Abstract:Resumo Este artigo tem como objeto a regulamentação adotada pelo Brasil no que tange ao controle sanitário da importação de produtos sob vigilância sanitária. O estudo incorporou os aspectos políticos, técnicos, econômicos e institucionais envolvidos no controle das importações. Destaca-se, ainda, a identificação de atores que se mostraram relevantes na formulação e na implantação das normas. Nesta perspectiva, foi realizado estudo singular do conjunto das normatizações publicadas entre 1996 e 2013 editadas de… Show more
“…The instruments or means of work for the sanitary control of products become social constructions, shaped by inspection actions, but which suffer variations according to political, economic, and social changes in the face of such a globalized world (Delphim;Kornis, 2018;Costa, 2009).…”
Section: The Work Of Drug Health Surveillancementioning
confidence: 99%
“…Brazil, like other developing countries, still imports a large volume of drugs and pharmaceutical ingredients from different regions of the world, which makes the health risk greater and requires the strengthening of the national regulatory system to ensure safety, quality, and effectiveness of the product imported (Delphim;Kornis, 2018). The consumption of substandard, falsified (SF), and non-registered (NR) drugs is a worldwide health problem, causing the following effects: 1) serious health risk, as these products prolong illness and can even lead to death; 2) increased antimicrobial resistance and drug-resistant infections; 3) discredit upon health professionals and health systems; 4) greater distrust in the effectiveness of vaccines and medicines; 5) waste of families' and health systems' resources; 6) increase in the income of offenders and criminals, if "urgent measures are not taken to prevent, detect and respond" to the proliferation of these products around the world (WHO, 2017a(WHO, , 2017b.…”
Drug health surveillance protects the health of the population by preventing substandard, falsified, or unregistered drugs from being consumed and causing harm. This essay discusses drug health surveillance in a context of continuous exposure of individuals to risks that directly interfere with the health-disease process. Based on reflections about health risk and risk society, associated with Canguilhem’s philosophy of life and Schwartz’s ergology, it argues for the need to understand human activity and work to act on risk. Possible challenges for health inspection action include: (1) conceptual review; (2) regulatory updating; (3) development of regulatory mechanisms and tools; and (4) expansion of technical and training capacity. To face them, the involvement and participation of the various actors in cooperation and collaboration spaces, as well as the construction of a permanent forum of discussion or technical/sectorial meetings, is considered promising. Studies that highlight the concrete work of supervision teams and that analyze human activity in the relationship between the prescribed and the real can help to understand the experience of dealing with risk, the adequacy of standards, training needs, among others.
“…The instruments or means of work for the sanitary control of products become social constructions, shaped by inspection actions, but which suffer variations according to political, economic, and social changes in the face of such a globalized world (Delphim;Kornis, 2018;Costa, 2009).…”
Section: The Work Of Drug Health Surveillancementioning
confidence: 99%
“…Brazil, like other developing countries, still imports a large volume of drugs and pharmaceutical ingredients from different regions of the world, which makes the health risk greater and requires the strengthening of the national regulatory system to ensure safety, quality, and effectiveness of the product imported (Delphim;Kornis, 2018). The consumption of substandard, falsified (SF), and non-registered (NR) drugs is a worldwide health problem, causing the following effects: 1) serious health risk, as these products prolong illness and can even lead to death; 2) increased antimicrobial resistance and drug-resistant infections; 3) discredit upon health professionals and health systems; 4) greater distrust in the effectiveness of vaccines and medicines; 5) waste of families' and health systems' resources; 6) increase in the income of offenders and criminals, if "urgent measures are not taken to prevent, detect and respond" to the proliferation of these products around the world (WHO, 2017a(WHO, , 2017b.…”
Drug health surveillance protects the health of the population by preventing substandard, falsified, or unregistered drugs from being consumed and causing harm. This essay discusses drug health surveillance in a context of continuous exposure of individuals to risks that directly interfere with the health-disease process. Based on reflections about health risk and risk society, associated with Canguilhem’s philosophy of life and Schwartz’s ergology, it argues for the need to understand human activity and work to act on risk. Possible challenges for health inspection action include: (1) conceptual review; (2) regulatory updating; (3) development of regulatory mechanisms and tools; and (4) expansion of technical and training capacity. To face them, the involvement and participation of the various actors in cooperation and collaboration spaces, as well as the construction of a permanent forum of discussion or technical/sectorial meetings, is considered promising. Studies that highlight the concrete work of supervision teams and that analyze human activity in the relationship between the prescribed and the real can help to understand the experience of dealing with risk, the adequacy of standards, training needs, among others.
“…Os instrumentos ou meios de trabalho para o controle sanitário de produtos tornam-se construções sociais, moldados pelas ações de fiscalização, mas que sofrem variações de acordo com as mudanças políticas, econômicas e sociais diante de um mundo tão globalizado (Delphim;Kornis, 2018;Costa, 2009).…”
Section: O Trabalho De Fiscalização Sanitária De Medicamentosunclassified
“…O Brasil, assim como outros países em desenvolvimento, ainda importa um grande volume de medicamentos e insumos farmacêuticos, procedentes das diversas regiões do mundo, o que possibilita a ampliação do risco sanitário e exige o fortalecimento do sistema regulatório nacional para garantia da segurança, qualidade e eficácia do produto importado (Delphim;Kornis, 2018).…”
Resumo A fiscalização sanitária busca proteger a saúde da população impedindo que medicamentos fora do padrão, falsificados ou não registrados sejam consumidos e causem danos à saúde. Este ensaio objetiva contribuir para o debate acerca da fiscalização sanitária de medicamentos, num contexto de exposição contínua dos indivíduos a riscos que interferem no processo saúde-doença. Baseado nas reflexões sobre o risco sanitário e a sociedade de risco, associado à filosofia da vida de Canguilhem e à ergologia de Schwartz, discorre sobre a necessidade de se compreender a atividade humana e o trabalho para agir sobre o risco. Foram identificados possíveis desafios para a ação da fiscalização sanitária: (1) revisão conceitual; (2) atualização normativa; (3) desenvolvimento de mecanismos e ferramentas regulatórias; e (4) ampliação da capacidade técnica - formativa. Para enfrentá-los, considera-se um caminho promissor o envolvimento e a participação dos diversos atores nos espaços de cooperação e colaboração, bem como a construção de fórum permanente de debates ou de câmeras técnicas/setoriais. Estudos que dão visibilidade ao trabalho concreto das equipes de fiscalização sanitária e que analisam a atividade humana na relação entre o prescrito e o real podem ajudar a compreender a experiência de lidar com o risco, a adequação das normas, as necessidades de formação, entre outros.
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