Olson Phayom Sookaneknun, Krska Janet, Taengthonglang Chatmanee, Tansin Pinyapat, Siangtrong Wilasinee, Pongrueangdilok Piyatida, Jarernsiripornkul Narumol, Potisarach Pemmarin
International Primary Care Practice Research Unit, Faculty of Pharmacy, Mahasarakham University, Maha Sarakham, Thailand.
Faculty of Pharmaceutical Sciences, UCSI University, Kuala Lumpur, Malaysia.
J Pharm Policy Pract. 2025 Apr 4;18(1):2483419. doi: 10.1080/20523211.2025.2483419. eCollection 2025.
Ibuprofen and diclofenac are nonsteroidal anti-inflammatory drugs widely used worldwide. Spontaneous reporting often results in an underestimation of the incidence of adverse drug reactions (ADRs), and a few studies have been conducted in community settings, particularly in community pharmacies. This study aimed to determine the frequency and characteristics of short-term ADRs associated with ibuprofen and diclofenac in community pharmacy patients.
This prospective cohort study was conducted in 15 community pharmacies. A questionnaire from a previous study was modified and tested for content validity. Community pharmacists distributed the questionnaire after dispensing ibuprofen or diclofenac and followed non-responders via telephone and online media platforms. The returned questionnaires were assessed for causality by a pharmacist and three researchers. Descriptive analyses and comparisons between reports on ibuprofen and diclofenac were performed using chi-square and independent t-tests for appropriate outcomes.
Of the 590 distributed questionnaires, 279 were included in the analysis. The percentage of participants who reported ADRs to ibuprofen and diclofenac was 33.3%. Among participants with suspected ADRs, the average number of suspected ADRs from diclofenac was higher than from ibuprofen; however, no significant difference was observed (5.5 ± 8.9 and 3.1 ± 3.0, > 0.05). Of the 347 self-reported ADRs, 45.2% were assessed as probable and possible ADRs. The highest rate of suspected ADRs was in Mental Health (14.4%), followed by the Nose, Throat, Neck, or Voice (9.8%), and the Stomach or Digestive Systems (8.9%), respectively.
Diclofenac showed more suspected ADRs than ibuprofen in a community setting. Almost half of the self-reported ADRs were assessed as probable or possible. Strategies for sustaining community pharmacists in monitoring patients and reporting ADRs should be supported.
布洛芬和双氯芬酸是全球广泛使用的非甾体抗炎药。自发报告往往会低估药物不良反应（ADR）的发生率，并且在社区环境中，特别是在社区药房中进行的研究较少。本研究旨在确定社区药房患者中与布洛芬和双氯芬酸相关的短期ADR的频率和特征。
这项前瞻性队列研究在15家社区药房进行。对先前研究中的一份问卷进行了修改，并对其内容效度进行了测试。社区药剂师在分发布洛芬或双氯芬酸后发放问卷，并通过电话和在线媒体平台追踪未回复者。由一名药剂师和三名研究人员对回收的问卷进行因果关系评估。使用卡方检验和独立t检验对布洛芬和双氯芬酸报告之间的描述性分析和比较进行适当的结果分析。
在分发的590份问卷中，279份被纳入分析。报告布洛芬和双氯芬酸ADR的参与者百分比为33.3%。在疑似ADR的参与者中，双氯芬酸的疑似ADR平均数量高于布洛芬；然而，未观察到显著差异（5.5±8.9和3.1±3.0，P>0.05）。在347例自我报告的ADR中，45.2%被评估为可能和很可能的ADR。疑似ADR发生率最高的是心理健康方面（14.4%），其次是鼻、喉、颈或声音方面（9.8%），以及胃或消化系统方面（8.9%）。
在社区环境中，双氯芬酸比布洛芬显示出更多的疑似ADR。几乎一半的自我报告ADR被评估为可能或很可能。应支持维持社区药剂师监测患者和报告ADR的策略。
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