RESUMO
PURPOSE: Our aim was to describe the adverse drug reactions (ADRs) detected following increased education about pharmacovigilance and drug toxicity in children in Camagüey Province, Cuba. METHODS: Over a period of 24 months (January 2009 to December 2010), all reports of suspected ADRs in children to the Provincial Pharmacovigilance Centre in Camagüey Province were analysed. ADRs were classified in relation to causality and severity. RESULTS: There were 533 reports involving suspected ADRs in children in the period. Almost one third of the reports received were classified as moderate (155, 29%) or severe (10, 2%). There was one fatality in association with the use of ceftriaxone. Vaccines and antibiotics were responsible for most of the ADR reports (392, 74%) and for all ten severe ADRs. After an intensive educational package, both within the community and the Children's Hospital, the number of reports increased from 124 in 2008 to 161 in 2009 and 372 in 2010. This was equivalent to a reporting rate of 879 and 2,031 reports per million children per year for 2009 and 2010, respectively. CONCLUSIONS: The incidence of ADRs in children Camagüey Province, Cuba, is greater than previously reported. An educational intervention about pharmacovigilance and drug toxicity in children can improve the reporting of ADRs.
Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Farmacovigilância , Adolescente , Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Criança , Pré-Escolar , Cuba/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/induzido quimicamente , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Hospitais Pediátricos/estatística & dados numéricos , Humanos , Lactente , Recém-Nascido , Índice de Gravidade de DoençaRESUMO
Objective To determine the incidence of adverse drug reactions (ADRs) in children in Camagüey Province, Cuba. Methods A national pharmacovigilance programme has been established in Cuba and involves suspected ADRs being reported to provinces. All suspected ADRs reported to Camagüey Province during 2008 were analysed and classified in relation to causality and severity. Results Over a 12-month period, there were 124 reports of 152 suspected ADRs in children. Most ADRs were mild (98, 79 por ciento), but two were fatal and five others were severe. Antibiotics were the group of medicines most likely to be associated with ADRs. The overall report rate of suspected ADRs was 634 per million children per year, which is considerably higher than previously reported rates. Conclusions ADRs in children are more frequent than previously reported. A successful pharmacovigilance programme can be established in lower middle income countries(AU)
Objetivo: Determinar la incidencia de reacciones adversas a medicamentos (RAM) en los niños en la provincia de Camagüey, Cuba. Métodos Se realizó un programa de farmacovigilancia nacionales se ha establecido en Cuba y consiste en sospecha de reacciones adversas que se informa a las provincias. Todos los ADR sospechosos notificados a la provincia de Camagüey durante el año 2008 fueron analizados y clasificados en relación a la causalidad y la gravedad. Resultados Durante un período de 12 meses, había 124 informes de reacciones adversas de 152 sospechosos en los niños. La mayoría de las RAM fueron leves (98, 79 percent), pero dos de ellos mortales y otros cinco fueron graves. Los antibióticos fueron el grupo de medicamentos más probable que esté asociado a la ADR. El tipo de informe general de las ADR se sospecha fue 634 por cada millón de niños al año, que es considerablemente más alta que la publicada tarifas. Conclusiones ADR en los niños son más frecuentes que lo reportado anteriormente. Un programa de farmacovigilancia éxito se puede establecer en los países de ingreso medio(AU)