ArticleInternational journal of environmental research and public health2022
Quality of Spontaneous Reports of Adverse Drug Reactions Sent to a Regional Pharmacovigilance Unit.
Article in International journal of environmental research and public health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed, 23 citations in OpenAlex.
- Computational Prediction of the Severity of Adverse Drug Reactions Caused by Drug-Drug Interactions.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Development and application of the vaccine reporting quality score to evaluate the vaccine adverse event reporting system.Frontiers in immunology · 2026Article
- Cytopenias as Adverse Drug Reactions: A 10-Year Analysis of Reporting Structure, Rate, and Trend.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Analysis of anticancer drug associated adverse reactions in depressive patients from vigibase.Scientific reports · 2025Article
- Completeness of spontaneously reported adverse drug reactions in 4 databases.British journal of clinical pharmacology · 2025Article
- Sex-Related Safety Signals of Sotorasib in Non-Small Cell Lung Cancer: A Real-World, Pharmacovigilance Study from the EudraVigilance Database.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Real-World Evidence of Neuropsychiatric Adverse Reactions to Isotretinoin: Insights from EudraVigilance (2005-2025).Pharmaceuticals (Basel, Switzerland) · 2025Article
- Comparison Study of the Safety Profile of Olaparib Versus Niraparib: Analysis of Real-World Data from EudraVigilance.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Assessment of public awareness and perspectives towards adverse drug reaction reporting system in Karachi, Pakistan.PloS one · 2025Article
- Pharmacovigilance in Vaccines: Importance, Main Aspects, Perspectives, and Challenges-A Narrative Review.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Trends in Adverse Event Reporting Before and After the Introduction of the Med Safety App in Nigeria.Pharmaceutical medicine · 2024Observational
- Disponibilité de l'information médicale requise pour la déclaration d'une réaction indésirable médicamenteuse à Santé Canada: une étude exploratoire.The Canadian journal of hospital pharmacy · 2024Article
- Skin Toxicities Associated with Botulin Toxin Injection for Aesthetic Procedures: Data from the European Spontaneous Reporting System.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Hematological Events Potentially Associated with CDK4/6 Inhibitors: An Analysis from the European Spontaneous Adverse Event Reporting System.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Analysis of Reports Sent to the Portuguese Pharmacovigilance System and Published Literature Regarding the Safety of Metformin in the Elderly.Healthcare (Basel, Switzerland) · 2023Article
- A Mobile App Leveraging Citizenship Engagement to Perform Anonymized Longitudinal Studies in the Context of COVID-19 Adverse Drug Reaction Monitoring: Development and Usability Study.JMIR human factors · 2022Article
- The role ofFrontiers in pharmacology · 2022Article
Corrections and comments
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Spontaneous reports (SRs) of adverse drug reactions (ADRs) remain the basis of pharmacovigilance systems. The main objective of this study was to evaluate the quality of SRs received by the Pharmacovigilance Unit of Beira Interior, in Central Portugal. The second objective was to identify factors associated with complete SRs. SRs received between 1 January 2017 and 31 October 2019 were analyzed. SR information was classified as "mandatory" or "recommended" criteria. SR were then grouped into three categories (well, slightly, and poorly documented). Association between "well documented" SR and confounding variables was estimated using a multiple logistic regression model. The results showed 22.4% of SRs are "well documented", and 41.2% are "poorly documented". Most of the complete SRs correspond to non-serious ADRs (55.8%), with a negative association between complete SRs and serious ADRs (OR = 0.595, [95% CI 0.362-0.977],
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.