We are pleased to announce that our colleague Jana Brajdih Čendak has had her research published in the peer-reviewed journal Therapeutic Innovation & Regulatory Science. Her article, “Quality of Reports on Drug Toxicity in Eudravigilance: A Safety Physician’s Perspective,” is available online here:
https://link.springer.com/article/10.1007/s43441-025-00884-x

This work examines the quality of adverse drug reaction reports and explores how improvements in the pharmacovigilance system can bolster patient safety.

Key findings & contributions

• Jana evaluated 500 individual case safety reports (ICSRs) from the EudraVigilance database over the period 2015–2024, focusing on five widely used substances: paracetamol, diazepam, fentanyl, quetiapine, and fluoxetine.
• She designed a scoring framework (maximum 25 points) to assess elements such as drug identification (dose/regimen), temporal information, patient history, event narrative, and classification of suspect vs. concomitant drugs.
• The average score was 11.57 / 25, reflecting notable deficiencies in many reports — especially missing or ambiguous data on dosage, timing (time to event), patient medical history, and attribution of suspect vs. concomitant drugs.
• Reports originating from non-EEA (non-European Economic Area) regions and those submitted by consumers (non-healthcare professionals) tended to have the lowest quality. By contrast, reports from regulatory authorities generally exhibited higher data completeness.
• The article discusses the implications of such gaps — including weakened signal detection, more challenging benefit-risk assessments, and greater burden on pharmacovigilance teams. Jana emphasizes the role of pharmacovigilance audit, systematic follow-up of incomplete reports, and stronger training efforts for reporters.
• She also notes that with increasing adoption of pharmacovigilance outsourcing, clarity of responsibilities — especially the role of the Qualified Person for Pharmacovigilance (QPPV) — is essential to maintain consistency and data integrity.
• In conclusion, Jana reaffirms why pharmacovigilance matters: it underpins drug safety, supports regulatory authority confidence, and ultimately protects patients.

Why this matters to us & the field

This publication is a milestone not only for Jana but for our organization’s engagement with key challenges in pharmacovigilance:

• Credibility and Trust: By highlighting issues in adverse drug reaction reporting, we demonstrate commitment to rigorous pharmacovigilance and drug safety practices.
• Driving Internal Improvements: The insights inform how we conduct pharmacovigilance audit procedures, refine training programs, and oversee processes — especially when parts of work are delegated (e.g. via pharmacovigilance outsourcing).
• Strengthening Strategic Positioning: In a landscape where external partners and outsourcing are more common, having in-house expertise rooted in original research gives us a competitive edge.
• Alignment with Patient Safety Goals: Robust data collection and interpretation are foundational to improving patient safety and delivering evidence that regulators and stakeholders can trust.

Congratulations & next steps

We heartily congratulate Jana Brajdih Čendak on this significant scientific achievement! Her scholarship, rigor, and dedication are exemplary. We also extend gratitude to all team members who contributed — whether through data, feedback, discussion, or support.