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Abstract(s)
A presente disseltação foi desenvolvida no ùmbito da Unidade Curricular Estågio e
destina-se Ă obtenção do grau de Mestre em CiĂȘncias FarmacĂȘuticas. Esta encontra-se
dividida em trĂȘs capĂtulos, sendo que, o CapĂtulo I corresponde Ă componente de
Investigação, o CapĂtulo II diz respeito ao relatĂłrio de estĂĄgio em FarmĂĄcia Hospitalar e
o CapĂtulo final correspondente ao relatĂłlio de estĂĄgio em FarmĂĄcia ComunitĂĄria.
o CapĂtulo I diz respeito ao trabalho de investigação desenvolvido sobre as novas
abordagens terapĂȘuticas no tratamento da psorĂase em placas. A psorĂase Ă© Ullla doença
inflamatĂłlia crĂłnica da pele com elevada prevalĂȘncia em Portugal, estando lImitas
vezes associada a um impacto negativo na qualidade de vida dos doentes que a
possuem. A investigação fisiopatolĂłgica da psorĂase permitiu identificar as principais
vias patogénicas envolvidas na doença, o que possibilitou o desenvolvimento de agentes
biológicos. Estes modulam seletivamente as etapas imunológicas envolvidas na indução
e manutenção das lesÔes psoriåticas, apresentando ao mesmo tempo alta eficåcia e
perfil de segurança favoråvel. Os objetivos deste trabalho consistiram na identificação
dos medicamentos biolĂłgicosfbiossimilares com interesse no tratamento da psorĂase
em placas, na identificação dos agentes qu.e estão aprovados em Portugal, e na
identificação dos medicamentos atualmente disponĂveis nos SeIViços FarmacĂȘuticos
Hospitalares Portugueses, dos critérios seguidos pelos Centros Hospitalares/Hospitais
para tratamento da doença e do tipo de acompanhamento efetuado pelos fannacĂȘuticos
hospitalares aos doentes com psorĂase. Para identificar quais os medicamentos
biolĂłgicos/ biossimilares com interesse no tratamento da psorĂase em placas foi
efetuada uma pesquisa bibliogrĂĄfica nas bases de dados PubMed, Scopus e Web of
Science. Para identificar os medicamentos biolĂłgicos aprovados em POltugal para
tratamento da psorĂase em placas, foram consultadas as bases de dados do INFARMED
(Infomed) e da AgĂȘncia Europeia do Medicamento (European Medicines Agency,
EMA). Para atingir os trĂȘs objetivos restantes foram contactados 41 Centros
Hospitalares/Hospitais. Os hospitais que aceitaram colaborar no estudo responderam
por e-mail a trĂȘs questĂ”es. Os medicamentos biolĂłgicos apenas estĂŁo indicados nas
formas moderadas a graves da doença, quando nĂŁo existe resposta Ă s terapĂȘuticas
convencionais, ou quando existe intolerùncia ou contraindicação às mesmas. Existem
12 medicamentos biolĂłgicos com interesse no tratamento da psorĂase em placas: os
inibidores do TNF-Q (adalimumab, infliximab, etanercept, certolizumab-pegol), os
inibidores da interleucina-17 (brodalumab, secucinumab, ixecizumab, bimecizumab), os inibidores da interleucina-23 (guselcumab, lisancizumab, tildracizumab) e os
inibidores da interleucina-12/ 23 (ustecinumab). Atualmente todos estes agentes estĂŁo
aprovados pela EMA e disponĂveis em Portugal. No entanto apenas 10 podem ser
dispensados pelos SFH pOltugueses para o tratamento da doença. A literatura mais
recente indica que os anti-IL-17 e anti-IL-23 sĂŁo mais eficazes que os anti-lNF-a, no
entanto, as OlientaçÔes pOltuguesas indicam que a plimeira linha de tratamento são os
inibidores do lNF-a (adalimumab, inl1iximab, etanercept), devido Ă existĂȘncia de
agentes biossimilares. Todavia, esta classe pode nĂŁo ser a mais adequada a todos os
doentes, pelo que se deve adaptar o tratamento biolĂłgico Ă s comorbilidades dos
doentes com psorĂase. Devido Ă necessidade de um maior controlo e vigilĂąncia da
patologia, das terapĂȘuticas prescritas e tambĂ©m por razĂ”es econĂłmicas, estes
medicamentos sĂŁo cedidos pelos SFH, que efetuam acompanhamento dos doentes com
psorĂase.
o CapĂtulo II relata a minha experiĂȘncia no estĂĄgio cunicular em FarmĂĄcia Hospitalar,
que foi realizado no Hospital Amato Lusitano, em Castelo Branco. O estĂĄgio decorreu
entre 6 de fevereiro e 31 de março de 2023, sob a orientação da Dr.a Sandra Queimado.
Este capĂtulo descreve a organização dos serviços farmacĂȘuticos e as vĂĄrias ĂĄreas de
intervenção do FarmacĂȘutico Hospitalar. Estas vĂŁo desde a seleção e aquisição de
medicamentos, validação das prescriçÔes médicas, dispensa de medicamentos em
ambulatório, preparação de medicamentos manipulados e citotóxicos, fannacocinética,
integração nas comissĂ”es tĂ©cnicas. A presença nos ensaios clĂnicos Ă© outra ĂĄrea de
intervenção do FarmacĂȘutico Hospitalar, que infelizmente nĂŁo tive oportunidade de
vivencial". Esta experiĂȘncia deu-me a conhecer esta palte da profissĂŁo farmacĂȘutica
menos conhecida, que Ă© extremamente impoltante para o bom funcionamento do
hospital.
O CapĂtulo III descreve a minha experiĂȘnc18 de estĂĄgio cunicular em FarmĂĄcia
ComunitĂĄria, que foi realizado na FannĂĄda Oliveira, em Ăbidos, entre 12 de abril e 7 de
julho de 2023, sob a orientação da Dr. a Margarida Oliveira. Este capĂtulo ilustra o
funcionamento da farmĂĄcia e as atividades em que o farmacĂȘutico estĂĄ envolvido no
dia-a-dia da Farmåcia Comunitåria. Estas vão desde as atividades de gestão e receção
de encomendas, controlo de stocks, amlazenamento, dispensa de medicamentos e de
produtos de saĂșde, medição de parĂąmetros analĂticos, aconselhamento farmacĂȘutico,
preparação de manipulados, dispensa de medicamentos hospitalares, e realização da
faturação. Durante esta expeliĂȘncia apliquei de forma mais prĂĄtica vĂĄlios dos
conhecimentos teĂłricos adquiridos ao longo do curso, e desenvolvi capacidades de
comunicação ao interagir com os utentes.
This dissertation was developed within the scope af the Internship Curricular Unit and is intended to obtain a Master's degree in Pharmaceutical Sciences. It is divided into three chapters, with Chapter I corresponding to the Research component, Chapter II concerning the internship repOlt in Hospital Pharmacy, and the final Chapter corresponding to the internship report in Comnmnity Phamlacy. Chapter I concems the research work carried out ou new therapeutic approaches in the treatment af plaque psoriasis. Psoriasis is a chronic inflammatory skin disease with high prevalence in Portugal and is often associated with a negative impact ou the quality af life af patients wha suffer from it. 111e pathophysiological investigation af psoriasis made it possible to identify the main pathogenic pathways involved in the disease, which enabled the development of biological agents. These selectively modulate the immunological steps involved in the induction and maintenance of psoriatic lesions, while presenting high efficacy and a favourable safety profile. The objectives of this work consisted of identifying biologicalfbiosimilar medicines of interest in the treatment of plaque psoriasis, identifying agents that are approved in Portugal, and identifying medicines currently available in Portuguese Hospital Pharmaceutical Services, the criteria followed by Hospital Centres / Hospitals for treating the disease and the type of monitoring canied out by hospital pharmacists for patients with psoriasis. To identify which biologicalfbiosimilar medicines are of interest in the treatment of pia que psoriasis, fi literature sem·ch was carried out in the PllbMed, SCOpllS, and Web ofScience databases. To identify which biologicalmedicines are approved in Portugal for the treatment of plaque psoriasis, the INFARMED (Infomed) and European Medicines Agency (EMA) databases were consulted. To achieve the remaining three objectives, 41 Hos pital Centres/ Hospitais were contacted. The hospitaIs that agreed to collaborate in the study responded to three questions by email. Biological medicines are only indicated for the treatment of moderate to severe forms of the disease, when there is no respo nse to conventional therapies, or when there is intolerance or contraindication to them. There are twelve biological medications with interest in the treatment of plaque psoriasis: TNF-a inhibitors (adalimumab, infliximab, etanercept, certolizumab-pegol), interleukin-17 inhibitors (brodalumab, secukinumab, ixekizumab, bimekizumab), interleukin-23 (guselkumab, lisankizumab, tildrakizumab) and interleukin-12/ 23 inhibitors (ustekinumab). Currently, ali of these agents are approved by the EMA and available in Portugal. However, only ten can be dispensed by the Portuguese SFH to treat the disease. TIle most recent literature indicates that anti-IL-17 and anti-IL-23 are more effective than anti-TNF-a, however, Portuguese guidelines indicate that the first line of treatment is TNF-a inhibitors (adalimumab, infliximab, etanercept), due to the existence of biosimilar agents . However, this class may not be the most suitable for ali patients, so biological treatment must be adapted to the comorbidities of patients with psoriasis. Due to the need for greater control and surveillance of the pathology, prescribed therapies, and also for economic reasons, these medicines are provided by the SFH, which monitor patients with pSOliasis. Chapter II reports on my experience in the curricular internship in Hospital Pharmacy, which was conducted at Hospital Amato Lusitano, in Castelo Branco. TIle internship took place between February 6th and March 31st, 2023, under the guidance of Dr. a Sandra Queimado. TIlis chapter describes the organization of phannaceutical services and the various areas of intervention of t:he Hospital Pharmacist. These range from the selection and acquisition of medicines, validation of medical prescriptions, dispensing of medicines in outpatient clinics, preparation of compounded and cytotoxic medicines, pharmacokinetics, and integration into technical committees. Presence in clinical trials is another area of intervention for the Hospital Pharmacist, which unfOltunately I did not have the opportunity to expelience. This expelience introduced me to this lesserknown part of the phannaceutical profession, which is extremely important for the proper functioning ofthe hospital. Chapter III describes my curricular internship experience in Community Pharmacy, which was conducted at FannĂĄcia Oliveira, in Ăbidos, between April12th and July 7th, 2023, under the guidance of Dr. a Ma rgarida Oliveira. This chapter illustrates the functioning of the pharmacy and the activities in which the pharmacist engages in the day-to-day running of the Community Pharmacy. TIlese range from order management and reception activities, stock control, storage, dispensing of medicines and health products, measurement of analytical parameters, phannaceutical advice, preparation of compounded products, dispensing of h ospital medicines, and billing. During this expenence, I applied more practically several of the theoretical knowledge acquired throughout the course and developed communication skills when interacting with users.
This dissertation was developed within the scope af the Internship Curricular Unit and is intended to obtain a Master's degree in Pharmaceutical Sciences. It is divided into three chapters, with Chapter I corresponding to the Research component, Chapter II concerning the internship repOlt in Hospital Pharmacy, and the final Chapter corresponding to the internship report in Comnmnity Phamlacy. Chapter I concems the research work carried out ou new therapeutic approaches in the treatment af plaque psoriasis. Psoriasis is a chronic inflammatory skin disease with high prevalence in Portugal and is often associated with a negative impact ou the quality af life af patients wha suffer from it. 111e pathophysiological investigation af psoriasis made it possible to identify the main pathogenic pathways involved in the disease, which enabled the development of biological agents. These selectively modulate the immunological steps involved in the induction and maintenance of psoriatic lesions, while presenting high efficacy and a favourable safety profile. The objectives of this work consisted of identifying biologicalfbiosimilar medicines of interest in the treatment of plaque psoriasis, identifying agents that are approved in Portugal, and identifying medicines currently available in Portuguese Hospital Pharmaceutical Services, the criteria followed by Hospital Centres / Hospitals for treating the disease and the type of monitoring canied out by hospital pharmacists for patients with psoriasis. To identify which biologicalfbiosimilar medicines are of interest in the treatment of pia que psoriasis, fi literature sem·ch was carried out in the PllbMed, SCOpllS, and Web ofScience databases. To identify which biologicalmedicines are approved in Portugal for the treatment of plaque psoriasis, the INFARMED (Infomed) and European Medicines Agency (EMA) databases were consulted. To achieve the remaining three objectives, 41 Hos pital Centres/ Hospitais were contacted. The hospitaIs that agreed to collaborate in the study responded to three questions by email. Biological medicines are only indicated for the treatment of moderate to severe forms of the disease, when there is no respo nse to conventional therapies, or when there is intolerance or contraindication to them. There are twelve biological medications with interest in the treatment of plaque psoriasis: TNF-a inhibitors (adalimumab, infliximab, etanercept, certolizumab-pegol), interleukin-17 inhibitors (brodalumab, secukinumab, ixekizumab, bimekizumab), interleukin-23 (guselkumab, lisankizumab, tildrakizumab) and interleukin-12/ 23 inhibitors (ustekinumab). Currently, ali of these agents are approved by the EMA and available in Portugal. However, only ten can be dispensed by the Portuguese SFH to treat the disease. TIle most recent literature indicates that anti-IL-17 and anti-IL-23 are more effective than anti-TNF-a, however, Portuguese guidelines indicate that the first line of treatment is TNF-a inhibitors (adalimumab, infliximab, etanercept), due to the existence of biosimilar agents . However, this class may not be the most suitable for ali patients, so biological treatment must be adapted to the comorbidities of patients with psoriasis. Due to the need for greater control and surveillance of the pathology, prescribed therapies, and also for economic reasons, these medicines are provided by the SFH, which monitor patients with pSOliasis. Chapter II reports on my experience in the curricular internship in Hospital Pharmacy, which was conducted at Hospital Amato Lusitano, in Castelo Branco. TIle internship took place between February 6th and March 31st, 2023, under the guidance of Dr. a Sandra Queimado. TIlis chapter describes the organization of phannaceutical services and the various areas of intervention of t:he Hospital Pharmacist. These range from the selection and acquisition of medicines, validation of medical prescriptions, dispensing of medicines in outpatient clinics, preparation of compounded and cytotoxic medicines, pharmacokinetics, and integration into technical committees. Presence in clinical trials is another area of intervention for the Hospital Pharmacist, which unfOltunately I did not have the opportunity to expelience. This expelience introduced me to this lesserknown part of the phannaceutical profession, which is extremely important for the proper functioning ofthe hospital. Chapter III describes my curricular internship experience in Community Pharmacy, which was conducted at FannĂĄcia Oliveira, in Ăbidos, between April12th and July 7th, 2023, under the guidance of Dr. a Ma rgarida Oliveira. This chapter illustrates the functioning of the pharmacy and the activities in which the pharmacist engages in the day-to-day running of the Community Pharmacy. TIlese range from order management and reception activities, stock control, storage, dispensing of medicines and health products, measurement of analytical parameters, phannaceutical advice, preparation of compounded products, dispensing of h ospital medicines, and billing. During this expenence, I applied more practically several of the theoretical knowledge acquired throughout the course and developed communication skills when interacting with users.
Description
Keywords
BiolĂłgicos Biossimilares FarmĂĄcia ComunitĂĄria FarmĂĄcia Hospitalar PsorĂase em Placas PsorĂase Vulgar Tratamento
Sistémico