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Patient Reporting in the EU: Analysis of EudraVigilance Data
Marin Banovac1, Gianmario Candore2, Jim Slattery2
1European Medicines Agency (EMA), 30 Churchill Place, Canary Wharf, London, E14 5EU, UK. marin.banovac@ema.europa.eu.
New EU pharmacovigilance legislation significantly increased patient reporting of adverse drug reactions (ADRs). Patients reported ADRs affecting quality of life, complementing healthcare professional reports and informing future awareness campaigns.
Area of Science:
- Pharmacovigilance and Drug Safety
- Regulatory Science
- Public Health
Background:
- New European Union (EU) pharmacovigilance legislation was enacted in 2010 and operationalized in July 2012.
- This legislation mandated reporting of suspected adverse drug reactions (ADRs) by national competent authorities (NCAs) and marketing authorization holders (MAHs).
Purpose of the Study:
- To analyze patient reporting trends in the EU before and after the implementation of new pharmacovigilance legislation.
- To compare characteristics of patient-reported ADRs with those reported by healthcare professionals (HCPs).
Main Methods:
- Descriptive study utilizing the EudraVigilance (EV) database.
- Analysis of patient and HCP reports for demographics, seriousness, ADR terms, indications, reporting time, and substances.
- Comparative analysis using relative risks where feasible.
Main Results:
- Patient reports in the EV database increased from 53,130 to 113,371 following legislation implementation.
- Patients were more likely to report ADRs related to genitourinary, hormonal, and reproductive indications.
- A significant overlap was observed in the top reported ADRs between patients and HCPs.
Conclusions:
- Patient reporting of ADRs complements that of HCPs, particularly for ADRs impacting quality of life.
- Findings can inform training and awareness initiatives for patient reporting among NCAs and patient associations.
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