The reporting of disproportionality analysis in pharmacovigilance: spotlight on the READUS-PV guideline

Abstract

Disproportionality analyses are the most-commonly used study design used in the post-marketing phase to detect suspected adverse drug reactions in individual case safety reports. Recent years have witnessed an exponential increase in published articles on disproportionality analyses, thanks to publicly accessible databases. Unfortunately, this trend was accompanied by concerns on lack of transparency and misinterpretation of results, both generating unjustified alarm and diluting true signals into overwhelming noise. The READUS-PV guideline for reporting disproportionality analysis was developed to tackle this emerging issue. In this perspective article, we describe the rationale behind the development of the READUS-PV guideline, the first collaborative initiative to harmonize the reporting of disproportionality analyses. The adoption of the checklists will assist researchers, regulators, and reviewers in the reporting, assessment, and publication of disproportionality analyses. Acknowledging the challenges ahead of effective implementation, we advocate for a global endorsement by Pharmacology Journals. A wide dissemination of the READUS-PV guideline is crucial to foster transparency and reproducibility of pharmacovigilance research, supporting an effective exploitation of disproportionality analysis among other irreplaceable post-marketing research tools to ensure drug safety.

Keywords: adverse drug reactions; disproportionality analysis; individual case safety reports; pharmacovigilance; signal detection.

FIGURE 1

Milestones in the development of disproportionality analysis and access to major pharmacovigilance databases. BCPNN, Bayesian Confidence Propagation Neural Network; DA:, disproportionality analysis; FAERS, FDA Adverse Event Reporting System; FDA, Food and Drug Administration; GVP, Good PharmacoVigilance Practices [Regulation (EU) No 1027/2012 and Directive 2012/26/EU].