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

Homero Contreras-Salinas; Leopoldo Martín Baiza-Durán; Manuel Alejandro Bautista-Castro; Diego Rodrigo Alonso-Rodríguez; Lourdes Yolotzin Rodríguez-Herrera

doi:10.20944/preprints202208.0207.v3

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preprints.org > medicine and pharmacology > ophthalmology > doi: 10.20944/preprints202208.0207.v3

Preprint Article Version 3 Preserved in Portico This version is not peer-reviewed

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

Homero Contreras-Salinas

^* ,

Leopoldo Martín Baiza-Durán

Manuel Alejandro Bautista-Castro

Diego Rodrigo Alonso-Rodríguez

Lourdes Yolotzin Rodríguez-Herrera

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)
Version 3 : Received: 7 October 2022 / Approved: 11 October 2022 / Online: 11 October 2022 (03:18:55 CEST)

A peer-reviewed article of this Preprint also exists.

Contreras-Salinas, H.; Baiza-Durán, L.M.; Bautista-Castro, M.A.; Alonso-Rodríguez, D.R.; Rodríguez-Herrera, L.Y. Underreporting and Triggering Factors for Reporting ADRs of Two Ophthalmic Drugs: A Comparison between Spontaneous Reports and Active Pharmacovigilance Databases. Healthcare 2022, 10, 2182. Contreras-Salinas, H.; Baiza-Durán, L.M.; Bautista-Castro, M.A.; Alonso-Rodríguez, D.R.; Rodríguez-Herrera, L.Y. Underreporting and Triggering Factors for Reporting ADRs of Two Ophthalmic Drugs: A Comparison between Spontaneous Reports and Active Pharmacovigilance Databases. Healthcare 2022, 10, 2182.

Abstract

(1)Aims of the study: calculating the underreporting ratio for two different medications, a fixed combination of 0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide (antiglaucoma) and a fixed combination of sodium hyaluronate 0.1% + chondroitin sulfate 0.18% (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 ADRs related to ophthalmic medications indicates worry since the cornerstone of pharmacovigilance focuses on spontaneous reporting. Besides, since underreporting seems to be selective, the role of certain aspects like gender, seriousness, severity, and unexpected ADRs, must be considered in future research.

Keywords

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

Subject

Medicine and Pharmacology, Ophthalmology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Comments (1)

Comment 1

Received: 11 October 2022
Commenter: Homero Contreras-Salinas
Commenter's Conflict of Interests: Author

Comment: The title was changed because the previous one gives the appearance that a large number of ophthalmic medications were analyzed.“Underreporting and triggering factors for two ophthalmic drugs’ ADR notification; a comparison between spontaneous reporting and active pharmacovigilance databases.”

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