Quality of Reports on Drug Toxicity in Eudravigilance: A Safety Physician's Perspective.
Background: European legislation requires Marketing Authorization Holders (MAHs) to continuously monitor Eudravigilance (EV) data and inform the European Medicines Agency and national competent authorities of validated safety signals. The process follows the Good Pharmacovigilance Practice Module IX...
| Published in: | Therapeutic Innovation & Regulatory Science Vol. 60; no. 1; pp. 285 - 293 |
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| Format: | research tables/charts Journal Article |
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Springer Nature
Jan2026
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=190570962&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 190570962 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 21684790 FUHO jtl: Therapeutic Innovation & Regulatory Science issn: 21684790 maglogo: N pubinfo: dt: Jan2026 vid: 60 iid: 1 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 190570962 188697277 190570962 190570962 10.1007/s43441-025-00884-x 190570962 ppf: 285 ppct: 8 formats: tig: atl: Quality of Reports on Drug Toxicity in Eudravigilance: A Safety Physician's Perspective. aug: au: Čendak, Jana Brajdih affil: Billev Pharma East Ltd, Ljubljana, Slovenia sug: subj: Quality Assessment Drug Toxicity Pharmacovigilance Europe Patient Safety Evaluation Physician Attitudes Evaluation Adverse Drug Event Precision Resource Databases Evaluation Acetaminophen Adverse Effects Diazepam Adverse Effects Fentanyl Adverse Effects Quetiapine Adverse Effects Fluoxetine Adverse Effects Human Europe Conceptual Framework Marketing Practice Guidelines Access to Information Time Factors Narratives Case Studies Sociodemographic Factors Patient History Taking Drugs, Prescription Classification Drugs, Non-Prescription Classification Reliability Documentation Quality Improvement Stakeholder Participation One-Way Analysis of Variance Kruskal-Wallis Test Nonparametric Statistics Post Hoc Analysis Confidence Intervals Pearson's Correlation Coefficient Chi Square Test Voluntary Reporting Analgesics, Opioid Adverse Effects Risk Assessment Retrospective Design Record Review Descriptive Statistics Data Analysis Software ab: Background: European legislation requires Marketing Authorization Holders (MAHs) to continuously monitor Eudravigilance (EV) data and inform the European Medicines Agency and national competent authorities of validated safety signals. The process follows the Good Pharmacovigilance Practice Module IX and is based on the review of individual case safety reports (ICSR) both from the MAH's internal database and from EV. The data is reviewed and evaluated by a medically trained person, who should, based on the information provided in the case, determine the causal relationship between the suspect drug and the reported event. In order to do this with a certain degree of confidence, the case needs to report enough high-quality information on the drug, patient and adverse event, without significant confounders. Methods: For this purpose, we performed an evaluation of data quality of ICSRs within the Eudravigilance database, focusing on drug toxicity cases for five commonly implicated substances: paracetamol, diazepam, fentanyl, quetiapine, and fluoxetine. A medically driven review was conducted on 500 randomly selected ICSRs from 2015 to 2024. A detailed quality assessment framework was developed and applied, scoring cases across several criteria (including data on suspect drugs, patient demographics, adverse event description, time to event, and case narratives), resulting in a maximum quality score of 25. Results: Main study findings revealed a generally low data quality, with an average score of 11.57 out of 25. Key quality deficiencies included improper classification of drugs as suspects (e.g., reporting concomitant medications or treatments as suspects), reporting of underlying diseases and indications as adverse events, lack of information on patients' medical history and missing time-to-event information. Cases from non-European Economic Area (non-EEA) countries and consumer-reported cases exhibited the lowest quality, while regulatory agency-reported cases were of higher quality. The study also identified a frequent misclassification of non-prescription or illicit substances (e.g., fentanyl) as prescription products, complicating signal detection and causality assessments. The analysis highlights a very important gap in pharmacovigilance signal detection and evaluation processes, underscoring risks for misleading results, increased workload, and potential misinterpretation of product safety profiles. The results highlight the need for enhanced case reporting trainings, improved quality control, better follow-up processes, and a collective mindset shift across stakeholders to prioritize data quality. Conclusion: In conclusion, significant improvements in the completeness, accuracy, and clinical relevance of ICSRs are essential to support effective safety signal detection and benefit-risk assessment in the post-marketing surveillance of medicinal products. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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