ArticleEuropean journal of clinical pharmacology2017
Lack of essential information in spontaneous reports of adverse drug reactions in Catalonia-a restraint to the potentiality for signal detection.
Article in European journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.
- Sports nutrition supplements and adverse events - a meta-epidemiological study of case reports specifically addressing causality assessment.European journal of clinical pharmacology · 2022Pooled it
- Completeness of spontaneously reported adverse drug reactions in 4 databases.British journal of clinical pharmacology · 2025Article
- Impact of Additional Monitoring on Pharmacovigilance and Pharmacists' Role: A Scoping Review.Pharmacoepidemiology and drug safety · 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
- Causality Assessment Between Drugs and Fatal Cerebral Haemorrhage Using Electronic Medical Records: Comparative Evaluation of Disease-Specific and Conventional Methods.Drugs - real world outcomes · 2024Article
- A Comparison of Signals of Designated Medical Events and Non-designated Medical Events: Results from a Scoping Review.Drug safety · 2024Article
- 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
- The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase®.African journal of primary health care & family medicine · 2023Article
- Adverse drug reaction management in hospital settings: review on practice variations, quality indicators and education focus.European journal of clinical pharmacology · 2022Review
- Quality of Spontaneous Reports of Adverse Drug Reactions Sent to a Regional Pharmacovigilance Unit.International journal of environmental research and public health · 2022Article
- Quantity is not enough: completeness of suspected adverse drug reaction reports in Spain-differences between regional pharmacovigilance centres and pharmaceutical industry.European journal of clinical pharmacology · 2020Article
- The quality assessment of the Japanese Adverse Drug Event Report database using vigiGrade.International journal of clinical pharmacy · 2020Article
- Article
- Importance of Publishing Adverse Drug Reaction Case Reports: Promoting Public Health and Advancing Pharmacology and Therapeutics.Drug safety - case reports · 2017Article
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe aim of this study is to analyze the quality of the information contained in the adverse drug reactions (ADR) reports and to describe the magnitude and characteristics of the lacking information.
methodsAll reports of serious ADR received by the Catalan Center of Pharmacovigilance in 2014 were analyzed using the VigiGrade and a more clinical and qualitative approach.
resultsUp to 824 reports describing serious ADR were included in the study; of them, 503 (61.0%) were sent by health care professionals (HPs) and the remaining 321 (39.0%) came from pharmaceutical companies (PhC). More than 80% of missing variables such as 'onset date' or 'time-to-onset' of the ADR were from PhCs reports. 'Onset of treatment date' was not filled in 28 (22.2%) of the reports including an 'additional monitoring' medicine, and 'end of treatment' date was not completed in 53 of those reports (42.1%). In summary, 39% of the reports involving a black triangle medicine sent by PhCs lacked some essential information such as the onset date of treatment.
conclusionsMore than one third of the reports coming from manufacturers did not include information that is considered a limiting factor to evaluate any causal relationship, and can be an issue for the detection of safety signals. To take advantage of this huge amount of potentially important information that is almost useless at present, data mining tools and new algorithms should be developed and tested with the aim of finding formulas to deal with a huge amount of low quality data without losing it, nor generating a number of false associations.
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