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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.Le texte complet de cet article est disponible en PDF.
Keywords : Pharmacists, Physicians, Spontaneous reports, Pharmacovigilance, Drug safety, Adverse drug reactions