An account on the history of pharmacology in Spain.

Here we present an account on the history of pharmacology in Spain. Pharmacology as an independent science in Europe began with the creation of university chairs. Of particular relevance was the appointment in 1872 of Osswald Shmiedeberg as chairman of an Institute of Pharmacology at the University of Strassbourg, Germany. Teófilo Hernando pioneered in Spain the new emerging pharmacology at the beginning of the XX Century. He made a posdoctoral stay in the laboratory of Schmiedeberg, working on digitalis. In 1912 he won the chair of "Materia Médica y Arte de Recetar" at "Universidad Central of Madrid" (today, "Universidad Complutense de Madrid", UCM). He soon decided to transform such subject to the emerging modern pharmacology, with the teaching of experimental pharmacology in the third course of medical studies and clinical therapeutics (today clinical pharmacology) in the sixth course. This was the status of pharmacology in 1920, supporting the view that Hernando was a pioneer of clinical pharmacology. However, the Spanish Civil War and the II Word War interropted this division of preclinical and clinical pharmacology; only in the 1980's was clinical pharmacolgy partially developed in Spain. From a scientific point of view, Hernando directly trained various young pharmacologists that extended the new science to various Spanish universities. Some of his direct disciples were Benigno Lorenzo Velázquez, Francisco García Valdecasas, Rafael Méndez, Tomás Alday, Gabriel Sánchez de la Cuesta, Dámaso Gutiérrez or Ramón P é rez-Cirera. One of the central research subject was the analysis of the effects of digitalis on the cat and frog heart. In the initiation of the 1970 s pharmacologists trained by those Hernando's students grew throughout various universities and the "Consejo Superior de Investigaciones Científicas" (CSIC). And hence, in 1972 the "Sociedad Española de Farmacología" (SEF) emerged. Later on, in the 1990's the "Sociedad Española de Farmacología Clínica (SEFC) also emerged. The relationship between the two societies is still weak. Out of the vast scope of the pharmacological sciences, Spanish pharmacologists have made relevant contributions in two areas namely, neuropsychopharmacology and cardiovacular pharmacology. Nonetheless, in other areas such as smooth muscle, gastroenterology, pharmacogenetics and hepatic toxicity, Spanish pharmacologists have also made relevant contributions. A succint description of such contributions is made. Finally, some hints on perspectives for the further development of preclinical and clinical pharmacology in Spain, are offered.

[Prescription of acetylcholinesterase inhibitors and memantine in the Canary Islands, comparison with the Spanish population.] / Prescripción de inhibidores de acetilcolinesterasa y memantina en Canarias: comparación con la población española.

OBJECTIVE: In the Canary Islands the prescriptions billed to the National Health System are registered in a database (FarmaCanarias). The main objective was to estimate the consumption of Acetylcholinesterase inhibitors (IACE) and Memantine in Canary Islands and to compare with a Spanish sample from Pharmacoepidemiological Research Base in Primary Care (PRBPC) which is national in scope. As secondary we determined the percentage in treatment in the Spanish sample. METHODS: The prescriptions of IACE and / or memantine in 2017 were calculated as Defined Daily Doses per 100 habitants (DHD) in FarmaCanarias and PRBPC. The prescriptions in FarmaCanarias were disclosed by island and age groups were also compared. The percentage of cases in treatment was calculated in PRBPC from records with diagnosis of "dementia". All the comparations were made by Pearson's χ2. RESULTS: The prescription of IACE and Memantine was: 3.042% (95% CI; 3.039-3.045) and 1.584% (95% CI; 1.582-1.587) in The Canary islands, respectively and 2.545% (95% CI; 2.518-2.572) and 0.922% (95% CI; 0.906-0.938), in PRBPC (p<0.001). DHDs between islands were different, except in two (p<0.001) The distribution by age group between FarmaCanarias and PRBPC was hetereogeneous (p<0.001). The percentage of dementia cases in treatment in PRBPC was 45.51% (95% CI; 45.186-45.838). CONCLUSIONS: The prescription of IACE and Memantine was higher in the Canary Islands, which added to the difference by age group, suggests epidemiological differences in dementia compared to the mainland. There is heterogeneity between islands that could be due to epidemiological factors, provider or the Public Health Service.

OBJETIVO: En Canarias las recetas facturadas al Sistema Nacional de Salud están registradas en una base de datos (FarmaCanarias). El objetivo principal de este estudio fue calcular el consumo de inhibidores de la acetilcolinesterasa (IACE) y memantina en Canarias y compararlo con una muestra representativa de la población española procedente de la Base de Investigación Farmacoepidemiológica en Atención Primaria (BIFAP). Como objetivo secundario determinamos el porcentaje de casos tratados en la muestra española. METODOS: Las prescripciones de IACE y/o memantina se calcularon como Dosis Diarias Definidas por 100 habitantes (DHD) en FarmaCanarias y en BIFAP. Se calcularon los resultados por isla y también se compararon por grupos de edad. Los casos tratados se calcularon como porcentaje sobre los casos con demencia totales en BIFAP. Todas las comparaciones fueron efectuadas con la χ2 de Pearson. RESULTADOS: El consumo de IACE y Memantina fue de 3,042% (IC 95%; 3,039-3,045) y 1,584% (IC 95%; 1,582-1,587) en Canarias, respectivamente y de 2,545% (IC 95%; 2,518-2,572) y 0,922% (IC 95%; 0,906-0,938), en BIFAP (p<0,001). Las DHD entre islas fueron diferentes, salvo en dos (p<0,001). La distribución por grupos de edad entre FarmaCanarias y BIFAP fue heterogénea (p<0,001). El porcentaje de casos tratados en BIFAP fue: 45,51% (IC 95%; 45,186-45,838). CONCLUSIONES: La prescripción de IACE y Memantina fue mayor en Canarias lo que, añadido a la diferencia por grupos de edad, sugiere diferencias epidemiológicas en demencia frente al resto de España. Existe heterogeneidad entre islas que podría deberse a factores epidemiológicos, de proveedor o del Servicio Público de Salud.

Utilidad de la ficha técnica de los medicamentos como herramienta para mejorar la prescripción en pacientes mayores / Usefulness of the summary of product characteristics as a tool to improve prescription in elderly patients

ANTECEDENTES Y OBJETIVO: La ficha técnica debe contribuir a un uso seguro y efectivo de medicamentos en las personas de edad avanzada, proporcionando información precisa sobre la prescripción, sobre los posibles beneficios o riesgos de los medicamentos, o en su defecto comunicando la falta de información sobre su uso en este grupo. Nuestro objetivo fue cuantificar la información específica para personas mayores de 65 años contenida en las fichas técnicas de los fármacos comercializados en España, y que permite una adecuada prescripción en dicha población. MATERIALES Y MÉTODOS: Un grupo multidisciplinar revisó todas las fichas técnicas de los medicamentos autorizados por la Agencia Española de Medicamentos y Productos Sanitarios. Se clasificó la calidad de la información en 4 categorías: información referida específicamente a la población de más de 65 años, información referida específicamente a la población de más de 80 años, recomendaciones no específicas para los ancianos e información específica para los ancianos. RESULTADOS: Se revisaron un total de 1.462 fichas técnicas, de las cuales el 48% tenía información relativa a la prescripción en ancianos. La información sobre el uso en mayores de 80 años estaba presente en el 1,23% de las fichas. Solo 6,83% del total de las fichas revisadas incluía recomendaciones específicas para el anciano. CONCLUSIONES: Hay poca información específica para la adecuada prescripción en personas de edad avanzada, en las fichas técnicas de los fármacos comercializados en España. Para mejorar el conocimiento en este campo debemos incluir datos en las fichas basados en la literatura científica, de ensayos clínicos dirigidos a personas mayores o de estudios de farmacovigilancia centrados en esta población

BACKGROUND AND OBJECTIVE: The Drug Technical Data Sheet should contribute to a safe and effective use of medications in the elderly, providing accurate information on the prescription, on the possible benefits or risks of the medications, or failing that, communicating the lack of information on their use in this group. The aim of this article was to quantify the specific information for people over 65 years of age included in the data sheets of the drugs available in Spain, and enables an adequate prescription in this population. MATERIALS AND METHODS: A multidisciplinary group reviewed all the Technical Data Sheets of drugs approved by the Spanish Agency for Medicines and Health Devices (AEMPS). The quality of the information was classified into 4 categories: information specifically referring to the population over 65 years old; information specifically referring to the population over 80 years old; recommendations not specific to the elderly; and specific information for the elderly. RESULTS: A total of 1,462 Technical Sheets were reviewed, of which 48% had information regarding prescription in the elderly. Information on the use in patients over 80 years old was present in 1.23% of the sheets. Only 6.83% of all the sheets reviewed included specific recommendations for the elderly. CONCLUSIONS: There is little specific information regarding prescription in the elderly in the technical data sheets of drugs prescribed/sold in Spain. To improve knowledge in this field, data must be provided in the sheets that are based on the scientific literature, clinical trials for the elderly, or pharmacovigilance studies focused on this population

[Usefulness of the summary of product characteristics as a tool to improve prescription in elderly patients]. / Utilidad de la ficha técnica de los medicamentos como herramienta para mejorar la prescripción en pacientes mayores.

BACKGROUND AND OBJECTIVE: The Drug Technical Data Sheet should contribute to a safe and effective use of medications in the elderly, providing accurate information on the prescription, on the possible benefits or risks of the medications, or failing that, communicating the lack of information on their use in this group. The aim of this article was to quantify the specific information for people over 65 years of age included in the data sheets of the drugs available in Spain, and enables an adequate prescription in this population. MATERIALS AND METHODS: A multidisciplinary group reviewed all the Technical Data Sheets of drugs approved by the Spanish Agency for Medicines and Health Devices (AEMPS). The quality of the information was classified into 4 categories: information specifically referring to the population over 65 years old; information specifically referring to the population over 80 years old; recommendations not specific to the elderly; and specific information for the elderly. RESULTS: A total of 1,462 Technical Sheets were reviewed, of which 48% had information regarding prescription in the elderly. Information on the use in patients over 80 years old was present in 1.23% of the sheets. Only 6.83% of all the sheets reviewed included specific recommendations for the elderly. CONCLUSIONS: There is little specific information regarding prescription in the elderly in the technical data sheets of drugs prescribed/sold in Spain. To improve knowledge in this field, data must be provided in the sheets that are based on the scientific literature, clinical trials for the elderly, or pharmacovigilance studies focused on this population.

Spanish list of potentially inappropriate drugs in the elderly (ES-PIA project).

PURPOSE: In the last decades, different criteria have been developed for detecting inappropriate prescription in older patients. In Spain, translations and adaptations of international lists are available but it would be necessary a national list which could cope with the peculiarities of our health system, existing pharmaceutical market, and prescription habits. We propose in this project the creation of a Spanish potentially inappropriate drugs list which could be applicable in our clinical scenario. METHODS: We use a Delphi method involving 25 experts from different backgrounds (Clinical Pharmacology, Geriatrics, Rational Use of Drugs and Pharmacy, Primary Care and Pharmacoepidemiology, and Pharmacovigilance) that were asked to participate in two-round questionnaires. For analysis, current recommendations of Worth and Pigni were applied, and every statement was classified into one of three groups: strong, moderate, or low agreement. Statements with strong agreement were accepted to be part of the inadequate prescription list. Moderate agreement statements were selected to enter the second questionnaire, and statements with low agreement were further analyzed to determine if it was due to heterogeneity or due to dispersion in the answers. RESULTS: The first questionnaire consisted of 160 proposed sentences, of which 106 reached a high agreement, 32 a moderate agreement, and 22 a low agreement. All sentences proposed in the second questionnaire reached a strong agreement. The total accepted sentences were 138. CONCLUSIONS: We offer a list of inadequate prescription in older patients adapted to the Spanish pharmacopeia and according to the prescription habits in our environment.