Abstract
Introduction: Automated unit-dose (UD) medication distribution systems are increasingly recognized as enabling technologies for safer, more efficient, and traceable drug administration in hospitals. Closed-loop UD systems integrate electronic prescribing, automated dispensing, and bedside barcode scanning to ensure full traceability throughout the medication process. This study evaluated the clinical effectiveness, organizational impact, and cost-effectiveness of a closed-loop UD system implemented at a 930-bed national referral hospital in Northern Italy, compared with the previous ward-stock system. Methods: A convergent mixed-methods mini-Health Technology Assessment combined administrative, clini cal, and financial data (2018–2021) with literature evidence and 18 semi-structured staff interviews. Outcomes included medication administration errors (MAEs), adverse drug reactions (ADRs), and preventable hospitalizations. Cost-effectiveness was assessed from the Italian National Health Service perspective, and qualitative findings were analyzed using framework analysis. Results: Based on literature-derived parameters, the model suggests a reduction in MAE rate from 10.6% to 5.0%, preventing an estimated 57,247 errors, 4,294 ADRs, and 42 hospitalizations per year. These outcomes were associated with net annual savings of €1.32 million and an ICER of €48.67 per error avoided. The model also in dicated that around 34,000 nursing hours could be reallocated to direct patient care, while qualitative evidence highlighted improved staff satisfaction and medication traceability. Sensitivity analyses confirmed economic ro bustness in 95% of simulations. Conclusions: Implementation of a closed-loop UD system enhances medication safety, workflow efficiency, and cost-effectiveness, supporting its scalability as a strategic innovation aligned with institutional goals for quality and sustainability.