A two-domain regulatory literacy instrument among Saudi pharmacy interns: a single-center pilot assessment under...

Saudi Arabia accelerates the nationalization of the pharmacy workforce under Vision 2030, making regulatory proficiency paramount for ensuring patient safety and institutional compliance. While foundational jurisprudence is integrated into Doctor of Pharmacy (PharmD) curricula, a significant knowledge-to-action gap often persists regarding the procedural execution of statutory mandates.

This pilot study aimed to develop a bilingual, two-domain regulatory literacy instrument and to compare declarative (basic) vs. procedural (operational) regulatory literacy of final-year pharmacy interns.

A cross-sectional pilot assessment was conducted among final-year PharmD interns (N = 40). An 11-item two-domain instrument assessed regulatory competencies across declarative (6 items) and procedural (5 items) domains. Statistical dependence was controlled by utilizing McNamar's test to evaluate performance variations across domains within the same cohort. The predictive validity of self-perceived literacy was analyzed using Fisher's exact test.

The cohort demonstrated high proficiency within the declarative sub-domain (80.0% overall success rate), with 95% correctly identifying pharmacy manager nationality mandates. Conversely, a critical deficiency emerged within the procedural sub-domain (23.5% overall success rate). Alarmingly, 50% (n = 20) misidentified the United States Food and Drug Administration as the local market authorization body, and (0%, n = 0) were aware of commercial non-promotional value caps. At the participant level, 80.0% passed the declarative sub-domain (95% CI: 64.4%-90.9%), whereas only 22.5% passed the procedural sub-domain, confirming a highly significant operational performance gap (95% CI: 10.8%-38.5%; χ ² = 21.04, df = 1, p < 0.0001). Self-perceived literacy strongly predicted objective outcomes (Fisher's exact test, p < 0.0001). However, this calibration exposed a profound systemic under preparedness.

These exploratory findings suggest a notable vulnerability within the evaluated cohort, where strong declarative knowledge masks deficits in procedural execution. To support practice-ready graduates and mitigate compliance risks under Saudi Vision 2030, a transition from theoretical jurisprudence to simulated operational training frameworks is recommended within undergraduate pharmacy curricula.