Trabalho em vigilância sanitária: o controle sanitário da produção de medicamentos no Brasil. / The work in sanitary surveillance: the sanitary control of production of medicines in Brazil.

AUTOR(ES)
DATA DE PUBLICAÇÃO

2008

RESUMO

The work analysis in sanitary surveillance was performed due to the need of research in this field. The work in sanitary surveillance was conceived as a social practice identified in the collective practices which are developed by the State for the mediation of the social relationship production-consumption having the protection of collective health as its main objective. By means of the sanitary surveillance, the State mediates the relationship between business and market, deciding on the access of medicine in the pharmaceutical market and, for that, it uses its tools of sanitary control. The objectives of this study were to analyze how the work in sanitary surveillance is performed by using the tools the State has in order to exert the sanitary control over the medicine manufacturing through their agents, means used to perform the work and its object. Besides, this study aims to identify and analyze limits, difficulties as well as possibilities concerning the performance of sanitary control as far as medicine manufacturing is concerned. The strategy set for this research was qualitative; it was characterized as an exploratory study case with three levels of imbricate analysis. The first level of analysis had medicine as the goal of sanitary surveillance; the second level considered the tools used when performing the sanitary control; the third level of analysis was focused both on the work organization and management of sanitary surveillance. Direct observation, semi-structured interviews and the documental analysis were used as techniques for data collection. These data were ordered and classified in a matrix of data made from the theoretical system of references of the work process, unfolded in both analytical and operational categories. This study made possible to identify the interdependence and the intercomplementarity of the work stages for the sanitary control of medicine production which is determined by social division and work technique in the medicine productive chain which requires a systemic organization form the work done in sanitary surveillance. However, for the achievement of the tools of sanitary control over medicine production, the work organization presented not only a fragmented structure but also a fragile articulation among the process of the work and the lack of integration among them as well. The practice of sanitary inspection and its products reports and formal written opinions are the elements that make the connection between the controlling tools and the empiric check of the risk factors; also practice establishes the complementarity of the action between the levels of the National Sanitary Surveillance System. The study also reveals the difficulties faced for performing the medicine sanitary control since there is both scientific and technological dependence, not to mention the little expertise in the area, that is, in the regulatory agency. Concerning the organization and work management of sanitary surveillance, there are problems such as: highly poor level of work relations in the SNVS, a nonexistent policy to overcome this problem and also a disconnection from the work management of the regulatory agency to the other levels of SNVS.

ASSUNTO(S)

vigilância sanitária saude publica tools for sanitary control pharmaceutical manufactories medicines sanitary surveillance instrumentos de controle sanitário medicamento indústria farmacêutica trabalho process of work

ACESSO AO ARTIGO

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