Pharmacovigilance Signals From Spontaneous Reporting: Disproportionality Methods and Their Confounders

Authors

  • Zuzka Michalkova Department of Pharmacovigilance, Liptov Institute of Translational Medicine, Liptovsky Mikulas, Slovakia Author
  • Klara Rosendahl Department of Biostatistics, Harjedalen Centre for Experimental Therapeutics, Sveg, Sweden Author
  • Sander Mardisoo Centre for Evidence Synthesis, Jarvamaa Institute of Translational Medicine, Paide, Estonia Author

DOI:

https://doi.org/10.5281/zenodo.22649297

Keywords:

Pharmacovigilance Signals From Spontaneous Reporting, Translational medicine; Evidence synthesis, Clinical implementation; Health services research

Abstract

Pharmacovigilance Signals From Spontaneous Reporting is an area of active development in translational medicine, with
evidence that has accumulated unevenly across its component questions. We review the current evidence base for
pharmacovigilance signals from spontaneous reporting, spanning analytical, clinical, implementation, governance, and economic
dimensions, focusing on where practice has converged and where it continues to vary, and set out the practical considerations
relevant to a service considering its adoption. We conclude that selective, context-specific use is best supported by the evidence
currently available, rather than uniform adoption or avoidance.

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Alvez D, Dumitrescu A, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a systematic review". BMJ Open 28(2011): 410-419. DOI: 10.4103/jrpp.jrpp_20_65

Brankovic K, Kowalczyk B, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a methodological appraisal". J Clin Epidemiol 30(2014): 421-431. DOI: 10.3389/fdgth.2026.1763884

Castellani R, Ristic C, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a multicentre analysis". Contemp Clin Trials 32(2017): 432-443. DOI: 10.2196/48297

Dumitrescu A, Andric D, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a prospective cohort study". Ther Innov Regul Sci 34(2020): 443-455. DOI: 10.1007/s00330-025-12031-z

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Farkas I, Ionescu F, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a consensus statement". PLoS Med 38(2011): 465-479. DOI: 10.3389/fdgth.2026.1834800

Grabowski P, Petrescu G, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a retrospective analysis". Lancet 40(2014): 476-482. DOI: 10.2196/69678

Hendriksen W, Wojcik H, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a validation study". N Engl J Med 42(2017): 487-494. DOI: 10.7759/cureus.46454

Ionescu F, Foscarini I, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a scoping review". JAMA 44(2020): 498-506. DOI: 10.1016/j.ssci.2025.107028

Jankowiak G, Grabowski J, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a health-economic analysis". Nat Med 46(2023): 509-518. DOI: 10.2196/48633

Kowalczyk N, Novotna K, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a systematic review". Cell Rep Med 8(2011): 520-530. DOI: 10.1371/journal.pone.0305949

Lindqvist U, Urbanek L, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a methodological appraisal". Clin Transl Sci 10(2014): 531-542. DOI: 10.1371/journal.pdig.0000514

Marchetti D, Doncheva M, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a multicentre analysis". Pharmacogenomics J 12(2017): 542-554. DOI: 10.17219/acem/208596

Novotna E, Eriksdottir N, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a prospective cohort study". Regul Toxicol Pharmacol 14(2020): 553-566. DOI: 10.7759/cureus.104086

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Quintero B, Balogh Q, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a retrospective analysis". BMC Med 20(2014): 586-593. DOI: 10.1177/08404704241291226

Ristic C, Castellani R, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a validation study". Sci Transl Med 22(2017): 597-605. DOI: 10.1093/medlaw/fwad013

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Vasquez A, Alvez V, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a methodological appraisal". Trials 30(2014): 641-653. DOI: 10.3390/diagnostics15162117

Wojcik H, Hendriksen W, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a multicentre analysis". Drug Discov Today 32(2017): 652-665. DOI: 10.4103/jrpp.jrpp_20_65

Zielinski O, Ostrowski Z, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a prospective cohort study". Clin Cancer Res 34(2020): 663-677. DOI: 10.3389/fdgth.2026.1763884

Andric V, Vasquez A, et al. "Pharmacovigilance Signals From Spontaneous Reporting: a randomised evaluation". BMJ Open 36(2023): 674-680. DOI: 10.2196/48297

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Published

2024-09-11

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Vol. 3 No. 2 (2024): vol 3 issue 2 2024

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How to Cite

Pharmacovigilance Signals From Spontaneous Reporting: Disproportionality Methods and Their Confounders. (2024). Translational Medicine & Therapeutics Journal, 3(2), 83-91. https://doi.org/10.5281/zenodo.22649297