| Name: | Description: | Size: | Format: | |
|---|---|---|---|---|
| 1.1 MB | Adobe PDF |
Abstract(s)
Este relatório está organizado em três capítulos. O primeiro capítulo é referente à
vertente de investigação, em que se realizou um estudo sobre as reações adversas dos
corticosteróides intranasais (INCS, Do Inglês, intranasal corticosteroid) reportadas à
EudraVigilance, durante o período de 1 de janeiro de 2011 e 12 de junho de 2023; o
segundo capítulo é referente ao relatório de estágio curricular realizado em Farmácia
Comunitária; e o terceiro capítulo aborda o relatório de estágio curricular realizado em
Farmácia Hospitalar.
O primeiro capítulo intitula-se: “Riscos Associados ao Uso dos Corticosteróides
Intranasais: Análise de Reações Adversas Notificadas à EudraVigilance”. O combate à
doença sempre foi um dos objetivos do ser humano, e os medicamentos desde cedo
contribuíram para isso. No entanto, os medicamentos não são isentos de riscos. A
farmacovigilância veio assumir um papel decisivo no controlo das reações adversas ao
medicamento (RAM), prevenindo e minimizando os riscos associados aos
medicamentos e, com isso, melhorando a saúde pública. Dentro de uma vasta gama de
medicamentos desenvolvidos, destacam-se os que contêm corticosteróides, os quais
assumem um papel crucial na prevenção, controlo e tratamento das mais diversas
patologias. Dentro desta classe, existem vários que são usadas por via intranasal e que
são alvo do presente estudo. Os corticosteroides intranasais analisados neste trabalho
foram: beclometasona, budesonida, flunisolido, fluticasona, mometasona e
triamcinolona. Deste modo, foram avaliados os dados das RAM associadas aos INCS
notificadas à EudroVigilance, durante o período de 1 de janeiro de 2011 e 12 de junho
de 2023. Para o estudo foram selecionadas 2641 notificações, e foram analisadas
variáveis como a quantidade de notificações realizadas ao longo dos anos, incluindo por
cada um dos INCS, o tipo de notificador, o género e idade da população. Em relação às
RAM analisadas, estas foram caraterizadas quanto à sua gravidade e critério de
gravidade, sua evolução, relação entre a gravidade e os INCS, e género e idade, e foram
também caracterizadas as RAM mais prevalentes quanto a estarem descritas ou não no
Resumo das Características do Medicamento (RCM). Também se caraterizaram as
RAM mais prevalentes por INCS com termos pertencentes à DME list e quanto à sua
descrição no RCM. A faixa etária da população mais afetada foi dos 18-64 anos, e o
género mais afetado foi o feminino. No geral, o INCS mais notificado foi a mometasona,
as RAM reportadas foram consideradas, na sua maioria, como não graves, evoluíram maioritariamente para cura, e não se encontravam descritas no RCM do respetivo
INCS. Sobre as RAM consideradas graves, o critério de gravidade mais reportado foi
“Clinicamente importante”. Face a estes resultados, concluiu-se que se deve continuar a
monitorizar estes medicamentos para prevenir e diminuir as RAM e, assim, proteger a
população e a saúde pública. Adicionalmente, novos estudos devem ser realizados para
confirmar se as RAM não descritas poderão ser novos sinais de segurança.
O segundo capítulo descreve a experiência profissionalizante no estágio curricular em
Farmácia Comunitária, realizada na Farmácia Nelsina, em Viana do Castelo, sob
orientação e supervisão do Dr. Michael Araújo, no período de 11 de setembro a 1 de
dezembro de 2023. Este período foi crucial para desenvolver o conhecimento adquirido
na faculdade, adquirir novas competências e perceber qual o papel que o farmacêutico
comunitário desempenha na sociedade.
O terceiro capítulo relata as atividades desenvolvidas durante o estágio curricular em
Farmácia Hospitalar, nos serviços farmacêuticos do Centro Hospitalar Universitário
Cova da Beira, entre 4 de dezembro de 2023 e 26 de janeiro de 2024, sob orientação e
supervisão da Dra. Olímpia Fonseca. Neste período acompanhei as tarefas
desenvolvidas pelo farmacêutico hospitalar, enquanto membro de uma equipa
multidisciplinar, nos diversos setores que constituem a farmácia hospitalar. Este
estágio também foi bastante enriquecedor para o meu desenvolvimento académico.
This report is organized into three chapters. The first chapter refers to the research work, in which a study was carried out on the adverse reactions of intranasal corticosteroids (ICNS) reported to EudraVigilance, during the period from January 1, 2011 to June 12, 2023; the second chapter refers to the report of the curricular internship carried out in Community Pharmacy; and the third chapter addresses the report of the curricular internship carried out in Hospital Pharmacy. The first chapter is entitled: “Risks Associated with the Use of Intranasal Corticosteroids: Analysis of Adverse Reactions Reported to EudraVigilance”. Fighting any disease has always been one of the goals of human beings, and drugs were developed early on to combat this. However, drugs are not risk-free. Pharmacovigilance has played a decisive role in controlling adverse drug reactions (ADRs), preventing and minimizing risks associated with public health. Within a wide range of drugs developed, corticosteroids stand out, playing a crucial role in the prevention, control and treatment of the most diverse pathologies. Within this class, there are several that are used through the nasal route, and which are the target of this study. The intranasal corticosteroids analyzed in this study were: beclomethasone, budesonide, flunisolide, fluticasone, mometasone and triamcinolone. In this way, ADRs data associated with INCS reported to EudraVigilance, during the period of January 1, 2011 and June 12, 2023, were analyzed. To this study 2,641 reports were selected, and variables such as the number of reports over the years, including for each of the INCS, the type of reporter, the gender and age of the population, were analyzed. In relation to the ADRs highlighted, they were characterized in terms of their seriousness and seriousness classifications, their evolution, the relationship between seriousness and INCS, gender and age and the most prevalent ADRs were also characterized whether or not they are described in the Summary of Product Characteristics (SmPC). It was also characterized as the most prevalent ADRs of INCS with terms belonging to the DME list and in terms of it is description in the SmPC. The age group of the most affected population was 18- 64 years old, and the most affected gender was female. In general, the most reported INCS was mometasone, the ADRs reported were considered, in the majority, as not serious, evolved mainly to cure and were not described in the SmPC. Regarding serious ADRs, the most associated seriousness criteria reported was “Clinically important”. In view of these results, it was concluded that these drugs should continue to be monitored to prevent and reduce ADRs and thus protect the population and public health. Additionally, new studies must be carried out to confirm whether undescribed ADRs could be new safety signals. The second chapter describes the professional experience in the curricular internship in Community Pharmacy, carried out at Farmácia Nelsina, in Viana do Castelo, under the guidance and supervision of Dr. Michael Araújo, from September 11th to December 1st, 2023. This period was crucial to develop the knowledge acquired at college, acquire new skills and understand the role that community pharmacists play in society. The third chapter reports on the activities developed during the curricular internship in Hospital Pharmacy, in the pharmaceutical services of “Centro Hospitalar Universitário Cova da Beira”, between December 4 th, 2023 and January 26 th, 2024, under the guidance and supervision of Dr. Olímpia Fonseca. During this period, I followed the tasks carried out by a hospital pharmacist, as a member of a multidisciplinary team and in the different sectors that make up the hospital pharmacy. This internship was also very enriching for my academic development.
This report is organized into three chapters. The first chapter refers to the research work, in which a study was carried out on the adverse reactions of intranasal corticosteroids (ICNS) reported to EudraVigilance, during the period from January 1, 2011 to June 12, 2023; the second chapter refers to the report of the curricular internship carried out in Community Pharmacy; and the third chapter addresses the report of the curricular internship carried out in Hospital Pharmacy. The first chapter is entitled: “Risks Associated with the Use of Intranasal Corticosteroids: Analysis of Adverse Reactions Reported to EudraVigilance”. Fighting any disease has always been one of the goals of human beings, and drugs were developed early on to combat this. However, drugs are not risk-free. Pharmacovigilance has played a decisive role in controlling adverse drug reactions (ADRs), preventing and minimizing risks associated with public health. Within a wide range of drugs developed, corticosteroids stand out, playing a crucial role in the prevention, control and treatment of the most diverse pathologies. Within this class, there are several that are used through the nasal route, and which are the target of this study. The intranasal corticosteroids analyzed in this study were: beclomethasone, budesonide, flunisolide, fluticasone, mometasone and triamcinolone. In this way, ADRs data associated with INCS reported to EudraVigilance, during the period of January 1, 2011 and June 12, 2023, were analyzed. To this study 2,641 reports were selected, and variables such as the number of reports over the years, including for each of the INCS, the type of reporter, the gender and age of the population, were analyzed. In relation to the ADRs highlighted, they were characterized in terms of their seriousness and seriousness classifications, their evolution, the relationship between seriousness and INCS, gender and age and the most prevalent ADRs were also characterized whether or not they are described in the Summary of Product Characteristics (SmPC). It was also characterized as the most prevalent ADRs of INCS with terms belonging to the DME list and in terms of it is description in the SmPC. The age group of the most affected population was 18- 64 years old, and the most affected gender was female. In general, the most reported INCS was mometasone, the ADRs reported were considered, in the majority, as not serious, evolved mainly to cure and were not described in the SmPC. Regarding serious ADRs, the most associated seriousness criteria reported was “Clinically important”. In view of these results, it was concluded that these drugs should continue to be monitored to prevent and reduce ADRs and thus protect the population and public health. Additionally, new studies must be carried out to confirm whether undescribed ADRs could be new safety signals. The second chapter describes the professional experience in the curricular internship in Community Pharmacy, carried out at Farmácia Nelsina, in Viana do Castelo, under the guidance and supervision of Dr. Michael Araújo, from September 11th to December 1st, 2023. This period was crucial to develop the knowledge acquired at college, acquire new skills and understand the role that community pharmacists play in society. The third chapter reports on the activities developed during the curricular internship in Hospital Pharmacy, in the pharmaceutical services of “Centro Hospitalar Universitário Cova da Beira”, between December 4 th, 2023 and January 26 th, 2024, under the guidance and supervision of Dr. Olímpia Fonseca. During this period, I followed the tasks carried out by a hospital pharmacist, as a member of a multidisciplinary team and in the different sectors that make up the hospital pharmacy. This internship was also very enriching for my academic development.
Description
Keywords
Corticosteróides Intranasais Eudravigilance Farmácia Comunitária Farmácia Hospitalar Farmacovigilância Reação Adversa a Medicamentos