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Clinical Recognition, Safe Triage, and Pharmacovigilance Reporting Readiness for Suspected Serious Adverse Drug Reactions in Community Pharmacies: A Covert Simulated-Patient Study in Central Jordan

Year: 2026

Type: article

Abstract: Background/Objectives: Serious adverse drug reactions (ADRs) may first present with nonspecific symptoms outside hospital settings, where delayed recognition or escalation can postpone definitive care. Community pharmacists are often a first point of contact, but behavior-based evidence on their clinical recognition and triage of serious ADRs is limited. We evaluated clinical assessment, recognition, safe triage, and subsequent pharmacovigilance reporting readiness across three high-risk presentations. Methods: A cross-sectional covert simulated-patient study was conducted in 384 urban community pharmacies in Amman, Zarqa, and Al-Balqa, Jordan. Pharmacies were randomly assigned one of three standardized scenarios: semaglutide-associated acute pancreatitis, empagliflozin-associated euglycemic diabetic ketoacidosis, or apixaban-associated gastrointestinal bleeding. The primary outcome was a guideline-informed safe-triage response requiring urgent ED/EMS referral, explicit communication of urgency, and no management likely to delay care; pharmacovigilance reporting behavior and readiness were assessed separately after completion of the clinical consultation. Results: Safe triage occurred in 41.7% of encounters (design-based 95% CI, 37.0–46.3), with higher performance for apixaban (60.9%) than semaglutide (42.2%) and empagliflozin (21.9%; overall p < 0.001). A medication-related cause was recognized in 72.9%, whereas the specific syndrome or harm was named in 39.6%; unsafe management likely to delay assessment occurred in 26.3%. Only 8.3% spontaneously raised reporting. In adjusted analysis, safe triage was less prevalent in the empagliflozin scenario (aPR 0.51, 95% CI 0.35–0.74) and more prevalent in the apixaban scenario (aPR 1.54, 95% CI 1.21–1.96) than in the semaglutide reference scenario. High workload was associated with lower safe-triage prevalence, whereas a visible consultation area and recent pharmacovigilance training were associated with higher prevalence. Conclusions: In urban community pharmacies in central Jordan, important gaps were observed in recognition, explicit escalation, and safe triage, particularly for the euglycemic ketoacidosis presentation. Spontaneous pharmacovigilance engagement was also limited. Interventions should prioritize drug-specific red-flag recognition, unambiguous escalation language, workflow support for focused assessment, and low-burden reporting after immediate patient safety has been addressed. These findings should not be generalized to rural pharmacies or other regions of Jordan without further evaluation.

Source: Journal of Clinical Medicine

DOI: 10.3390/jcm15218652