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Publication
Medidas de minimização de risco adicionais em Portugal
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Authors
Advisor(s)
Abstract(s)
Introdução: A gestão do risco é um processo contínuo ao longo do ciclo de vida do
produto e consiste numa avaliação conjunta dos riscos a nível individual e populacional. As
medidas de minimização de risco, previstas num Plano de Gestão de Risco, pretendem reduzir
a ocorrência de uma RAM ou a sua gravidade. Sempre que as medidas de rotina mostrem ser
insuficientes podem ser cumulativamente aplicáveis medidas de minimização de risco
adicionais focadas num problema específico. A avaliação da efetividade permite perceber a
forma como as medidas foram recebidas pela população alvo e o impacto das mesmas.
Metodologia: Estudo descritivo, retrospetivo e observacional sobre Medidas de
Minimização de Risco adicionais em Portugal no período de 2014 a 2018, com recurso a
informação disponibilizada pelo INFARMED, I.P. e de Boletins de Farmacovigilância.
Resultados: No período de estudo foram publicadas 673 medidas de minimização de
risco adicionais, englobando materiais educacionais (81,7 %) e comunicações dirigidas aos
profissionais de saúde (18,3 %). A maioria das medidas corresponde agentes antineoplásicos e
imunomodeladores (44,1 %). As informações adicionais de risco para o profissional de saúde e
para o doente, as informações de prescrição/ administração para profissionais de saúde e os
cartões de alerta para o doente correspondem a mais de 75% da totalidade dos materiais
educacionais aprovados. Cerca de 65 % das medidas teve como assunto principal ou
complementar a partilha de informação acerca de efeitos adversos. Mais de metade das medidas
estão descritas no Plano de Gestão de Risco aprovado para o produto em questão.
Conclusão: A nível nacional, a implementação de medidas adicionais de minimização
de risco é um tópico ainda pouco estudado. As principais medidas implementadas, quer no
âmbito dos PGR, quer decorrentes de acontecimentos não esperados, são materiais educacionais
sob a forma de brochuras ou guias dirigidas a profissionais de saúde, com o intuito de
providenciar informação adicional acerca do risco. A percentagem de PGR com estudos
previstos para avaliação da efetividade das MMR é reduzida, sendo este um dos tópicos mais
importantes a focar no futuro por parte das Autoridades Competentes e titulares de AIM.
Introduction: Risk management is an ongoing process throughout the product life cycle and consists of a joint risk assessment at individual and population level. Risk minimisation measures described in the Risk Management Plan are intended to reduce the occurrence of an adverse drug reaction or its severity. When routine measures are shown to be insufficient, additional risk minimisation measures may be cumulatively applied, focusing on a specific problem. The effectiveness assessment is a strategy to understand how the measurements were received by the target population and their impact. Methodology: Descriptive, retrospective and observational study on Additional Risk Minimization Measures in Portugal from 2014 to 2018, using information provided by INFARMED, I.P. and Boletins de Farmacovigilância. Results: During the study period, 673 additional risk minimization measures were published, covering educational materials (81.7%) and direct healthcare professionals communications (18.3%). Most measures correspond to antineoplastic and immunomodulating agents (44.1%). Additional risk information for the healthcare professional and patient, prescription / administration information for healthcare professionals and patient alert cards correspond to over 75% of all approved educational materials. About 65% of the measures had as their main or complementary subject the communication about adverse effects. More than half of the measures are described in the approved Risk Management Plan for the product concerned. Conclusion: At the national level, the implementation of additional risk minimization measures is a topic that is still under study. The main measures implemented, both within the scope of the RMP or arising from unexpected events, are educational materials in the form of brochures or guides for healthcare professionals to provide additional information about the product’s risk. The percentage of RMPs with studies planned to assess the effectiveness of MMRs is low and this is one of the most important topics to be addressed in the future by the competent authorities and MA holders.
Introduction: Risk management is an ongoing process throughout the product life cycle and consists of a joint risk assessment at individual and population level. Risk minimisation measures described in the Risk Management Plan are intended to reduce the occurrence of an adverse drug reaction or its severity. When routine measures are shown to be insufficient, additional risk minimisation measures may be cumulatively applied, focusing on a specific problem. The effectiveness assessment is a strategy to understand how the measurements were received by the target population and their impact. Methodology: Descriptive, retrospective and observational study on Additional Risk Minimization Measures in Portugal from 2014 to 2018, using information provided by INFARMED, I.P. and Boletins de Farmacovigilância. Results: During the study period, 673 additional risk minimization measures were published, covering educational materials (81.7%) and direct healthcare professionals communications (18.3%). Most measures correspond to antineoplastic and immunomodulating agents (44.1%). Additional risk information for the healthcare professional and patient, prescription / administration information for healthcare professionals and patient alert cards correspond to over 75% of all approved educational materials. About 65% of the measures had as their main or complementary subject the communication about adverse effects. More than half of the measures are described in the approved Risk Management Plan for the product concerned. Conclusion: At the national level, the implementation of additional risk minimization measures is a topic that is still under study. The main measures implemented, both within the scope of the RMP or arising from unexpected events, are educational materials in the form of brochures or guides for healthcare professionals to provide additional information about the product’s risk. The percentage of RMPs with studies planned to assess the effectiveness of MMRs is low and this is one of the most important topics to be addressed in the future by the competent authorities and MA holders.
Description
Tese de mestrado, Regulação e Avaliação do Medicamento e Produtos de Saúde, 2020, Universidade de Lisboa, Faculdade de Farmácia.
Keywords
Farmacovigilância Plano de gestão de risco Medidas de minimização de risco Comunicações dirigidas a profissionais de saúde Materiais educacionais Teses de mestrado -2020