Spontaneous adverse drug reaction reporting in France: A retrospective analysis of reports made to the French medicines agency from 2002 to 2014

Introduction The French pharmacovigilance system is coordinated by the French Medicines Agency (‘Agence nationale de securite du medicament et des produits de sante’ [ANSM]). The availability of a database containing all adverse drug reactions (ADRs) spontaneously reported by healthcare professionals and since 2011 by consumers, represents a major tool to ensure the drug safety. The aim of this study is to describe the characteristics of the reports and the reporting trends in the French pharmacovigilance spontaneous reporting database over the past 13 years. Methods We analyzed all ADR reports submitted to the ANSM via the network of 31 regional centres of pharmacovigilance (CRPV) from January 2002 to December 2014. Drugs and ADRs were respectively translated to anatomical therapeutic chemical (ATC) codes and Medical Dictionary for Regulatory Activities (MedDRA) classifications. Results In total 329,105 reports were received from ANSM for the 13-year study period, with linearly increase over time. Overall, 56.4% of reports were considered as serious. The median (interquartile range [IQR]) age of the patients was 57 (35–73) and the male/female ratio was 0.80. The median (IQR) time between the date of occurrence of the ADR and the date of report was 38 days (13–116). The reporter was a specialist physician in 72.0% of the reports, a pharmacist in 15.3%, and a general practitioner (GP) in 7.5%. The ADRs were most frequently related to nervous system drugs (21.6%), followed by systemic anti-infectives (16.7%) and cardiovascular drugs (16.3%). According to the Medical Dictionary for Regulatory Activities (MedDRA) coding, the system organ most often reported was skin and subcutaneous tissue disorders (17.7%), followed by general disorders and administration site conditions (11.4%), nervous system disorders (10.0%), gastrointestinal disorders (9.4%) and blood and lymphatic system disorders (6.8%). Conclusion This description of the data of the French pharmacovigilance database involving all drugs and ADRs follows a previous analysis describing ADR reports collected between 1986 and 2001 and shows an increasing tendency to reporting over time. In this study, seriousness of reports and age of patients has increased. The contribution of GPs remained very low and stable and the time lag between the suspected ADR and reporting shortened. There has been no significant change according to other characteristics.