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Perfil da notificação espontânea de suspeitas de reações adversas associadas à Varfarina na região Sul de Portugal, no período de 2011 a 2015. Reflexões após 50 anos de mercado em Portugal
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Authors
Advisor(s)
Abstract(s)
Introdução
Em Portugal, é a Direção de Gestão do Risco do Medicamento em estreita relação com as Unidades Regionais de Farmacovigilância, que monitoriza a segurança dos medicamentos com autorização de introdução no mercado nacional, avaliando os eventuais problemas relacionados com RAM, principalmente através da análise de notificações espontâneas. No âmbito da informação recolhida no avaliar das notificações espontâneas recebidas na Unidade de Farmacovigilância do Sul nos últimos cinco anos, verificou-se uma contínua tendência de notificação de RAM associadas à utilização de varfarina.
Objetivo
Caraterização do perfil da notificação espontânea de reações adversas associadas à varfarina na região Sul de Portugal no período de 2011 a 2015.
Metodologia
Análise das notificações de suspeitas de reações adversas notificadas à UFS, no período de 2011 a 2015, através de um estudo observacional descritivo, de orientação transversal, com análise descritiva efetuada pelo Software EPI InfoTM 7.
Resultados
Durante o período em análise foram enviadas à UFS 1664 notificações de suspeitas de reações adversas a medicamentos, sendo 43 das mesmas referentes a suspeitas de reações adversas à varfarina. Das 1664 NE, 482 NE (28,97%) disseram respeito a notificação de RAM graves. Do total das 482 NE graves, 37 NE (7,68%) foram provocadas pela utilização de varfarina. Foram classificadas com critério de gravidade de perigo de vida ou morte 5 em 43 NE com varfarina e 2 destas NE resultaram em morte do doente. Do total das 43 NE, 38 NE (88,37 %) notificavam RAM cuja descrição em RCM era incompleta, e 30,23% destas 43 NE obtiveram uma imputação de causalidade de definitivo.
Conclusões
Embora tenha aumentado o número de NE enviadas à UFS no decorrer do período em análise, a subnotificação mantém-se patente neste tipo de metodologia. Em particular com a varfarina, confirmou-se que a notificação de suspeitas de RAM se deu essencialmente pela realização de projetos específicos, e não pela notificação per si. A grande maioria destas NE diziam respeito a notificações de RAM graves evitáveis, muitas delas responsáveis por aumentar os custos do SNS com esta terapêutica. Contudo, a genotipagem dos genes CYP2C9 e do VKORC1 em doentes a iniciar esta terapêutica, bem como a alteração do paradigma do acompanhamento destes doentes, poderão revelar-se como medidas fulcrais para a diminuição dos custos pelo SNS e para o aumento da qualidade de vida destes doentes.
Introduction In Portugal, the National Pharmacovigilance System in close relationship with the Regional Pharmacovigilance Units, monitors the safety of medicines with marketing authorization in the national market by assessing any adverse reaction (ADR) problems, mainly through the analysis of spontaneous reports. By reviewing the information of spontaneous reports received in the past five years by the Southern Pharmacvigilance Unit, it has been shown a continuous trend of ADR reporting associated with the use of warfarin. Objective This study aims to describe the profile of the spontaneous reports of adverse reactions caused by warfarin in the southern region of Portugal between 2011 and 2015. Methodology Analysis of suspected adverse reactions reported to the UFS in the period between 2011 and 2015, through a descriptive observational study transversely oriented, with descriptive analysis performed by the software EPI InfoTM 7. Results During the period under review, 1664 reports of suspected ADR were sent to the UFS and 43 of them were related to suspected adverse reactions to warfarin. 483 spontaneous reports (28.97 %) were related to serious ADR reporting. Considering the 482 serious reports, 37 (7.68 %) were caused by the use of warfarin. Of the 43 spontaneous reports induced by warfarin, 5 were classified as life threatening, and 2 of those caused the death of the patient. Also 88.37% of these 43 spontaneous reports had no SPC description, and 30.23 % obtained definitive as a causality degree. Conclusion Although the high number of spontaneous reports received by the UFS during the period under review, underreporting remains as a disadvantage of this type of methodology. Particularly with warfarin, it was been confirmed that the notification of suspected ADR was due to the performance of specific projects and not for the notification per si. The majority of these reports concerned serious ADR reports, consequently responsible for increasing the costs for the SNS. However, genotyping of CYP2C9 and VKORC1 genes in patients starting this therapy, as well as improving its monitoring, have proved to be key measures for the reduction of costs by the SNS and to increase the life quality of these patients.
Introduction In Portugal, the National Pharmacovigilance System in close relationship with the Regional Pharmacovigilance Units, monitors the safety of medicines with marketing authorization in the national market by assessing any adverse reaction (ADR) problems, mainly through the analysis of spontaneous reports. By reviewing the information of spontaneous reports received in the past five years by the Southern Pharmacvigilance Unit, it has been shown a continuous trend of ADR reporting associated with the use of warfarin. Objective This study aims to describe the profile of the spontaneous reports of adverse reactions caused by warfarin in the southern region of Portugal between 2011 and 2015. Methodology Analysis of suspected adverse reactions reported to the UFS in the period between 2011 and 2015, through a descriptive observational study transversely oriented, with descriptive analysis performed by the software EPI InfoTM 7. Results During the period under review, 1664 reports of suspected ADR were sent to the UFS and 43 of them were related to suspected adverse reactions to warfarin. 483 spontaneous reports (28.97 %) were related to serious ADR reporting. Considering the 482 serious reports, 37 (7.68 %) were caused by the use of warfarin. Of the 43 spontaneous reports induced by warfarin, 5 were classified as life threatening, and 2 of those caused the death of the patient. Also 88.37% of these 43 spontaneous reports had no SPC description, and 30.23 % obtained definitive as a causality degree. Conclusion Although the high number of spontaneous reports received by the UFS during the period under review, underreporting remains as a disadvantage of this type of methodology. Particularly with warfarin, it was been confirmed that the notification of suspected ADR was due to the performance of specific projects and not for the notification per si. The majority of these reports concerned serious ADR reports, consequently responsible for increasing the costs for the SNS. However, genotyping of CYP2C9 and VKORC1 genes in patients starting this therapy, as well as improving its monitoring, have proved to be key measures for the reduction of costs by the SNS and to increase the life quality of these patients.
Description
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2016
Keywords
Varfarina RAM UFS Notificação espontânea Farmacovigilância Mestrado Integrado - 2016