Pharmacovigilance in Neuroscience

Background: Adverse drug reactions (ADRs) have a high impact on morbidity and mortality of the population, becoming a public health issue. Studying and publishing about these is referred as pharmacovigilance.Objective: To describe and compare the adverse reactions produced by drugs of nervous system...

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Bibliographic Details
Published in:Journal of Applied Cognitive Neuroscience 2021-08, Vol.2 (1), p.e00163800
Main Authors: Sánchez-de-Paz, María-Pilar, Da-Prat-de-Magalhaes, Gustavo, Isa, Santiago, Aldinio, Victoria, Norberto-Latella, Andres, Mabel-Gatto, Emilia, Rojas, Galeno J
Format: Article
Language:English
Subjects:
Antibiotics
Classification
Drug dosages
Hospitalization
Mortality
Nervous system
Patients
Pharmacokinetics
Pharmacovigilance
Polypharmacy
Psychotropic drugs
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Summary:Background: Adverse drug reactions (ADRs) have a high impact on morbidity and mortality of the population, becoming a public health issue. Studying and publishing about these is referred as pharmacovigilance.Objective: To describe and compare the adverse reactions produced by drugs of nervous system action (CNS-D) and neurological ADRs produced by drugs of systemic action (Sys-D). To further develop the need of reporting adverse reactions.Methods: An observational, cross-sectional, retrospective study performed on a database of neurological consultations which took place at the Neurology department. Patients meeting the inclusion criteria were selected and divided into two groups: Sys-D and CNS-D. Demographic and neurological variables were analyzed. Parametric and non-parametric statistics were used according to distribution. The Naranjo Algorithm (NA) was used to define causality.Results: 71 ADRs were described, from which 63.38% (n=45) were produced by CNS-D, especially antiepileptics by 47% (n=21) and psycholeptics by 44%. Of the total, 36.62% (n=26) were caused by Sys-D, such as antineoplastics (n=9) and antibiotics (n=9), being Cefepime the most frequent. The diagnosis of ADRs caused by a Sys-D was delayed prolonging hospitalization (p 0.05) due to a lower NA score (p 0.003) compared to the CNS-D group.Conclusion: Multiple frequently used drugs of systemic action, such as antineoplastics and antibiotics, generate neurological adverse effects. From our analysis, it was presumed that the suspicion of a neurological ADR caused by these drugs was scarce, thus causing a higher morbidity for the patient.
ISSN:2745-0031
DOI:10.17981/JACN.2.1.2021.04