ReviewDrug safety2022
Factors Contributing to Best Practices for Patient Involvement in Pharmacovigilance in Europe: A Stakeholder Analysis.
Review in Drug safety, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 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
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Patient and Public Involvement in Pharmacoepidemiological Research: An Environmental Scan of an Emerging Area.Pharmacoepidemiology and drug safety · 2025Pooled it
- Consumer Views on the Role of the Natural Health Products (NHPs) Industry in Pharmacovigilance for NHPs: A Qualitative Study in New Zealand.Drug safety · 2026Article
- 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
- VigiBase: Resource Profile Update with a Summary of Global Patterns and Trends in Adverse Event Reports for Medicines and Vaccines.Drug safety · 2026Review
- Patient perspectives on drug recalls in the Netherlands: a qualitative study.International journal of clinical pharmacy · 2026Article
- An analysis of awareness and acceptability of the Medicines Side Effect Reporting Form for Consumer and the quality of data entered by consumers - An Indian perspective.Indian journal of pharmacology · 2025Article
- Pharmacovigilance - Technological Advancements, Recent Developments and Innovations.Current drug safety · 2025Review
- Assessment of public awareness and perspectives towards adverse drug reaction reporting system in Karachi, Pakistan.PloS one · 2025Article
- Misuse, Abuse and Medication Errors' Adverse Events Associated with Opioids-A Systematic Review.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making.Drug safety · 2024Article
- The ISoP PatEG-SIG for Promoting Patient Engagement in Pharmacovigilance: A Change of Paradigm is Needed.Drug safety · 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
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionInvolving patients in decision making adds value in the context of pharmacovigilance (PV). This added value goes beyond participation in spontaneous reporting systems for adverse drug reactions. However, there is a gap between allowing patients to report and actual patient involvement. Views regarding best practices from regulators, patient organizations and pharmaceutical companies could help increase and improve patient involvement in PV.
objectiveThe aim of this study was to investigate the factors contributing to best practices for patient involvement in PV and to develop a definition of patient involvement based on a qualitative multistakeholder study across Europe.
methodsA literature review was conducted to map the field of study and obtain insights for the elaboration of an interview guide. Subsequently, patient representatives, members of the pharmaceutical industry and regulators were invited to participate in interviews. These interviews were analyzed using NVIVO
resultsA total of 20 interviews were conducted with representatives at both the national and European levels. The best practices identified were engagement from the start, face-to-face communication, a full circle of feedback, same-level partners, structured involvement and guidelines, establishing common goals, patient education and empowerment, and developing trust and balance. These activities can be implemented via deep collaboration among stakeholders. A definition of patient involvement was constructed in accordance with the input of all stakeholder groups, which reflects the involvement of all types of patients at all levels of the decision-making process.
conclusionIn this study, we developed a definition for patient involvement based on qualitative interviews. The factors contributing to best practices for patient involvement were mentioned across stakeholder groups and aimed to stimulate patient involvement in PV. Patients are eager to become equal partners and to engage effortlessly in the same manner as other stakeholders.
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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.