Farmacovigilância em tuberculose: relato de uma experiência no Brasil
Farmacovigilância em tuberculose: relato de uma experiência no Brasil
Data
2015
Autores
Rocha, Jorge Luiz da
Silva, Claudia Hermínia de Lima e
Cyriaco, Caroline Silveira Santos
Cury, Maria Eugênia Carvalhaes
Oliveira, Márcia Gonçalves de
Gasparotto, Fernanda Simioni
Penido, Carolina Souza
Silva, Leandro Roberto da
David, Cristiane Angeli
Bartholomay, Patricia
Journal Title
Journal ISSN
Volume Title
Publisher
Vigil. sanit. debate
Resumo
O tratamento da tuberculose (TB) causa frequentes reações adversas por necessitar da
associação de quatro fármacos e por ser frequentemente usado em associação com outros
medicamentos, como antirretrovirais e hipoglicemiantes, que apresentam importantes
interações com os tuberculostáticos. Com o propósito de reforçar a farmacovigilância em TB
no Brasil, o Programa Nacional de Controle da Tuberculose e a Agência Nacional de Vigilância
Sanitária desenvolveram um projeto piloto para estimular a notificação das reações
adversas aos tuberculostáticos. Foram realizadas capacitações e visitas de monitoramentos
em três unidades de saúde de referência para o tratamento da TB. Dentre as dificuldades
identificadas, encontramos limitações ao acesso ao sistema NOTIVISA, a precariedade da
rede de internet, a ausência de registro das reações adversas nos prontuários dos pacientes,
a reduzida integração multiprofissional, o pouco envolvimento dos gestores e a fragilidade
dos fluxos de informação. Como desdobramentos, materiais instrucionais foram elaborados,
a ficha de notificação do NOTIVISA foi aprimorada, indicadores para o monitoramento das
notificações foram propostos e os fluxos redefinidos. Concluímos que a parceria foi bem
sucedida, e sugerimos estratégia semelhante para outros programas. A integração das
equipes de saúde e a elaboração de ferramentas simplificadas de notificação são desafios a
serem vencidos para conferir sustentabilidade às ações de farmacovigilância no país.
Tuberculosis (TB) treatment frequently causes adverse reactions, because on one hand, it employs at least four drugs and on the other hand, these drugs are often used in association with other drugs, such as antiretroviral and glucose-lowering drugs, that interact with antitubercular agents. The Brazilian National Tuberculosis Control Program and the National Health Surveillance Agency (ANVISA) developed a partnership to implement a pilot pharmacovigilance project to encourage the reporting of adverse reactions to antitubercular agents. Training followed by monitoring visits was conducted by three reference health services for TB treatment. Among the bottlenecks identified, we found limitations in access to the information system (NOTIVISA), slow Internet connection, poor adverse event reporting in medical records, lack of multidisciplinary integration and involvement of managers, and fragility of information flows. As a consequence, technical instructional materials were developed, the NOTIVISA form was improved and shortened, indicators for monitoring notifications were proposed, and information flows were reset. We conclude that the partnership was successful and suggest a similar strategy for other programs. Integration of health teams as well as development of simplified notification tools are challenges to be overcome if pharmacovigilance actions are to be sustainable in the country.
Tuberculosis (TB) treatment frequently causes adverse reactions, because on one hand, it employs at least four drugs and on the other hand, these drugs are often used in association with other drugs, such as antiretroviral and glucose-lowering drugs, that interact with antitubercular agents. The Brazilian National Tuberculosis Control Program and the National Health Surveillance Agency (ANVISA) developed a partnership to implement a pilot pharmacovigilance project to encourage the reporting of adverse reactions to antitubercular agents. Training followed by monitoring visits was conducted by three reference health services for TB treatment. Among the bottlenecks identified, we found limitations in access to the information system (NOTIVISA), slow Internet connection, poor adverse event reporting in medical records, lack of multidisciplinary integration and involvement of managers, and fragility of information flows. As a consequence, technical instructional materials were developed, the NOTIVISA form was improved and shortened, indicators for monitoring notifications were proposed, and information flows were reset. We conclude that the partnership was successful and suggest a similar strategy for other programs. Integration of health teams as well as development of simplified notification tools are challenges to be overcome if pharmacovigilance actions are to be sustainable in the country.
Description
Palavras-chave
Farmacovigilância, Sistemas de Notificação de Reações Adversas a
Medicamentos, Tuberculose, Pharmacovigilance, Tuberculosis, Antitubercular Agents, Adverse Drug Reaction
Reporting Systems
Citação
Rocha JL, Silva CHL, Cyriaco CSS, Cury MEC, Oliveira MG, Trajman A. Farmacovigilância em tuberculose: relato de uma experiência no Brasil [Pharmacovigilance in tuberculosis: report of an experience in Brazil]. (2015). Vigilância Sanitária Em Debate; 3(2):131-135. doi: 10.3395/2317-269x.00270.