Tribunal identifica falhas da Anvisa em relação ao controle dos medicamentos pós registro

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imagesHoje não são consideradas as informações do sistema de notificações do estado de São Paulo (Periweb), o qual, sozinho, contempla mais notificações do que todo o sistema nacional.

As notificações dizem respeito a eventos adversos e queixas técnicas relacionadas ao uso de produtos e de serviços sob vigilância sanitária.

No Brasil, uma das principais fontes de dados sobre o comportamento dos produtos no seu uso são as notificações oriundas de profissionais e estabelecimentos de saúde, por meio do Sistema de Notificações em Vigilância Sanitária (Notivisa). Este entrou em operação em dezembro de 2006 e constitui-se em ferramenta para captar e armazenar dados sobre as notificações de eventos adversos e queixas técnicas relacionadas aos medicamentos.

Também foram identificadas falhas quanto a descontinuidade do Programa Nacional de Verificação da Qualidade de Medicamentos (Proveme) e ausência do efetivo monitoramento nacional da qualidade dos medicamentos comercializados no país. Além de deficiências na coordenação dos laboratórios centrais de saúde pública exercida pela Gerência de Laboratórios de Vigilância Sanitária (Gelas), foi identificado falta de informações acerca da situação da Rede Nacional de Laboratórios de Vigilância Sanitária em relação à estrutura física e operacional, às atividades executadas e agenda de supervisões técnicas regulares para acompanhar a estruturação da rede.

Acontece que o Notivisa não apresenta ferramentas essenciais para execução da vigilância pós-comercialização, possuindo falhas que fragilizam o gerenciamento de risco de medicamentos. O sistema não permite a identificação de sinais de segurança, a análise de tendências (ausência de ferramentas estatísticas que permitam essa análise), a interoperabilidade com outras bases de dados (como o sistema Periweb, sistema de notificações do estado de São Paulo, o SI-PNI, sistema informatizado do Programa Nacional de Imunizações, e o sistema de notificações do centro internacional de monitorização de medicamentos da OMS) e a integração dos módulos de notificação e investigação.

O escopo desta auditoria limitou-se a examinar os procedimentos adotados em relação ao controle posterior ao registro dos medicamentos. O monitoramento dos medicamentos na fase de uso, ou seja, após o período de autorização, constitui-se em importante atividade para que novas informações sobre o perfil de segurança possam ser analisadas, em momento oportuno e de maneira efetiva.

“A relevância de acompanhar o pós-uso dos medicamentos vem se tornando mais crítica e necessária, porque, além de as limitações dos estudos clínicos e não clínicos exigidos para o registro não detectarem reações menos frequentes ou que acontecem em grupos mais vulneráveis da população ou as interações medicamentosas, há lançamento crescente de drogas novas, sintéticas e biológicas, devido à evolução da indústria farmacêutica”, afirma o relator ministro Bruno Dantas.

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