0427/2018 - Avaliação do desempenho do Sistema Nacional de Notificações para a Vigilância Sanitária: Uma ferramenta do sistema de farmacovigilância no Brasil. Performance Issues of the Brazilian Notification System for Health Surveillance: A Tool in the Brazil’s Pharmacovigilance System.
Avaliar o desempenho do Sistema Nacional de Notificações para a Vigilância Sanitária no que diz respeito ao registro de informações sobre danos à saúde relacionados com medicamentos (Notivisa-medicamento) a partir de atributos previamente selecionados. Realizou-se um estudo de avaliação em saúde de corte transversal, entre 2008 e 2013, que empregou oito atributos previstos em diretrizes para avaliação de sistemas de vigilância da saúde pública (simplicidade, aceitabilidade, representatividade, completude, validade, consistência, erro preditivo positivo e oportunidade). No período estudado, 63.512 registros foram identificados no Notivisa-medicamento, sendo a maioria classificados como graves (60,5%). O desempenho do Notivisa-medicamento foi considerado satisfatório para dois dos oito atributos (validade e erro preditivo positivo) e deficitário para os demais (simplicidade, aceitabilidade, representatividade, completude, consistência e oportunidade). É necessário discutir e implementar maneiras de como aprimorar o sistema com vistas a fornecer informações completas, oportunas e confiáveis para diferentes segmentos da sociedade brasileira, sobretudo os gestores de vigilância sanitária.
Palavras-chave:
Avaliação em saúde. Farmacovigilância. Sistemas de informação em Saúde. Sistemas de Notificação de Reações Adversas a Medicamentos.
Abstract:
To assess the performance of the Brazilian Notification System for Health Surveillance, regarding the registration that entails the information about drug-related adverse effects (Notivisa/medication) according to previously ed attributes. A cross-sectional health evaluation study was carried out between 2008 and 2013 using eight attributes established by international guidelines to assess public health surveillance systems: simplicity, acceptability, representativeness, completeness, validity, consistency, positive predictive error and timeliness. In the study period, 63,512 registries were identified in Notivisa/medication, most of them considered severe adverse effects (60.5%). The performance of Notivisa/medication was considered satisfactory regarding two of the eight attributes (validity and positive predictive error) and deficient in six of the remaining (simplicity, acceptability, representability, completeness, consistency and timeliness). Quality improvement strategies to change that situation of the system are necessary in order to provide complete, timely and reliable surveillance information for different stakeholders of the Brazilian communities – particularly health surveillance managers.
Keywords:
Health evaluation. Pharmacovigilance. Health Information Systems. Adverse Drug Reaction Reporting Systems.
Performance Issues of the Brazilian Notification System for Health Surveillance: A Tool in the Brazil’s Pharmacovigilance System.
Resumo (abstract):
To assess the performance of the Brazilian Notification System for Health Surveillance, regarding the registration that entails the information about drug-related adverse effects (Notivisa/medication) according to previously ed attributes. A cross-sectional health evaluation study was carried out between 2008 and 2013 using eight attributes established by international guidelines to assess public health surveillance systems: simplicity, acceptability, representativeness, completeness, validity, consistency, positive predictive error and timeliness. In the study period, 63,512 registries were identified in Notivisa/medication, most of them considered severe adverse effects (60.5%). The performance of Notivisa/medication was considered satisfactory regarding two of the eight attributes (validity and positive predictive error) and deficient in six of the remaining (simplicity, acceptability, representability, completeness, consistency and timeliness). Quality improvement strategies to change that situation of the system are necessary in order to provide complete, timely and reliable surveillance information for different stakeholders of the Brazilian communities – particularly health surveillance managers.
Palavras-chave (keywords):
Health evaluation. Pharmacovigilance. Health Information Systems. Adverse Drug Reaction Reporting Systems.
Mota, D.M, Vigo, A, Kuchenbecker, R.S. Avaliação do desempenho do Sistema Nacional de Notificações para a Vigilância Sanitária: Uma ferramenta do sistema de farmacovigilância no Brasil.. Cien Saude Colet [periódico na internet] (2018/Set). [Citado em 07/11/2024].
Está disponível em: http://cienciaesaudecoletiva.com.br/artigos/avaliacao-do-desempenho-do-sistema-nacional-de-notificacoes-para-a-vigilancia-sanitaria-uma-ferramenta-do-sistema-de-farmacovigilancia-no-brasil/16960?id=16960
