Martins, Rand RandallOliveira, Lucas Vinicius Silva de2022-12-132022-12-132022-11-25OLIVEIRA, Lucas Vinicius Silva de. Avaliação de causalidade de reações adversas a medicamentos suspeitas em neonatos: comparação do desempenho de dois instrumentos. 2022. 32 f. Trabalho de Conclusão de Curso (graduação) - Departamento de Farmácia, Centro de Ciências da Saúde, Universidade Federal do Rio Grande do Norte, Natal, RN, 2022.https://repositorio.ufrn.br/handle/123456789/50111Introduction: In the face of the vulnerability of neonates regarding the occurrence of Adverse Drug Reactions (ADRs), tools for determining the causality of ADRs are essential for the practice of clinical pharmacy. Objective: To compare the Du and Naranjo algorithms in determining the causality of ADRs in neonates by analyzing inter-rater and inter-instrument reliability. Methods: Approved by the Ethics and Research Committee of the Onofre Lopes University Hospital under nº 2,591,495/2018, this observational and prospective study was developed in neonates admitted under intensive therapy in a maternity hospital in Natal/Brazil between January 2019 and December 2020. The causality algorithms Naranjo et al. and Du et al. were applied by three independent clinical pharmacists in the collected cases of suspected ADRs. The performance of these tools among themselves and the evaluators was measured by Cohen's Kappa (k). Results: We evaluated 79 suspected cases of ADRs that were observed in 57 neonates, especially females (30; 56.6%). Du proved to be more effective as it obtained a higher proportion of probable (10.1 – 27.9%) and defined ADRs (53.2 – 79.8%). On the other hand, less reproducible (global k = 0.108; 95%CI 0.064 – 0.149) when compared to Naranjo (global k = 0.402; 95%CI 0.379 – 0.429). There was no agreement between the methods (global k = -0.031; 95%CI -0.049 – 0.065). Conclusion: The tools are not equivalent in terms of causality assessment, however, the Du algorithm is more suitable for the context of neonatal intensive care.Attribution-NonCommercial-NoDerivs 3.0 Brazilhttp://creativecommons.org/licenses/by-nc-nd/3.0/br/Recém-nascidoPrematuridadeReação Adversa a MedicamentosTerapia Intensiva NeonatalFarmacovigilânciaAvaliação da causalidade de reações adversas a medicamentos suspeitas em neonatos: comparação do desempenho de dois instrumentosCausality assessment of suspected adverse drug reactions in neonates: comparing the performance of two instrumentsbachelorThesisCNPQ::CIENCIAS DA SAUDE::FARMACIA