<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>2794-1140</journal-id>
<journal-title><![CDATA[Pharmaceutical Care España]]></journal-title>
<abbrev-journal-title><![CDATA[Pharm Care Esp.]]></abbrev-journal-title>
<issn>2794-1140</issn>
<publisher>
<publisher-name><![CDATA[Fundación Pharmaceutical Care España]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S2794-11402025000100616</article-id>
<article-id pub-id-type="doi">10.60103/phc.v27.e900</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Reacciones Adversas a Radiofármacos: Análisis Retrospectivo del Sistema de Farmacovigilancia Español]]></article-title>
<article-title xml:lang="en"><![CDATA[Adverse Reactions to Radiopharmaceuticals: Retrospective analysis of the Spanish Pharmacovigilance System]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Martins]]></surname>
<given-names><![CDATA[Sara]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
<xref ref-type="aff" rid="Aaf"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Martín-Suárez]]></surname>
<given-names><![CDATA[Ana]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
<xref ref-type="aff" rid="Aaf"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Jesus]]></surname>
<given-names><![CDATA[Ângelo]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Universidad de Salamanca Departamento de Ciencias Farmacéuticas ]]></institution>
<addr-line><![CDATA[Salamanca ]]></addr-line>
<country>Spain</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Instituto Politécnico do Porto LAQV/REQUIMTE, Escola Superior de Saúde ]]></institution>
<addr-line><![CDATA[Porto ]]></addr-line>
<country>Portugal</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,Instituto de Investigación Biomédica de Salamanca  ]]></institution>
<addr-line><![CDATA[Salamanca ]]></addr-line>
<country>Spain</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>00</month>
<year>2025</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>00</month>
<year>2025</year>
</pub-date>
<volume>27</volume>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_arttext&amp;pid=S2794-11402025000100616&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_abstract&amp;pid=S2794-11402025000100616&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_pdf&amp;pid=S2794-11402025000100616&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN Introducción: Los radiofármacos se han convertido en herramientas indispensables en la medicina moderna, pero como cualquier otro medicamento, pueden causar reacciones adversas en los pacientes. El objetivo de este estudio fue realizar un análisis de las notificaciones relacionadas con sospechas de reacciones adversas (RAM) relacionadas con radiofármacos, en el contexto sanitario español. Método: Se realizó un estudio observacional, cross-sectional, retrospectivo y descriptivo, centrándose en el análisis de notificaciones espontáneas sobre reacciones adversas asociadas con el uso de radiofármacos (RAMr), presentadas al Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano, durante el periodo de 2010 a 2023. Resultados: Se recibieron 518 notificaciones espontáneas, que resultaran en 1717 RAMr. 53,1% de las reacciones fueron consideradas graves. El Radio (223Ra) dicloruro fue el radiofármaco identificado con más frecuencia en los informes (29,4%) y, de las 37 muertes reportadas en notificaciones asociadas a la administración de radiofármacos, 22 ocurrieron con este radiofármaco. Conclusiones: Los radiofármacos tienen una menor incidencia de RAM reportadas en comparación con los medicamentos convencionales, pero no se puede descartar por completo la posibilidad de aparición, con graves consecuencias en algunos casos. El hecho de que en 14 años solo se hayan enviado 518 informes confirma las sospechas de subnotificación por parte de profesionales, pacientes y otros. Es necesario tomar más medidas de sensibilización y formación, para aumentar la notificación de posibles RAMr.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT Introduction: Radiopharmaceuticals have become indispensable tools in modern medicine, but like any other medication, they can cause adverse reactions in patients. The objective of this study was to analyze reports of suspected adverse reactions (ADR) related to radiopharmaceuticals in the Spanish healthcare context. Method: An observational, cross-sectional, retrospective and descriptive study was carried out, focusing on the analysis of spontaneous notifications of adverse reactions associated with the use of radiopharmaceuticals (ADRr), submitted to the Spanish Pharmacovigilance System for Medicinal Products for Human Use, during the period from 2010 to 2023. Results: A total of 518 spontaneous reports were received, resulting in 1717 ADRs. 53.1% of the reactions were considered serious. Radium (223Ra) dichloride was the most frequently identified radiopharmaceutical in the reports (29.4%), and of the 37 deaths reported in reports associated with the administration of radiopharmaceuticals, 22 occurred with this radiopharmaceutical. Conclusions: Radiopharmaceuticals have a lower incidence of reported ADRs compared to conventional medicines, but the possibility of their occurrence cannot be completely ruled out, with serious consequences in some cases. The fact that only 518 reports have been submitted in 14 years confirms suspicions of underreporting by professionals, patients, and others. Further awareness-raising and training measures are needed to increase the reporting of potential ADRr.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Farmacovigilancia]]></kwd>
<kwd lng="es"><![CDATA[Reacciones adversas a medicamentos]]></kwd>
<kwd lng="es"><![CDATA[Radiofármacos.]]></kwd>
<kwd lng="en"><![CDATA[Pharmacovigilance]]></kwd>
<kwd lng="en"><![CDATA[Adverse reactions]]></kwd>
<kwd lng="en"><![CDATA[Radiopharmaceuticals]]></kwd>
</kwd-group>
</article-meta>
</front><back>
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