Banca de DEFESA: Mary Anne Fontenele Martins

Uma banca de DEFESA de DOUTORADO foi cadastrada pelo programa.
STUDENT : Mary Anne Fontenele Martins
DATE: 07/07/2022
TIME: 14:30
LOCAL: https://conferenciaweb.rnp.br/events/defesa-de-mary-anne-fontenele-martins
TITLE:

The drug health survellance process in the federal regulatory authorlty

KEY WORDS:

Post marketing Drug Surveillance - National Health Surveillance Agency - Working Conditions - Health Surveillance - Work.

PAGES: 100
BIG AREA: Ciências da Saúde
AREA: Saúde Coletiva
SUMMARY:

Introduction: The consumption of substandard, unregistered, contaminated, or falsified medicines presents a potential risk of causing damage to health, and being a complex problem, with multiple dimensions, that affects public health worldwide. The enforcement's actives are intrinsic to health surveillance, representative of the Democratic State in protecting the health of the population. Its purpose is to identify and investigate sanitary infractions; apply sanctions and determine the withdrawal from the market of medicines that are irregular, ineffective, or harmful to human health. The research problem was based on the assumption that the market medicines´ control and surveillance have limitations that restrict the fulfillment of its purpose, essential the involvement of the worker to show what changes are necessary for the inspection work. Objective: To understand the dynamics of the health inspection process of medicines at the federal level. Methodology: This is a single case study, with a qualitative and comprehensive approach, based on the theoretical framework of ergology and the collective discursive practices of professionals regarding the work process. The ergology framework enabled the production of knowledge about the relationship between knowledge and the experience of those who experience real situations of inspection and are always in debates on norms and values, having to make decisions, make choices, and manage the variabilities of the environment, in renormalization processes. Data production was carried out from July 2020 to September 2021, through documentary research, participant observation, and semi-structured interview. The drug inspection process carried out by Anvisa was considered the unit of analysis and the participants were career professionals from the agency who work or have worked in drug inspection, for two years or more of experience in the activity. For the organization and analysis of the data, the Atlas.Ti 9.1® application was used and the conception of the ergodialogical maps was developed. The research was approved by the Ethics Committee in Research with Human Beings of FS/UnB. Results and discussion: The results confirmed the assumptions of the thesis, where the context of the covid-19 pandemic, the outdated regulatory framework, the operating model, the fragmentation of the work process, and its conditions lead to obstacles to the performance of the activity by the professional of the Anvisa. Although the work process is organized, structured, and standardized, the inspection logic is still legalistic, bureaucratic, and disciplinary, framed in the passive-reactive model of action. It was highlighted how outdated the regulatory framework is and does not correspond to the regulatory context required by society, becoming, in some cases, a barrier to the decision-making process at Anvisa. Regarding working conditions, the weaknesses of information systems and the scarcity of advanced technological resources predominated, which prevent greater rationality and agility in the process. The Logical Model built proved to be promising for reviewing the inspection, being able to drive changes, supporting professionals in the planning, structuring, execution, and evaluation of the process, as well as enabling the construction of indicators for objective measurement of results. In 15 months of the pandemic, there was an increase in e-commerce and irregular advertising of slimming, anabolic steroids, baldness treatment, sexual stimulants, products "so-called natural" or with MTC claims, among others, usually related to body image or the health and well-being experience. A large part of unregistered drugs continued to circulate on the internet, even after a decision by the federal government forbidding and determining their seizure and destruction. The work of professionals acquires a sense of “work´s repetitive” due to the volume of demands and the few effects of inspection in the virtual drug market. The study showed the dramatic experiences experienced by workers
when managing their work, the uses of themselves in search of achieving goals, amid changes in the work environment, accelerated due to the covid-19 pandemic. Final Considerations: The creation of a new way of doing inspection involves a combination of interventions, aimed at preventing, detecting, and responding to irregularities and illegal drug practices. Seek transformation from real work, going beyond the restricted function of control and punishment, to build a model (or several models) of proactive action, based on health risk management, with the development of new practices and new knowledge adaptable to various situations. Changes in the inspection of medicines necessarily pass through the worker and imply agility, proactivity, flexibility, justice, integration, and rationality, which can be expressed in the diversity of types of health surveillance work, such as “educational work; “work based on risk management”; “proactive work” and “effective work”.

BANKING MEMBERS:
Presidente - 514.220.779-34 - MAGDA DUARTE DOS ANJOS SCHERER - NÃO INFORMADO
Externa à Instituição - GISÉLIA SANTANA SOUZA - UFBA
Externa à Instituição - MARIA CELIA DELDUQUE NOGUEIRA PIRES DE SA
Externa à Instituição - MONICA VIEIRA - Fiocruz
Externo à Instituição - NILIA MARIA DE BRITO LIMA PRADO - UFBA