Phenobarbital: effect of interchangeability on the profile of adverse effect, on quality of life and on plasma concentrations - a pilot study
DOI:
https://doi.org/10.30968/rbfhss.2019.101.0410Abstract
Introduction: Phenobarbital is one of the drugs most used in the treatment of epilepsy, with different formulations available on the market today. Objectives: The objective of this study was to evaluate the effect of interchangeability on the profile of the adverse effect, on quality of life and on plasma concentrations before and after the exchange of phenobarbital formulations in patients with epilepsy. Methods: This is a before and after study, in which adult patients with a diagnosis of epilepsy were included in outpatient treatment with phenobarbital. The Adverse Events Profile (AEP) and Quality of Life in Epilepsy-31 (QOLIE) questionnaires were applied before and after the brand change in phenobarbital, as well as the determination of the plasma concentration of phenobarbital. In the first meeting, the “Interchangeable Pharmaceutical Product in the Treatment of Epilepsy” questionnaire was also applied. Physical-chemical tests to evaluate the quality of the tablets were performed according to the parameters of the Brazilian pharmacopoeia. Results: The population was composed of eight patients; six were females, with a mean age of 51.4 (SD=5.4) years old and four did not have a full first degree. Of the interviewees, six had no knowledge of the three types of existing antiepileptic formulations. Significant differences were found for the “Emotional wellbeing” domain of quality of life before and after the formulation change (p=0.016) and no significant difference between frequencies of adverse effects and plasma concentrations. Conclusion: The results suggest the importance of pharmacovigilance, in addition to being able to subsidize new clinical studies regarding the interchangeability between antiepileptics. In addition, the physical-chemical tests point to the need to strengthen health surveillance actions.
Downloads
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2019 RBFHSS and the Authors
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
The authors hereby transfer, assign, or otherwise convey to RBFHSS: (1) the right to grant permission to republish or reprint the stated material, in whole or in part, without a fee; (2) the right to print republish copies for free distribution or sale; and (3) the right to republish the stated material in any format (electronic or printed). In addition, the undersigned affirms that the article described above has not previously been published, in whole or part, is not subject to copyright or other rights except by the author(s), and has not been submitted for publication elsewhere, except as communicated in writing to RHFHSS with this document.
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License (CC-BY-NC-ND) that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
Serlf-archiving policy
This journal permits and encourages authors to post and archive the final pdf of the articles submitted to the journal on personal websites or institutional repositories after publication, while providing bibliographic details that credit its publication in this journal.
