Drug health surveillance in the risk society

Abstract

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.

Análise de situações de trabalho na fiscalização sanitária de medicamentos da agência reguladora federal

“…Entretanto, a fiscalização trabalha num contexto permeado por disputas e interesses, onde é necessário atuar como função do Estado, regulando e disciplinando as relações sociais no ciclo de produção-consumo 5 . Esse ciclo é caracterizado por duas lógicas iterativas: a do mercado globalizado, que busca o lucro e promove o consumo intenso de produtos e tecnologias; e a da sociedade contemporânea, que demanda acesso a esses produtos com qualidade, segurança e eficácia, visando atender às suas necessidades de saúde e bem-estar 5,9,16 .…”

Analysis of work scenarios in the sanitary enforcement of medicines from the federal regulatory agency

“…However, the fiscalization takes place in a context riddled with disputes and interests, so there is a need for acting as a State function, regulating and disciplining social relationships in the production-consumption cycle 5 . This cycle is characterized by two interacting logics: that of the globalized market, which seeks profits and promotes intense consumption of products and technologies; and the logic of contemporary society, which demands access to those products, with quality, safety, and effect, in order to address its needs in terms of health and welfare 5,9,16 .…”