Nova Resolução da Anvisa determina que mais nove antibióticos passem a ter retenção de receita a partir do dia 16 de dezembro

anvisa

A Anvisa publicou, nesta segunda (1/12), a atualização da Lista de antimicrobianos de uso sob prescrição médica com retenção de receita. As novas substâncias incluídas na lista são: Besifloxacino, Rifabutina, Ceftarolina fosamila, Dactinomicina, Mitomicina, Nitrofural, Sulfacetamida Clorfenesina e Gramicidina.

A nova determinação consta da RDC 68/2014, que entra em vigor a partir do próximo dia 16 de dezembro de 2014. Com isso, a lista de antimicrobianos sujeitos à retenção de receita chega a 128 substâncias. As drogarias e farmácias privadas passarão a reter a 2ª via da receita de medicamentos à base das substâncias inseridas e escriturar no SNGPC (Sistema Nacional de Gerenciamento de Produtos Controlados).

O sistema funciona de forma eletrônica e permite à Anvisa e às vigilâncias sanitárias acompanhar e fiscalizar a venda destes produtos em todo o país. O objetivo da norma é reduzir os danos por conta do uso indevido ou sem orientação médica de antibióticos. O uso incorreto destes produtos leva ao aumento da resistência microbiana e, a médio prazo, torna os produtos menos efetivos, tornando mais difícil o tratamento de determinadas doenças.

Farmácias e Drogarias

Os estabelecimentos farmacêuticos devem estar atentos à entrada em vigor da norma. Os primeiros arquivos enviados ao SNGPC devem conter dados de movimentação destas substâncias e dos medicamentos que as contenham relativos a todas as movimentações realizadas a partir da 00h do dia 16/12/2014 em diante, respeitando o intervalo máximo de transmissão, que pode ser de até 7 dias.

A entrada desses medicamentos no sistema deve ser realizada normalmente, como a dos outros antimicrobianos presentes na lista. Para isso, é necessário que essa atualização seja comunicada ao suporte do sistema informatizado de cada estabelecimento para as adequações necessárias.

Orientação aos Prescritores

A prescrição de antibióticos deverá ser realizada em receituário privativo do prescritor (médico, odontólogo ou veterinário) ou do estabelecimento de saúde, não havendo, portanto, um modelo de receita específico. A receita deve ser prescrita de forma legível, sem rasuras, em 2 (duas) vias e contendo os seguintes dados obrigatórios:

I – identificação do paciente: nome completo, idade e sexo;
II – nome do medicamento ou da substância prescrita sob a forma de Denominação Comum Brasileira (DCB), dose ou concentração, forma farmacêutica, posologia e quantidade (em algarismos arábicos ); III – identificação do emitente: nome do profissional com sua inscrição no Conselho Regional ou nome da instituição, endereço completo, telefone, assinatura e marcação gráfica (carimbo);
IV – data da emissão.

Todos estes dados devem ser preenchidos pelo profissional. Entretanto, nos casos em que a receita não contenha os dados de idade e sexo do paciente, estes poderão ser preenchidos pelo farmacêutico responsável pela dispensação.

Segundo o Art. 5º da RDC nº 20/2011, a prescrição deve apresentar a identificação do emitente (prescritor): identificação do emitente: nome do profissional com sua inscrição no Conselho Regional ou nome da instituição, endereço completo, telefone, assinatura e marcação gráfica (carimbo).

Não é necessário constar, obrigatoriamente, o endereço completo e telefone da instituição, uma vez que nem sempre o prescritor está vinculado a uma instituição.

A prescrição deve identificar quem é o responsável por ela, com seu nome, assinatura e informação do número de inscrição no seu respectivo Conselho Regional, sendo que estes dados não precisam ser apostos na receita na forma de carimbo, ou seja, podem ser dados já presentes em papel timbrado.

Confira a resolução RDC 68/2014, clicando aqui!

Fonte: Assessoria de Imprensa da Anvisa



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