| Name: | Description: | Size: | Format: | |
|---|---|---|---|---|
| 2.66 MB | Adobe PDF |
Abstract(s)
Este trabalho foi desenvolvido no âmbito da Unidade Curricular Estágio e retrata as
atividades desenvolvidas para obtenção do grau de mestre em Ciências Farmacêuticas.
Está organizado em 3 capítulos, consoante as áreas realizadas.
O capítulo 1, relativo à componente de investigação, é uma monografia com o título “Os
Ensaios Clínicos e a sua Regulamentação no Contexto Europeu”. Pretende evidenciar o
papel fundamental dos ensaios clínicos na disponibilização de novos medicamentos no
mercado, bem como a sua necessária regulamentação. Os ensaios clínicos correspondem
à parcela mais longa e dispendiosa do processo de investigação e desenvolvimento de
novos medicamentos e, por isso, são necessariamente bem planeados obedecendo ao
cumprimento de requisitos científicos e éticos devidamente regulamentados. Estes
requisitos foram implementados após uma longa discussão a nível global, à medida que
a sociedade foi sendo confrontada com a revelação de factos chocantes, como as
experiências conduzidas em humanos dos campos de concentração nazis, ou tragédias
associadas ao uso de medicamentos como o famoso caso da talidomida. Se as primeiras
resultaram no estabelecimento de princípios éticos, as segundas tornaram evidente a
necessidade de incorporar ensaios clínicos bem planeados antes da introdução de novos
medicamentos no mercado. Tendo em conta o impacto que os novos medicamentos têm
na saúde pública e na economia das diferentes instituições, a aposta nesta área de
investigação e desenvolvimento, revela-se bastante vantajosa. Na última década e meia,
observou-se uma tendência de diminuição do número de ensaios conduzidos na Europa
e identificaram-se na diretiva vigente motivos para a falta de pedidos por parte dos
promotores. A diretiva foi assim revogada por um regulamento que visa atrair os
promotores, com base na simplificação, harmonização e transparência de todo o
processo de avaliação, aprovação e condução de ensaios clínicos em humanos.
O capítulo 2, descreve a experiência de estágio em Farmácia Hospitalar, numa perspetiva
maioritariamente observacional. Foi desenvolvido nos Serviços Farmacêuticos do Centro
Hospitalar Tondela Viseu e permitiu-me compreender a organização dos Serviços
Farmacêuticos nos seus diversos setores nomeadamente gestão e aprovisionamento;
receção de encomendas e armazenamento; distribuição; ambulatório; farmacotecnia;
unidade centralizada de preparação de citotóxicos; ensaios clínicos e informação sobre
medicamentos. Ao longo do capítulo, pretendo evidenciar como esta divisão é essencial
para proporcionar ao doente do hospital, seja internado, em ambulatório, em hospital de dia ou na urgência, a melhor resposta terapêutica. Destaco como características
fundamentais do farmacêutico hospitalar, a necessária aprendizagem contínua e uma
boa relação com o clínico e restantes profissionais de saúde, para da melhor forma
corresponder às exigências de cada setor.
O capítulo 3, diz respeito ao estágio em Farmácia Comunitária que é a atividade mais
visível do farmacêutico. Também por isso, foi a vertente mais desafiante, devido ao
necessário contacto com os utentes da farmácia. Este relatório pretende evidenciar como
é essencial compreender a organização da farmácia e os critérios de seleção dos produtos
disponibilizados, de forma a assegurar a melhor resposta à comunidade em que a
farmácia se insere. Esta resposta engloba o atendimento de utentes, com ou sem
prescrição médica, que implicam sempre, por parte do farmacêutico, um atendimento
responsável, informado, promovendo o uso racional do medicamento, no cumprimento
dos deveres de farmacovigilância e assente nos princípios e normas de conduta do código
deontológico da Ordem dos Farmacêuticos. Destaco como características fundamentais
do farmacêutico comunitário, a empatia com o utente, espírito de equipa e vontade de
aprender.
This work was developed within the scope of the Curricular Unit Internship and depicts the activities carried out to obtain the master's degree in Pharmaceutical Sciences. It is organized into 3 chapters, corresponding to the areas undertaken. Chapter 1, concerning the research component, is a monograph titled "Clinical Trials and their Regulation in the European Context." It aims to highlight the crucial role of clinical trials in bringing new drugs to the market, as well as the necessary regulations governing them. Clinical trials represent the longest and most expensive part of the research and development process for new drugs and, therefore, they are meticulously planned to adhere to scientifically and ethically regulated requirements. These requirements were implemented after extensive global discussions, as society was confronted with shocking revelations such as the human experiments conducted in Nazi concentration camps or tragedies associated with the use of drugs, such as the infamous case of thalidomide. While the former led to the establishment of ethical principles, the latter made it evident that well-planned clinical trials were necessary before introducing new drugs to the market. Considering the impact that new drugs have on public health and the economy of various institutions, investing in this area of research and development proves to be highly advantageous. In the last decade and a half, there has been a trend of decreasing the number of trials conducted in Europe, and reasons for the lack of requests from promoters were identified in the existing directive. Consequently, the directive was revoked and replaced by a regulation aimed at attracting promoters through the simplification, harmonization, and transparency of the entire evaluation, approval, and conduction process for clinical trials in humans. Chapter 2 describes the internship experience in hospital pharmacy, primarily from an observational perspective. It was carried out in the Pharmaceutical Services of the Tondela Viseu Hospital Center and allowed me to understand the organization of Pharmaceutical Services in various sectors, including management and procurement, order reception and storage, distribution, outpatient care, pharmaceutical technology, centralized unit for cytotoxic preparation, clinical trials, and drug information. Throughout the chapter, I aim to highlight how this division is essential to provide the best therapeutic response to inpatients, outpatients, day hospital patients, or those in emergencies. I emphasize continuous learning and a good relationship with clinicians as fundamental characteristics of the hospital pharmacist to effectively meet the demands of each sector. Chapter 3 concerns the internship in community pharmacy, which is the most visible activity of the pharmacist. For this reason, it was also the most challenging aspect due to the necessary interaction with pharmacy users. This report aims to highlight how crucial it is to understand the organization of the pharmacy and the criteria for selecting available products to ensure the best response to the community in which the pharmacy operates. This response involves serving users with or without a medical prescription, which always requires responsible and informed service from the pharmacist, promoting the rational use of medication in compliance with pharmacovigilance duties and based on the principles and norms of conduct outlined in the code of ethics of the Order of Pharmacists. I emphasize empathy with the user, team spirit, and a willingness to learn as fundamental characteristics of the community pharmacist.
This work was developed within the scope of the Curricular Unit Internship and depicts the activities carried out to obtain the master's degree in Pharmaceutical Sciences. It is organized into 3 chapters, corresponding to the areas undertaken. Chapter 1, concerning the research component, is a monograph titled "Clinical Trials and their Regulation in the European Context." It aims to highlight the crucial role of clinical trials in bringing new drugs to the market, as well as the necessary regulations governing them. Clinical trials represent the longest and most expensive part of the research and development process for new drugs and, therefore, they are meticulously planned to adhere to scientifically and ethically regulated requirements. These requirements were implemented after extensive global discussions, as society was confronted with shocking revelations such as the human experiments conducted in Nazi concentration camps or tragedies associated with the use of drugs, such as the infamous case of thalidomide. While the former led to the establishment of ethical principles, the latter made it evident that well-planned clinical trials were necessary before introducing new drugs to the market. Considering the impact that new drugs have on public health and the economy of various institutions, investing in this area of research and development proves to be highly advantageous. In the last decade and a half, there has been a trend of decreasing the number of trials conducted in Europe, and reasons for the lack of requests from promoters were identified in the existing directive. Consequently, the directive was revoked and replaced by a regulation aimed at attracting promoters through the simplification, harmonization, and transparency of the entire evaluation, approval, and conduction process for clinical trials in humans. Chapter 2 describes the internship experience in hospital pharmacy, primarily from an observational perspective. It was carried out in the Pharmaceutical Services of the Tondela Viseu Hospital Center and allowed me to understand the organization of Pharmaceutical Services in various sectors, including management and procurement, order reception and storage, distribution, outpatient care, pharmaceutical technology, centralized unit for cytotoxic preparation, clinical trials, and drug information. Throughout the chapter, I aim to highlight how this division is essential to provide the best therapeutic response to inpatients, outpatients, day hospital patients, or those in emergencies. I emphasize continuous learning and a good relationship with clinicians as fundamental characteristics of the hospital pharmacist to effectively meet the demands of each sector. Chapter 3 concerns the internship in community pharmacy, which is the most visible activity of the pharmacist. For this reason, it was also the most challenging aspect due to the necessary interaction with pharmacy users. This report aims to highlight how crucial it is to understand the organization of the pharmacy and the criteria for selecting available products to ensure the best response to the community in which the pharmacy operates. This response involves serving users with or without a medical prescription, which always requires responsible and informed service from the pharmacist, promoting the rational use of medication in compliance with pharmacovigilance duties and based on the principles and norms of conduct outlined in the code of ethics of the Order of Pharmacists. I emphasize empathy with the user, team spirit, and a willingness to learn as fundamental characteristics of the community pharmacist.
Description
Keywords
Boas Práticas Clínicas Diretiva Europeia Ensaios Clínicos Ética Farmácia Comunitária Farmácia Hospitalar Fase Clínica Fase Pré-Clínica Regulamento Europeu