Real-World Safety Profile of Biologic Drugs for Severe Uncontrolled Asthma: A Descriptive Analysis from the Spanish Pharmacovigilance Database.

: 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. : 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.

[Usefulness of the summary of product characteristics as a tool to improve prescription in elderly patients].

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).

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.