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Background: The present investigation provides a thorough analysis of adverse drug reactions (ADRs) reported in the Database of the Spanish Pharmacovigilance System (FEDRA) for biologic medications primarily indicated for severe refractory asthma, including omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, and tezepelumab. Our main objective was to identify ADRs not documented in the drugs' Technical Sheets (summary of product characteristics, SmPC), potentially indicating unrecognized risks meriting pharmacovigilance attention. Methods: Data spanning from each drug's market introduction until 22 January 2024, were analyzed, sourced from direct submissions to the Spanish Pharmacovigilance System, industry communications, and literature reviews. We evaluated notifications impartially to ensure a comprehensive review of all the ADRs associated with these medications. Results: This investigation underlines the critical role of post-marketing surveillance in enhancing patient safety. It emphasizes the necessity for healthcare professionals to report ADRs comprehensively to foster a robust pharmacovigilance system. Furthermore, the study highlights gaps between the reported ADRs and the information provided in SmPCs, signaling potential areas for improvement in drug safety monitoring and regulatory oversight. Conclusions: Finally, these findings may contribute to informed decision making in clinical practice and regulatory policy, ultimately advancing patient care and safety in the management of severe uncontrolled asthma.

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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

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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.

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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.

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