Pharmacovigilance profile in a reference center in Ecuador: A retrospective study
1 Department of Pharmacovigilance, Hospital Vozandes, Quito, Ecuador.
2 Department of Internal Medicine, Hospital Vozandes, Quito, Ecuador.
3 Department of Hepatology, Hospital Vozandes, Quito, Ecuador.
Research Article
GSC Advanced Research and Reviews, 2022, 12(03), 064–069.
Article DOI: 10.30574/gscarr.2022.12.3.0234
Publication history:
Received on 30 July 2022; revised on 02 September 2022; accepted on 04 September 2022
Abstract:
Background: The development of new health technologies – drugs has allowed to change the therapeutics of some diseases, however, despite the advantages in various clinical scenarios – prevention, prophylaxis, treatment, etc., there is evidence that adverse drug reactions (ADR) are a frequent but preventable cause of disease, disability, or death.
Therefore, it is estimated that in some countries ADRs represent between the fourth and sixth cause of mortality.
Objectives: To determine the prevalence and profile of ADRs in a reference center in Ecuador.
Design and setting: This historical cohort study included patients aged ≥ 18 years with diagnosed Adverse Reaction to Medications in the period March 2018 – March 2019, at a reference center in Ecuador. Patients were divided into three groups: I) Adverse drug reaction; ii) medication error (ME); and iii) therapeutic failure, according to WHO and ARCSA definitions.
Methods: Continuous variables were compared using t-test or Mann-Whitney test, when distributional assumptions were in doubt. Categories were compared via chi-square test or Fisher exact test, when needed. The analyses were conducted with IBM-SPSS version 25. P values < 0.05 were deemed statistically significant.
Results: Antibiotics and analgesics - antipyretics were the pharmacological groups responsible for the highest number of cases of ADRs (accounting for 9.0% and 7.6% respectively) and EM (24.7% and 20.8% respectively).
Conclusion: The ADRs, ME present an important prevalence, for this reason all health institutions have pharmacovigilance systems that allow early detection of these events within a public policy of quality and safety of care.
Keywords:
Pharmacologic actions; Drug-related side effects; Adverse reactions; Epidemiology
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Copyright © 2022 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0
