| Autor: |
D. Adopo, P. Daynes, M. Benkebil, A. Debs, AP. Jonville-Berra, E. Polard, J. Micallef, P. Maison |
| Rok vydání: |
2022 |
| Předmět: |
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| Zdroj: |
European journal of clinical pharmacology. |
| ISSN: |
1432-1041 |
| Popis: |
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 r = 0.27, p = 0.002) has been observed. Patient ADR report activities compared to HCP concerned more women (80% vs. 55%, p p p p 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. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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