Introduction Because patients and patient organizations want to strengthen their role in the care pathway and drug evaluation and in order to improve pharmacovigilance activities, European competent authorities implemented regulations to allow direct reporting of adverse drug reactions related to medicinal products by patients in 2012. Objectives To describe evolution and analyze determinants of patient reporting activity in France in order to assess patient involvement in pharmacovigilance. Method Using the French national pharmacovigilance database, univariate and multivariate analyses were performed to compare the characteristics of adverse drug reaction (ADR) reports from patients and healthcare professionals (HCP) between 2011 and 2020. The relationship between regional patient ADR report activity and regional care provision and socio-professional characteristics was analyzed using the principal component analysis. Results A significant and higher increase in ADR reports over time from patients (r = 0.89, p < 0.001) compared to HCP (r = 0.27, p = 0.002) has been observed. Patient ADR report activities compared to HCP concerned more women (80% vs. 55%, p < 0.001), younger age classes (p < 0.001), reporting through web portal (83% vs. 17%, p < 0.001), and less serious events (26% vs. 63%, p < 0.001). In the principal component analysis, regional patient reporting activity was related to socio-professional categories, age classes, and densities of hospital beds and physicians. Conclusion Our results confirm an increasing involvement of patients in ADR report activities. The determinants of patient reporting activities are not only related to drug and medical factors but also to social factors. Digital tools may also play a role in health democracy in pharmacovigilance.

Introduction: Because patients and patient organizations want to strengthen their role in the care pathway and drug evaluation and in order to improve pharmacovigilance activities, European competent authorities implemented regulations to allow direct reporting of adverse drug reactions related to medicinal products by patients in 2012. Objectives: Describe and study determinants and evolution of patient reporting activity in France to assess patient involvement in pharmacovigilance.Method: Using the French national pharmacovigilance database, univariate and multivariate analyses were performed to compare characteristics of patients and healthcare professionals (HCP) adverse drug reaction (ADR) report from 2011 to 2020. Then, we analyzed ADR report activities from patients according to regional demographics and economics characteristics.Results: We observed a significant and higher increase in ADR report over time from patient (r=0.89, p<0.001) compared to HCP reporting (r=0.27, p=0.002). Patient ADR report activities compared to HCP concerned more women (80% vs 55%, p<0.001), younger age classes (p<0.001) or reporting through web portal (83% vs 17%, p<0.001) and less serious events (26% vs 63%, p<0.001). In the principal component analysis, regional patient reporting activity was mainly related to socio-professional categories, age classes and densities of hospital beds and physicians. Conclusion: Our results confirm an increasing involvement of patients in ADR report activities. The determinants of patient reporting activities are not only related to drug and medical factors but also to social factors. Digital tools may also play a role in health democracy in pharmacovigilance.