Publications

Authors:

Cutroneo, Paola Maria; Sartori, Daniele; Tuccori, Marco; Crisafulli, Salvatore; Battini, Vera; Carnovale, Carla; Rafaniello, Concetta; Capuano, Annalisa; Poluzzi, Elisabetta; Moretti, Ugo; Raschi, Emanuel

Title:

Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems

Year:

2023

Type of item:

Articolo in Rivista

Tipologia ANVUR:

Articolo su rivista

Language:

Inglese

Referee:

No

Name of journal:

FRONTIERS IN DRUG SAFETY AND REGULATION

ISSN of journal:

2674-0869

N° Volume:

3

Page numbers:

1-15

Keyword:

Pharmacovigilance, disproportionality analysis, spontaneous reporting systems

Short description of contents:

Spontaneous reporting systems remain pivotal for post-marketing surveillance and disproportionality analysis (DA) represents a recognized approach for early signal detection. Although DAs cannot be used per se as a standalone approach to assess a drug-related risk and cannot replace clinical judgment in the individual patient, their role remain irreplaceable for rapid detection of rare and unpredictable adverse drug reactions with strong drug-attributable component (e.g., designated medical events), especially when developed by a multidisciplinary team and combined with a careful case-by-case analysis (individual inspection of reports for causality assessment or to uncover reporting patterns and clinical features). In the recent past, a remarkable increase in publications of pharmacovigilance studies using DAs was observed, albeit the quality was debated: several publications contained “spin”, namely, misinterpretation of results to infer causality, calculate incidence, or provide risk stratification, which may ultimately result in unjustified alarm. The development of dedicated Guidelines by the international READUS-PV project (https://readusstatement.org/) will allow reproducible and transparent publication of accurate DAs, thus supporting their real transferability and exploitation by regulators and clinicians. This review offered a perspective on methodological aspects (and understanding) of DAs, their rationale, design, reporting, and interpretation.

Product ID:

141137

Handle IRIS:

11562/1137172

Last Modified:

December 12, 2024

Bibliographic citation:

Cutroneo, Paola Maria; Sartori, Daniele; Tuccori, Marco; Crisafulli, Salvatore; Battini, Vera; Carnovale, Carla; Rafaniello, Concetta; Capuano, Annalisa; Poluzzi, Elisabetta; Moretti, Ugo; Raschi, Emanuel, Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems «FRONTIERS IN DRUG SAFETY AND REGULATION» , vol. 3 , 2023 , pp. 1-15

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