Guía de práctica clínica de consenso de la Sociedad Andaluza de Epilepsia sobre prescripción de fármacos antiepilépticos genéricos / Consensus clinical practice guidelines of the andalusian epilepsy society on prescibing generic antiepileptic drugs

Resumen. Introducción. El consumo farmacéutico en España supone el 1,2-1,4% del producto interior bruto y aumenta anualmente un 5-12%. Entre las medidas estatales adoptadas para moderar este gasto está la posibilidad de sustituir el fármaco original prescrito por su genérico. En el caso de los fármacos antiepilépticos (FAE), caracterizados por un escaso margen terapéutico, dicha medida ha generado un debate científico acerca de su repercusión sobre el control del enfermo epiléptico. Nos proponemos la elaboración de una guía de práctica de consenso basada en evidencias implícitas acerca de cuestiones relacionadas con este tema. Desarrollo. Realizamos una búsqueda selectiva de la información científica de calidad vinculada con el objetivo propuesto en Pubmed-Medline, Tripdatabase y Biblioteca Cochrane Plus. Las referencias seleccionadas fueron analizadas y discutidas por los autores y se extrajeron las recomendaciones de ellas derivadas. Se identificaron 21 documentos primarios y 16 guías de práctica, protocolos o recomendaciones de expertos. Nuestras recomendaciones se recogieron al final del documento de manera explícita. Conclusiones. La Sociedad Andaluza de Epilepsia recomienda: 1) no sustituir un FAE innovador por su genérico en un epiléptico controlado; 2) es admisible iniciar un tratamiento con un FAE genérico en monoterapia o en asociación; 3) no intercambiar FAE genéricos de distintas empresas farmacéuticas; 4) explicar al paciente las normas de autorización de los genéricos y la importancia de evitar intercambios entre diferentes FAE genéricos; y 5) en caso de empeoramiento clínico o efectos adversos tras la introducción de un genérico, investigar las razones y comunicarlos a los órganos de farmacovigilancia (AU)

Summary. Introduction. Pharmaceutical spending in Spain accounts for 1.2-1.4% of the gross domestic product and is increasing by 5-12% per year. One of the measures adopted by the government to cut this spending is the possible substitution of original prescribed drugs by generics. In the case of antiepileptic drugs (AED), which are characterised by a scant therapeutic margin, these steps have sparked a scientific debate about their repercussion on the control of epileptic patients. We propose to draw up a set of implicit evidence-based consensus practice guidelines concerning issues related with this topic. Development. A selective search for quality scientific information on the subject was conducted on PubMed-Medline, Tripdatabase and the Biblioteca Cochrane Plus. The selected references were analysed and discussed by the authors, and the recommendations deriving from them were collected. A total of 21 primary documents and 16 practice guidelines, protocols or experts’ recommendations were identified. Our recommendations were explicitly included at the end of the text. Conclusions. The Andalusian Epilepsy Society makes the following recommendations: 1) not replacing an innovative AED by its generic in a controlled patient; 2) beginning treatment with a generic AED in monotherapy or in association is acceptable; 3) not exchanging generic AED from different pharmaceutical companies; 4) explaining to the patient the rules governing the authorisation of generics and the importance of avoiding exchanges between different generic AED; and 5) if there is some worsening of the clinical condition or side effects appear following the introduction of a generic, the causes must be investigated and communicated to the bodies responsible for pharmacovigilance (AU)

[Consensus clinical practice guidelines of the Andalusian Epilepsy Society on prescribing generic antiepileptic drugs]. / Guía de práctica clínica de consenso de la Sociedad Andaluza de Epilepsia sobre prescripción de fármacos antiepilépticos genéricos.

INTRODUCTION: Pharmaceutical spending in Spain accounts for 1.2-1.4% of the gross domestic product and is increasing by 5-12% per year. One of the measures adopted by the government to cut this spending is the possible substitution of original prescribed drugs by generics. In the case of antiepileptic drugs (AED), which are characterised by a scant therapeutic margin, these steps have sparked a scientific debate about their repercussion on the control of epileptic patients. We propose to draw up a set of implicit evidence-based consensus practice guidelines concerning issues related with this topic. DEVELOPMENT: A selective search for quality scientific information on the subject was conducted on PubMed-Medline, Tripdatabase and the Biblioteca Cochrane Plus. The selected references were analysed and discussed by the authors, and the recommendations deriving from them were collected. A total of 21 primary documents and 16 practice guidelines, protocols or experts' recommendations were identified. Our recommendations were explicitly included at the end of the text. CONCLUSIONS: The Andalusian Epilepsy Society makes the following recommendations: 1) not replacing an innovative AED by its generic in a controlled patient; 2) beginning treatment with a generic AED in monotherapy or in association is acceptable; 3) not exchanging generic AED from different pharmaceutical companies; 4) explaining to the patient the rules governing the authorization of generics and the importance of avoiding exchanges between different generic AED; and 5) if there is some worsening of the clinical condition or side effects appear following the introduction of a generic, the causes must be investigated and communicated to the bodies responsible for pharmacovigilance.

[Consensus clinical practice guidelines of the Andalusian Epilepsy Society: therapeutic recommendations when dealing with a first epileptic seizure and in epileptic status]. / Guia de practica clinica de consenso de la Sociedad Andaluza de Epilepsia: recomendaciones terapeuticas ante una crisis epileptica y en el estado epileptico.

INTRODUCTION: Most epileptic seizures are brief and self-limiting, but sometimes they can last longer than expected and this entails (in the case of generalised seizures) a high risk of morbidity and mortality, which increases as they get longer. This severity justifies the need to draw up a set of consensus-based practice guidelines based on implicit evidence, to use Liberati's nomenclature, concerning aspects related to the recommended therapeutic management of a patient with prolonged seizures who is being attended in an emergency department. MATERIALS AND METHODS: A selective search was conducted on PubMed-Medline for scientific information related to the subject using scientific evidence filters. This search was completed in other scientific evidence search engines, such as Tripdatabase, Biblioteca Cochrane Plus or DARE. The selected references were analysed and discussed by the authors, and the available evidence and any recommendations that could be drawn from it were collected. RESULTS: The search revealed the existence of 33 primary documents and six practice guidelines or protocols related with the topic under study. The recommendations were inserted in the text explicitly. CONCLUSIONS: The therapeutic protocol must be started when faced with any seizures that last more than five minutes. First, steps must be taken to ensure proper respiratory and cardiocirculatory functioning, and then fast-acting antiepileptic drugs are administered intravenously and in high doses until the cause is identified and controlled. Due to their lower level of morbidity and mortality, prolonged non-convulsive seizures do not generally require therapy that is so vigorous and with such a high risk of complications.

[Consensus clinical practice guidelines of the Sociedad Andaluza de Epilepsia for the diagnosis and treatment of patients with their first epileptic seizure in emergencies]. / Guía de práctica clínica de consenso de la Sociedad Andaluza de Epilepsia para el diagnóstico y tratamiento del paciente con una primera crisis epiléptica en situaciones de urgencia.

INTRODUCTION AND AIMS: Epileptic seizures are the cause of between 0.3 and 1.2% of all visits to hospital emergency departments. Twenty-five per cent of patients visit after having their first seizure. Such an impact seems to justify the development of a health care protocol. Our proposal is to draw up a set of implicit evidence-based consensus practice guidelines, to use Liberati's nomenclature, concerning aspects related to the diagnostic procedure and recommended therapeutic management of patients with a first seizure who are being attended in an emergency department. MATERIALS AND METHODS: A selective search was conducted on PubMed-Medline for quality scientific information on the subject using scientific evidence filters. This search was completed in other scientific evidence search engines, such as Tripdatabase, Biblioteca Cochrane Plus or DARE. The selected references were analysed and discussed by the authors, and the available evidence and any recommendations that could be drawn from it were collected. RESULTS: A total of 47 primary documents and 10 practice guidelines or protocols related with the proposed topic were identified. The recommendations were inserted in the text explicitly. CONCLUSIONS: The diagnostic and therapeutic protocol for all paroxysmal phenomena in emergencies consists of three successive phases: diagnosis of the cause of the epilepsy, integration of the significance of the seizure within the clinical context, and designing the therapeutic scheme. Each phase will depend on the outcomes of the previous one as a decision algorithm. The fundamental tools in each phase are: patient record and examination (phase 1), and complementary tests (phase 2). They are then used to produce a therapeutic decision scheme.

[The safety and tolerability profile of gabapentin in optimal doses]. / Perfil de seguridad y tolerabilidad de gabapentina en dosis óptimas.

INTRODUCTION: Gabapentin (GBP) is an amino acid that is structurally analogous to GABA with the capacity to cross the blood-brain barrier and an antiepileptic action. It is indicated in the treatment of partial seizures with or without secondary generalisation. It has been suggested that the dosages used in pilot studies were not suitable to achieve optimal efficiency. AIMS: The aims of this study were to investigate the safety and tolerability of GBP with doses above those initially advocated in the literature. DEVELOPMENT: We review its pharmacological characteristics and analyse the results of different placebo-controlled, open, short and long-term trials, both in monotherapy and associated to other antiepileptic drugs. CONCLUSION: Enough evidence was found to allow us to state that the efficiency of GBP can be increased with the utilisation of higher doses than those recommended to date, without the risk of generating unacceptable side effects at the same time.