ReviewInternational journal of environmental research and public health2021
The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process.
Review in International journal of environmental research and public health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 2 of them syntheses 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
28 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Estimating Adverse Events Associated With Herbal Medicines Using Pharmacovigilance Databases: Systematic Review and Meta-Analysis.JMIR public health and surveillance · 2024Pooled it
- Factors associated with underreporting of adverse drug reactions by patients: a systematic review.International journal of clinical pharmacy · 2023Pooled it
- Proton Pump Inhibitors and Disproportionate Reporting of Acute Kidney Injury and Tubulointerstitial Nephritis: A FAERS Pharmacovigilance Study, 2020-2025.Journal of clinical medicine · 2026Article
- Divergent System Organ Class Safety Profiles of Isotretinoin Versus Topical Retinoids: An EudraVigilance Disproportionality Analysis.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Pharmacovigilance in medical cannabis therapy among physicians in Poland: pharmacovigilance knowledge, ADR reporting practice and cannabis-related safety reporting.Frontiers in public health · 2026Article
- Safety assessment for ibuprofen using disproportionality analysis: a decade of data from the Romanian national pharmacovigilance system.Frontiers in pharmacology · 2026Article
- Adverse Event Profiles of Monoclonal Antibodies: A Descriptive Analysis of FAERS Data.Health services insights · 2026Article
- Pregnant Women and Vaccine Safety in Uganda: Knowledge, Barriers, and Opportunities for Engagement.Vaccines · 2025Article
- Underreporting of Adverse Events Following COVID-19 Vaccination Among Healthcare Professionals in Poland: Potential Implications for Vaccine Hesitancy.Tropical medicine and infectious disease · 2025Article
- Barriers and enablers of adverse drug event reporting in South Africa: a cross-sectional survey of medicine users.BMC public health · 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
- Part 1 - imidazolines and the changing face of nasal decongestants.Frontiers in pharmacology · 2025Review
- Article
- Consumers' knowledge and experiences of adverse drug reaction reporting in Australia: a national survey.European journal of clinical pharmacology · 2024Article
- SMS-Based Active Surveillance of Adverse Events following Immunization in Children: The VigiVax Study.Vaccines · 2024Article
- Patient safety reporting and learning system of Catalonia (SNiSP Cat): a health policy initiative to enhance culture, leadership and professional engagement.BMJ open quality · 2024Article
- Identifying strategies to improve adverse drug reporting through key informant interviews among community pharmacists in a developing country.Scientific reports · 2024Article
- Pharmacovigilance in Vaccines: Importance, Main Aspects, Perspectives, and Challenges-A Narrative Review.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Exploring Adverse Drug Reactions in Psychotropic Medications: A Retrospective Analysis of Portuguese Pharmacovigilance Data.Healthcare (Basel, Switzerland) · 2024Article
- Real-World Safety Data of the Orphan Drug Onasemnogene Abeparvovec (ZolgensmaPharmaceuticals (Basel, Switzerland) · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
All medicinal products authorized in the European Union are subjects of constant drug-safety monitoring processes. It is organized in a pharmacovigilance system that is designed to protect human health and life by the detection, analysis and prevention of adverse drug reactions (ADRs) and other drug-related problems. The main role of the aforementioned system is to collect and analyze adverse drug reaction reports. Legislation introduced several years ago allowed patients, their legal representatives and caregivers to report adverse drug reactions, which caused them to be an additional source of safety data. This paper presents the analysis of EudraVigilance data related to adverse drug reactions provided by patients, their representatives, as well as those obtained from healthcare professionals related to medicines which belong to M01A anti-inflammatory and antirheumatic products, a non-steroid group. The objective of the study was to identify the changes in the number and structure of adverse reaction reporting after the introduction of pharmacovigilance (PV) obligations in EU. A review of scientific literature was also conducted to assess the differences in adverse reactions reported by patients or their representatives and by healthcare professionals. We also identified other factors which, according to literature review, influenced the number of adverse reaction reports provided by patients. Analysis of data collected from the EudraVigilance showed that from 2011 to 2013 the number of reports made by patients and their caregivers increased by approx. 24 percentage points, and then, from 2014, it constituted around 30% of the total of reported reactions every year, so patient reporting is an important part of pharmacovigilance system and a source of drugs' safety information throughout their use in healthcare practice. Additionally, there was no interrelationship between the seriousness of reported adverse reactions and the overall number of patient reports when compared to reports form healthcare professionals.
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Registered trials
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