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O que os RCM (não) dizem acerca das alergias aos β-lactâmicos
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Os β-lactâmicos são o tipo de antibiótico mais usado em Portugal, e cerca de 10% dos doentes considera-se alérgico às penicilinas, o tipo de antibiótico mais usado. Destes, estima-se que 90% tolere penicilinas sem reacções de hipersensibilidade.
As reacções cruzadas entre os diversos grupos de β-lactâmicos não são mediadas apenas pelo anel β-lactâmico, mas também pelas cadeias laterais variáveis que fazem parte da estrutura destes fármacos e que são iguais/semelhantes em alguns casos.
A identificação dos mecanismos que levam a reacção imunomediada em cada caso - que provocam reacções cruzadas entre os diversos fármacos - permite a identificação dos casos passíveis de colocar o problema de reactividade cruzada. Com base neste facto, foram desenvolvidos testes simples e eficazes que avaliam em cada doente se este é ou não sensível aos fármacos em questão.
Em Portugal, o INFARMED, I. P. tem por missão regular e supervisionar o sector dos medicamentos, bem como promover o acesso dos profissionais de saúde às informações necessárias à utilização racional de medicamentos de uso humano. Para isso, aprova o RCM (Resumo das Características do Medicamento) dos medicamentos para uso humano, assegurando que têm a informação relevante, correcta e actualizada.
Neste trabalho é feita a revisão da literatura recente, focando-se sobretudo em fontes de investigação recente e em revisões da literatura/textos académicos/guidelines publicadas nos últimos anos, sobre reactividade imunológica a β-lactâmicos. Foram coligidos os RCM disponibilizados pelo INFARMED, I. P. sobre todos os β-lactâmicos disponíveis em Portugal à data de 31 de Outubro de 2015, e procedeu-se à discussão da informação disponibilizada acerca de contraindicações e avisos de reactividade cruzada dos β-lactâmicos, comparando-a com a informação recolhida anteriormente e propondo-se a uniformização da informação presente.
Concluímos que a informação é pouco uniforme e que parte importante dos conhecimentos recentes – referente aos testes cutâneos – está quase ausente, pelo que deve ser feita uma revisão destes documentos, de forma a cumprir o objectivo de serem o documento de referência para os profissionais de saúde acerca dos fármacos a nível nacional.
The β-lactam antibiotics are the most used antibiotics in Portugal. 10% of the patients consider themselves as being allergic to penicillins, the most used antibiotic. Of those, about 90% can tolerate penicillins without hypersensivity reactions. The cross reactions between β-lactam antibiotics aren’t exclusively caused by reactions to the β-lactam ring, but also by the variable side chains that are part of the structure of these molecules and that are the same in some cases. Identifying the mechanisms of immunomediated reactions in each case – which cause the cross reactivity between the different drugs – allow for identification of the situations prone to cross react. With this knowledge, simple and effective tests were developed which evaluate if each patient is hypersensitive to a certain drug. In Portugal, INFARMED, I. P. is responsible for regulating and supervising the medicines department as well as promoting the access of healthcare professionals to the information needed for the rational use of medicines for use in humans. With that goal in mind, INFARMED, I. P. approves the SmPC (Summary of Product Characteristics) of the medicines for use in humans, making sure it has all the relevant information, correct and up to date. In this essay a short review of the recent publications was made, mostly using recent articles and recently published reviews/academic works/guidelines, in an attempt to give a general view on the current knowledge about immune mediated reactivity between β-lactam antibiotics. Then, a database was built using the SmPCs available in INFARMED, I. P.’s own database with all the β-lactam antibiotics available by October 31st 2015, and the information available in the SmPCs about the contraindications and the warnings for use considering the cross reactivity between β-lactam antibiotics was discussed. Using the literary review and this essay’s database, some suggestions to standardize the information given were made. The conclusion of this essay was the information is not standardized and that an important part of the recent developments – the skin tests – is almost absent. It is important to review the SmPCs so that they accomplish their goal of being the document of reference for the healthcare professionals about the drugs available on national level.
The β-lactam antibiotics are the most used antibiotics in Portugal. 10% of the patients consider themselves as being allergic to penicillins, the most used antibiotic. Of those, about 90% can tolerate penicillins without hypersensivity reactions. The cross reactions between β-lactam antibiotics aren’t exclusively caused by reactions to the β-lactam ring, but also by the variable side chains that are part of the structure of these molecules and that are the same in some cases. Identifying the mechanisms of immunomediated reactions in each case – which cause the cross reactivity between the different drugs – allow for identification of the situations prone to cross react. With this knowledge, simple and effective tests were developed which evaluate if each patient is hypersensitive to a certain drug. In Portugal, INFARMED, I. P. is responsible for regulating and supervising the medicines department as well as promoting the access of healthcare professionals to the information needed for the rational use of medicines for use in humans. With that goal in mind, INFARMED, I. P. approves the SmPC (Summary of Product Characteristics) of the medicines for use in humans, making sure it has all the relevant information, correct and up to date. In this essay a short review of the recent publications was made, mostly using recent articles and recently published reviews/academic works/guidelines, in an attempt to give a general view on the current knowledge about immune mediated reactivity between β-lactam antibiotics. Then, a database was built using the SmPCs available in INFARMED, I. P.’s own database with all the β-lactam antibiotics available by October 31st 2015, and the information available in the SmPCs about the contraindications and the warnings for use considering the cross reactivity between β-lactam antibiotics was discussed. Using the literary review and this essay’s database, some suggestions to standardize the information given were made. The conclusion of this essay was the information is not standardized and that an important part of the recent developments – the skin tests – is almost absent. It is important to review the SmPCs so that they accomplish their goal of being the document of reference for the healthcare professionals about the drugs available on national level.
Descrição
Trabalho Final do Curso de Mestrado Integrado em Medicina, Faculdade de Medicina, Universidade de Lisboa, 2016
Palavras-chave
Beta-lactâmicos Antibióticos Sensibilidade à medicação Bulas de medicamentos