ArticleDrug safety2016
Completeness of Spontaneous Adverse Drug Reaction Reports Sent by General Practitioners to a Regional Pharmacovigilance Centre: A Descriptive Study.
Article in Drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Factors that influence patient and public adverse drug reaction reporting: a systematic review using the theoretical domains framework.International journal of clinical pharmacy · 2023Pooled it
- Do consumers and healthcare professionals report the same adverse event differently? A paired analysis of duplicate vaccine safety reports in Norway.British journal of clinical pharmacology · 2026Article
- Reporting patterns of adverse drug withdrawal events using individual case safety reports in the FAERS and Eudravigilance databases.Exploratory research in clinical and social pharmacy · 2026Article
- Quality of adverse drug reaction reports submitted to the national pharmacovigilance center of Nepal: a pre- and post-training evaluation.BMC medical education · 2026Article
- 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
- Comparative Analysis of Drugs Frequently Suspected of Causing Adverse Drug Reactions Reported via the Spontaneous Reporting System Versus in a Prospective Multicentre Cohort Study in Hospital Emergency Departments.Journal of clinical medicine · 2025Article
- Factors associated with the completeness of information provided in adverse drug reaction reports of physicians, pharmacists and consumers from Germany.Scientific reports · 2025Article
- Oropharyngeal adverse drug reactions: knowledge, attitudes, and practice (KAP) among Italian healthcare professionals and students.Frontiers in public health · 2025Article
- Testing the Feasibility of a Digital Point of Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information.Therapeutic innovation & regulatory science · 2025Article
- 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
- Evaluation of a simplified pharmacovigilance tool for general practitioners: 5 years of insight.Scientific reports · 2024Article
- 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
- Characteristics of adverse drug reactions due to nonsteroidal anti-inflammatory drugs: a cross-sectional study.Nagoya journal of medical science · 2023Article
- 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
- Safety Profile of Medicines Used for the Treatment of Drug-Resistant Tuberculosis: A Descriptive Study Based on the WHO Database (VigiBaseAntibiotics (Basel, Switzerland) · 2023Article
- Pharmacovigilance and Adverse Drug Reaction Reporting among the General Public in Lithuania: A Cross-Sectional Study.Healthcare (Basel, Switzerland) · 2023Article
- The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase®.African journal of primary health care & family medicine · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSpontaneous reporting of adverse drug reactions (ADRs) remains the cornerstone of postmarketing drug safety surveillance (pharmacovigilance); however, one of its main limitations is incomplete data, thus limiting conclusions about causality assessment.
objectiveThe primary aim of this study was to assess the completeness of ADR reports sent by general practitioners (GPs) to regional pharmacovigilance centres and the secondary objective was to identify factors associated with complete ADR reports.
methodsAll ADR reports sent by GPs to the Midi-Pyrénées Regional Pharmacovigilance Center (Toulouse, France) from 1 January 2010 to 31 December 2013 were reviewed. Healthcare professionals and patients can forward an ADR using either an online form through the Pharmacology Information Bulletin website ( http://www.bip31.fr ) or 'traditional' ADR reports (i.e. email, letter or fax). According to information provided in ADR reports (i.e. patient identification, ADR, date of occurrence, clinical description, drugs, etc.), reports were classified into three groups: 'well-documented', 'slightly documented' or 'poorly documented'. A multivariate logistic regression was performed to investigate potential factors associated with a 'well-documented' ADR report.
resultsDuring the study period, 613 ADR reports were analysed. Among these reports, only 12.7 % were classified as 'well-documented', 68.5 % as 'slightly documented' and 18.8 % as 'poorly documented'. An association between a 'well-documented' ADR report and its 'seriousness' was found (odds ratio = 1.70 [95 % CI 1.04-2.76], p = 0.01). No association between report completeness ('well-documented' report) and GP practice location or mode of ADR reporting was found.
conclusionsThe study shows that only one out of eight ADR reports from GPs was 'well-documented'. Therefore, it appears to be important to promote further information being available regarding the data required in ADR reports to optimise the evaluation of drug causality.
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Registered trials
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