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Master's Dissertation
DOI
https://doi.org/10.11606/D.10.2020.tde-11022020-125046
Document
Author
Full name
Danillo Silva Marcon
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2019
Supervisor
Committee
Baquero, Oswaldo Santos (President)
Gattás, Vera Lúcia
Pimentel, Jorge Couto
Title in Portuguese
Farmacovigilância veterinária baseada em relatos espontâneos de uma empresa farmacêutica no Brasil
Keywords in Portuguese
Detecção de sinais
Eventos adversos
Farmacovigilância veterinária
Notificações espontâneas
Abstract in Portuguese
A farmacovigilância de uma empresa veterinária pode compreender a análise de relatos espontâneos de eventos adversos (EA) relacionados aos seus produtos. No presente estudo foi elaborado um fluxograma de classificação de EA que foi usado para analisar EA notificados ao serviço de atendimento ao cliente e farmacovigilância de uma empresa veterinária no Brasil. Os binômios produto-EA foram caracterizados em termos das suas frequências e posteriormente foram utilizados três modelos de detecção de sinais: Reporting Odds Ratio, Bayesian confidence propagation neural network, e Gamma Poisson Shrinker. Os sinais detectados com os três métodos foram classificados de acordo com a sua intensidade, sempre com o sinal mais intenso na primeira posição. Entre os sinais detectados pelos três métodos, as posições de cada sinal foram somadas para obter uma classificação agregada que levasse em consideração os resultados dos três métodos e permitisse uma interpretação serial. Entre os 531 relatos foram identificados 20 EA, 54 binômios produto-EA e 34 binômios produto-reação adversa medicamentosa. Do total de relatos 7 foram sinais identificados pelos três métodos utilizados. A classificação de EA seguindo critérios explícitos e o uso combinado de mais de um método de detecção de sinais aprimoram a farmacovigilância baseada em relatos espontâneos
Title in English
Spontaneous-reports-based veterinary pharmacovigilance of a pharmaceutical company in Brazil
Keywords in English
Adverse events
Signal detection
Spontaneous notifications
Veterinary pharmacovigilance
Abstract in English
The pharmacovigilance of a veterinary company may include the analysis of spontaneous reports of adverse events (AE) related to its products. The present study developed an AE classification flowchart to analyze AE notified to the customer service and pharmacovigilance of a veterinary company in Brazil. The product-AE binomials were characterized in terms of their frequencies and subsequently, three signal detection models were used: Reporting Odds Ratio, Bayesian confidence propagation neural network, and Gamma Poisson Shrinker. The signals detected with the three methods were classified according to their intensity, always with the most intense signal in the first position. Among the signals detected by the three methods, the positions of each signal were summed to obtain an aggregated classification that took into account the results of the three methods and allowed a serial interpretation. Among the 531 reports, 20 AE, 54 product-AE binomials and 34 product-Adverse Drug Reaction binomials were identified. From the total of reports, seven were signs identified by the three methods. The classification of AE following explicit criteria and the combined use of more than one signal detection method enhances spontaneous-reports-based pharmacovigilance
 
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Publishing Date
2020-04-22
 
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