Biovigilância: estudo de sistemas de notificação e caracterização dos eventos adversos notificados no estado de São Paulo – Brasil

• Autor(a) principal: Paim, Sibele Maria Schuantes [UNIFESP]
• Data de Publicação: 2022
• Tipo de documento: Dissertação
• Idioma: por
• Título da fonte: Repositório Institucional da UNIFESP
• Texto Completo: https://hdl.handle.net/11600/64058
• topic: Biovigilância; Sistema de notificação de incidentes; Eventos adversos; Transplante; Obtenção de Tecidos e Órgãos; Transplante de Células-Tronco Hematopoéticas; Segurança do Paciente; Enfermagem

Objective: To identify adverse event reporting systems in cell, organ and tissue donation and transplantation and to characterize adverse events in biovigilance reported in the state of São Paulo. Methods: To achieve the objective, the research was carried out in two phases. The first is a scoping review performed using the Joanna Briggs Institute method. The research question was elaborated according to population, concept, and context strategy. The search strategies were established in three phases with the supervision of a librarian and was carried out in Pubmed, CINAHL, Embase, LILACS databases. The gray literature searches were carried out in Google Scholar, government, and donation and transplant associations websites. Data collection was carried out by two researchers independently. The review protocol was registered. The second phase of the research was a descriptive study with a quantitative approach. The data collected were the adverse events reported on the FormSUS virtual platform between 2016 and 2019 provided by the State Transplant Center of São Paulo. These data were categorized according to the nomenclature recommended by the World Health Organization regarding nature and type of event, severity, and imputability. Data analyses were performed using descriptive statistics with absolute and relative frequencies. Results: Two scientific manuscripts were written. In the first scientific manuscript, 24 materials were selected, 15 scientific articles and nine from gray literature. It was possible to compare the adverse event notification systems of 11 countries, as well as the concepts used in biovigilance by countries and by the scientific literature. The second manuscript analyzed 52 reports of adverse events, of which 90.4% related to the recipient, 78.8% from allogeneic procedures, 48.2% related to organs and 44.2% to hematopoietic stem cells. Most notifications were related to infections (55.7%), followed by other causes (30.8%) and neoplasms (13.5%). Most of the events were considered moderate (44.3%) and 36.5% of them as confirmed. Conclusions: The research reached the proposed objective since the scoping review demonstrated the relevance of notification systems as strategies to promote safety and quality and presented fundamental characteristics that can support the development of new systems and the improvement in the way of identifying, notifying, and evaluating adverse events in this scenario. Regarding the concepts, standardization is important to enable the development of coping strategies, decision-making and convergent research that ensure safety and quality in donations and transplants. The quantitative study can support the development of security strategies and institutional and governmental training to prevent the recurrence of reported events, as well as mitigate incidents and encourage notification. Especially focused on infections, the biggest cause of adverse events in the years under study. It is important to encourage educational activities and discussions on the subject since it is only possible to establish safety and biovigilance strategies based on the recognition of the health reality.