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Introduction <p>Spontaneous reporting systems are essential for post-marketing pharmacovigilance, enabling the identification of new adverse drug reactions (ADRs). However, differences in report origin, structure and completeness may affect the effectiveness of signal detection.</p> Objective <p>To analyse the characteristics of ADR reports submitted in Spain between 2019 and 2023, comparing cases reported directly to the Spanish Pharmacovigilance System (SEFV) with those submitted via marketing authorisation holders (MAHs), and to identify areas for improvement in spontaneous reporting practices.</p> Methods <p>This was a retrospective analysis of individual case safety reports (ICSRs) included in the national database FEDRA. Reports were classified according to their origin (SEFV or MAH), seriousness, report type (spontaneous or study), reporter qualification, suspected ADR (MedDRA HLT level), and suspected drug (ATC classification and substance level). Additional approach was also carried out in SEFV cases, with the variables qualification reporter, seriousness and unknown adverse reactions.</p> Results <p>A total of 145,498 ICSRs were analysed, 62.4% submitted by MAHs and 38.1% by SEFV. Only 31% of MAH reports were serious compared to 45.9% of SEFV reports. Nearly half of MAH reports were from studies. The main reporter in MAH cases was the consumer, while physicians predominated in SEFV reports. Notably, 12.6% of serious SEFV reports submitted by consumers included unknown ADRs.</p> Conclusion <p>Direct reporting to SEFV should be actively encouraged, as these reports show higher completeness and greater clinical relevance. This is particularly important for newly authorised medicines, which are predominantly reported via MAHs. Strengthening direct reporting pathways would improve signal detection. </p>

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“Trends and challenges in adverse drug reaction reporting in Spain: Analysis of the FEDRA database (2019–2023)”

  • 期刊论文

  • 发表日期：

    2025年12月20日

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  • Cristina Fernandez-Fernandez,
  • Araceli Núñez Ventura,
  • Lara Quiroga-González,
  • María del Mar Gutiérrez-Lobón,
  • Edurne Lázaro-Bengoa

摘要

Introduction

Spontaneous reporting systems are essential for post-marketing pharmacovigilance, enabling the identification of new adverse drug reactions (ADRs). However, differences in report origin, structure and completeness may affect the effectiveness of signal detection.

Objective

To analyse the characteristics of ADR reports submitted in Spain between 2019 and 2023, comparing cases reported directly to the Spanish Pharmacovigilance System (SEFV) with those submitted via marketing authorisation holders (MAHs), and to identify areas for improvement in spontaneous reporting practices.

Methods

This was a retrospective analysis of individual case safety reports (ICSRs) included in the national database FEDRA. Reports were classified according to their origin (SEFV or MAH), seriousness, report type (spontaneous or study), reporter qualification, suspected ADR (MedDRA HLT level), and suspected drug (ATC classification and substance level). Additional approach was also carried out in SEFV cases, with the variables qualification reporter, seriousness and unknown adverse reactions.

Results

A total of 145,498 ICSRs were analysed, 62.4% submitted by MAHs and 38.1% by SEFV. Only 31% of MAH reports were serious compared to 45.9% of SEFV reports. Nearly half of MAH reports were from studies. The main reporter in MAH cases was the consumer, while physicians predominated in SEFV reports. Notably, 12.6% of serious SEFV reports submitted by consumers included unknown ADRs.

Conclusion

Direct reporting to SEFV should be actively encouraged, as these reports show higher completeness and greater clinical relevance. This is particularly important for newly authorised medicines, which are predominantly reported via MAHs. Strengthening direct reporting pathways would improve signal detection.