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Authors
Abstract(s)
O presente relatório tem como fim a obtenção do Grau de Mestre em Ciências
Farmacêuticas e encontra-se dividido em quatro capítulos.
O primeiro capítulo é referente à componente de investigação e intitula-se de “Reações
adversas ao febuxostate: análise de reações adversas notificadas à EudraVigilance”. Os
medicamentos estão maioritariamente associados a usos benéficos, mas não se
encontram isentos de reações adversas. A identificação, avaliação e prevenção dessas
reações considera-se o papel da farmacovigilância. Neste trabalho estudaram-se as
reações adversas ao febuxostate, um inibidor da xantina oxidase, que leva à diminuição
da produção de ácido úrico, e que é utilizado no tratamento da gota. Para isso, foram
analisadas as reações adversas notificadas à EudraVigilance, durante o período de 1 de
janeiro de 2009 e 31 de dezembro de 2023. Neste estudo, foram selecionadas 2722
notificações e avaliadas variáveis como: a quantidade de notificações ao longo dos anos;
o tipo de notificador; a faixa etária e sexo da população; a gravidade e os critérios de
gravidade das notificações; a evolução do estado clínico dos doentes; a relação entre a
gravidade e a faixa etária e gravidade e o sexo dos doentes; as reações mais prevalentes
descritas no resumo das características do medicamento (RCM) e as reações
pertencentes à Designated Medical Event list. Nestes doentes, a faixa etária mais
afetada foi entre os 65 e os 85 anos e o sexo masculino. Na sua maioria, as reações
reportadas foram consideradas graves, o critério de gravidade mais reportado foi
“Clinicamente Importante” e a evolução foi, na sua maioria, positiva, tendo os doentes
recuperado. A maioria destas reações encontra-se descrita no RCM. Em suma,
concluiu-se que é importante continuar a investigar e a monitorizar este medicamento,
sendo importante rever e atualizar as reações adversas presentes no RCM.
O segundo capítulo descreve a minha experiência profissionalizante no estágio
curricular em Farmácia Hospitalar no Centro Hospitalar Universitário Cova da Beira,
entre 2 de outubro de 2023 e 24 de novembro de 2023, sob a orientação da Dra.
Olímpia Fonseca. Neste capítulo destaca-se o papel do farmacêutico hospitalar, a
organização dos serviços farmacêuticos do hospital e as atividades desenvolvidas nos
mesmos.
O terceiro capítulo, relata a minha experiência profissionalizante no estágio em
Farmácia Comunitária na Farmácia Pacheco Pereira, entre 27 de novembro de 2023 e 16 de fevereiro de 2024, sob a orientação da Dra. Ana Salgueira. Neste capítulo o papel
do farmacêutico comunitário encontra-se em destaque.
O quarto e último capítulo, descreve a minha experiência profissionalizante no estágio
em Farmácia Comunitária na Farmácia Medeiros, entre 15 de março e 15 de abril de
2024, sob a orientação da Dra. Carolina Marques. É um capítulo que reflete o papel e a
importância do farmacêutico comunitário.
The purpose of this report is to obtain the Master’s Degree in Pharmaceutical Sciences and is divided into three chapters. The first chapter pertains to the research component and is titled “Adverse Reactions to Febuxostat: Analysis of Adverse Reactions Reported to EudraVigilance.” Drugs are primarily associated with beneficial uses but are not exempt from adverse reactions. The identification, assessment, and prevention of these reactions is considered the role of pharmacovigilance. This work highlights the adverse reactions to febuxostat, a xanthine oxidase inhibitor that reduces uric acid production and is used in the treatment of gout. Accordingly, adverse reactions reported to EudraVigilance between January 1, 2009, and December 31, 2023, were analyzed. In this study, 2,722 reports were selected, and variables evaluated included: the number of reports over the years; type of reporter; age group and sex of the population; the seriousness and seriousness criteria of reports; the evolution of patients' clinical status; the relationship between seriousness and age group and seriousness and sex; the most prevalent reactions described in the Summary of Product Characteristics (SmPC) and reactions included in the Designated Medical Event list. The most affected age group was between 65 and 85 years, and male sex was predominant. The reported reactions were mostly classified as serious, with "Clinically Significant" being the most frequently reported seriousness criterion, and the evolution was mostly positive, with patients recovering. Most of these reactions are described in the SmPC. In summary, it was concluded that it is important to continue investigating and monitoring the drugs, with an emphasis on reviewing and updating the adverse reactions listed in the SmPC. The second chapter describes my professional experience during the internship in Hospital Pharmacy at the Cova da Beira University Hospital Center, from October 2, 2023, to November 24, 2023, under the supervision of Dr. Olímpia Fonseca. This chapter highlights the role of the hospital pharmacist, the organization of the hospital's pharmaceutical services, and the activities carried out therein. The third chapter recounts my professional experience during the internship in Community Pharmacy at Pacheco Pereira Pharmacy, from November 27, 2023, to February 16, 2024, under the supervision of Dr. Ana Salgueira. In this chapter, the role of the community pharmacist is emphasized. The fourth and final chapter describes my professional experience in the Community Pharmacy internship at Farmácia Medeiros, between March 15 and April 15, 2024, under the guidance of Dr. Carolina Marques. It's a chapter that reflects the role and importance of the community pharmacist.
The purpose of this report is to obtain the Master’s Degree in Pharmaceutical Sciences and is divided into three chapters. The first chapter pertains to the research component and is titled “Adverse Reactions to Febuxostat: Analysis of Adverse Reactions Reported to EudraVigilance.” Drugs are primarily associated with beneficial uses but are not exempt from adverse reactions. The identification, assessment, and prevention of these reactions is considered the role of pharmacovigilance. This work highlights the adverse reactions to febuxostat, a xanthine oxidase inhibitor that reduces uric acid production and is used in the treatment of gout. Accordingly, adverse reactions reported to EudraVigilance between January 1, 2009, and December 31, 2023, were analyzed. In this study, 2,722 reports were selected, and variables evaluated included: the number of reports over the years; type of reporter; age group and sex of the population; the seriousness and seriousness criteria of reports; the evolution of patients' clinical status; the relationship between seriousness and age group and seriousness and sex; the most prevalent reactions described in the Summary of Product Characteristics (SmPC) and reactions included in the Designated Medical Event list. The most affected age group was between 65 and 85 years, and male sex was predominant. The reported reactions were mostly classified as serious, with "Clinically Significant" being the most frequently reported seriousness criterion, and the evolution was mostly positive, with patients recovering. Most of these reactions are described in the SmPC. In summary, it was concluded that it is important to continue investigating and monitoring the drugs, with an emphasis on reviewing and updating the adverse reactions listed in the SmPC. The second chapter describes my professional experience during the internship in Hospital Pharmacy at the Cova da Beira University Hospital Center, from October 2, 2023, to November 24, 2023, under the supervision of Dr. Olímpia Fonseca. This chapter highlights the role of the hospital pharmacist, the organization of the hospital's pharmaceutical services, and the activities carried out therein. The third chapter recounts my professional experience during the internship in Community Pharmacy at Pacheco Pereira Pharmacy, from November 27, 2023, to February 16, 2024, under the supervision of Dr. Ana Salgueira. In this chapter, the role of the community pharmacist is emphasized. The fourth and final chapter describes my professional experience in the Community Pharmacy internship at Farmácia Medeiros, between March 15 and April 15, 2024, under the guidance of Dr. Carolina Marques. It's a chapter that reflects the role and importance of the community pharmacist.
Description
Keywords
Farmácia Hospitalar Estágio Eudravigilance Farmácia Comunitária Farmacovigilância Febuxostate