{"id":82723,"date":"2025-11-10T12:11:31","date_gmt":"2025-11-10T12:11:31","guid":{"rendered":"https:\/\/www.cofb.org\/?p=82723"},"modified":"2025-11-10T14:24:54","modified_gmt":"2025-11-10T14:24:54","slug":"reial-decret-sobre-lus-medicinal-del-cannabis-un-timid-primer-pas-insuficient-per-als-pacients-que-reclamen-acces-al-tractament-a-les-farmacies","status":"publish","type":"post","link":"https:\/\/www.cofb.org\/es\/2025\/11\/10\/reial-decret-sobre-lus-medicinal-del-cannabis-un-timid-primer-pas-insuficient-per-als-pacients-que-reclamen-acces-al-tractament-a-les-farmacies\/","title":{"rendered":"Real decreto sobre el uso medicinal del cannabis: un t\u00edmido primer paso insuficiente para los pacientes, que reclaman acceso al tratamiento en las farmacias"},"content":{"rendered":"<h4 class=\"wp-block-heading\"><strong>Art\u00edculo de Josep Allu\u00e9, vocal de Plantas Medicinales y Homeopat\u00eda del Colegio de Farmac\u00e9uticos de Barcelona (COFB)<\/strong><\/h4>\n\n\n\n<div class=\"destacat-blog\">\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><strong>&quot;La poblaci\u00f3n susceptible de utilizar el cannabis terap\u00e9utico son pacientes cr\u00f3nicos, de riesgo, vulnerables, dependientes o alejados de los centros hospitalarios, pensamos que gracias a su capilaridad y proximidad, las farmacias comunitarias son la mejor v\u00eda para acercar este recurso terap\u00e9utico a los pacientes y hacerlo m\u00e1s la m\u00e1s&quot;.<\/strong><\/p>\n<\/blockquote>\n\n\n\n<\/div>\n\n\n\n<p><\/p>\n\n\n\n<p>El Real Decreto 903\/2025 de 7 de octubre, sobre el uso medicinal del cannabis, tiene como objetivo principal establecer un marco normativo para la <strong>prescripci\u00f3n, elaboraci\u00f3n, dispensaci\u00f3n y uso<\/strong> de<strong> f\u00f3rmulas magistrales tipificadas <\/strong>elaboradas a partir de <strong>preparados estandarizados de cannabis<\/strong>. Esta regulaci\u00f3n pretende dar <strong>seguridad jur\u00eddica<\/strong> y garantizar la<strong> calidad y el control de los productos derivados del cannabis <\/strong>que se utilizan con <strong>fines terap\u00e9uticos<\/strong> dentro del sistema sanitario espa\u00f1ol.<\/p>\n\n\n\n<p>Quedan fuera del \u00e1mbito de este real decreto los <strong>medicamentos industriales ya autorizados<\/strong>, los <strong>productos en investigaci\u00f3n<\/strong> con cannabis y los cannabinoides sint\u00e9ticos o de origen distinto al de la planta. El texto introduce algunas definiciones fundamentales: se entiende por \u201c<strong>preparado estandarizado de cannabis<\/strong>\u201d aquel producto con una <strong>cantidad definida de THC y\/o CBD<\/strong>, <strong>registrado ante el AEMPS<\/strong>, y destinado a servir de<strong> materia prima para la preparaci\u00f3n de f\u00f3rmulas magistrales<\/strong>. Tambi\u00e9n se define la \u201c<strong>f\u00f3rmula magistral tipificada<\/strong>\u201d como aquella incluida en el <strong>Formulario Nacional<\/strong> por su utilidad frecuente y su uso en preparaciones con cannabis. Igualmente, se establece que el THC es una <strong>sustancia psicotr\u00f3pica <\/strong>sometida a regulaci\u00f3n especial.<\/p>\n\n\n\n<figure class=\"wp-block-image aligncenter size-large\"><a href=\"https:\/\/www.cofb.org\/wp-content\/uploads\/2025\/11\/Josep-Allue-opinio.jpg\" target=\"_blank\" rel=\" noreferrer noopener\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"564\" src=\"https:\/\/www.cofb.org\/wp-content\/uploads\/2025\/11\/Josep-Allue-opinio-1024x564.jpg\" alt=\"Josep Allu\u00e9, vocal de Plantes Medicinals i Homeopatia del Col\u00b7legi de Farmac\u00e8utics de Barcelona (COFB).\" class=\"wp-image-82732\" srcset=\"https:\/\/www.cofb.org\/wp-content\/uploads\/2025\/11\/Josep-Allue-opinio-1024x564.jpg 1024w, https:\/\/www.cofb.org\/wp-content\/uploads\/2025\/11\/Josep-Allue-opinio-300x165.jpg 300w, https:\/\/www.cofb.org\/wp-content\/uploads\/2025\/11\/Josep-Allue-opinio-768x423.jpg 768w, https:\/\/www.cofb.org\/wp-content\/uploads\/2025\/11\/Josep-Allue-opinio-18x10.jpg 18w, https:\/\/www.cofb.org\/wp-content\/uploads\/2025\/11\/Josep-Allue-opinio.jpg 1187w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><figcaption class=\"wp-element-caption\">Josep Allu\u00e9, vocal de Plantas Medicinales y Homeopat\u00eda del Colegio de Farmac\u00e9uticos de Barcelona (COFB).<\/figcaption><\/figure>\n\n\n\n<p>El decreto prev\u00e9 la creaci\u00f3n, por parte de la AEMPS, de un<strong> Registro p\u00fablico de preparados estandarizados de cannabis<\/strong>, donde deben inscribirse los productos utilizados para las f\u00f3rmulas magistrales. Adem\u00e1s, en un plazo m\u00e1ximo de tres meses desde la entrada en vigor del decreto, deber\u00e1n publicarse en el<strong> Formulario Nacional las monograf\u00edas correspondientes<\/strong>, que fijar\u00e1n las normas de elaboraci\u00f3n, dosificaci\u00f3n y usos autorizados. Estas monograf\u00edas ser\u00e1n claves para definir en qu\u00e9 patolog\u00edas y con qu\u00e9 dosis podr\u00e1 prescribirse el cannabis medicinal.<\/p>\n\n\n\n<p>S\u00f3lo les <strong>m\u00e9dicos especialistas hospitalarios<\/strong> pueden prescribir estas f\u00f3rmulas magistrales, y s\u00f3lo cuando no exista un medicamento autorizado adecuado o cuando \u00e9ste no haya sido eficaz. La prescripci\u00f3n deber\u00e1 <strong>documentar la justificaci\u00f3n cl\u00ednica<\/strong>, informar al paciente de los beneficios y riesgos, y revisar peri\u00f3dicamente la utilidad del tratamiento. Las <strong>f\u00f3rmulas <\/strong>s\u00f3lo pueden prepararse en <strong>servicios de farmacia hospitalaria <\/strong>que dispongan de los medios t\u00e9cnicos adecuados y bajo controles rigurosos. La dispensaci\u00f3n se realizar\u00e1 tambi\u00e9n desde estas farmacias hospitalarias, incluso para pacientes externos, con seguimiento farmacoterap\u00e9utico continuado. Tanto los <strong>equipos m\u00e9dicos como los farmac\u00e9uticos <\/strong>tienen la obligaci\u00f3n <strong>de evaluar peri\u00f3dicamente <\/strong>si es necesario <strong>continuar o suspender el tratamiento <\/strong>seg\u00fan la relaci\u00f3n entre beneficios y riesgos observados.<\/p>\n\n\n\n<p>Este real decreto representa un <strong>avance esperado despu\u00e9s de a\u00f1os sin una regulaci\u00f3n clara<\/strong> sobre el cannabis medicinal en Espa\u00f1a. No establece un listado cerrado de indicaciones m\u00e9dicas, y las monograf\u00edas podr\u00e1n actualizarse a medida que avance la evidencia cient\u00edfica, lo que permitir\u00e1 incorporar nuevas aplicaciones terap\u00e9uticas con el tiempo.<\/p>\n\n\n\n<p><strong>El acceso restringido s\u00f3lo a hospitales<\/strong> puede<strong> dificultar la equidad territorial<\/strong>, especialmente en <strong>zonas rurales con menos especialistas<\/strong>. Los <strong>laboratorios <\/strong>pueden encontrar <strong>barreras <\/strong>para cumplir con todos los requisitos de calidad y trazabilidad, y el desfase entre las necesidades inmediatas de los pacientes y el tiempo que requerir\u00e1 la plena implementaci\u00f3n de la norma. Por \u00faltimo, el <strong>sistema de farmacovigilancia<\/strong> requerir\u00e1 una <strong>coordinaci\u00f3n eficaz entre m\u00e9dicos<\/strong>, <strong>farmac\u00e9uticos y autoridades auton\u00f3micas<\/strong>, para garantizar un seguimiento real de los efectos adversos y la seguridad de los tratamientos.<\/p>\n\n\n\n<p><strong>El \u00e9xito del real decreto <\/strong>depender\u00e1 de la <strong>rapidez <\/strong>con qu\u00e9 <strong>se implementen las monograf\u00edas<\/strong>, de la efectividad del registro de preparados y, sobre todo, de la capacidad del sistema sanitario para garantizar un acceso equitativo y <strong>un seguimiento cl\u00ednico de calidad<\/strong> para todos los pacientes que puedan beneficiarse de esa terapia. Es necesaria una<strong> formaci\u00f3n de todos los profesionales sanitarios implicados <\/strong>en el uso del cannabis medicinal, para su uso racional (o para garantizar la seguridad y eficiencia).<\/p>\n\n\n\n<p>Considerando que, como dice el real decreto, la <strong>poblaci\u00f3n susceptible<\/strong> de utilizar el cannabis terap\u00e9utico son<strong> pacientes cr\u00f3nicos<\/strong>, de <strong>riesgo<\/strong>, <strong>vulnerables<\/strong>, <strong>dependientes <\/strong>o <strong>alejados de los centros hospitalarios<\/strong>, pensamos que gracias a su capilaridad y cercan\u00eda, las farmacias comunitarias son la mejor v\u00eda para acercar este recurso terap\u00e9utico a los pacientes y hacerlo m\u00e1s accesible, tal y como ya se hace en otros pa\u00edses de la UE.<\/p>\n\n\n\n<p><strong>En ning\u00fan caso<\/strong> se puede producir una<strong> banalizaci\u00f3n del uso del cannabis medicinal<\/strong>, que estar\u00e1 sometido a la regulaci\u00f3n y control correspondiente, dado que es un medicamento.<\/p>\n\n\n\n<p>Art\u00edculo originalmente&nbsp;<strong>publicado en el blog del&nbsp;<a href=\"https:\/\/cercledesalut.cat\/bloc\/un-timid-primer-pas-insuficient-per-als-pacients-que-reclamen-acces-al-tractament-a-les-farmacies\/\" target=\"_blank\" rel=\"noreferrer noopener\">C\u00edrculo de Salud<\/a>,&nbsp;<\/strong>el 24 de octubre de 2025.<\/p>","protected":false},"excerpt":{"rendered":"<p>Art\u00edculo de Josep Allu\u00e9, vocal de Plantas Medicinales y Homeopat\u00eda del Colegio de Farmac\u00e9uticos de Barcelona (COFB) \u201cLa poblaci\u00f3n susceptible de utilizar el cannabis terap\u00e9utico son pacientes cr\u00f3nicos, de riesgo, vulnerables, dependientes o alejados de los centros hospitalarios, pensamos que gracias a su capilar<\/p>","protected":false},"author":10,"featured_media":82732,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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