Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Underreporting and Triggering Factors for Ophthalmic Drugs’ ADR Notification; a Comparison between Spontaneous Reporting and Active Pharmacovigilance Databases

Version 1 : Received: 9 August 2022 / Approved: 11 August 2022 / Online: 11 August 2022 (04:07:15 CEST)
Version 2 : Received: 21 September 2022 / Approved: 22 September 2022 / Online: 22 September 2022 (07:17:10 CEST)

How to cite: Contreras-Salinas, H.; Baiza-Durán, L.M.; Bautista-Castro, M.A.; Alonso-Rodríguez, D.R.; Rodríguez-Herrera, L.Y. Underreporting and Triggering Factors for Ophthalmic Drugs’ ADR Notification; a Comparison between Spontaneous Reporting and Active Pharmacovigilance Databases. Preprints 2022, 2022080207 (doi: 10.20944/preprints202208.0207.v1). Contreras-Salinas, H.; Baiza-Durán, L.M.; Bautista-Castro, M.A.; Alonso-Rodríguez, D.R.; Rodríguez-Herrera, L.Y. Underreporting and Triggering Factors for Ophthalmic Drugs’ ADR Notification; a Comparison between Spontaneous Reporting and Active Pharmacovigilance Databases. Preprints 2022, 2022080207 (doi: 10.20944/preprints202208.0207.v1).

Abstract

(1)Aims of the study: calculating the underreporting ratio for two different kinds of medications (antiglaucoma and artificial tear) and characterizing the features influencing the reporting of adverse drug reactions (ADRs) in spontaneous reporting; (2) Methods: the underreporting ratio was calculated by comparing the adverse drug reactions reported in the spontaneous reporting database for every 10,000 defined daily doses marketed and the adverse drug reactions from an active surveillance study for every 10,000 defined daily doses used for different drugs (antiglaucoma and artificial tear). The factors related to the report in spontaneous reporting through statistical tests were also determined; (3) Results: The underreporting ratio of spontaneous reporting was 0.006029% for antiglaucoma and 0.003552% for artificial tear; additionally, statistically significant differences were found for severity, unexpected adverse drug reactions, and incidence of adverse drug reactions in females; (4) Conclusions: the underreporting ratio of ophthalmic medications, especially in Latin America, shows higher rates than those reported in the literature. On the other hand, gender, seriousness, severity, and unexpected adverse drug reactions influence spontaneous reporting.

Keywords

Adverse Drug Reaction; Spontaneous reporting; Active surveillance; Underreporting; Antiglau-coma; Artificial tear

Subject

MEDICINE & PHARMACOLOGY, Ophthalmology

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