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
6 affiliations
- 1Pharmacy Department, College of Pharmacy, Amman Arab University, Amman 11953, Jordan
- 2Clinical Pharmacy Department, Faculty of Pharmacy, Zarqa University, Zarqa 13132, Jordan
- 3Department of Biopharmaceutics and Clinical Pharmacy, Faculty of Pharmacy, Al-Ahliyya Amman University, Amman 19111, Jordan
- 4Department of Biopharmaceutics and Clinical Pharmacy, Faculty of Pharmacy, The University of Jordan, Amman 11942, Jordan
- 5Clinical Affairs Department, Qatar University, Doha 2713, Qatar
- 6Department of Pharmacy Practice, College of Pharmacy, Princess Nourah bint Abdulrahman University, P.O. Box 84428, Riyadh 11671, Saudi Arabia
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.
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BibTeX
@article{merdas2026clinical,
title = {{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}},
author = {Zekrayat J. H. Merdas and Mohammad Abu Assab and Anas Abed and Wala’a Al. Safadi and Zain Z. Zakaria and Zainab Zakaraya and Sireen Abdul Rahim Shilbayeh},
journal = {Journal of Clinical Medicine},
year = {2026},
month = nov,
doi = {10.3390/jcm15218652},
url = {https://www.mdpi.com/2077-0383/15/21/8652},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - 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
AU - Zekrayat J. H. Merdas
AU - Mohammad Abu Assab
AU - Anas Abed
AU - Wala’a Al. Safadi
AU - Zain Z. Zakaria
AU - Zainab Zakaraya
AU - Sireen Abdul Rahim Shilbayeh
PY - 2026
DA - 2026/11/06
JO - Journal of Clinical Medicine
DO - 10.3390/jcm15218652
UR - https://www.mdpi.com/2077-0383/15/21/8652
AB - 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.
SN - 2077-0383
ER -