Pharmacovigilance in Neuroscience

  • María-Pilar Sánchez-de-Paz Sanatorio de la Trinidad Mitre
  • Gustavo Da-Prat-de-Magalhaes Sanatorio de la Trinidad Mitre
  • Santiago Isa Sanatorio de la Trinidad Mitre
  • Victoria Aldinio Sanatorio de la Trinidad Mitre
  • Andres Norberto-Latella Universidad de Buenos Aires
  • Emilia Mabel-Gatto Sanatorio de la Trinidad Mitre
  • Galeno J. Rojas Sanatorio de la Trinidad Mitre/Universidad de Buenos Aires

Abstract

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.

Keywords: Pharmacovigilance, Epidemiology, Adverse reactions, Drugs, Neurology, Pharmacology

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Published
2021-08-27
How to Cite
Sánchez-de-Paz, M.-P., Da-Prat-de-Magalhaes, G., Isa, S., Aldinio, V., Norberto-Latella, A., Mabel-Gatto, E., & Rojas, G. (2021). Pharmacovigilance in Neuroscience. Journal of Applied Cognitive Neuroscience, 2(1), e00163800. https://doi.org/10.17981/JACN.2.1.2021.04