Effect of Pharmacist Involvement on Patient Reporting of Adverse Drug Reactions: First Italian Study
Effect of Pharmacist Involvement on Patient Reporting of Adverse Drug Reactions: First Italian Study
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DOI：
10.1007/s40264-013-0028-8
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发表时间：
2013-04-01
期刊：
影响因子：
4.2
通讯作者：
Velo, Giampaolo
中科院分区：
文献类型：
--
作者：
Leone, Roberto;Moretti, Ugo;Velo, Giampaolo
将患者添加到药物不良反应（ADR）的潜在报告者范围可能会增加自发报告，并有助于检测信号，这是自发报告系统的主要目的之一。社区药房作为促进患者报告ADRs的服务在这方面可能发挥重要作用。本研究的主要目的是评估干预措施对促进意大利韦内托地区社区药房患者报告的潜在影响，并比较患者和全科医生的特点该研究在意大利的韦内托地区进行，涉及在118个社区药房工作的211名药剂师。每位药剂师被要求在研究期间选择约250名接受过至少一种药物的客户，然后向那些经历过可疑ADR的客户提交自发报告表。要求患者填写ADR报告表，并将其交还给药剂师，或通过传真或邮件发送，或在线填写表格。在4个月的时间内，药剂师访问了52，495名客户，其中4，949人（9.4%）提到可疑ADR。韦内托地区的药物警戒中心收到了2，311份与研究相关的公民ADR报告表（来自46.7%发生疑似ADR的所有受访患者）。质量控制后，将其中1，794份报告输入意大利药物警戒数据库，并与同期韦内托地区GP发送的报告（226份）进行比较。患者报告的已知和非严重反应的百分比高于GP。社区广泛使用的药物和非处方药是患者最常报告的药物。相比之下，很少有报告涉及的药物反应或造影剂，药物主要用于医院setting.Our研究表明，患者报告有可能增加价值的药物警戒系统。患者报告中提供的信息的总体质量良好。患者报告和全科医生报告之间的差异表明不同的观点可以丰富自发报告。
Adding patients to the range of potential reporters of adverse drug reactions (ADRs) may increase spontaneous reporting and contribute to the detection of signals, one of the primary aims of spontaneous reporting systems. Community pharmacies could have an important role in this context as a service for promoting patient reporting of ADRs.The main objectives of the present study were to assess the potential impact of an intervention to promote patient reporting in community pharmacies in the Veneto region of Italy, and to compare the characteristics of patients' and general practitioners' (GPs) reports of ADRs.The study was conducted in the Veneto region of Italy and involved 211 pharmacists working in 118 community pharmacies. Each pharmacist was asked to select, during the study period, about 250 customers who had received at least one drug, and then to present the spontaneous reporting form to those who had experienced a suspected ADR. Patients were asked to complete the ADR report form and either give it back to the pharmacist, or send it by fax or mail, or else to fill in the form online.In a 4-month period, 52,495 customers were interviewed by the pharmacists and 4,949 of them (9.4 %) referred a suspected ADR. The Pharmacovigilance Centre of the Veneto region received 2,311 citizen's ADR reporting forms related to the study (from 46.7 % of all patients interviewed who had experienced suspected ADRs). After quality control 1,794 of these reports were entered into the Italian Pharmacovigilance Database and were compared with the reports (226) sent by GPs in the Veneto region in the same period. Patients reported a higher percentage of known and non-serious reactions than did GPs. Drugs widely used in the community setting, and over-the-counter products, were the drugs most frequently reported by patients. In contrast, few reports involving reactions to antineoplastic agents or contrast media-drugs mostly used in a hospital setting-were sent by patients.Our study shows that patient reporting has the potential to add value to the pharmacovigilance system. The overall quality of the information provided in patients' reports was good. The differences between reports by patients and by GPs indicate different points of view that can enrich spontaneous reporting.