ArticleEuropean journal of clinical pharmacology2020
Quantity is not enough: completeness of suspected adverse drug reaction reports in Spain-differences between regional pharmacovigilance centres and pharmaceutical industry.
Article in European journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
- Masking effect in the Spanish spontaneous reporting database FEDRA.European journal of clinical pharmacology · 2026Article
- Safety Profile of Zavegepant in the Treatment of Acute Migraine: Insights from the FDA Adverse Event Monitoring System Database.Pharmaceuticals (Basel, Switzerland) · 2026Article
- VigiBase: Resource Profile Update with a Summary of Global Patterns and Trends in Adverse Event Reports for Medicines and Vaccines.Drug safety · 2026Review
- Completeness of spontaneously reported adverse drug reactions in 4 databases.British journal of clinical pharmacology · 2025Article
- Comparison of the Completeness of Spontaneously Reported Adverse Drug Reactions by Consumers, Healthcare Professionals, and Pharmaceutical Companies: An Evaluation of Databases From Two High-Income Countries.Pharmacology research & perspectives · 2025Article
- Data-Driven Identification of Factors That Influence the Quality of Adverse Event Reports: 15-Year Interpretable Machine Learning and Time-Series Analyses of VigiBase and QUEST.JMIR medical informatics · 2024Article
- Regulatory Measures to Improve the Safety of CAR-T-Cell Treatment.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2023Article
- Pharmacovigilance in China: Evolution and future challenges.British journal of clinical pharmacology · 2023Review
- Adverse drug reaction management in hospital settings: review on practice variations, quality indicators and education focus.European journal of clinical pharmacology · 2022Review
- Status and strategies of college English teaching using adaptive deep learning from the perspective of multiculturalism.Frontiers in psychology · 2022Article
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Authors and funding
5 authors.
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Abstract
purposeThe aim of this study is to compare the completeness of relevant structured fields such as age, sex, drug and reaction start dates, time to onset, outcome and drug indication, in serious spontaneous cases reported in Spain depending on whether they have been collected by regional pharmacovigilance centres or by the marketing authorization holders.
methodsWe analyzed the completeness of key variables for causality assessment related to the patient, the reaction and the suspected drug in all serious cases spontaneously reported and registered in the Spanish Pharmacovilance database, called FEDRA, from 1 January 2011 until 31 December 2018. The completeness scores were calculated according to the type of field and taking into account the VigiGrade tool. Cases were classified according to the reporting pathway, that is whether they were received and transmitted by marketing authorization holder or by regional pharmacovigilance centres.
resultsThe completeness score of cases collected by regional pharmacovigilance centres was higher in all the studied variables. The main differences were found in drug and reaction start date, and time to onset.
conclusionsThis study shows a high completeness score in cases of suspected adverse reactions reported to the regional pharmacovigilance centres with regard to key elements for causality assessment, signal and duplicate detection. In contrast, marketing authorization holder cases show a low completeness score and a decreasing tendency in all the studied variables over the studied period.
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