Background The resolution CM/ResAP(2011)1 established the need for undertaking an appropriate risk assessment when making a pharmacy preparation.
Our national Group of Pharmaceutical Compounding designed a quality tool that allows classification of sterile preparations following the premises of the resolution.
Purpose To design and validate a matrix allowing classification of sterile compounded preparations at different risk levels.
Material and methods The design process included three stages: literature review, identification of risks associated with the elaboration process by means of the failure mode and effect analysis methodology, and estimation of the severity associated with the risks detected.
Once the risk matrix was designed, the tool was validated in order to assure its validity and reliability. The analysis included construct validity, as well as inter-rater and intra-rater reliability, assessed by unweighted kappa coefficients (Light’s kappa). Qualitative instruments are considered reliable if overall agreement was 95% and kappa ≥0.6. A sample of 15 representative sterile preparations usually compounded in the hospital setting were used in this qualitative study. These were evaluated by 10 hospital pharmacists working in the compounding area.
Results The final model included 6 different dimensions of risk: compounding process, route of administration, drug’s safety profile, amount prepared, distribution and susceptibility for microbiological contamination. In each dimension, criteria were graded for risk from A to D. A final combination of 6 letters was obtained, representing three possible risk levels: low, medium and high. Considering physicochemical stability, an attached table proposes a microbiological beyond use date based on risk level, preparation environment and storing conditions. As regards the validity and reliability assessment, the final risk matrix showed an overall percentage of agreement of 96.7%, with Light’s kappa values between 0.68 and 1 (lower limit of confidence interval >0.4) in dimensions 1–5. Intra-rater reliability also had a kappa coefficient ≥0.6 for dimensions 1–5. Dimension 6, related to distribution of the preparation, showed high homogeneity in the answers and hence kappa was not calculated.
Conclusion The designed risk matrix is a reproducible tool adaptable to daily practice in hospital settings that may increase patient safety and allow a better use of resources in sterile preparations.
References and/or Acknowledgements This is a SEFH granted project
No conflict of interest.
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