{"id":71,"date":"2013-12-24T20:47:55","date_gmt":"2013-12-24T20:47:55","guid":{"rendered":"http:\/\/eurekainfomed.it\/?p=71"},"modified":"2026-07-30T13:52:28","modified_gmt":"2026-07-30T13:52:28","slug":"italy-reports-suspected-adverse-reactions","status":"publish","type":"post","link":"https:\/\/eurekainfomed.it\/en\/italy-reports-suspected-adverse-reactions\/","title":{"rendered":"Italy reports &#8220;suspected adverse reactions&#8221;"},"content":{"rendered":"<p>In Italy, reports of <strong>suspected adverse reactions<\/strong> increased by <strong>38% during 2012<\/strong>. These figures were published in an AIFA report presented by Minister Lorenzin to Parliament.<\/p>\n<div>\n<p>Overall, <strong>148,340 reports of suspected adverse reactions to medicinal products and vaccines<\/strong> were collected, resulting in <strong>29,036 reports<\/strong> entered into the Italian National Pharmacovigilance Network (RNF), corresponding to <strong>479 reports per million inhabitants<\/strong>. These figures place Italy <strong>well above the World Health Organization (WHO) gold standard<\/strong> of 300 reports per million inhabitants.<\/p>\n<p>However, the report also highlighted significant regional differences in reporting rates. While <strong>Lombardy and Tuscany<\/strong> reached approximately <strong>1,200 reports per million inhabitants<\/strong>, reporting activity decreased in <strong>Molise, Lazio, Basilicata, and Liguria<\/strong>.<\/p>\n<h2>Some data on reported suspected adverse reactions<\/h2>\n<p>Approximately <strong>21.8% of reports required or prolonged hospitalization<\/strong>, while <strong>70.3% were classified as non-serious<\/strong>.<\/p>\n<p>The increase was more pronounced for <strong>medicinal products<\/strong> (<strong>+47%<\/strong>) than for <strong>vaccines<\/strong> (<strong>+7%<\/strong>).<\/p>\n<p><strong>Antineoplastic agents<\/strong> and <strong>immunomodulators<\/strong> accounted for the highest proportion of reports (<strong>25.5%<\/strong>), followed by <strong>antimicrobials<\/strong> (<strong>15.5%<\/strong>) and <strong>central nervous system medicines<\/strong> (<strong>13.0%<\/strong>).<\/p>\n<p>Among individual active substances, some of the most widely used medicines ranked highest:<\/p>\n<ul>\n<li><strong>Amoxicillin\/clavulanic acid<\/strong>: 1,361 reports (<strong>+21% vs. 2011<\/strong>)<\/li>\n<li><strong>Warfarin<\/strong>: 1,347 reports (<strong>+36% vs. 2011<\/strong>)<\/li>\n<li><strong>Acetylsalicylic acid<\/strong>: 936 reports (<strong>+43% vs. 2011<\/strong>)<\/li>\n<\/ul>\n<p>According to the authors, these data suggest a <strong>positive impact of the new European pharmacovigilance legislation<\/strong>, which has contributed to improving the effectiveness, speed, and transparency of pharmacovigilance activities and regulatory interventions.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>In Italy, reports of suspected adverse reactions increased by 38% during 2012. These figures were published in an AIFA report presented by Minister Lorenzin to Parliament. Overall, 148,340 reports of&#8230;<\/p>\n","protected":false},"author":1,"featured_media":375,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[25,4],"tags":[],"class_list":["post-71","post","type-post","status-publish","format-standard","has-post-thumbnail","category-pharmacovigilance","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Italy reports &quot;suspected adverse reactions&quot;<\/title>\n<meta name=\"description\" content=\"Data on reports of suspected adverse reactions in Italy have been published in an AIFA report presented by Minister Lorenzin to Parliament.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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