Alsulami Fahad T, Alqarni Yousef Saeed, Alruqayb Wadia Saad, Alharthi Mohammed S, Alzahrani Mohammad S, Algarni Majed A, Althobaiti Musaad M, Almalki Saad Mohammed, Altowarqi Nawaf Abid, Mathkur Hussain Ali, Althumali Anas Muslih, Alharthi Ayman Mohammed, Fadil Haifa Abdulrahman, Altowairqi Adel A, Alharthi Mubarak S
Clinical Pharmacy Department, College of Pharmacy, Taif University, Taif, Saudi Arabia.
Department of Pharmacy Practice, College of Pharmacy, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
Front Pharmacol. 2025 May 20;16:1574412. doi: 10.3389/fphar.2025.1574412. eCollection 2025.
Adverse drug reaction (ADR) reporting is critical for ensuring medication safety. However, underreporting remains a global concern, particularly in community pharmacy settings. This study explores the behavioral factors influencing community pharmacists' intention to report ADRs in Saudi Arabia, using the Theory of Planned Behavior (TPB) as a guiding framework.
This study aimed to estimate factors affecting community pharmacists' intention to report ADRs to the Saudi National Pharmacovigilance Center (NPC) through a TPB-based analysis.
A cross-sectional survey was conducted to collect data on pharmacists' intentions, attitudes, subjective norms, perceived behavioral control, and moral obligation regarding ADR reporting. Descriptive statistics summarized the sample characteristics. Binary logistic regression was used to evaluate the influence of TPB constructs on reporting intentions.
Among 452 participating community pharmacists, 88% were aware of the NPC, but only 27.4% had reported ADRs in the past year. Pharmacists who were non-Saudi, aware of the NPC and its procedures, and trained in ADR reporting demonstrated significantly higher intentions to report (p < 0.05). Attitudes (OR = 1.141, 95% CI: 1.09-1.18, p < 0.001), subjective norms (OR = 1.280, 95% CI: 1.16-1.40, p < 0.001), perceived behavioral control (OR = 1.168, 95% CI: 1.03-1.31, p = 0.010), and moral obligation (OR = 1.417, 95% CI: 1.05-1.89, p = 0.019) were all significantly associated with reporting intention.
Findings reinforce the importance of targeting TPB constructs (particularly attitudes, social norms, and perceived control) and perceived moral obligation in designing interventions to improve ADR reporting. Strategies such as structured training, institutional support, and promoting moral responsibility may bridge the gap between awareness and actual reporting practices among community pharmacists in Saudi Arabia.
药物不良反应（ADR）报告对于确保用药安全至关重要。然而，报告不足仍是一个全球关注的问题，尤其是在社区药房环境中。本研究以计划行为理论（TPB）为指导框架，探讨影响沙特阿拉伯社区药剂师报告ADR意愿的行为因素。
本研究旨在通过基于TPB的分析，评估影响社区药剂师向沙特国家药物警戒中心（NPC）报告ADR意愿的因素。
进行了一项横断面调查，以收集有关药剂师对ADR报告的意愿、态度、主观规范、感知行为控制和道德义务的数据。描述性统计总结了样本特征。二元逻辑回归用于评估TPB构念对报告意愿的影响。
在452名参与调查的社区药剂师中，88%知晓NPC，但过去一年中只有27.4%报告过ADR。非沙特籍、知晓NPC及其程序并接受过ADR报告培训的药剂师报告意愿显著更高（p<0.05）。态度（OR=1.141，95%CI：1.09-1.18，p<0.001）、主观规范（OR=1.280，95%CI：1.16-1.40，p<0.001）、感知行为控制（OR=1.168，95%CI：1.03-1.31，p=0.010）和道德义务（OR=1.417，95%CI：1.05-1.89，p=0.019）均与报告意愿显著相关。
研究结果强化了在设计干预措施以改善ADR报告时，针对TPB构念（特别是态度、社会规范和感知控制）以及感知道德义务的重要性。结构化培训、机构支持和促进道德责任等策略可能会缩小沙特阿拉伯社区药剂师在知晓与实际报告行为之间的差距。
