Self-reporting of adverse drug reactions of nonsteroidal anti-inflammatory drugs in community pharmacies.

IF 3.3 Q1 HEALTH POLICY & SERVICES
Journal of Pharmaceutical Policy and Practice Pub Date : 2025-04-04 eCollection Date: 2025-01-01 DOI:10.1080/20523211.2025.2483419
Phayom Sookaneknun Olson, Janet Krska, Chatmanee Taengthonglang, Pinyapat Tansin, Wilasinee Siangtrong, Piyatida Pongrueangdilok, Narumol Jarernsiripornkul, Pemmarin Potisarach
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Abstract

Background: 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.

Methods: 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.

Results: 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, p > 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.

Conclusions: 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.

社区药房非甾体类抗炎药不良反应的自我报告。
背景:布洛芬和双氯芬酸是世界范围内广泛使用的非甾体类抗炎药。自发报告往往导致对药物不良反应(adr)发生率的低估,在社区环境中,特别是在社区药房中进行了一些研究。本研究旨在确定社区药房患者与布洛芬和双氯芬酸相关的短期不良反应的频率和特征。方法:对15家社区药店进行前瞻性队列研究。对先前研究的问卷进行了修改和内容效度测试。社区药师在分配布洛芬或双氯芬酸后发放问卷,并通过电话和网络媒体平台对无应答者进行随访。一名药剂师和三名研究人员对返回的问卷进行了因果关系评估。对布洛芬和双氯芬酸的报告进行描述性分析和比较,采用卡方检验和独立t检验,以确定适当的结果。结果:发放的590份问卷中,279份纳入分析。报告布洛芬和双氯芬酸不良反应的参与者比例为33.3%。在疑似不良反应的受试者中,双氯芬酸的平均疑似不良反应数高于布洛芬;但两组差异无统计学意义(分别为5.5±8.9和3.1±3.0,p < 0.05)。在347例自我报告的不良反应中,45.2%被评估为可能和可能的不良反应。疑似不良反应发生率最高的是心理健康(14.4%),其次是鼻、喉、颈或声音(9.8%)和胃或消化系统(8.9%)。结论:在社区环境中,双氯芬酸比布洛芬出现更多的可疑不良反应。几乎一半的自我报告的不良反应被评估为可能或可能。应支持维持社区药剂师监测患者和报告不良反应的策略。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Pharmaceutical Policy and Practice
Journal of Pharmaceutical Policy and Practice Health Professions-Pharmacy
CiteScore
4.70
自引率
9.50%
发文量
81
审稿时长
14 weeks
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