Faculty of Pharmaceutical Sciences, Department of Pharmacology and Pharmacotherapy, University of Copenhagen, Copenhagen, Denmark.
Pharmacoepidemiol Drug Saf. 2011 Apr;20(4):399-404. doi: 10.1002/pds.2069. Epub 2010 Nov 26.
Post-marketing safety studies of adverse drug reactions (ADRs) form an important part of pharmacovigilance. Countries having a formal pharmacovigilance system to a large extent rely on voluntary ADR reporting from health professionals through spontaneous report systems. The contribution of pharmacists in ADR reporting, although varies significantly among countries. Pharmacists in community pharmacies are in a unique position for detection of experienced ADRs by the drug users. The study reports from a study on community pharmacy internship students' proactive role in ADR detection through direct encountering and questioning with drug users.
Pharmacy students undertaking internship in a community pharmacy were approached. Thirteen students from nine community pharmacies participated in the project as data collectors. Prior to the study students attended an educational seminar focusing on ADR detection and reporting in general. Ibuprofen was chosen as the drug of study. Pharmacy students approached recurrent drug users purchasing the drug. Participating users were asked about experienced ADRs linked to ibuprofen use. Reported ADRs were collected and analysed.
Hundred and twenty eight ibuprofen users participated in the study out of who thirty three reported forty five ADRs possibly linked to ibuprofen use. The reported ADRs followed earlier reported patterns of distribution with gastric pain showing up as the most commonly reported symptom followed by heartburn, nausea, diarrhoea and constipation.
Through adequate training community pharmacy internship students get competencies and are capable of detecting and reporting ADRs through direct questions to drug users.
药物不良反应(ADR)上市后安全性研究是药物警戒的重要组成部分。在很大程度上,拥有正式药物警戒系统的国家主要依靠卫生专业人员通过自发报告系统报告 ADR。药剂师在报告 ADR 方面的作用在各国之间差异很大。社区药剂师在发现药物使用者经历的 ADR 方面处于独特的地位。本研究报告了一项关于社区药房实习学生通过直接与药物使用者接触和询问来主动发现 ADR 的研究。
接触正在社区药房实习的药学学生。来自 9 家社区药房的 13 名学生作为数据收集者参与了该项目。在研究之前,学生参加了一个关于一般 ADR 检测和报告的教育研讨会。选择布洛芬作为研究药物。社区药房的学生接触经常购买该药的药物使用者。询问参与的使用者与布洛芬使用相关的经历过的 ADR。收集并分析报告的 ADR。
128 名布洛芬使用者参与了该研究,其中 33 名报告了可能与布洛芬使用相关的 45 种 ADR。报告的 ADR 遵循先前报道的分布模式,胃痛是最常见的报告症状,其次是胃灼热、恶心、腹泻和便秘。
通过充分的培训,社区药房实习学生获得了能力,并能够通过直接向药物使用者提问来检测和报告 ADR。