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

Abstract

Abstract This study analyzes the work situations experienced by professionals in the sanitary fiscalization of medicines at the Brazilian Health Regulatory Agency, during the COVID-19 pandemic. This is a single-case study, qualitative in nature, with an ergological approach. The data were collected from 2020 to 2021. During this period, 18 interviews and 3 online work meetings were conducted. The discursive practices were systematized in ergodialogical maps, resulting in three categories: the works experienced in the sanitary 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 The fragilities of the information systems, the outdated regulatory framework, the performance model, the fragmentation of the work, among others, have caused barriers to the professional’s activity.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 performing the sanitary fiscalization of medicines involves the combination of interventions aimed at prevention, detection, and response to the consumption of medicines that are 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 Good Fiscalization Practices.