{"title":"Self-reporting of adverse drug reactions of nonsteroidal anti-inflammatory drugs in community pharmacies.","authors":"Phayom Sookaneknun Olson, Janet Krska, Chatmanee Taengthonglang, Pinyapat Tansin, Wilasinee Siangtrong, Piyatida Pongrueangdilok, Narumol Jarernsiripornkul, Pemmarin Potisarach","doi":"10.1080/20523211.2025.2483419","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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, <i>p</i> > 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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"18 1","pages":"2483419"},"PeriodicalIF":3.3000,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11998303/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Pharmaceutical Policy and Practice","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1080/20523211.2025.2483419","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"HEALTH POLICY & SERVICES","Score":null,"Total":0}
引用次数: 0
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.