Service de pharmacologie médicale et clinique, centre de pharmacovigilance, de pharmacoépidémiologie et d'informations sur le médicament, centre hospitalier universitaire, faculté de médecine, université de Toulouse, 37, allées Jules-Guesde, 31000 Toulouse, France.
Service de pharmacologie médicale et clinique, centre de pharmacovigilance, de pharmacoépidémiologie et d'informations sur le médicament, centre hospitalier universitaire, faculté de médecine, université de Toulouse, 37, allées Jules-Guesde, 31000 Toulouse, France.
Therapie. 2019 Oct;74(5):521-525. doi: 10.1016/j.therap.2019.01.008. Epub 2019 Mar 31.
In France since 2011, report of adverse drug reactions (ADRs) has been extended to patients (and patients' associations) who can declare directly ADRs to their regional pharmacovigilance centre. In pharmacovigilance, informativeness of ADRs reports is important to improve signal's detection. The present study was performed to compare the quality of patients', physicians and community pharmacists' reports.
We performed a retrospective study investigating the quality of patients', physicians and community pharmacies' ADRs reported to Toulouse University PharmacoVigilance Centre (TUPVC) from January 2014 to June 2017. We used mandatory and non-mandatory criteria, as defined by European Medicines Agency. Reports' quality was defined as "satisfactory" when more than 90% of items were completed. We also compared reports' quality according to ADRs seriousness and the used reporting tools (email or the mobile app VigiBip).
The number of reports to TUPVC increased between 2014 and 2016 (+51%) for patients and remained stable for pharmacists and physicians. According to the mandatory criteria, quality of the investigated reports was "satisfactory" (more than 90% of the items filled) whatever the reporter and without significant differences between reporters. For the non-mandatory criteria, clinical description of ADRs and ADRs' outcome were only filled over 90%. Significant differences were observed between the different reporters: community pharmacists informed better clinical description, ADR outcome and concomitant drugs versus both patients and physicians. Physicians informed better medical history and biological data whereas patients informed medical history and other aetiologies better than pharmacists and clinical description of ADRs better than physicians.
The present study failed to show differences between pharmacies', physicians' and patients' ADRs reports, for the mandatory criteria. However, significant differences were found for non-mandatory criteria with drug data more filled by pharmacists and medical ones more by physicians and patients.
自 2011 年以来，法国已将药物不良反应（ADR）报告扩展到可以直接向地区药物警戒中心报告 ADR 的患者（和患者协会）。在药物警戒中，ADR 报告的信息量对于提高信号检测的灵敏度非常重要。本研究旨在比较患者、医生和社区药剂师报告的质量。
我们进行了一项回顾性研究，调查了 2014 年 1 月至 2017 年 6 月期间向图卢兹大学药物警戒中心（TUPVC）报告的患者、医生和社区药剂师的 ADR 质量。我们使用了欧洲药品管理局定义的强制性和非强制性标准。当超过 90％的项目完成时，报告质量被定义为“满意”。我们还根据 ADR 的严重程度和使用的报告工具（电子邮件或移动应用程序 VigiBip）比较了报告的质量。
TUPVC 的报告数量在 2014 年至 2016 年期间（患者增加了 51％）保持稳定，而药剂师和医生的报告数量保持稳定。根据强制性标准，无论报告者是谁，调查报告的质量都是“满意”（填写的项目超过 90％），且报告者之间没有显着差异。对于非强制性标准，仅填写了超过 90％的 ADR 临床描述和 ADR 结局。不同报告者之间存在显着差异：社区药剂师比患者和医生更好地提供了 ADR 的临床描述、结局和伴随药物信息。医生比药剂师和患者更好地提供了医疗史和生物学数据，而患者比药剂师更好地提供了医疗史和其他病因以及 ADR 的临床描述。
本研究未能显示药剂师、医生和患者的 ADR 报告在强制性标准方面存在差异。然而，对于非强制性标准，发现了显着差异，药剂师提供了更多的药物数据，医生和患者提供了更多的医学数据。
