{"id":9490,"date":"2019-02-12T15:59:15","date_gmt":"2019-02-12T15:59:15","guid":{"rendered":"http:\/\/fefac.cat\/empresarial\/?p=9490"},"modified":"2019-02-12T15:59:15","modified_gmt":"2019-02-12T15:59:15","slug":"entra-en-vigor-el-nou-sistema-de-verificaci-de-me","status":"publish","type":"post","link":"https:\/\/fefac.cat\/empresarial\/entra-en-vigor-el-nou-sistema-de-verificaci-de-me\/","title":{"rendered":"Entra en vigor el nou sistema de verificaci\u00f3 de medicaments"},"content":{"rendered":"<p>Quatre dies despr&eacute;s de la seva entrada en vigor, s&rsquo;han connectat al nou Sistema de Verificaci&oacute; de Medicaments (SEVeM) 100 hospitals i pr&agrave;cticament totes les farm&agrave;cies espanyoles, aix&iacute; com els distribu&iuml;dors i 331 titulars d&rsquo;autoritzaci&oacute; de comercialitzaci&oacute;. S&rsquo;han carregat 12.000 refer&egrave;ncies de medicaments i 121 milions d&rsquo;identificadors &uacute;nics i nom&eacute;s durant el cap de setmana s&rsquo;han verificat 50.000 dispensacions a les farm&agrave;cies, segons el SEVeM.<\/p>\n<p>Prevenir l&rsquo;entrada de medicaments falsificats en la cadena legal, refor&ccedil;ar la seguretat dels pacients i complir amb la normativa europea &eacute;s el triple objectiu del Sistema Espanyol de Verificaci&oacute; de Medicaments (SEVeM) que, integrant d&rsquo;una plataforma europea, ja &eacute;s una realitat a Espanya despr&eacute;s de la seva entrada en funcionament, el dissabte 9 de febrer, en connectar-se el conjunt de la cadena del medicament, des de les companyies farmac&egrave;utiques fabricants fins a les oficines de farm&agrave;cia de tota Espanya, passant per la distribuci&oacute; majorista.<\/p>\n<p><strong>Dispositius de seguretat<\/strong><\/p>\n<p>Els medicaments subjectes a recepta m&egrave;dica han d&rsquo;estar prove&iuml;ts de dos dispositius de seguretat:<\/p>\n<ul>\n<li><strong>Identificador &uacute;nic en forma de codi datamatrix,<\/strong> que cont&eacute; el codi del producte, un n&uacute;mero de s&egrave;rie de 20 car&agrave;cters generats per un algorisme d&rsquo;aleatoritzaci&oacute;, el n&uacute;mero de lot i la data de caducitat. D&rsquo;aquesta forma es pot verificar l&rsquo;autenticitat i identificar cada env&agrave;s de medicament de manera individual. Addicionalment, en el cas d&rsquo;Espanya, i a requeriment de les autoritats nacionals, el codi datamatrix cont&eacute; tamb&eacute; el n&uacute;mero nacional de reemborsament, ja sigui dins del mateix codi de producte o en un altre camp.<\/li>\n<li><strong>Sistema antimanipulaci&oacute;<\/strong> per garantir que l&rsquo;env&agrave;s no ha estat obert des de la sortida de la cadena de producci&oacute; fins a la seva dispensaci&oacute; a la farm&agrave;cia.<\/li>\n<\/ul>\n<p><strong>Conviv&egrave;ncia de f&agrave;rmacs sense identificador<\/strong><\/p>\n<p>Durant uns mesos, fins que s&rsquo;esgotin els lots alliberats abans del 9 de febrer seguint l&rsquo;etiquetatge &uacute;nic, conviuran a les farm&agrave;cies els nous medicaments serialitzats amb els f&agrave;rmacs sense identificador &uacute;nic. Els responsables del SEVeM esperen que, en menys d&rsquo;un any, el 98% dels envasos que circulin en la cadena de subministrament ja portin un identificador &uacute;nic que pugui verificar-se. M&eacute;s endavant, quan tots els medicaments estiguin serialitzats, es podr&agrave; eliminar el cup&oacute; precinte, que deixar&agrave; de ser necessari com a comprovant de la dispensaci&oacute;.<\/p>\n<p><strong>Un esfor&ccedil; conjunt<\/strong><\/p>\n<p>L&rsquo;entrada en vigor del nou sistema i la seva connexi&oacute; a escala europea s&rsquo;han dut a terme dintre del termini en la forma escaient, i de manera satisfact&ograve;ria per a totes les parts malgrat la complexitat del proc&eacute;s, si b&eacute; el seu major &egrave;xit ha estat el treball conjunt i el consens dels agents que integren el nou sistema i la seva estreta coordinaci&oacute; amb les autoritats sanit&agrave;ries.<\/p>\n<p><strong>Iniciativa europea<\/strong><\/p>\n<p>Aquest model de serialitzaci&oacute; de medicaments neix l&rsquo;any 2008, quan la Comissi&oacute; Europea va presentar una proposta legislativa per evitar l&rsquo;entrada de medicaments falsificats en la cadena legal de subministrament de f&agrave;rmacs. Les autoritats europees responien aix&iacute; a una preocupaci&oacute; global davant l&rsquo;amena&ccedil;a que per a la salut p&uacute;blica representa la falsificaci&oacute; de medicaments, un problema que afortunadament a Espanya, t&eacute; un car&agrave;cter testimonial.<\/p>\n<p>Fruit d&rsquo;aquesta preocupaci&oacute; es va adoptar, l&rsquo;any 2011, l&rsquo;anomenada Directiva antifalsificaci&oacute;, introduint mesures preventives en l&rsquo;&agrave;mbit europeu. Posteriorment, l&rsquo;octubre de 2015, la Comissi&oacute; va adoptar el Reglament Delegat corresponent, que es va publicar al febrer de l&rsquo;any seg&uuml;ent i que seria aplicable tres anys despr&eacute;s de la seva publicaci&oacute;, el 9 de febrer de 2019. El nou model est&agrave; estructurat com a sistema d&rsquo;extrem a extrem, on els diferents agents de la cadena legal de subministrament de medicaments tenen assignades les seves corresponents obligacions.<\/p>\n<div style=\"background:#eee;border:1px solid #ccc;padding:5px 10px;\"><strong>Not&iacute;cies relacionades<\/strong>:&nbsp;<strong><a href=\"http:\/\/www.fefac.cat\/noticia.asp?id=7481\" target=\"_blank\">Verifiaci&oacute;: qu&egrave; ha de saber la farm&agrave;cia?<\/a><\/strong><\/div>\n<div style=\"background:#eee;border:1px solid #ccc;padding:5px 10px;\"><strong style=\"font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 12px;\">No has rebut aquesta not&iacute;cia per e-mail?&nbsp;<a href=\"https:\/\/fefac.us13.list-manage.com\/subscribe?u=1311ec6dc48b0ce978cd11b98&amp;id=e86c9f9c9d\" target=\"_blank\">Subscriu-te a la newsletter di&agrave;ria de FEFAC<\/a><\/strong><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Quatre dies despr&eacute;s de la seva entrada en vigor, s&rsquo;han connectat al nou Sistema de Verificaci&oacute; de Medicaments (SEVeM) 100 hospitals i pr&agrave;cticament totes les farm&agrave;cies espanyoles, aix&iacute; com els [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[11,12,13,14,15],"tags":[136,936,937,1906,1907,1908,1909],"class_list":["post-9490","post","type-post","status-publish","format-standard","hentry","category-fefac","category-afb","category-afet","category-afell","category-agfe","tag-medicaments","tag-sevem","tag-verificacio","tag-snsfarma","tag-nodo-snsfarma","tag-identificador-unic","tag-cupo-precinte"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Entra en vigor el nou sistema de verificaci\u00f3 de medicaments - FEFAC<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fefac.cat\/empresarial\/entra-en-vigor-el-nou-sistema-de-verificaci-de-me\/\" \/>\n<meta property=\"og:locale\" content=\"ca_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Entra en vigor el nou sistema de verificaci\u00f3 de medicaments - FEFAC\" \/>\n<meta property=\"og:description\" content=\"Quatre dies despr&eacute;s de la seva entrada en vigor, s&rsquo;han connectat al nou Sistema de Verificaci&oacute; 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