Preprint Article Version 2 Preserved in Portico This version is not peer-reviewed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.v2). 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.v2).

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 & PHARMACOLOGY, Ophthalmology

Comments (1)

Comment 1
Received: 22 September 2022
Commenter: Homero Contreras-Salinas
Commenter's Conflict of Interests: Author
Comment: The wording was changed to avoid generalizing that the pharmacovigilance system is a possible cause of the phenomena of non-reporting since there is not enough information to support it.The change made is consistent with the study objective and shows relevant information regarding the concern of a low underreporting rate.
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