ArticleEuropean journal of clinical pharmacology2023
Patient involvement in pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in France.
Article in European journal of clinical pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
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Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Patient and Public Involvement in Pharmacoepidemiological Research: An Environmental Scan of an Emerging Area.Pharmacoepidemiology and drug safety · 2025Pooled it
- Do consumers and healthcare professionals report the same adverse event differently? A paired analysis of duplicate vaccine safety reports in Norway.British journal of clinical pharmacology · 2026Article
- Comparative analysis of the characteristics and trends of adverse drug reaction reports from patients in Japan and the Japanese Adverse Drug Event Report database.British journal of clinical pharmacology · 2026Article
- Strengthening pharmacovigilance through patient reporting: a scoping review of awareness, barriers, and facilitators.Journal of pharmaceutical policy and practice · 2026Review
- The Value of Sensitivity Analyses in Assessing the Risk of Two Rare Neurological Adverse Events and Pseudoephedrine Use.Drug safety · 2025Article
- Real-World Evidence of Neuropsychiatric Adverse Reactions to Isotretinoin: Insights from EudraVigilance (2005-2025).Pharmaceuticals (Basel, Switzerland) · 2025Article
- The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System.Drug safety · 2024Review
- Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making.Drug safety · 2024Article
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Authors and funding
8 authors.
Funding
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Abstract
introductionBecause 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.
objectivesTo describe evolution and analyze determinants of patient reporting activity in France in order to assess patient involvement in pharmacovigilance.
methodUsing 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.
resultsA 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.
conclusionOur 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.
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