0182/2023 - Análise de situações de trabalho na fiscalização sanitária de medicamentos da agência reguladora federal Analysis of work situations in the enforcement of medicines at the federal regulatory agency
Este estudo analisa as situações de trabalho vividas pelos profissionais na fiscalização sanitária de medicamentos da Agência Nacional de Vigilância Sanitária, durante a pandemia de COVID-19. Estudo de caso único, de natureza qualitativa, com abordagem ergológica. Os dados foram produzidos entre 2020 e 2021, por meio de 18 entrevistas e observação participante em três reuniões de trabalho online. As práticas discursivas foram sistematizadas em mapas ergodialógicos, resultando em três categorias: os trabalhos vividos na fiscalização dos medicamentos; as variabilidades do contexto organizacional e as renormalizações frente à pandemia. As fragilidades dos sistemas de informação, o marco regulatório desatualizado, o modelo de atuação, a fragmentação do trabalho, dentre outros, ocasionaram entraves à realização da atividade pelo profissional. A conformação de novo modo de fazer fiscalização envolve a combinação de intervenções direcionadas à prevenção, detecção e resposta ao consumo de medicamentos nocivos à saúde. A transformação necessária ultrapassa a função restrita de controle e punição e se consolida como um novo modelo de atuação proativo e dinâmico, baseado na gestão do risco sanitário e na implantação das Boas Práticas de Fiscalização.
This study analyzes the work situations experienced by professionals in the health enforcement of medicines at the Brazilian Health Regulatory Agency, during the COVID-19 pandemic. Single-case study, qualitative in nature, with an ergological approach. The data were collected during 2020 and 2021. In this period, 18 interviews and 3 online work meetings were made. The discursive practices were systematized in ergodialogical maps, resulting in three categories: the works experienced in the health enforcement of medicines; the variabilities of the organizational context and the renormalizations facing the pandemic. The fragilities of the information systems, the outdated regulatory framework, the performance model, the fragmentation of the work, among others, have caused barriers to the professional’s activity. The conformation of a new way of doing health enforcement of medicines involves the combination of interventions aimed at prevention, detection, and response to the consumption of medicines harmful to health. The necessary transformation goes beyond the restricted function of control and punishment and consolidates itself as a new proactive and dynamic action model, based on health risk management and the implementation of Health Enforcement Good Practices.
Keywords:
Health Supervision; Drug control; COVID 19 Pandemic; Work.
Analysis of work situations in the enforcement of medicines at the federal regulatory agency
Resumo (abstract):
This study analyzes the work situations experienced by professionals in the health enforcement of medicines at the Brazilian Health Regulatory Agency, during the COVID-19 pandemic. Single-case study, qualitative in nature, with an ergological approach. The data were collected during 2020 and 2021. In this period, 18 interviews and 3 online work meetings were made. The discursive practices were systematized in ergodialogical maps, resulting in three categories: the works experienced in the health enforcement of medicines; the variabilities of the organizational context and the renormalizations facing the pandemic. The fragilities of the information systems, the outdated regulatory framework, the performance model, the fragmentation of the work, among others, have caused barriers to the professional’s activity. The conformation of a new way of doing health enforcement of medicines involves the combination of interventions aimed at prevention, detection, and response to the consumption of medicines harmful to health. The necessary transformation goes beyond the restricted function of control and punishment and consolidates itself as a new proactive and dynamic action model, based on health risk management and the implementation of Health Enforcement Good Practices.
Palavras-chave (keywords):
Health Supervision; Drug control; COVID 19 Pandemic; Work.
Martins, M.A.F, Scherer, M.D.A. Análise de situações de trabalho na fiscalização sanitária de medicamentos da agência reguladora federal. Cien Saude Colet [periódico na internet] (2023/Jul). [Citado em 08/10/2024].
Está disponível em: http://cienciaesaudecoletiva.com.br/artigos/analise-de-situacoes-de-trabalho-na-fiscalizacao-sanitaria-de-medicamentos-da-agencia-reguladora-federal/18808?id=18808
