ArticleDrug safety2016
Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?
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 28 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
- Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial.Drug safety · 2021Trial
- 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
- Theoretical Framework and Key Considerations for Time-to-Onset Analysis in Spontaneous Reporting Systems.Drug safety · 2026Review
- VigiBase: Resource Profile Update with a Summary of Global Patterns and Trends in Adverse Event Reports for Medicines and Vaccines.Drug safety · 2026Review
- Causal Inference Tools for Pharmacovigilance: Using Causal Graphs to Identify and Address Biases in Disproportionality Analysis.Drug safety · 2026Article
- Pharmacovigilance - Technological Advancements, Recent Developments and Innovations.Current drug safety · 2025Review
- Incorporating patient-reported outcome measures into routine paediatric pharmacovigilance: opportunities for safety monitoring with practical use scenarios from paediatric oncology.Frontiers in pharmacology · 2025Review
- Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System.Drug safety · 2024Article
- The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System.Drug safety · 2024Review
- Appeal for Increasing the Impact of Pharmacovigilance.Drug safety · 2024Article
- Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient's Perspective.Drug safety · 2023Article
- Patient involvement in pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in France.European journal of clinical pharmacology · 2023Article
- A cross-sectional study: comparison of public perceptions of adverse drug reaction reporting and monitoring in eastern and western China.BMC health services research · 2022Article
- Inhaled Drug Therapy-Associated Adverse Reactions in Obstructive Respiratory Diseases: A Review of a Decade of Reporting to the Portuguese Pharmacovigilance System.International journal of environmental research and public health · 2021Review
- Ten years of vaccinovigilance in Italy: an overview of the pharmacovigilance data from 2008 to 2017.Scientific reports · 2020Article
- Realizing the Potential of the Patient Perspective.Patient preference and adherence · 2020Article
- Diabetes patient's pharmacovigilance knowledge and risk perception: the influence of being part of a patient organisation.Therapeutic advances in drug safety · 2020Article
- Review
- 'Engagement' of patients and healthcare professionals in regulatory pharmacovigilance: establishing a conceptual and methodological framework.European journal of clinical pharmacology · 2019Review
- Recommendations on the Use of Mobile Applications for the Collection and Communication of Pharmaceutical Product Safety Information: Lessons from IMI WEB-RADR.Drug safety · 2019Article
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
The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years have passed since the legislation was introduced and the key question is: does pharmacovigilance yet make optimal use of patient-reported safety information? Independent research has shown beyond doubt that patients make an important contribution to pharmacovigilance signal detection. Patient reports provide first-hand information about the suspected ADR and the circumstances under which it occurred, including medication errors, quality failures, and 'near misses'. Patient-reported safety information leads to a better understanding of the patient's experiences of the ADR. Patients are better at explaining the nature, personal significance and consequences of ADRs than healthcare professionals' reports on similar associations and they give more detailed information regarding quality of life including psychological effects and effects on everyday tasks. Current methods used in pharmacovigilance need to optimise use of the information reported from patients. To make the most of information from patients, the systems we use for collecting, coding and recording patient-reported information and the methodologies applied for signal detection and assessment need to be further developed, such as a patient-specific form, development of a severity grading and evolution of the database structure and the signal detection methods applied. It is time for a renaissance of pharmacovigilance.
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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.