0040/2015 - Planos de minimização de riscos em farmacovigilância: uma ação de saúde pública para promoção da segurança de medicamentos Risk evaluation mitigation plans: an action in public health to promove medication safety
• Stephanie Ferreira Botelho - Botelho, Stephanie Ferreira - Universidade Federal de Minas Gerais, Faculdade de Farmácia, Programa de Pós Graduação em Medicamentos e Assistência Farmacêutica - <sf.botelho@hotmail.com> +
O plano de minimização de risco (PMR) é uma estratégia inovadora e importante para monitorar o risco sanitário de medicamentos. O estudo visou a identificar os planos de minimização de risco (PMR) de medicamentos registrados na Food and Drug Administration (FDA) e as ações de minimização de riscos instituídas no Brasil pela Agência Nacional de Vigilância Sanitária (ANVISA) e pelos fabricantes desses medicamentos. Estudo descritivo, de natureza quantitativa, com inquérito a indústrias farmacêuticas, pesquisa em sites e bases de dados da ANVISA, FDA e indústrias farmacêuticas. Identificaram-se 40 medicamentos com PMR na FDA e cadastrados no site da ANVISA. Apenas quatro (10,0%) laboratórios informaram desenvolver PMR no Brasil. No site da ANVISA identificaram-se informações de segurança para 15 dos medicamentos (37,5%) com PMR no FDA. Em 91,4% das bulas brasileiras constavam informações de segurança equivalentes às ações de promoção do uso seguro descritas nos PMR disponíveis no site da FDA. As ações de comunicação sobre segurança e risco sanitário de medicamentos precisam ser ampliadas pela ANVISA. O PMR é uma estratégia importante em saúde pública no gerenciamento de novos riscos, no acompanhamento de riscos conhecidos e para a promoção do uso seguro dos medicamentos.
The risk evaluations and mitigation plan (REMP) is an innovative and important strategy to monitor the sanitary risk of medicines. The study of the study was to identify risk minimization plans (PMR) of drugs registered in the Food and Drug Administration (FDA) and the actions to minimize risks established in Brazil by ANVISA and the manufacturers of these drugs The study is quantitative and descriptive including survey to pharmaceutical industries, research in sites of pharmaceutical industries and databases of the Brazilian Health Surveillance Agency and FDA. 0. Forty drugs with REMP in FDA was also registered in Brazilian Health Surveillance Agency. Only 4 (10.0%) industries reported REMP developed in Brazil. In the site of Brazilian National Health Surveillance Agency was identified safety information for 15 drugs (37.5%). In 91.4% of Brazilian package REPLACEs have safety information equivalent to actions to promote safety use described in REMP available on the FDA website. The communication actions on drug safety and sanitary risk of drugs needs to be expanded by ANVISA. The REMP is an important strategy in public healthy for managing new risks from post-marketing, to surveillance of known risks and especially to promote the safe use of medicines.
Risk evaluation mitigation plans: an action in public health to promove medication safety
Resumo (abstract):
The risk evaluations and mitigation plan (REMP) is an innovative and important strategy to monitor the sanitary risk of medicines. The study of the study was to identify risk minimization plans (PMR) of drugs registered in the Food and Drug Administration (FDA) and the actions to minimize risks established in Brazil by ANVISA and the manufacturers of these drugs The study is quantitative and descriptive including survey to pharmaceutical industries, research in sites of pharmaceutical industries and databases of the Brazilian Health Surveillance Agency and FDA. 0. Forty drugs with REMP in FDA was also registered in Brazilian Health Surveillance Agency. Only 4 (10.0%) industries reported REMP developed in Brazil. In the site of Brazilian National Health Surveillance Agency was identified safety information for 15 drugs (37.5%). In 91.4% of Brazilian package REPLACEs have safety information equivalent to actions to promote safety use described in REMP available on the FDA website. The communication actions on drug safety and sanitary risk of drugs needs to be expanded by ANVISA. The REMP is an important strategy in public healthy for managing new risks from post-marketing, to surveillance of known risks and especially to promote the safe use of medicines.
Botelho, Stephanie Ferreira, Reis, A.M.M. Planos de minimização de riscos em farmacovigilância: uma ação de saúde pública para promoção da segurança de medicamentos. Cien Saude Colet [periódico na internet] (2015/abr). [Citado em 23/12/2024].
Está disponível em: http://cienciaesaudecoletiva.com.br/artigos/planos-de-minimizacao-de-riscos-em-farmacovigilancia-uma-acao-de-saude-publica-para-promocao-da-seguranca-de-medicamentos/15105?id=15105
