Novas regras devem inibir erros de administração de medicamentos, trocas indesejadas e uso equivocado

medicamentos Freepik

Publicado 14/01/2016

Foi publicada no Diário Oficial da União (DOU) de 30 de dezembro, a Lei nº 13.236, que estabelece normas gerais para inibir erros de administração, trocas indesejadas e uso equivocado de medicamentos. A publicação altera a Lei nº 6.360, de 23 de setembro de 1976, que “dispõe sobre a Vigilância Sanitária a que ficam sujeitos os Medicamentos, as Drogas, os Insumos Farmacêuticos e Correlatos, Cosméticos, Saneantes e Outros Produtos.

As mudanças são no sentido impedir a troca de medicamentos, além de obrigar os fabricantes a disponibilizar bulas com letras maiores e informações mais explicativas ao público. O objetivo é evitar enganos, como nos episódios com morte em função da administração de medicamentos errados, em hospitais, e também evitar possíveis erros em situação de urgência. O texto também determina que embalagens de medicamentos de uso infantil sejam diferentes das de uso adulto.

Para o coordenador técnico-científico do Conselho Federal de Farmácia, José Luis Miranda Maldonado, nos últimos anos, o aumento considerável de estudos relacionados à segurança do paciente e erros de medicação levou a um maior conhecimento sobre o assunto, confirmando sua importância como um problema mundial de saúde pública. “Erro de medicação é qualquer evento evitável que, de fato ou potencialmente, pode levar ao uso inadequado de medicamento. Esse conceito implica que o uso inadequado pode ou não lesar o paciente, e não importa se o medicamento se encontra sob o controle de profissionais de saúde, do paciente ou do consumidor”, explica.

Segundo Maldonado, o erro pode estar relacionado à prática profissional, produtos usados na área de saúde, procedimentos, problemas de comunicação, incluindo prescrição, rótulos, embalagens, nomes, preparação, dispensação, distribuição, administração, educação, monitoramento e uso de medicamentos. Para facilitar a adequada identificação e uso dos medicamentos, fabricantes, agências regulatórias, organizações de saúde e especialmente as farmácias devem assegurar que todos os medicamentos tenham rótulos claros, identificações diferenciadas para medicamentos com nomes e pronúncia semelhantes.

A orientação geral para as pessoas é não guardar os seus medicamentos fora das caixas originais. Isso pode gerar confusão. E sempre olhar antes de tomar. Em caso de ingestão de medicamento errado, a recomendação é buscar ajuda em uma Unidade Básica de Saúde.

Matéria publicada no Blog de Humberto Costa, autor do Projeto de Lei,  explica que a medicação passará a ter rotulagem e embalagem “claramente” diferentes em caso de produtos de composição distinta para possibilitar a sua imediata e precisa identificação. “Observamos muitos casos em todo o país em razão de erros na administração de medicamentos. Uma das causas é, justamente, a utilização de rótulos e embalagens iguais ou semelhantes para produtos de composição diferente”, avalia. “É uma lei que vem ajudar os brasileiros nesse sentido.”

As regras da Lei nº 13.236 passam a valer 180 dias após a publicação no Diário Oficial da União.

Medicamentos similares

Também foi publicada no Diário Oficial da União, em 29 de dezembro, a Lei 13.235/2015, que obriga a indústria farmacêutica a verificar a equivalência dos medicamentos similares, fabricados ou não no País, aos de referência. Com isso, medicamentos similares e genéricos deverão passar pelos mesmos controles de qualidade. A lei é resultado do Projeto de Lei do Senado 152/2012, do senador Walter Pinheiro (PT-BA), aprovado na Câmara dos Deputados em dezembro. Ela também atualiza a Lei 6.360/1976, que trata da vigilância sanitária referente a esses produtos. A Lei 13.235 passa a valer em 180 dias da data de publicação.

Fonte: Comunicação do CFF

Foto: Freepik

 



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