A carregar...
Publicação
Uma proposta de modelo de farmacovigilância para Cabo Verde
| Nome: | Descrição: | Tamanho: | Formato: | |
|---|---|---|---|---|
| 4.63 MB | Adobe PDF |
Autores
Orientador(es)
Resumo(s)
Este trabalho de investigação tem por objetivo apresentar uma proposta de modelo de sistema de farmacovigilância adaptada às condições de Cabo Verde, sustentada em dados dos estudos realizados, alinhada com os compromissos de integração na região africana em que Cabo Verde se enquadra e de convergência técnica e normativa com a União Europeia. A farmacovigilância tem-se transformado numa disciplina essencial do ponto de vista da clínica, da ciência e dos assuntos regulamentares. O conhecimento incompleto do perfil de segurança dos medicamentos constitui uma das maiores fragilidades da terapêutica moderna e tem levado à implementação de sistemas de monitorização num grande número de países sob a coordenação da OMS. Cabo Verde, apesar dos avanços notáveis alcançados na área da saúde, tem como fragilidades um sistema de autorização de introdução no mercado de medicamentos ainda em fase de consolidação e a inexistência de um sistema de farmacovigilância. Com o objetivo de suportar a proposta de modelo, procedeu-se a uma análise descritiva dos elementos de convergência, mas também das diferenças, entre modelos de sistemas de farmacovigilância de diferentes regiões e países (capítulo 1). Para que o delineamento da proposta fosse adaptada à realidade de Cabo Verde, foi necessário proceder à caracterização do país em geral, mas com enfoque particular no sistema nacional de saúde e no sistema farmacêutico, que acolherão o funcionamento deste instrumento fundamental para a segurança do utente (capítulo 2). Da conjugação destes elementos e das fragilidades identificadas no país, reconheceu-se a necessidade de obter dados em diversas vertentes da farmacovigilância, nunca antes recolhidos, fundamentais para a formulação da proposta (capítulo 3) e que foram objeto de publicação em revistas científicas da especialidade. O primeiro estudo foi dirigido ao consumidor para caracterizar a dimensão, razões e fatores de risco da compra de medicamentos no mercado ilícito, uma prática crescente em países africanos e que vai contra os princípios de proteção da saúde e a segurança na utilização de medicamentos que a farmacovigilância defende. Os resultados deste estudo mostraram que 25,6% dos inquiridos compra medicamentos fora do circuito legal e que destes, 61,1% não tem a perceção do risco associado a esta prática, pelo que se promoveu, subsequentemente, a realização de um inquérito para aferir os conhecimentos gerais sobre medicamentos e seu uso racional. Os resultados desse segundo estudo identificaram a falta de informação junto da população, registando-se 29,3% sem perceção do risco associado à utilização de medicamentos. Entendeu-se então fundamental, pelo papel que os profissionais de saúde devem ter nesse quesito e atendendo à sua participação em sistemas de farmacovigilância, inquiri-los, por forma a aferir os conhecimentos e sensibilidade para a matéria. O inquérito foi realizado no âmbito do lançamento de uma fase experimental do sistema de notificação espontânea com sessões de sensibilização. Demonstrou-se que apenas 24,8% dos profissionais inquiridos conhecia os objetivos da farmacovigilância e constatou-se uma reduzida participação por parte dos profissionais de hospitais nas sessões de sensibilização (19%). Considerando a importância que os hospitais devem assumir no sistema, foi realizado um estudo de caracterização de suspeitas de reações adversas a medicamentos (RAM) identificadas pela revisão de processos clínicos, utilizando uma metodologia baseada em rastreadores da autoria do Institute for Healthcare Improvement, com o objetivo de testar a utilização da metodologia, caracterizar as suspeitas de RAM, comparar os dados recolhidos antes e depois das sessões referidas e, indiretamente, promover maior interesse por parte dos profissionais de saúde, para com este tema. Foram detetadas suspeitas de RAM em cerca de ¼ dos processos analisados e em mais de 50% dos processos com rastreadores. Conjugados os elementos essenciais da análise dos diferentes modelos de sistemas de farmacovigilância feita no capítulo 1, com a necessária adaptação às condições específicas do país, do sistema de saúde e do setor farmacêutico descritos no capítulo 2 foram identificados os elementos fundamentais a reter para a proposta. Os estudos acima referidos, os primeiros a serem realizados em Cabo Verde na área da farmacovigilância, permitiram obter dados que suportaram a elaboração da proposta de modelo de funcionamento do sistema de farmacovigilância em Cabo Verde (capítulo 4). O modelo proposto funciona, numa perspetiva de evolução gradual, suportado pela metodologia de notificação espontânea e a organização está integrada com a agência reguladora de medicamentos. O âmbito inclui a vertente da segurança e da qualidade de medicamentos prevendo-se o alargamento gradual aos outros produtos de saúde da competência da agência, nomeadamente cosméticos e biocidas. O funcionamento do sistema prevê a identificação das responsabilidades de todos os intervenientes, conta com mecanismos de articulação, designando centros de gestão de risco e uma comissão consultiva e com a colaboração dos programas de saúde existentes na vertente de recolha de informação. O enfoque será feito na informação e comunicação, na recolha e gestão de dados, assumindo-se a geração de sinal como uma competência de instalação gradual. A monitorização será implementada recorrendo a indicadores já estabelecidos. Finalmente, foi feita uma apreciação crítica, com identificação dos principais constrangimentos e fatores de risco ao funcionamento sistema de farmacovigilância (capítulo 5) pois o desenvolvimento do país e a sustentabilidade do sistema de saúde obriga à implementação de um sistema de farmacovigilância que possa ter em conta a realidade cabo-verdiana e as metodologias cientificamente estabelecidas.
This research aims to present a proposal for a model of a pharmacovigilance system adapted to Cabo Verde conditions, sustained on data from studies carried out, aligned with commitments due to integration in the African region in which Cabo Verde is part and due to technical and normative convergence with the EU. Pharmacovigilance has become an essential subject, with regards to clinical science and regulatory affairs. The incomplete knowledge about the safety profile of medicines represents one of the biggest shortcomings of modern therapeutic and has led to the implementation of monitoring systems in several countries, under WHO coordination. Cabo Verde, despite the remarkable progress made in health care, has weakness as a marketing authorization system for medicinal products still in consolidation phase and a lack of a pharmacovigilance system. To support the proposed model, a descriptive analysis has been made, considering both convergence elements and differences between pharmacovigilance model systems from different countries and regions in the world (Chapter 1). In order to be able to present a proposal that could be adequate to Cabo Verde´s reality, it was necessary an overall characterization of the country, focusing in particular the national health and pharmaceutical systems, which will host this critical instrument for patients and users safety (Chapter 2). The combination of all these elements and of the weaknesses identified within the country, it became necessary to obtain data on various aspects of pharmacovigilance related, collected for the first time ever (Chapter 3) and that were subject of publication in scientific journals. The first study was directed to consumers, in order to characterize the extent, reasons and risk factors of buying medicines on the illicit market, a growing practice in African countries, which goes against the principles of health protection that pharmacovigilance stands for. The results of this particular inquiry showed that 25.6% of the questioned buy medicines out of the legal circuit and, within this group, 61.1% has no perception of the risks they are taking, leading, subsequently, to an inquiry to describe the knowledge and attitudes of the consumers regarding the rational use of medicine. The results of this second study identified the lack of information among the population, registering 29.3% without perception of risk associated with the use of medicines. Once diagnosed the lack of information, it was thought to be essential, considering the role health professionals ought to have regarding that specific issue towards the population, and also bearing in mind the role they play within any pharmacovigilance systems, to also inquiry these professionals, so it could be possible to assess their knowledge and awareness on this matter. The inquiry took place at beginning of awareness sessions part of the launch of a experimental initiative for spontaneous reporting. It was possible to identify that only 24.8% of the health professionals that responded knew about pharmacovigilance objectives and it was noted that hospitals professionals had very little participation on this inquiry (19%). Reflecting the importance that hospitals have within the system, it was then conducted a study using a trigger tool methodology developed by the Institute for Healthcare Improvement (IHI) with the purpose of testing this methodology, characterize suspected ADR identified through chart review, compare data collected before and after the above mentioned awareness sessions and, indirectly, to promote an increase of interest by health professionals regarding this subject. Suspected ADR was identified in approximately ¼ of analyzed charts and in more than 50% of charts with identified triggers. Conjugating the essential elements gathered from the analysis of different models in chapter 1, with the necessary adaptation to the specific conditions of the country, health care system and pharmaceutical sector described on chapter 2, the basic elements to be adopted in the proposal were identified. The above referred studies, the first to be held in Cabo Verde in the area of pharmacovigilance, allowed to obtain data to support the model of the proposed pharmacovigilance system in Cape Verde (Chapter 4). The proposed model, within a gradual evolution perspective, is supported by spontaneous reporting methodology and the organization is integrated within the drug regulatory agency. The scope includes safety and quality of medicines but is expected to gradually extend to other health products regulated by the Agency as cosmetics and biocides. The system establish identification of responsabilities of all stakeholders and has coordination mechanisms, designated risk management centers, advisory committee and cooperation with existing heath programs regarding the collection of suspected ADR. The focus will be on information and communication, on data collection and management, assuming that signal generation requires to be a competence for gradual installation. The monitoring system will be implemented using indicators already established. Finally, a critical assessment was made, identifying the main constrains and risk factors to full operation of the pharmacovigilance system in Cabo Verde (Chapter 5) because the country's development and sustainability of the health system requires the implementation of a pharmacovigilance system which can take into account the national reality and scientifically based methodologies.
This research aims to present a proposal for a model of a pharmacovigilance system adapted to Cabo Verde conditions, sustained on data from studies carried out, aligned with commitments due to integration in the African region in which Cabo Verde is part and due to technical and normative convergence with the EU. Pharmacovigilance has become an essential subject, with regards to clinical science and regulatory affairs. The incomplete knowledge about the safety profile of medicines represents one of the biggest shortcomings of modern therapeutic and has led to the implementation of monitoring systems in several countries, under WHO coordination. Cabo Verde, despite the remarkable progress made in health care, has weakness as a marketing authorization system for medicinal products still in consolidation phase and a lack of a pharmacovigilance system. To support the proposed model, a descriptive analysis has been made, considering both convergence elements and differences between pharmacovigilance model systems from different countries and regions in the world (Chapter 1). In order to be able to present a proposal that could be adequate to Cabo Verde´s reality, it was necessary an overall characterization of the country, focusing in particular the national health and pharmaceutical systems, which will host this critical instrument for patients and users safety (Chapter 2). The combination of all these elements and of the weaknesses identified within the country, it became necessary to obtain data on various aspects of pharmacovigilance related, collected for the first time ever (Chapter 3) and that were subject of publication in scientific journals. The first study was directed to consumers, in order to characterize the extent, reasons and risk factors of buying medicines on the illicit market, a growing practice in African countries, which goes against the principles of health protection that pharmacovigilance stands for. The results of this particular inquiry showed that 25.6% of the questioned buy medicines out of the legal circuit and, within this group, 61.1% has no perception of the risks they are taking, leading, subsequently, to an inquiry to describe the knowledge and attitudes of the consumers regarding the rational use of medicine. The results of this second study identified the lack of information among the population, registering 29.3% without perception of risk associated with the use of medicines. Once diagnosed the lack of information, it was thought to be essential, considering the role health professionals ought to have regarding that specific issue towards the population, and also bearing in mind the role they play within any pharmacovigilance systems, to also inquiry these professionals, so it could be possible to assess their knowledge and awareness on this matter. The inquiry took place at beginning of awareness sessions part of the launch of a experimental initiative for spontaneous reporting. It was possible to identify that only 24.8% of the health professionals that responded knew about pharmacovigilance objectives and it was noted that hospitals professionals had very little participation on this inquiry (19%). Reflecting the importance that hospitals have within the system, it was then conducted a study using a trigger tool methodology developed by the Institute for Healthcare Improvement (IHI) with the purpose of testing this methodology, characterize suspected ADR identified through chart review, compare data collected before and after the above mentioned awareness sessions and, indirectly, to promote an increase of interest by health professionals regarding this subject. Suspected ADR was identified in approximately ¼ of analyzed charts and in more than 50% of charts with identified triggers. Conjugating the essential elements gathered from the analysis of different models in chapter 1, with the necessary adaptation to the specific conditions of the country, health care system and pharmaceutical sector described on chapter 2, the basic elements to be adopted in the proposal were identified. The above referred studies, the first to be held in Cabo Verde in the area of pharmacovigilance, allowed to obtain data to support the model of the proposed pharmacovigilance system in Cape Verde (Chapter 4). The proposed model, within a gradual evolution perspective, is supported by spontaneous reporting methodology and the organization is integrated within the drug regulatory agency. The scope includes safety and quality of medicines but is expected to gradually extend to other health products regulated by the Agency as cosmetics and biocides. The system establish identification of responsabilities of all stakeholders and has coordination mechanisms, designated risk management centers, advisory committee and cooperation with existing heath programs regarding the collection of suspected ADR. The focus will be on information and communication, on data collection and management, assuming that signal generation requires to be a competence for gradual installation. The monitoring system will be implemented using indicators already established. Finally, a critical assessment was made, identifying the main constrains and risk factors to full operation of the pharmacovigilance system in Cabo Verde (Chapter 5) because the country's development and sustainability of the health system requires the implementation of a pharmacovigilance system which can take into account the national reality and scientifically based methodologies.
Descrição
Tese de doutoramento, Farmácia (Farmacoepidemiologia), Universidade de Lisboa, Faculdade de Farmácia, 2016
Palavras-chave
Teses de doutoramento - 2016