Patient involvement in pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in France.
Adverse drug reaction reporting systems
Drug safety
Patient empowerment
Pharmacoepidemiology
Pharmacovigilance
Social pharmacology
Journal
European journal of clinical pharmacology
ISSN: 1432-1041
Titre abrégé: Eur J Clin Pharmacol
Pays: Germany
ID NLM: 1256165
Informations de publication
Date de publication:
Feb 2023
Feb 2023
Historique:
received:
05
08
2022
accepted:
07
11
2022
pubmed:
13
12
2022
medline:
31
1
2023
entrez:
12
12
2022
Statut:
ppublish
Résumé
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. To describe evolution and analyze determinants of patient reporting activity in France in order to assess patient involvement in pharmacovigilance. 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. 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. 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.
Identifiants
pubmed: 36508012
doi: 10.1007/s00228-022-03422-y
pii: 10.1007/s00228-022-03422-y
pmc: PMC9744045
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
229-236Informations de copyright
© 2022. The Author(s).
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