formulations at health care facilities

Abstract

Objective: To design a matrix allowing classifying sterile formulationsprepared at the hospital with different risk levels. Material and methods: i) Literature search and critical appraisalof the model proposed by the European Resolution CM/ResAp(2011)1, ii) Identification of the risk associated to the elaborationprocess by means of the AMFE methodology (ModalAnalysis of Failures and Effects), iii) estimation of the severityassociated to the risks detected. After initially trying a model ofnumeric scoring, the classification matrix was changed to analphabetical classification, grading each criterion from A to D.Each preparation assessed is given a 6-letter combination withthree possible risk levels: low, intermediate, and high. Thismodel was easier for risk assignment, and more reproducible. Results: The final model designed analyzes 6 criteria: formulationprocess, administration route, the drug’s safety profile, amountprepared, distribution, and susceptibility for microbiological contamination.The risk level obtained will condition the requirementsof the formulation area, validity time, and storing conditions. Conclusions: The matrix model proposed may help health careinstitutions to better assess the risk of sterile formulations prepared,and provides information about the acceptable validitytime according to the storing conditions and the manufacturingarea. Its use will increase the safety level of this procedure aswell as help in resources planning and distribution.

Keywords

• Drug preparation
• ; Risk analysis
• ; Risk matrix
• Aseptic preparation
• Sterile medications
• Quality
• ; Patient’s .