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Inibidores Seletivos da Recaptação da Serotonina: Análise dos Efeitos Adversos Graves Notificados à EudraVigilance
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Authors
Abstract(s)
Este relatório tem como fim a obtenção de Grau de Mestre em Ciências Farmacêuticas e
está dividido em dois capítulos.
O Capítulo I corresponde à componente de investigação e consiste num estudo intitulado
“Inibidores Seletivos da Recaptação da Serotonina: Análise das Reações Adversas Graves
Notificadas à EudraVigilance”. Com a evolução dos medicamentos foi possível perceber
que estes não proporcionam somente efeitos benéficos, mas também efeitos indesejáveis
designados por reações adversas a medicamentos (RAM). Assim, a farmacovigilância
pretende detetar, avaliar, compreender e prevenir as RAM, tendo como objetivo a
proteção da saúde pública. Os Inibidores Seletivos da Recaptação da Serotonina (ISRS)
são uma classe de antidepressivos e segundo a Organização Mundial de Saúde (OMS),
aproximadamente 280 milhões de pessoas no mundo estão diagnosticadas com
depressão. Por este motivo e tendo em consideração que os ISRS são frequentemente
prescritos para esta patologia, considerou-se importante analisar a RAM graves
notificadas à EudraVigilance durante o período entre o dia 1 de janeiro de 2020 até ao
dia 31 de dezembro de 2023, sendo que estas datas foram selecionadas porque
compreendem os dias em que foram declarados o início e o fim da pandemia de COVID19. Para a realização deste estudo selecionaram-se 7359 notificações e analisaram-se
variáveis como a quantidade de notificações graves entre 2020 e 2023, quantidade de
notificações por ISRS suspeito, por tipo de notificador, por idade e por sexo. Além disso,
as notificações graves foram caracterizadas tendo em conta o critério de gravidade e a
evolução do estado clínico do doente e foram também identificadas as RAM notificadas
mais frequentemente por ISRS. Resumidamente, a sertralina foi o ISRS que foi mais
notificado, a maioria das notificações foram reportadas por profissionais de saúde.
Relativamente à população, a faixa etária mais afetada foi 18-64 anos e o sexo mais
afetado foi o feminino. Em relação ao critério de gravidade e à evolução do estado clínico
do doente, os mais reportados foram “Clinicamente importante” e “Desconhecido”,
respetivamente. Relativamente às RAM que foram notificadas para a classe de ISRS com
maior frequência, de um modo geral foram a “Ideação Suicida”, “Náuseas” e “Tonturas”,
as mais reportadas. Tendo em conta os resultados obtidos, verifica-se que é necessário
realizar mais estudos para que haja uma melhor caracterização das RAM.
O capítulo II é referente à experiência profissionalizante no estágio curricular em
Farmácia Comunitária, realizada na Farmácia Pinho, sob a orientação da Dra. Daniela
Melo no período decorrente desde o dia 5 de fevereiro ao dia 21 de junho de 2024. Sendo
que esta foi uma experiência fundamental para adquirir novos conhecimentos e aprofundar aqueles que foram aprendidos na faculdade e também para vivenciar a
importância do farmacêutico comunitário.
This report aims to obtain a Master's Degree in Pharmaceutical Sciences is divided into two chapters. The first chapter corresponds to the investigation, and it consists of a study titled “Selective Serotonin Reuptake Inhibitor: Analysis of Serious Adverse Reactions Reported to EudraVigilance”. With the evolution of drugs, it was possible to find out that they do not have only benefits, but also harmful effects designated by Adverse Drug Reactions (ADR). Thus, pharmacovigilance arises in this sense to detect, evaluate, understand and prevent ADRs, aiming to protect public health. Selective Serotonin Reuptake Inhibitors (SSRIs) are a class of antidepressants and according to the World Health Organisation (WHO), approximately 280 million people in the world are diagnosed with depression. For this reason and considering that SSRIs are often prescribed for this pathology, it was considered important to analyse the serious ADRs notified to EudraVigilance during the period between January 1, 2020, and December 31, 2023, these dates were selected because they comprise the days on wich the beginning and end of the COVID-19 pandemic were declared. For this study, 7359 reports were selected, and variables were analysed such as the number of serious reports between 2020 and 2023, number of reports by suspected SSRI, by type of reporter, by age and by sex. In addition, serious reports were characterised considering the seriousness and the evolution of the patient's clinical status and the most frequently reported ADRs were also identified. Sertraline was the most report SSRI and most reports were reported by health professionals. Regarding the population, the age group that was more affected was 18- 64 years and the most affected sex was female. Regarding the seriousness criterion and the evolution of the clinical status, the most reported were "Clinically important" and "Unknown", respectively. Regarding the ADRs that were reported most frequently for SSRI class, in general, “Suicidal Ideation”, “Nausea” and “Dizziness” were the most reported. Taking into account the results obtained, it is verified that it is necessary to carry out more studies to have a better characterisation of the ADRs. The second chapter refers to the professional experience in the curricular internship in the Community Pharmacy, held at the Pinho Pharmacy, under the guidance of Dr. Daniela Melo, from February 5th to June 21st , 2024. This was a fundamental experience to acquire new knowledge and deepen that learned in college and also to experience the importance of the community pharmacist.
This report aims to obtain a Master's Degree in Pharmaceutical Sciences is divided into two chapters. The first chapter corresponds to the investigation, and it consists of a study titled “Selective Serotonin Reuptake Inhibitor: Analysis of Serious Adverse Reactions Reported to EudraVigilance”. With the evolution of drugs, it was possible to find out that they do not have only benefits, but also harmful effects designated by Adverse Drug Reactions (ADR). Thus, pharmacovigilance arises in this sense to detect, evaluate, understand and prevent ADRs, aiming to protect public health. Selective Serotonin Reuptake Inhibitors (SSRIs) are a class of antidepressants and according to the World Health Organisation (WHO), approximately 280 million people in the world are diagnosed with depression. For this reason and considering that SSRIs are often prescribed for this pathology, it was considered important to analyse the serious ADRs notified to EudraVigilance during the period between January 1, 2020, and December 31, 2023, these dates were selected because they comprise the days on wich the beginning and end of the COVID-19 pandemic were declared. For this study, 7359 reports were selected, and variables were analysed such as the number of serious reports between 2020 and 2023, number of reports by suspected SSRI, by type of reporter, by age and by sex. In addition, serious reports were characterised considering the seriousness and the evolution of the patient's clinical status and the most frequently reported ADRs were also identified. Sertraline was the most report SSRI and most reports were reported by health professionals. Regarding the population, the age group that was more affected was 18- 64 years and the most affected sex was female. Regarding the seriousness criterion and the evolution of the clinical status, the most reported were "Clinically important" and "Unknown", respectively. Regarding the ADRs that were reported most frequently for SSRI class, in general, “Suicidal Ideation”, “Nausea” and “Dizziness” were the most reported. Taking into account the results obtained, it is verified that it is necessary to carry out more studies to have a better characterisation of the ADRs. The second chapter refers to the professional experience in the curricular internship in the Community Pharmacy, held at the Pinho Pharmacy, under the guidance of Dr. Daniela Melo, from February 5th to June 21st , 2024. This was a fundamental experience to acquire new knowledge and deepen that learned in college and also to experience the importance of the community pharmacist.
Description
Keywords
Eudravigilance Farmácia Comunitária Farmacovigilância Inibidores Seletivos da Recaptação da Serotonina Notificações Espontâneas Reações Adversas a Medicamentos