DSCSA Implementation and Unit-Level Serialization Challenges at the U.S. Dispenser Layer: Evidence from Hospital and Community Pharmacy Operations

Abstract

The Drug Supply Chain Security Act (DSCSA) established a national framework for enhancing pharmaceutical supply chain security through electronic traceability and unit-level serialization. As dispenser organizations represent the final point of pharmaceutical distribution before medications reach patients, understanding the challenges associated with DSCSA implementation at hospital and community pharmacies is essential for evaluating compliance readiness and operational effectiveness. This study investigated the determinants of DSCSA implementation and unit-level serialization challenges at the U.S. dispenser layer by examining technological, organizational, financial, and workforce-related factors influencing compliance performance. A quantitative cross-sectional survey design was employed, and data were collected from 312 pharmacy professionals representing hospital pharmacies, health-system pharmacies, independent community pharmacies, chain community pharmacies, and specialty pharmacies across the United States. Descriptive statistics, independent-samples t-tests, one-way ANOVA, Pearson correlation analysis, and multiple linear regression were conducted using statistical software to evaluate relationships among study variables and identify significant predictors of serialization implementation success. The findings revealed that information systems readiness (M = 4.01, SD = 0.62), interoperability capability (M = 3.92, SD = 0.65), leadership support (M = 4.08, SD = 0.61), workforce preparedness (M = 3.78, SD = 0.67), and financial resource availability significantly influenced DSCSA compliance performance. Correlation analysis indicated strong positive relationships between interoperability capability and compliance performance (r = .721, p < .001) and between information systems readiness and compliance performance (r = .684, p < .001). Multiple regression analysis demonstrated that interoperability capability was the strongest predictor of compliance performance (β = .341, p < .001), followed by information systems readiness (β = .286, p < .001), leadership support (β = .221, p < .001), workforce preparedness (β = .183, p = .002), and financial resources (β = .149, p = .011). The regression model explained 58.8% of the variance in compliance performance (R² = .588). Comparative analysis further showed that hospital pharmacies achieved significantly higher compliance performance scores (M = 4.12, SD = 0.48) than community pharmacies (M = 3.74, SD = 0.57). The study concluded that successful DSCSA implementation at the dispenser level depended on the integration of robust information systems, effective interoperability capabilities, organizational support, workforce readiness, and adequate resource allocation. These findings provide quantitative evidence regarding the critical factors influencing serialization adoption and pharmaceutical traceability compliance within U.S. pharmacy operations.