Working Paper Article Version 2 This version is not peer-reviewed

A Drug Safety Surveillance Study of a Ciprofloxacin / Dexamethasone Ophthalmic Fixed Combination in Peruvian Population

Version 1 : Received: 23 November 2020 / Approved: 25 November 2020 / Online: 25 November 2020 (08:02:47 CET)
Version 2 : Received: 30 December 2020 / Approved: 5 January 2021 / Online: 5 January 2021 (11:51:06 CET)

A peer-reviewed article of this Preprint also exists.

Contreras-Salinas, H.; Baiza-Durán, L.M.; Barajas-Hernández, M.; Vázquez-Álvarez, A.O.; Rodríguez-Herrera, L.Y. A Drug Safety Surveillance Study of a Ciprofloxacin/Dexamethasone Ophthalmic Fixed Combination in Peruvian Population. Pharmacy 2021, 9, 15. Contreras-Salinas, H.; Baiza-Durán, L.M.; Barajas-Hernández, M.; Vázquez-Álvarez, A.O.; Rodríguez-Herrera, L.Y. A Drug Safety Surveillance Study of a Ciprofloxacin/Dexamethasone Ophthalmic Fixed Combination in Peruvian Population. Pharmacy 2021, 9, 15.

Journal reference: Pharmacy 2021, 9, 15
DOI: 10.3390/pharmacy9010015

Abstract

Background: drugs provide a significant benefit; however, their use implies an intrinsic potential danger, with the possibility to cause unwanted effects. These effects are known as adverse drug reactions (ADRs). Post-marketing drug safety surveillance detects unknown risks that have not been identified in clinical trials and it is necessary to monitor marketed medications under real-life practice. Due to the scarce information about fixed combination of ciprofloxacin 0.3% / dexamethasone 0.1% (SDO), we performed a drug safety surveillance study. (2) Methods: A prospective non-controlled drug safety surveillance study was conducted in Peruvian population. A total of 236 patients prescribed SDO were included derivates from 12 sites. Patients' standardized information was collected through two phone calls, including demographics, medical history, prescribing patterns of SDO, concomitant medication, and ADRs in detail. The ADRs were classified by causality and severity, followed by outcome measures to identify new risk. (3) Results: 236 patients prescribed with SDO participated in the study and 220 were included. A total of 82 ADRs/220 patients were reported after the use of SDO, presenting a ratio 0.37 ADR/patient. The most frequent ADR with SDO administration was eye irritation (30%). The totality of the ADR was classified as non-serious, and the 97.5% (n=80) was classified as mild and 2.5% as moderate (n=2). No cases under the severe category were identified. (4) Conclusion: No new risks were found in the population where this study was conducted.

Keywords

Drug Safety Surveillance; Adverse Drug Reaction; Ophthalmic; Ciprofloxacin; Dexamethasone

Comments (1)

Comment 1
Received: 5 January 2021
Commenter: Homero Contreras-Salinas
Commenter's Conflict of Interests: Author
Comment: The survey has some limitations,  and also some advantages, such as individualized pharmacovigilance, continuous monitoring and access to more detailed information on adverse events from a large number of patients.
The data was collected in a follow-up contact form (on paper) . The information collected was recorded in a database in Excel format (password protected) by the main researcher. Subsequently, the correspondence author verified the database’s information vs paper follow-up contact form, in order to avoid errors.
A multivariate analysis was conducted to evaluate the drug's tolerability in patients with different demographic factors such as: age group, comorbidities, gender; prescriptions and medication dosage, and a multinomial logistic regression was performed to compare SDO vs the incidences of the literature.  In the case of the causality, severity, and severity of ADRs, they are considered descriptive and were not included in the multivariate analysis.

The data provided by the multivariate analysis were used to strengthen the results and thus give more support to the conclusions.
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