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Implementação de planos de prevenção da gravidez (PPG) no âmbito da gestão de risco em Portugal: análise comparativa entre medicamentos
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Introdução: A farmacovigilância engloba o Plano de Gestão de Risco (PGR), no qual estão incluídas as Medidas de Minimização de Risco (MMR). Estas medidas podem ser medidas de minimização de risco de rotina ou adicionais. Nas medidas adicionais estão presentes os Planos de Prevenção da Gravidez (PPG), que são implementados para medicamentos teratogénicos.
Objetivos: Criar uma lista de medicamentos teratogénicos, bem como, analisar e comparar as Medidas de Minimização de Risco (MMR) associadas, que estão implementadas em Portugal.
Materiais e métodos: Foi realizada uma revisão de literatura, recorrendo às bases de dados NCBI, Google e B-on, utilizando termos de pesquisa como: “planos de prevenção da gravidez minimização de risco” ou “teratogenic medication”, com o objetivo de aprofundar o conhecimento sobre este tema e identificar uma parte da listagem dos medicamentos teratogénicos. Seguidamente, no Infomed - base de dados do INFARMED, foram selecionados, e analisados os medicamentos cujas Medidas de Minimização de Risco (MMR) estavam associadas ao uso na gravidez. Finalmente, realizou-se a comparação entre as medidas de minimização de risco implementadas, que incidiu sobre o Resumo de Características do Medicamento (RCM), as Cartas de Comunicação Direta com Profissionais de Saúde (DHPC), os materiais educacionais para profissionais de saúde e para o doente.
Resultados: Foram analisados 113 medicamentos. As Medidas de Minimização de Risco (MMR) de rotina estão presentes em todos. Das Medidas de Minimização de Risco (MMR) adicionais (em 36 medicamentos), as que mais figuram são os guias do doente (16 medicamentos), do profissional de saúde (13 medicamentos) e as Cartas de Comunicação Direta com Profissionais de Saúde (DHPC) (16 medicamentos). As medidas específicas para prevenção da gravidez mais presentes são a utilização de contraceção (96 medicamentos) e os testes de gravidez (28 medicamentos). O ácido valpróico, acitretina, isotreinoína, lenalidomida, pomalidomida, talidomida e vismodegib são os 7 fármacos que apresentam os Planos de Prevenção da Gravidez (PPG) mais elaborados e exigentes. Os profissionais de saúde devem transmitir o risco associado ao medicamento, garantindo que o doente compreende estas informações e recebe os materiais educacionais disponíveis.
Conclusões: Existe uma grande diversidade de abordagens nos medicamentos analisados, desde ter só uma advertência para a possibilidade de teratogenicidade no Resumo de Características do Medicamento (RCM), a Planos de Prevenção da Gravidez (PPG) muito complexos com várias Medidas de Minimização de Risco (MMR) adicionais associadas.
Introduction: Pharmacovigilance includes the Risk Management Plan (RMP), which contains Risk Minimization Measures (MMR). These measures can be routine risk minimization measures or additional risk minimization measures. Teratogenic drugs have implemented additional measures, that include Pregnancy Prevention Plans (PPP). Objectives: Create a list of teratogenic drugs, analyse, and compare the Risk Minimization Measures (RMM), that are implemented in Portugal, associated with them. Materials and methods: Using the NCBI, Google and B-on databases, a literature review was carried out, with keywords such as: “pregnancy prevention plans, risk minimization” or “teratogenic medication”, with the aim of expanding the knowledge on this topic and identify part of the list of teratogenic drugs. Then, the drugs that had Risk Minimization Measures (RMM) associated with pregnancy prevention, were selected in the Infomed - INFARMED database and analysed. Lastly, a comparison was made, between the risk mimization measures, that focused on the Summary of Product Characteristics (SPC), the Direct Communication Letters with Health Professionals (DHPC), the educational materials for health professionals and the patient. Results: It were analysed 113 drugs. Routine Risk Minimization Measures (MMR) are present in all of them. Patient guides (16 drugs), health professional guides (13 drugs) and the Letters of Direct Communication with Health Professionals (DHPC) (16 drugs) are the ones from the additional risk minimization measures (in 36 drugs), that appear the most. The most common measures, that are specific for preventing pregnancy, are the use of contraception (96 drugs) and pregnancy tests (28 drugs). The 7 drugs that have the most elaborate and demanding Pregnancy Prevention Plans (PPP) are Valproic acid, acitretin, isotreinoin, lenalidomide, pomalidomide, thalidomide and vismodegib. Healthcare professionals must convey the risk associated with the medication, ensure that the patient understands this information and receives the educational materials available. Conclusions: There are countless approaches in the analyzed drugs, from only having one warning for the possibility of teratogenicity in the Summary of Product Characteristics (SmPC), to have very complex Pregnancy Prevention Plans (PPP), with various Risk Minimization Measures (RMM) additional associated.
Introduction: Pharmacovigilance includes the Risk Management Plan (RMP), which contains Risk Minimization Measures (MMR). These measures can be routine risk minimization measures or additional risk minimization measures. Teratogenic drugs have implemented additional measures, that include Pregnancy Prevention Plans (PPP). Objectives: Create a list of teratogenic drugs, analyse, and compare the Risk Minimization Measures (RMM), that are implemented in Portugal, associated with them. Materials and methods: Using the NCBI, Google and B-on databases, a literature review was carried out, with keywords such as: “pregnancy prevention plans, risk minimization” or “teratogenic medication”, with the aim of expanding the knowledge on this topic and identify part of the list of teratogenic drugs. Then, the drugs that had Risk Minimization Measures (RMM) associated with pregnancy prevention, were selected in the Infomed - INFARMED database and analysed. Lastly, a comparison was made, between the risk mimization measures, that focused on the Summary of Product Characteristics (SPC), the Direct Communication Letters with Health Professionals (DHPC), the educational materials for health professionals and the patient. Results: It were analysed 113 drugs. Routine Risk Minimization Measures (MMR) are present in all of them. Patient guides (16 drugs), health professional guides (13 drugs) and the Letters of Direct Communication with Health Professionals (DHPC) (16 drugs) are the ones from the additional risk minimization measures (in 36 drugs), that appear the most. The most common measures, that are specific for preventing pregnancy, are the use of contraception (96 drugs) and pregnancy tests (28 drugs). The 7 drugs that have the most elaborate and demanding Pregnancy Prevention Plans (PPP) are Valproic acid, acitretin, isotreinoin, lenalidomide, pomalidomide, thalidomide and vismodegib. Healthcare professionals must convey the risk associated with the medication, ensure that the patient understands this information and receives the educational materials available. Conclusions: There are countless approaches in the analyzed drugs, from only having one warning for the possibility of teratogenicity in the Summary of Product Characteristics (SmPC), to have very complex Pregnancy Prevention Plans (PPP), with various Risk Minimization Measures (RMM) additional associated.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, 2021, Universidade de Lisboa, Faculdade de Farmácia.
Palavras-chave
Contracepção Medicamento Medidas de minimização de risco Planos de prevenção da gravidez Teratogénico Mestrado integrado - 2021