Quality indicators of the pharmaceutical preparation process in the hospital pharmacy service

To describe the quality indicators applied to the pharmaceutical preparation process in the Hospital Pharmacy Service of a tertiary hospital between 2018 and 2024, to assess their evolution, and to record the reported incidents and improvement measures implemented.

Observational, retrospective, longitudinal study. Seven quality indicators related to centralized pharmaceutical preparations were monitored: incidents in the repackaging of oral solids, preparation of cytostatic mixtures, handling of investigational drugs, preparation of parenteral nutrition, and preparation of sterile magistral formulations, as well as preparation time for cytostatic mixtures and rejection rate after quality control of parenteral nutrition and cytostatic mixtures. Reference values, quality targets, and alert thresholds were defined mainly on the basis of the Hospital Pharmacy Service's prior experience. Data were collected quarterly from internal records, and a temporal trend analysis was performed.

The indicators showed interannual variability. Incidents were recorded in the repackaging of oral solids (labeling, traceability, and dosing errors) and in the preparation of cytostatic mixtures and investigational drugs (technical errors related to volume, diluent, or product presentation). Preparation time for cytostatic mixtures remained within the reference range. Incidence rates were very low for parenteral nutrition and sterile magistral formulations. Improvement measures included space reorganization, automation, structured technical training, standardized procedures, and reinforcement of control and traceability. In the temporal analysis, preparation time for cytostatic mixtures showed a downward trend, whereas incidents involving investigational drugs showed an upward trend, with no significant lineal trend in the remaining indicators.

Systematic monitoring through quality indicators enabled the identification of areas of improvement in the pharmaceutical preparation process and supported decision-making within a patient safety framework. These findings support the value of continuous surveillance and a culture of quality in the hospital pharmacy service.