Pharmacology Unit, Department of Public Health and Community Medicine, University of Verona, Verona, Italy.
Drug Saf. 2013 Apr;36(4):267-76. doi: 10.1007/s40264-013-0028-8.
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.
将患者纳入不良反应（ADR）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标之一。在这方面，社区药房可以作为促进患者报告 ADR 的服务发挥重要作用。
本研究的主要目的是评估在意大利威尼托地区促进社区药房患者报告的干预措施的潜在影响，并比较患者和全科医生（GP）报告 ADR 的特征。
该研究在意大利威尼托地区进行，涉及 211 名在 118 家社区药房工作的药剂师。每位药剂师都被要求在研究期间选择大约 250 名接受至少一种药物的顾客，然后向经历疑似 ADR 的顾客出示自发报告表。患者被要求填写 ADR 报告表，然后将其交还给药剂师，或者通过传真或邮件发送，或者在线填写。
在 4 个月的时间里，药剂师共对 52495 名顾客进行了访谈，其中 4949 名（9.4%）报告了疑似 ADR。威尼托地区药物警戒中心收到了与该研究相关的 2311 份公民 ADR 报告表（占接受过疑似 ADR 治疗的所有患者的 46.7%）。经过质量控制后，其中 1794 份报告被录入意大利药物警戒数据库，并与同期威尼托地区全科医生报告的 226 份报告进行了比较。患者报告的已知和非严重反应比例高于全科医生。在社区环境中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，患者报告的抗肿瘤药物或对比剂反应报告很少，这些药物主要在医院环境中使用。
我们的研究表明，患者报告有可能为药物警戒系统增加价值。患者报告提供的信息整体质量良好。患者报告和全科医生报告之间的差异表明了不同的观点，可以丰富自发报告。
