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Abstract(s)
Introdução: Os corticosteroides são uma classe de fármacos amplamente utilizada no
tratamento de diversas doenças e com efeito em diferentes sistemas orgânicos. Apesar do seu
benefício clínico, existem riscos associados à sua utilização, especialmente em contexto de
regime terapêutico prolongado e/ou doses altas, ou seja, reações adversas dose e tempo
dependentes. A ocorrência destes eventos adversos tem impacto na qualidade de vida e adesão
ao tratamento, e devem constituir um permanente alerta para a subsequente notificação dos
mesmos. Tal atividade de Farmacovigilância permite uma constante monitorização póscomercialização dos medicamentos, neste caso corticosteroides, e também uma contínua
revisão do seu perfil de segurança. Este estudo tem como objetivo a caraterização das reações
adversas a corticosteroides notificadas ao Sistema Português de Farmacovigilância durante 10
anos.
Material e Métodos: Estudo retrospetivo, observacional e descritivo acerca das notificações de
reações adversas decorrentes da utilização de corticosteroides, tendo como base os dados do
Sistema Português de Farmacovigilância durante um período de 10 anos (2009-2018). As
notificações que apresentavam pelo menos um corticosteroide suspeito, excluindo as
duplicadas e anuladas, foram analisadas em termos de dados demográficos e caraterísticas dos
eventos adversos.
Resultados e Discussão: Foram incluídas no estudo 569 notificações com pelo menos um
corticosteroide suspeito, das quais 59,1% relativas a doentes com idade compreendida entre os
19 e os 64 anos. Não se verificou uma predominância significativa de sexo, com 55% do sexo
feminino. A tendência de notificação aumentou ao longo dos anos, registando-se o maior
número de casos no ano de 2018, 29,5%. Entre os três grupos de profissionais de saúde
(enfermeiros, farmacêuticos e médicos), os médicos foram os que mais notificaram. Quanto à
gravidade, 89,1% das notificações foram classificadas como graves, e o corticosteroide mais
comumente descrito como suspeito foi a prednisolona, 65,6%. O grupo do sistema de
classificação de órgãos primários reportado em 37,8% dos eventos adversos foi Infeções e
Infestações. Apesar da gravidade da maioria das notificações, 42,7% evoluiu para cura,
registando-se 9,3% mortes. O estudo de causalidade por parte da autoridade reguladora não foi
realizado em 84,4% dos casos notificados.
Conclusão: Assim sendo, apesar de um aumento de notificações de reações adversas aos
corticosteroides é necessária uma consciencialização crescente para a sinalização destas
situações. Para além disso, são necessários mais estudos de causalidade entre corticosteroide
suspeito e evento adverso para que possam ser retiradas conclusões com maior evidência.
Atendendo aos resultados obtidos, são fundamentais programas de ensino acerca da
importância da Farmacovigilância.
Introduction: Corticosteroids are a group of drugs commonly used as treatment for a variety of conditions and targeting different organ systems. Despite their clinical benefit, there are risks associated with their use, especially in the context of long-term exposures and/or with high doses, that is, dose and time dependent reactions. The appearance of these adverse events has an impact on the quality of life and on adherence to treatment, and should be a permanent alert for their subsequent notification. Such Pharmacovigilance activity allows constant postmarketing monitoring of drugs, in this case corticosteroids, and also a continuous review of their safety profile. The aim of this study is to characterize suspected adverse reactions caused by corticosteroids notified to the Portuguese Pharmacovigilance System for 10 years. Material and Methods: Retrospective, observational and descriptive study on the reports of adverse reactions resulting from the use of corticosteroids, based on data from the Portuguese Pharmacovigilance System over a period of 10 years (2009-2018). Notifications that had at least one suspected corticosteroid, excluding duplicates and canceled ones, were analyzed in terms of demographic data and characteristics of adverse events. Results and Discussion: A total of 569 reports with at least one suspected corticosteroid were included in the study, of which 59.1% belonged to the ages between 19 and 64 years. There was no significant predominance of gender, with 55% female patients. The notification trend has increased over the years, with the highest number of cases in 2018, 29.5%. Among the three groups of health professionals (nurses, pharmacists and physicians), physicians were the ones who notified the majority. Regarding seriousness, 89.1% were classified as serious, and the most commonly reported corticosteroid as suspected drug was prednisolone, 65.6%. The group of the System Organ Class reported in 37.8% of adverse events was Infections and Infestations. Despite the seriousness of most reports, 42.7% evolved to cure, and 9.3% of the reports lead to the death of patients. The assessment of causality by the regulatory authority was not performed in 84.4% of the reported cases. Conclusion: Despite an increase in reports of adverse reactions for corticosteroids, increasing awareness is needed to signal these situations. In addition, further causality studies between suspected corticosteroids and adverse events are needed in order to draw conclusions with greater evidence. In view of the results obtained, teaching programs about the importance of Pharmacovigilance are essential.
Introduction: Corticosteroids are a group of drugs commonly used as treatment for a variety of conditions and targeting different organ systems. Despite their clinical benefit, there are risks associated with their use, especially in the context of long-term exposures and/or with high doses, that is, dose and time dependent reactions. The appearance of these adverse events has an impact on the quality of life and on adherence to treatment, and should be a permanent alert for their subsequent notification. Such Pharmacovigilance activity allows constant postmarketing monitoring of drugs, in this case corticosteroids, and also a continuous review of their safety profile. The aim of this study is to characterize suspected adverse reactions caused by corticosteroids notified to the Portuguese Pharmacovigilance System for 10 years. Material and Methods: Retrospective, observational and descriptive study on the reports of adverse reactions resulting from the use of corticosteroids, based on data from the Portuguese Pharmacovigilance System over a period of 10 years (2009-2018). Notifications that had at least one suspected corticosteroid, excluding duplicates and canceled ones, were analyzed in terms of demographic data and characteristics of adverse events. Results and Discussion: A total of 569 reports with at least one suspected corticosteroid were included in the study, of which 59.1% belonged to the ages between 19 and 64 years. There was no significant predominance of gender, with 55% female patients. The notification trend has increased over the years, with the highest number of cases in 2018, 29.5%. Among the three groups of health professionals (nurses, pharmacists and physicians), physicians were the ones who notified the majority. Regarding seriousness, 89.1% were classified as serious, and the most commonly reported corticosteroid as suspected drug was prednisolone, 65.6%. The group of the System Organ Class reported in 37.8% of adverse events was Infections and Infestations. Despite the seriousness of most reports, 42.7% evolved to cure, and 9.3% of the reports lead to the death of patients. The assessment of causality by the regulatory authority was not performed in 84.4% of the reported cases. Conclusion: Despite an increase in reports of adverse reactions for corticosteroids, increasing awareness is needed to signal these situations. In addition, further causality studies between suspected corticosteroids and adverse events are needed in order to draw conclusions with greater evidence. In view of the results obtained, teaching programs about the importance of Pharmacovigilance are essential.
Description
Keywords
Coricosteroides Evento Adverso Reação Adversa Medicamentosa Sistema Português de Farmacovigilância