Patient involvement in pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in France.

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.

Determination of the optimal statistical uncertainty to perform electron-beam Monte Carlo absorbed dose estimation in the target volume.

PURPOSE OF STUDY: Monte Carlo based treatment planning system are known to be more accurate than analytical methods for performing absorbed dose estimation, particularly in and near heterogeneities. However, the required computation time can still be an issue. The present study focused on the determination of the optimum statistical uncertainty in order to minimise computation time while keeping the reliability of the absorbed dose estimation in treatments planned with electron-beams. MATERIALS AND METHODS: Three radiotherapy plans (medulloblastoma, breast and gynaecological) were used to investigate the influence of the statistical uncertainty of the absorbed dose on the target volume dose-volume histograms (spinal cord, intramammary nodes and pelvic lymph nodes, respectively). RESULTS: The study of the dose-volume histograms showed that for statistical uncertainty levels (1 S.D.) above 2 to 3%, the standard deviation of the mean dose in the target volume calculated from the dose-volume histograms increases by at least 6%, reflecting the gradual flattening of the dose-volume histograms. CONCLUSIONS: This work suggests that, in clinical context, Monte Carlo based absorbed dose estimations should be performed with a maximum statistical uncertainty of 2 to 3%.