Pharmacovigilance in tuberculosis: report of an experience in Brazil

• Autor(a) principal: da Rocha, Jorge Luiz
• Data de Publicação: 2015
• Outros Autores: 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, Johansen, Faber Katsume, Costa, Fernanda Dockhorn, Lima, Josué Nazareno de, Barreira, Draurio, Trajman, Anete
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/270
• topic: Farmacovigilância; Sistemas de Notificação de Reações Adversas a Medicamentos; Tuberculose; Pharmacovigilance; Tuberculosis; Antitubercular Agents; Adverse Drug Reaction Reporting Systems

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.