0193/2019 - Formulários de notificação de reações adversas a medicamento nos sistemas de farmacovigilância do Brasil e outros doze países latino-americanos: Análise comparativa. Adverse Drug Reactions Notification Forms of the Pharmacovigilance Systems in Brazil and Twelve Other Latin-American Countries: A Comparative Analysis.
Avaliou-se os formulários de notificação de suspeitas de reações adversas a medicamentos (RAM) do sistema de farmacovigilância do Brasil e outros doze países latinoamericanos. O estudo foi composto por três etapas. Na primeira, os formulários foram pontuados em relação à presença de itens essenciais para compor uma notificação de RAM. Na segunda, as variáveis dos formulários foram quantificadas e classificadas, quanto à razoabilidade em contribuírem para a avaliação de causalidade. Na última etapa, recorreu-se à análise de agrupamento hierárquico para identificar os formulários similares. O formulário da Venezuela obteve a maior pontuação (18 pontos). A mediana das variáveis nos formulários dos países foi de 41 [26 (Guatemala) a 95 (Brasil)]. A maioria das variáveis dos formulários foram classificadas como vitais e a maior parte contribui como fator de explicação alternativo para a avaliação de causalidade. Quatro agrupamentos foram identificados (1, 2, 3 e 4). Os formulários do Brasil e da Bolívia formaram dois grupos distintos, 1 e 3 respectivamente. Há necessidade de modificação dos formulários dos países ou até mesmo exclusão de variáveis, tornando-os mais adequados ao processo de avaliação da causalidade das RAM.
Palavras-chave:
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos. Farmacovigilância. Sistemas de Notificação de Reações Adversas a Medicamentos.
Abstract:
The objective was to assess the forms used to report suspected adverse drug reactions (ADR) to the pharmacovigilance system in Brazil and twelve other Latin-American countries. The study was composed of three stages. During the first one, the forms were compared and scored against the presence of items critical to create ADR notification. In the second stage, the variables of the forms were quantified and classified regarding feasibility to contribute to an appropriate causality assessment. In the last stage, hierarchical clustering was used to identify the similar forms. The Venezuelan form scored the highest score (18 points). The median number of variables in the form of each country was 41 [26 (Guatemala) to 95 (Brazil)]. Most of the form variables were classified as life-critical and most part contributes as an alternative explanation to causality assessment. Four clusters were identified (1, 2, 3 and 4). The forms of Brazil and Bolivia formed two separate distinct groups, 1 and 3 respectively. The results of this study indicate a need to change the forms of the different countries studied or even some variables, making it more appropriate to the assessment of ADRs causality.
Keywords:
Drug-Related Side Effects and Adverse Reactions. Pharmacovigilance. Adverse Drug Reaction Reporting Systems.
Adverse Drug Reactions Notification Forms of the Pharmacovigilance Systems in Brazil and Twelve Other Latin-American Countries: A Comparative Analysis.
Resumo (abstract):
The objective was to assess the forms used to report suspected adverse drug reactions (ADR) to the pharmacovigilance system in Brazil and twelve other Latin-American countries. The study was composed of three stages. During the first one, the forms were compared and scored against the presence of items critical to create ADR notification. In the second stage, the variables of the forms were quantified and classified regarding feasibility to contribute to an appropriate causality assessment. In the last stage, hierarchical clustering was used to identify the similar forms. The Venezuelan form scored the highest score (18 points). The median number of variables in the form of each country was 41 [26 (Guatemala) to 95 (Brazil)]. Most of the form variables were classified as life-critical and most part contributes as an alternative explanation to causality assessment. Four clusters were identified (1, 2, 3 and 4). The forms of Brazil and Bolivia formed two separate distinct groups, 1 and 3 respectively. The results of this study indicate a need to change the forms of the different countries studied or even some variables, making it more appropriate to the assessment of ADRs causality.
Palavras-chave (keywords):
Drug-Related Side Effects and Adverse Reactions. Pharmacovigilance. Adverse Drug Reaction Reporting Systems.
Mota, D.M, Vigo, A, Kuchenbecker, R.S. Formulários de notificação de reações adversas a medicamento nos sistemas de farmacovigilância do Brasil e outros doze países latino-americanos: Análise comparativa.. Cien Saude Colet [periódico na internet] (2019/Jul). [Citado em 01/07/2024].
Está disponível em: http://cienciaesaudecoletiva.com.br/artigos/formularios-de-notificacao-de-reacoes-adversas-a-medicamento-nos-sistemas-de-farmacovigilancia-do-brasil-e-outros-doze-paises-latinoamericanos-analise-comparativa/17267?id=17267
