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Labeling na gravidez, no aleitamento, e na idade fértil : comparação entre EMA, FDA e ANVISA
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Resumo(s)
A ausência de informações de segurança e eficácia do uso de medicamentos em
mulheres grávidas, em fase de aleitamento e em idade fértil, assim como as questões
éticas envolvidas, representam um conjunto de características de alto impacto e com
grandes riscos relacionados à saúde pública.
A existência de diferentes regras, nas diversas agências reguladoras, de disposição das
informações de uso de medicamentos nestas populações, assim como a ausência de
registo do uso de medicamentos considerados off-label, gera diferentes interpretações
e comportamentos dos profissionais de saúde e dos doentes.
Depois de mais de 30 anos de um sistema consolidado de classificação de riscos, a
Food and Drug Administration (FDA) publicou, em 2014, novas regras, dispostas no
documento Pregnancy and Lactation Labeling Rule (PLLR), com alterações
significativas na apresentação das informações de uso do medicamento nesta
população.
O objetivo principal trabalho estudo reside na comparação das exigências das
legislações das agências reguladoras dos EUA, da União Europeia e do Brasil, no que
se refere às informações de uso de medicamentos neste público, disponíveis no
Resumo das Características do Medicamento (RCM), que é base para elaboração dos
demais documentos de informação do medicamento.
A assertividade demonstrada nos RCMs americanos que já cumprem com o PLLR
transmitem certa ausência de informação nos RCMs da Europa e do Brasil, porém,
ainda é cedo para discutir sobre os impactos reais do PLLR na rotina da população
america.
A velocidade com que as informações e a tecnologia tem avançado, assim como os
acordos entre as diferentes agências reguladoras de medicamentos, tendem a provocar
uma aceleração no que se refere à harmonização. Este facto exige cada vez mais de
agentes reguladores, regulados, e profissionais de saúde em geral.
O surgimento de novas ações por parte de todos, entretanto, envolve custos, e gera a
necessidade de políticas de incentivo às companhias farmacêuticas, como o
desenvolvimento de novos Registos de Exposição na Gravidez (REG), e a contínua
avaliação dos resultados destes.
The absence of safety and efficacy information on the use of medicines in pregnancy, lactation and childbearing age, as well as the ethical issues involved, represent a set of high-impact characteristics with high risks related to public health. The existence of different rules in the various regulatory agencies for the provision of information on the use of medicines in these populations, as well as the absence of registration of use of off-label drugs, generate different interpretations and behaviors of health professionals and patients. After more than 30 years of a consolidated system of risk classification, the US Food and Drug Administration (FDA) published, in 2014, new rules, laid out in the document Pregnancy and Lactation Labeling Rule (PLLR), with significant changes in the information of drug use displayed for this population. The main objective of this study is to compare the legal requirements of the United States of America (USA), European Union (EU) and Brazil’s regulatory agencies, regarding information on the use of medicines for this population available in the Summary of Product Characteristics (SPC), which works as basis for preparation of the other information documents of the medicinal products. The assertiveness manifested in the American SPCs that already comply with the PLLR, demonstrates some lack of information in the SPCs from EU and Brazil, but it is still early to conclude about the real impacts of the PLLR in the rotine. The speed with which information and technology has advanced, as well as the agreements between the different medicine’s regulatory agencies, tend to accelerate harmonization, requiring more and more from regulatory and regulated agents, and health professionals in general. The emergence of new actions by all, however, involves costs, and generates the need to implement urgent policies to encourage pharmaceutical companies, as the development of new Pregnancy Registries, and their continuous evaluation.
The absence of safety and efficacy information on the use of medicines in pregnancy, lactation and childbearing age, as well as the ethical issues involved, represent a set of high-impact characteristics with high risks related to public health. The existence of different rules in the various regulatory agencies for the provision of information on the use of medicines in these populations, as well as the absence of registration of use of off-label drugs, generate different interpretations and behaviors of health professionals and patients. After more than 30 years of a consolidated system of risk classification, the US Food and Drug Administration (FDA) published, in 2014, new rules, laid out in the document Pregnancy and Lactation Labeling Rule (PLLR), with significant changes in the information of drug use displayed for this population. The main objective of this study is to compare the legal requirements of the United States of America (USA), European Union (EU) and Brazil’s regulatory agencies, regarding information on the use of medicines for this population available in the Summary of Product Characteristics (SPC), which works as basis for preparation of the other information documents of the medicinal products. The assertiveness manifested in the American SPCs that already comply with the PLLR, demonstrates some lack of information in the SPCs from EU and Brazil, but it is still early to conclude about the real impacts of the PLLR in the rotine. The speed with which information and technology has advanced, as well as the agreements between the different medicine’s regulatory agencies, tend to accelerate harmonization, requiring more and more from regulatory and regulated agents, and health professionals in general. The emergence of new actions by all, however, involves costs, and generates the need to implement urgent policies to encourage pharmaceutical companies, as the development of new Pregnancy Registries, and their continuous evaluation.
Descrição
Tese de mestrado, Regulação e Avaliação do Medicamento e Produtos de Saúde, 2019, Universidade de Lisboa, Faculdade de Farmácia.
Palavras-chave
Labeling Resumo das características do medicamento Regulamentação Gravidez Avaliação do risco Teses de mestrado - 2019