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Reações Adversas dos Medicamentos Anti vertiginosos na população adulta notificadas ao sistema nacional de farmacovigilância
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O presente trabalho foi realizado no âmbito da unidade curricular de Estágio, do
Mestrado Integrado em Ciências Farmacêuticas, e encontra-se dividido em dois
capítulos. O primeiro capítulo diz respeito à análise das notificações de reações adversas
a medicamentos (RAMs) associadas ao uso de medicamentos anti vertiginosos em
adultos, reportadas ao Sistema Nacional de Farmacovigilância (SNF). O segundo
Capítulo corresponde ao relatório de estágio curricular desenvolvido em farmácia
Comunitária, realizado entre os dias 3 de fevereiro e 20 junho de 2025.
O primeiro capítulo, intitulado “Reações Adversas a Medicamentos Anti vertiginosos na
População Adulta Notificadas ao Sistema Nacional de Farmacovigilância”, teve como
objetivo caracterizar o perfil de segurança de seis substâncias ativas com indicação anti
vertiginosa ou frequentemente utilizadas no controlo de sintomas como náuseas,
vómitos e tonturas. O presente estudo descritivo e retrospetivo teve como base a análise
de notificações espontâneas de RAMs submetidas ao Portal RAM, plataforma de
notificação gerida pelo INFARMED no âmbito do SNF. Foram consideradas notificações
registadas entre janeiro de 2014 e dezembro de 2024, referentes a indivíduos com idade
igual ou superior a 18 anos, cuja suspeita de RAM estivesse associada a medicamentos
com indicação anti vertiginosa ou frequentemente utilizados no controlo de sintomas
como náuseas, vómitos e tonturas. As substâncias ativas selecionadas para análise foram:
Cinarizina, Cinarizina + Dimenidrinato, Beta-Histina, Dimenidrinato, Flunarizina,
Ondansetrom e Palonossetrom. Foram excluídas notificações que se encontravam
duplicadas, fora do intervalo temporal definido, relativas a indivíduos com idade inferior
a 18 anos ou que envolviam mais do que um medicamento suspeito não classificado como
anti vertiginoso. Em cada notificação foram avaliados diversos parâmetros,
nomeadamente o tipo de notificador, os dados demográficos dos indivíduos afetados
(sexo e faixa etária), a caracterização das RAMs com base nos grupos System Organ
Classes (SOC), de acordo com a terminologia MedDRA (Medical Dictionary for
Regulatory Activities), bem como a gravidade das reações e os critérios associados a essa
classificação. Durante o período analisado, verificou-se predominância do sexo feminino
(72,41%) entre os doentes. Observou-se variação etária conforme o fármaco em estudo,
sendo que 50,86% dos doentes encontravam-se na faixa etária de 18 a 65 anos. A maioria
das RAMs foi classificada como não grave com 63,79%, apresentando evolução clínica
favorável na maioria dos casos. Os profissionais de saúde foram os principais
notificadores, destacando-se farmacêuticos, médicos e utentes, conforme o fármaco. As
RAMs variaram em função do fármaco, predominando distúrbios do sistema nervoso e
perturbações gerais, sendo que algumas reações não estão descritas nos Resumos das Características do Medicamento (RCM). Não se registaram desfechos fatais. Estes
resultados salientam a importância da farmacovigilância na monitorização contínua do
perfil de segurança destes fármacos.
O segundo capítulo apresenta as atividades realizadas durante o estágio curricular em
Farmácia Comunitária, efetuado na Farmácia Braga, localizada na cidade de Braga, sob
a supervisão da Dra. Helena Carvalho, entre os dias 3 de fevereiro e 20 de junho. Ao
longo deste período, foi possível observar de forma direta o papel do farmacêutico
comunitário na prestação de cuidados de saúde primários, incluindo o aconselhamento
aos utentes, a dispensa de medicamentos, a gestão de terapias crónicas e o apoio à adesão
ao tratamento. O estágio constituiu uma oportunidade valiosa para consolidar os
conhecimentos teóricos adquiridos durante o curso, desenvolver competências técnicas
e interpessoais e aprofundar a compreensão do impacto da prática farmacêutica na saúde
da comunidade.
The present work was carried out within the scope of the Internship curricular unit, of the Integrated Master's Degree in Pharmaceutical Sciences, and is divided into two chapters. The first chapter concerns the analysis of reports of adverse drug reactions (ADRs) associated with the use of antivertigo drugs in adults, reported to the National Pharmacovigilance System (NPS). The second Chapter corresponds to the curricular internship report developed in Community Pharmacy, carried out between February 3 and June 20, 2025. The first chapter, entitled "Adverse Reactions to Antivertigo Drugs in the Adult Population reported to the National Pharmacovigilance System", aimed to characterize the safety profile of six active substances with antivertigo indication or frequently used in the control of symptoms such as nausea, vomiting and dizziness. This descriptive and retrospective study was based on the analysis of spontaneous reports of ADRs submitted to the RAM Portal, a report platform managed by INFARMED within the scope of the NPS. Reports registered between January 2014 and December 2024, referring to individuals aged 18 years or older, whose suspected ADR was associated with drugs with anti-vertigo indication or frequently used to control symptoms such as nausea, vomiting and dizziness, were considered. The active substances selected for analysis were: Cinarizine, Cinarizine + Dimenhydrinate, Beta-Hihistine, Dimenhydrinate, Flunarizine, Ondansetrom and Palonosetrom. Duplicate reports outside the defined time interval for individuals under the age of 18 or involving more than one suspected drug not classified as an antivertigo were excluded. In each report, several parameters were assessed, including the type of reporter, the demographic data of the affected individuals (sex and age group), the characterization of ADRs based on System Organ Classes (SOC) groups, according to MedDRA (Medical Dictionary for Regulatory Activities) terminology, as well as the seriousness of reactions and the criteria associated with this classification. During the period analyzed, there was a predominance of females (72,41%) among the patients. Age variation was observed according to the drug under study, with 50,86% of patients being in the age group of 18 to 65 years. Most ADRs were classified as nonserious (63,19%), with a favorable clinical evolution in most cases. Health professionals were the main notifiers, with pharmacists, physicians and users standing out, depending on the drug. ADRs varied according to the drug, with a predominance of nervous system disorders and general disorders, and some reactions are not described in the Summary of Product Characteristics (SmPC). There were no fatal outcomes. These results highlight the importance of pharmacovigilance in the continuous monitoring of the safety profile of these drugs. The second chapter presents the activities carried out during the curricular internship in Community Pharmacy, carried out at Farmacia Braga, located in the city of Braga, under the supervision of Dr. Helena Carvalho, between the 3rd of February and the 20th of June. Throughout this period, it was possible to directly observe the role of the community pharmacist in the provision of primary health care, including counseling users, dispensing drugs, managing chronic therapies and supporting treatment adherence. The internship was a valuable opportunity to consolidate the theoretical knowledge acquired during the course, develop technical and interpersonal skills and deepen the understanding of the impact of pharmaceutical practice on community health.
The present work was carried out within the scope of the Internship curricular unit, of the Integrated Master's Degree in Pharmaceutical Sciences, and is divided into two chapters. The first chapter concerns the analysis of reports of adverse drug reactions (ADRs) associated with the use of antivertigo drugs in adults, reported to the National Pharmacovigilance System (NPS). The second Chapter corresponds to the curricular internship report developed in Community Pharmacy, carried out between February 3 and June 20, 2025. The first chapter, entitled "Adverse Reactions to Antivertigo Drugs in the Adult Population reported to the National Pharmacovigilance System", aimed to characterize the safety profile of six active substances with antivertigo indication or frequently used in the control of symptoms such as nausea, vomiting and dizziness. This descriptive and retrospective study was based on the analysis of spontaneous reports of ADRs submitted to the RAM Portal, a report platform managed by INFARMED within the scope of the NPS. Reports registered between January 2014 and December 2024, referring to individuals aged 18 years or older, whose suspected ADR was associated with drugs with anti-vertigo indication or frequently used to control symptoms such as nausea, vomiting and dizziness, were considered. The active substances selected for analysis were: Cinarizine, Cinarizine + Dimenhydrinate, Beta-Hihistine, Dimenhydrinate, Flunarizine, Ondansetrom and Palonosetrom. Duplicate reports outside the defined time interval for individuals under the age of 18 or involving more than one suspected drug not classified as an antivertigo were excluded. In each report, several parameters were assessed, including the type of reporter, the demographic data of the affected individuals (sex and age group), the characterization of ADRs based on System Organ Classes (SOC) groups, according to MedDRA (Medical Dictionary for Regulatory Activities) terminology, as well as the seriousness of reactions and the criteria associated with this classification. During the period analyzed, there was a predominance of females (72,41%) among the patients. Age variation was observed according to the drug under study, with 50,86% of patients being in the age group of 18 to 65 years. Most ADRs were classified as nonserious (63,19%), with a favorable clinical evolution in most cases. Health professionals were the main notifiers, with pharmacists, physicians and users standing out, depending on the drug. ADRs varied according to the drug, with a predominance of nervous system disorders and general disorders, and some reactions are not described in the Summary of Product Characteristics (SmPC). There were no fatal outcomes. These results highlight the importance of pharmacovigilance in the continuous monitoring of the safety profile of these drugs. The second chapter presents the activities carried out during the curricular internship in Community Pharmacy, carried out at Farmacia Braga, located in the city of Braga, under the supervision of Dr. Helena Carvalho, between the 3rd of February and the 20th of June. Throughout this period, it was possible to directly observe the role of the community pharmacist in the provision of primary health care, including counseling users, dispensing drugs, managing chronic therapies and supporting treatment adherence. The internship was a valuable opportunity to consolidate the theoretical knowledge acquired during the course, develop technical and interpersonal skills and deepen the understanding of the impact of pharmaceutical practice on community health.
Descrição
Palavras-chave
Anti Vertiginosos Farmácia Comunitária Farmacovigilância Reação Adversas de
Medicamentos