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Abstract(s)
O presente trabalho foi elaborado no âmbito da Unidade Curricular “Estágio”, do Mestrado
Integrado em Ciências Farmacêuticas, encontrando-se dividido em três capítulos: o primeiro
capítulo refere-se a um estudo farmacoepidemiológico de reações adversas às vacinas utilizadas
na imunização contra a COVID-19 recebidas na Unidade de Farmacovigilância da Beira Interior
entre dezembro de 2020 e dezembro de 2021; o segundo capítulo diz respeito ao relatório de
estágio curricular realizado em Farmácia Hospitalar; e o terceiro capítulo apresenta o relatório
de estágio curricular realizado em Farmácia Comunitária.
O primeiro capítulo, intitulado “Reações adversas às vacinas usadas na imunização contra a
COVID-19 notificadas para a Unidade de Farmacovigilância da Beira Interior”, reúne dados
obtidos de um estudo farmacoepidemiológico das reações adversas medicamentosas (RAMs) às
vacinas, notificadas entre dezembro de 2020 e dezembro de 2021. A COVID-19 é uma doença
respiratória aguda, provocada pelo SARSCoV-2, que surgiu pela primeira vez em Wuhan, na
China, em dezembro de 2019. Uma vez que esta doença se tornou uma grave emergência de
saúde pública devido à rápida transmissão do vírus, e tendo em conta que a vacinação pode ser
utilizada para prevenir infeções ou diminuir a gravidade de uma doença, houve a necessidade de
estudar estratégias para desenvolver vacinas contra o novo coronavírus. No entanto, tal como
todos os medicamentos, as vacinas podem apresentar respostas nocivas e não intencionais, que
podem ser notificadas ao Sistema Nacional de Farmacovigilância. Tendo em conta a recente
introdução das vacinas no mercado, e a necessidade de estudar o seu perfil de segurança, o
objetivo deste estudo prendeu-se com a caracterização das RAMs notificadas na região
abrangida pela Unidade de Farmacovigilância da Beira Interior entre dezembro de 2020 e
dezembro de 2021. Durante este período, foram administradas 2 vacinas de mRNA com
nucleósido modificado (Comirnaty e Spikevax) e 2 vacinas com um vetor viral não replicativo
(Vaxzevria e Jcovden). Este estudo englobou 2134 notificações correspondentes a 5685 RAMs.
Foram avaliados vários parâmetros entre os quais a caraterização demográfica da população, a
caraterização das RAMs por órgãos e sistemas afetados, a caraterização das RAMs quanto à
gravidade e critério de gravidade, a caraterização mais pormenorizada das RAMs onde o critério
de gravidade foi “Risco de Vida”, “Hospitalização” e “Morte” e a caraterização das RAMs de
acordo com a evolução da reação. Os nossos resultados evidenciaram que as vacinas mais
notificadas durante este período de estudo foram as vacinas mRNA, encontrando-se a
Comirnaty com um grande destaque, estando a maioria das notificações associadas ao género
feminino e à faixa etária dos 25 aos 49 anos. Os três grupos SOC mais frequentemente
notificados foram “Perturbações gerais e alterações no local de administração”, “Doenças do
Sistema Nervoso”, e “Afeções musculosqueléticas e dos tecidos conjuntivos”, sendo que a
maioria das RAMs foram consideradas “Não graves”. Em geral, as RAMs foram resolvidas em
poucas horas ou dias sem sequelas, o que confirma um perfil de segurança favorável das vacinas. Todavia, sugere-se ainda a realização de estudos futuros que avaliem a gravidade das RAMs
associadas às mesmas, bem como estudos que demonstrem a relação entre a administração das
vacinas e o aparecimento de RAMs não descritas no Resumo das Caraterísticas do
Medicamento, de forma a atualizar o perfil de segurança das vacinas. Este estudo demonstrou a
importância da Farmacovigilância na deteção e prevenção de RAMs, diminuindo o
aparecimento dos resultados negativos associados aos medicamentos e consequentemente
aumentando a qualidade de vida dos utentes que os utilizam.
O segundo capítulo descreve as atividades decorrentes durante o estágio curricular em Farmácia
Hospitalar, nos Serviços Farmacêuticos do Centro Hospitalar Universitário da Cova da Beira,
entre o dia 7 de fevereiro e o dia 25 de março de 2022, sob a orientação da Dr.a
Maria Olímpia
Fonseca. Este relatório descreve as atividades desenvolvidas nos Serviços Farmacêuticos, nos
vários setores que o compõem, as quais tive oportunidade de acompanhar durante o período de
estágio, e que me permitiram observar o circuito do medicamento. Este estágio permitiu
consolidar o que aprendi ao longo do curso bem como ter o contato com a prática farmacêutica
em âmbito hospitalar, adquirindo assim novas competências em contexto real.
O terceiro capítulo descreve as atividades decorrentes durante o estágio curricular em Farmácia
Comunitária, na Farmácia Avenida situada na cidade do Fundão, entre o dia 28 de março e o dia
23 de junho de 2022, sob orientação da Dr.a Cátia Pereira. Este relatório descreve as atividades
realizadas durante o estágio e as funções inerentes ao farmacêutico comunitário. Durante este
período tive oportunidade de verificar o papel crucial do farmacêutico na sociedade e consolidar
os conhecimentos adquiridos ao longo do curso, bem como adquirir novas competências.
The present work was elaborated within the scope of the Curricular Unit "Internship", inserted in the Integrated Master in Pharmaceutical Sciences, and is structured in three chapters: the first chapter concerns a pharmacoepidemiological study of adverse reactions to vaccines used in immunization against COVID -19 notified to the Beira Interior Pharmacovigilance Unit between December 2020 and December 2021; the second chapter refer to the report of the curricular internship in Hospital Pharmacy; and the third chapter presents the report of the curricular internship in Community Pharmacy. The first chapter, entitled “Adverse reactions to vaccines used in immunization against COVID19 notified to the Pharmacovigilance Unit of Beira Interior”, presents the results of a pharmacoepidemiological study of vaccines adverse drug reactions (ADRs), occurred in Portugal, between December 2020 and December 2021. COVID-19 is an acute respiratory disease caused by SARSCoV-2, which first emerged in Wuhan, China, in December 2019. Since this disease has become a serious public health emergency due to the rapid transmission of the virus and given that vaccination can be used to prevent infections or reduce the seriousness of a disease, there was a need to study strategies to develop vaccines against the new coronavirus. However, like all medicines, vaccines can present harmful and unintended responses, which can be reported to the National Pharmacovigilance System. Considering the recent market introduction of vaccines used in immunization against COVID-19, and the need to study their safety profile, the aim of this study was to characterize the ADRs notified in the region covered by the Pharmacovigilance Unit of Beira Interior between December 2020 and December 2021. During this period, 2 mRNA vaccines with modified nucleoside (Comirnaty and Spikevax) and 2 vaccines with a non-replicating viral vector (Vaxzevria and Jcovden) were administered. 2134 reports were studied corresponding to 5685 ADRs. Several parameters were evaluated, including the demographic characterization of the population, the characterization of ADRs by affected organs and systems, the characterization of ADRs in terms of seriousness and seriousness criteria, the characterization of ADRs where the seriousness criteria were “Life Risk”, “Hospitalization” and “Death” and the characterization of ADRs according to the evolution of the reaction. Our results showed that the most notified vaccines during this study period were mRNA vaccines, with Comirnaty being the most prominent. Most notifications were associated with the female gender and the age group from 25 to 49 years. The three most frequently reported SOC groups were “General disorders and administration site conditions”, “Nervous system disorders”, and “Musculoskeletal and connective tissue disorders”, with the majority of ADRs being considered “Non-serious”. In general, ADRs resolved within a few hours or days without sequelae, which confirms a favourable safety profile of the vaccines. However, further studies are suggested to assess the seriousness of ADRs associated with them, as well as studies to demonstrate the relationship between the administration of vaccines and theappearance of ADRs not described in the Summary of Drug Characteristics, in order to update the vaccine safety profile. This study demonstrated the importance of Pharmacovigilance in the detection and prevention of ADRs, decreasing the appearance of negative results associated with drugs and consequently increasing the quality of life of patients who use them. The second chapter describes the activities arising during the curricular internship in Hospital Pharmacy, at Centro Hospitalar Universitário da Cova da Beira, between February 7th and March 25th of 2022, under the guidance of Dr. Maria Olímpia Fonseca. This report describes the activities carried out in Hospital Pharmacy, in the various sectors that integrate it, which I had the opportunity to follow during the internship, and which allowed me to observe the drug circuit. This internship allowed me to consolidate what I learned during the course as well as to have contact with pharmaceutical practice in a hospital environment, thus acquiring new skills in a real context. The third chapter describes the activities arising during the curricular internship in Community Pharmacy, at Farmácia Avenida located in the city of Fundão, between March 28th and June 23rd of 2022, under the guidance of Dr. Cátia Pereira. This report describes the activities carried out during the internship and the functions inherent to the community pharmacist. During this period, I had the opportunity to verify the crucial role of the pharmacist in society and consolidate the knowledge acquired throughout the course, as well as acquire new skills
The present work was elaborated within the scope of the Curricular Unit "Internship", inserted in the Integrated Master in Pharmaceutical Sciences, and is structured in three chapters: the first chapter concerns a pharmacoepidemiological study of adverse reactions to vaccines used in immunization against COVID -19 notified to the Beira Interior Pharmacovigilance Unit between December 2020 and December 2021; the second chapter refer to the report of the curricular internship in Hospital Pharmacy; and the third chapter presents the report of the curricular internship in Community Pharmacy. The first chapter, entitled “Adverse reactions to vaccines used in immunization against COVID19 notified to the Pharmacovigilance Unit of Beira Interior”, presents the results of a pharmacoepidemiological study of vaccines adverse drug reactions (ADRs), occurred in Portugal, between December 2020 and December 2021. COVID-19 is an acute respiratory disease caused by SARSCoV-2, which first emerged in Wuhan, China, in December 2019. Since this disease has become a serious public health emergency due to the rapid transmission of the virus and given that vaccination can be used to prevent infections or reduce the seriousness of a disease, there was a need to study strategies to develop vaccines against the new coronavirus. However, like all medicines, vaccines can present harmful and unintended responses, which can be reported to the National Pharmacovigilance System. Considering the recent market introduction of vaccines used in immunization against COVID-19, and the need to study their safety profile, the aim of this study was to characterize the ADRs notified in the region covered by the Pharmacovigilance Unit of Beira Interior between December 2020 and December 2021. During this period, 2 mRNA vaccines with modified nucleoside (Comirnaty and Spikevax) and 2 vaccines with a non-replicating viral vector (Vaxzevria and Jcovden) were administered. 2134 reports were studied corresponding to 5685 ADRs. Several parameters were evaluated, including the demographic characterization of the population, the characterization of ADRs by affected organs and systems, the characterization of ADRs in terms of seriousness and seriousness criteria, the characterization of ADRs where the seriousness criteria were “Life Risk”, “Hospitalization” and “Death” and the characterization of ADRs according to the evolution of the reaction. Our results showed that the most notified vaccines during this study period were mRNA vaccines, with Comirnaty being the most prominent. Most notifications were associated with the female gender and the age group from 25 to 49 years. The three most frequently reported SOC groups were “General disorders and administration site conditions”, “Nervous system disorders”, and “Musculoskeletal and connective tissue disorders”, with the majority of ADRs being considered “Non-serious”. In general, ADRs resolved within a few hours or days without sequelae, which confirms a favourable safety profile of the vaccines. However, further studies are suggested to assess the seriousness of ADRs associated with them, as well as studies to demonstrate the relationship between the administration of vaccines and theappearance of ADRs not described in the Summary of Drug Characteristics, in order to update the vaccine safety profile. This study demonstrated the importance of Pharmacovigilance in the detection and prevention of ADRs, decreasing the appearance of negative results associated with drugs and consequently increasing the quality of life of patients who use them. The second chapter describes the activities arising during the curricular internship in Hospital Pharmacy, at Centro Hospitalar Universitário da Cova da Beira, between February 7th and March 25th of 2022, under the guidance of Dr. Maria Olímpia Fonseca. This report describes the activities carried out in Hospital Pharmacy, in the various sectors that integrate it, which I had the opportunity to follow during the internship, and which allowed me to observe the drug circuit. This internship allowed me to consolidate what I learned during the course as well as to have contact with pharmaceutical practice in a hospital environment, thus acquiring new skills in a real context. The third chapter describes the activities arising during the curricular internship in Community Pharmacy, at Farmácia Avenida located in the city of Fundão, between March 28th and June 23rd of 2022, under the guidance of Dr. Cátia Pereira. This report describes the activities carried out during the internship and the functions inherent to the community pharmacist. During this period, I had the opportunity to verify the crucial role of the pharmacist in society and consolidate the knowledge acquired throughout the course, as well as acquire new skills
Description
Keywords
Coronavírus Covid-19 Farmácia Comunitária Farmácia Hospitalar Farmacovigilância Reações Adversas Medicamentosas Segurança Sistema Nacional de Farmacovigilância Vacinas