ArticlePharmacology research & perspectives2025
What Affects the Quality of Pharmacovigilance? Insights From Qualitative Comparative Analysis.
Article in Pharmacology research & perspectives, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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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.
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Who cites it
2 citing papers in PubMed.
- Article
- Evaluating the effectiveness of AI-enhanced "One Body, Two Wings" pharmacovigilance models in China: a nationwide survey on medication safety and risk management.Frontiers in health services · 2025Article
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Authors and funding
7 authors.
Funding
Abstract
Pharmacovigilance plays a significant role in guaranteeing the safety of medications for patients. Over the last three decades, China has significantly advanced its pharmacovigilance practices, yet the factors that drive the quality of pharmacovigilance remain unclear. This study aimed to investigate how multiple factors interactively influence the quality of pharmacovigilance and identify pathways for achieving high-quality pharmacovigilance practices. A unique sample of pharmacovigilance-specific inspection reports from 13 representative companies in China was adopted in analysis. Given the qualitative nature of the inspection reports, we utilized crisp-set qualitative comparative analysis (csQCA) with five factors structure based on the technology-organization-environment (TOE) theoretical framework. The csQCA enabled us to elucidate the interactions among the antecedents of pharmacovigilance quality through quantitative univariate necessity analysis and configuration analysis. Three pathways contributing to high-quality pharmacovigilance were identified, and "Dedicated and Qualified Person for Pharmacovigilance (DQPPV)" was shown to be involved in all three pathways. Upon examining the manner in which multiple variables influence the quality of pharmacovigilance, it becomes evident that the DQPPV represents a factor that warrants further investigation. The results of the configuration allow companies to implement targeted measures to enhance the functionality of the pharmacovigilance system and to improve the quality of the system. Further research could explore the influence of additional factors on pharmacovigilance efforts, which could then contribute to marketing authorization holders' (MAHs') pharmacovigilance efforts.
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Registered trials
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