Avaliação da comercialização de produto fitoterápico em sítios eletrônicos: aspectos regulatórios e analíticos
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Data
2021-01-18
Autores
Fabbri, Henrique Faggion [UNIFESP]
Orientadores
Calixto, Leandro Augusto [UNIFESP]
Tipo
Trabalho de conclusão de curso de graduação
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Resumo
A falsificação de medicamentos no Brasil é um tema que vem ganhando mais relevância, devido à expansão do número de incidentes reportados e seus efeitos prejudiciais para a população. Dependendo da agência regulatória, diferentes termos são utilizados para se referir a produtos que mimetizam outros, ou que não apresentem princípios ativos e demais componentes na quantidade adequada. Diferentes categorias de medicamento podem ser afetadas, inclusive os medicamentos fitoterápicos. O presente trabalho, avaliou a comercialização do produto “Saúde Total”, em relação aos requisitos regulatórios e de qualidade, utilizando metodologias compendiais. O produto é anunciado como natural e com propriedades terapêuticas, sendo comercializado livremente através de diversos sites de vendas. Procurou-se elucidar e comparar as definições dos termos “Falsificação”, ”Adulteração” e “Contrafacção”, utilizadas pelas autoridades regulatórias europeia (EMA), estadunidense (FDA) e brasileira (Anvisa) assim como da Organização Mundial da Saúde (OMS). O produto foi analisado em relação às legislações vigentes, suas indicações e possíveis componentes, além dos riscos de sua utilização. Para verificar o status regulatório do produto, foi conduzida uma busca no site da Anvisa, pelo número do registro informado em seu rótulo, nome do produto e princípio ativo. Foram pesquisados anúncios em sites de venda, analisando as informações do anúncio, como a composição, indicações, número de registro na Anvisa e itens presentes no rótulo. Procurou-se em um jornal eletrônico, notícias sobre o produto. Algumas amostras do produto foram adquiridas em diferentes anos, para avaliar se havia uniformidade entre as amostras. Estas foram submetidas à análise macroscópica e comparadas com as monografias de plantas que supostamente compõe o produto. Adicionalmente, conduziu-se uma revisão bibliográfica, acerca das técnicas analíticas que podem ser utilizadas para detectar adulterações, falsificações e contrafacções em medicamentos fitoterápicos. As diferentes definições das agências regulatórias foram discutidas e elucidadas. A pesquisa no site da Anvisa revelou que o produto não apresenta registro perante à agência e que já teve a publicidade e comercialização proibida por diversas vezes. Os anúncios do produto possuem muitas variações, nos elementos do rótulo e apresentação, número de registro e indicações. A análise macroscópica apontou que há certa similaridade com a descrição das monografias das possíveis drogas vegetais componentes do produto, entretanto a granulometria indicou grande variação nas frações do produto. As amostras possuem pesos médios distintos, sendo classificadas em diferentes categorias. A pesquisa bibliográfica ilustrou diversas técnicas analíticas capazes de identificar adulterações, falsificações e contrafacções. O produto analisado é anunciado com propriedades terapêuticas, entretanto não cumpre as exigências legais necessárias, como registro sanitário ou garantia de qualidade, exigidos para a comercialização de medicamentos fitoterápicos.
The falsification of medicines in Brazil is an issue that is gaining more relevance due to the expansion of the number of reported incidents and their harmful effects on the population. Depending on the regulatory agency, different terms are used to refer to products that mimic others, or that do not present active principles and other components in the appropriate amount. Different drug categories may be affected, including herbal medicines. The present work evaluated the commercialization of the product "Saúde Total", in relation to the regulatory and quality requirements, using compendiate methodologies. The product is advertised as natural and with therapeutic properties, being commercialized freely through several sales sites. We tried to elucidate and compare the definitions of the terms "Falsification", "Adulteration" and "Counterfeiting", used by European (EMA), American (FDA) and Brazilian (Anvisa) regulatory authorities, as well as the World Health Organization (WHO). The product was analyzed in relation to the current legislation, its indications and possible components, besides the risks of its use. To check the regulatory status of the product, a search was conducted on the site of Anvisa, by the registration number informed on its label, product name and active ingredient. It was researched advertisements in sale sites, analyzing the information of the advertisement, such as the composition, indications, registration number at Anvisa and items present on the label. It was searched in an electronic newspaper, news about the product. Some samples of the product were acquired in different years, to evaluate if there was uniformity between the samples. These were submitted to macroscopic analysis and compared with the plant monographs that supposedly compose the product. A bibliographic review was conducted on the analytical techniques that can be used to detect adulterations, falsifications and counterfeits in herbal medicines. The different definitions of regulatory agencies were discussed and elucidated. The research on the Anvisa website revealed that the product is not registered with the agency and that it has already been banned from advertising and marketing several times. The product's announces have many variations, on the elements of label and presentation, registration number and indications. The macroscopic analysis has pointed out that there is certain similarity with the monographs description of possible plant drugs components of the product, however the granulometry indicated great variation on the product fractions. The samples have different average weights, being classified into different categories. The bibliographical research illustrated several analytical techniques capable of identifying adulterations, falsifications and counterfeits. The analyzed product is advertised with therapeutic properties, however it does not meet the necessary legal requirements, such as sanitary registration or quality assurance, required for the marketing of herbal medicines.
The falsification of medicines in Brazil is an issue that is gaining more relevance due to the expansion of the number of reported incidents and their harmful effects on the population. Depending on the regulatory agency, different terms are used to refer to products that mimic others, or that do not present active principles and other components in the appropriate amount. Different drug categories may be affected, including herbal medicines. The present work evaluated the commercialization of the product "Saúde Total", in relation to the regulatory and quality requirements, using compendiate methodologies. The product is advertised as natural and with therapeutic properties, being commercialized freely through several sales sites. We tried to elucidate and compare the definitions of the terms "Falsification", "Adulteration" and "Counterfeiting", used by European (EMA), American (FDA) and Brazilian (Anvisa) regulatory authorities, as well as the World Health Organization (WHO). The product was analyzed in relation to the current legislation, its indications and possible components, besides the risks of its use. To check the regulatory status of the product, a search was conducted on the site of Anvisa, by the registration number informed on its label, product name and active ingredient. It was researched advertisements in sale sites, analyzing the information of the advertisement, such as the composition, indications, registration number at Anvisa and items present on the label. It was searched in an electronic newspaper, news about the product. Some samples of the product were acquired in different years, to evaluate if there was uniformity between the samples. These were submitted to macroscopic analysis and compared with the plant monographs that supposedly compose the product. A bibliographic review was conducted on the analytical techniques that can be used to detect adulterations, falsifications and counterfeits in herbal medicines. The different definitions of regulatory agencies were discussed and elucidated. The research on the Anvisa website revealed that the product is not registered with the agency and that it has already been banned from advertising and marketing several times. The product's announces have many variations, on the elements of label and presentation, registration number and indications. The macroscopic analysis has pointed out that there is certain similarity with the monographs description of possible plant drugs components of the product, however the granulometry indicated great variation on the product fractions. The samples have different average weights, being classified into different categories. The bibliographical research illustrated several analytical techniques capable of identifying adulterations, falsifications and counterfeits. The analyzed product is advertised with therapeutic properties, however it does not meet the necessary legal requirements, such as sanitary registration or quality assurance, required for the marketing of herbal medicines.