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. 2024 Jun;47(6):585-599.
doi: 10.1007/s40264-024-01423-7. Epub 2024 May 7.

The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration

Michele Fusaroli  1 , Francesco Salvo  2   3 , Bernard Begaud  4 , Thamir M AlShammari  5 , Andrew Bate  6   7 , Vera Battini  8 , Andreas Brueckner  9 , Gianmario Candore  10 , Carla Carnovale  8 , Salvatore Crisafulli  11 , Paola Maria Cutroneo  12 , Charles Dolladille  13   14 , Milou-Daniel Drici  15 , Jean-Luc Faillie  16 , Adam Goldman  17   18 , Manfred Hauben  19   20 , Maria Teresa Herdeiro  21 , Olivia Mahaux  6 , Katrin Manlik  10 , François Montastruc  22   23 , Yoshihiro Noguchi  24 , G Niklas Norén  25 , Roberta Noseda  26 , Igho J Onakpoya  27 , Antoine Pariente  4   28 , Elisabetta Poluzzi  29 , Myriam Salem  30 , Daniele Sartori  25   31 , Nhung T H Trinh  32 , Marco Tuccori  33 , Florence van Hunsel  34   35 , Eugène van Puijenbroek  34   35 , Emanuel Raschi  29 , Charles Khouri  36   37
Affiliations

The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration

Michele Fusaroli et al. Drug Saf. 2024 Jun.

Abstract

In pharmacovigilance, disproportionality analyses based on individual case safety reports are widely used to detect safety signals. Unfortunately, publishing disproportionality analyses lacks specific guidelines, often leading to incomplete and ambiguous reporting, and carries the risk of incorrect conclusions when data are not placed in the correct context. The REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance (READUS-PV) statement was developed to address this issue by promoting transparent and comprehensive reporting of disproportionality studies. While the statement paper explains in greater detail the procedure followed to develop these guidelines, with this explanation paper we present the 14 items retained for READUS-PV guidelines, together with an in-depth explanation of their rationale and bullet points to illustrate their practical implementation. Our primary objective is to foster the adoption of the READUS-PV guidelines among authors, editors, peer reviewers, and readers of disproportionality analyses. Enhancing transparency, completeness, and accuracy of reporting, as well as proper interpretation of their results, READUS-PV guidelines will ultimately facilitate evidence-based decision making in pharmacovigilance.

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Conflict of interest statement

Gianmario Candore and Katrin Malik are full-time employees at Bayer AG. Olivia Mahaux and Andrew Bate are full-time employees at GSK and own GSK restricted shares. Manfred Hauben was a full-time employee at Pfizer when the Delphi was conducted and owns stock/stock options in pharmaceutical companies that may manufacture/market drugs mentioned in this paper. Michele Fusaroli, Francesco Salvo, Bernard Begaud, Thamir M. AlShammari, Vera Battini, Andreas Brueckner, Carla Carnovale, Salvatore Crisafulli, Paola Maria Cutroneo, Charles Dolladille, Milou-Daniel Drici, Jean-Luc Faillie, Adam Goldman, Maria Teresa Herdeiro, François Montastruc, Yoshihiro Noguchi, G. Niklas Norén, Roberta Noseda, Igho J. Onakpoya, Antoine Pariente, Elisabetta Poluzzi, Myriam Salem, Daniele Sartori, Nhung T.H. Trinh, Marco Tuccori, Florence van Hunsel, Eugène van Puijenbroek, Emanuel Raschi, and Charles Khouri declare no conflicts of interest in relation to this research.

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References

    1. Raschi E, Moretti U, Salvo F, Pariente A, Antonazzo IC, Ponti FD, et al. Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety. Pharmacovigilance. 2018. Available at: https://www.intechopen.com/online-first/evolving-roles-of-spontaneous-re...
    1. Croteau D, Pinnow E, Wu E, Muñoz M, Bulatao I, Dal Pan G. Sources of evidence triggering and supporting safety-related labeling changes: a 10-year longitudinal assessment of 22 new molecular entities approved in 2008 by the US food and drug administration. Drug Saf. 2022;45:169–180. doi: 10.1007/s40264-021-01142-3. - DOI - PubMed
    1. Faillie J-L. Case-non-case studies: principle, methods, bias and interpretation. Therapie. 2019;74:225–232. doi: 10.1016/j.therap.2019.01.006. - DOI - PubMed
    1. Insani WN, Pacurariu AC, Mantel-Teeuwisse AK, Gross-Martirosyan L. Characteristics of drugs safety signals that predict safety related product information update. Pharmacoepidemiol Drug Saf. 2018;27:789–796. doi: 10.1002/pds.4446. - DOI - PMC - PubMed
    1. Onakpoya IJ, Heneghan CJ, Aronson JK. Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature. BMC Med. 2016;14:10. doi: 10.1186/s12916-016-0553-2. - DOI - PMC - PubMed

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