{"id":4506,"date":"2013-12-10T18:59:27","date_gmt":"2013-12-10T17:59:27","guid":{"rendered":"http:\/\/blog.cofb.cat\/?p=4506"},"modified":"2013-12-10T18:59:27","modified_gmt":"2013-12-10T17:59:27","slug":"sobre-la-regulacio-de-medicaments-homeopatics","status":"publish","type":"post","link":"https:\/\/www.cofb.org\/ca\/2013\/12\/10\/sobre-la-regulacio-de-medicaments-homeopatics\/","title":{"rendered":"Sobre la regulaci\u00f3 de medicaments homeop\u00e0tics"},"content":{"rendered":"<p><em><br \/>\n<a href=\"http:\/\/blog.cofb.cat\/wp-content\/uploads\/2013\/04\/mjosealonso.jpg\"><img decoding=\"async\" class=\"alignleft  wp-image-1131\" alt=\"mjosealonso\" src=\"http:\/\/blog.cofb.cat\/wp-content\/uploads\/2013\/04\/mjosealonso.jpg\" width=\"120\" height=\"142\" \/><\/a><\/em><span style=\"color: #888888;\"><strong>Davant la not\u00edcia que el Ministeri de Sanitat regular\u00e0 el perm\u00eds als productes homeop\u00e0tics, Maria Jos\u00e9 Alonso, vocal de Plantes Medicinals i Homeopatia del COFB, ha escrit el seg\u00fcent article. \u00a0<\/strong><\/span><\/p>\n<p>En els \u00faltims dies s&#8217;ha publicat el projecte de l&#8217;Ordre Ministerial que regular\u00e0 el procediment de petici\u00f3 de registre dels medicaments homeop\u00e0tics, de fabricaci\u00f3 industrial, que actualment es comercialitzen a l&#8217;empar de la disposici\u00f3 transit\u00f2ria segona del Reial decret 2208\/1994, pel qual es regulaven els medicaments homeop\u00e0tics d&#8217;\u00fas hum\u00e0 de fabricaci\u00f3 industrial, per adequar-los a l&#8217;estipulat en el RD 1345\/2007, pel qual es regula el procediment d&#8217;autoritzaci\u00f3, registre i condicions de dispensaci\u00f3 dels medicaments d&#8217;\u00fas hum\u00e0 fabricats industrialment.<\/p>\n<p>Davant la diversitat de not\u00edcies i interpretacions que estan apareixent als mitjans, cal dir que aquesta normativa s\u2019ha de valorar en principi com a positiva, doncs resoldr\u00e0 una situaci\u00f3 an\u00f2mala de transitorietat que es venia arrossegant des de fa gaireb\u00e9 20 anys. Cal dir tamb\u00e9 que la ind\u00fastria de medicaments homeop\u00e0tics i el col\u00b7lectiu de farmac\u00e8utics comunitaris, venia demanant des de fa molt de temps aquesta normalitzaci\u00f3, ja que garantir\u00e0 un millor acc\u00e9s a aquests medicaments en \u00f2ptimes condicions de seguretat i qualitat. El registre definitiu dels medicaments homeop\u00e0tics permetr\u00e0 la creaci\u00f3 d&#8217;una llista dels mateixos que podran integrar-se a les bases de dades de medicaments, i, en un futur, el registre de nous medicaments que ja porten comercialitzant-se des de fa anys en altres pa\u00efsos europeus.<\/p>\n<p>Un dels cavalls de batalla perqu\u00e8 aquest projecte surti a la llum ha estat la regulaci\u00f3 de taxes, ja que en l&#8217;anterior esborrany (2088) es proposava un pagament de taxes per cada diluci\u00f3 d&#8217;un mateix medicament, la qual cosa augmentava de forma exponencial el cost de registre dels medicaments per part dels laboratoris i ho feia inviable. Al document actual es proposa una sola taxa per cep, la qual cosa \u00e9s m\u00e9s adequat i coherent amb els propis textos de la Llei 29\/2006 de Garanties i \u00das Racional dels Medicaments i el propi RD 1345\/2007.<\/p>\n<p>Segons el text del projecte les exig\u00e8ncies per a cada sol\u00b7licitud de registre d&#8217;aquests medicaments seran les que marquen les directrius a tots els pa\u00efsos de la UE, per\u00f2 seria desitjable que tamb\u00e9 coincideixin els criteris d&#8217;avaluaci\u00f3 de les sol\u00b7licituds. No obstant aix\u00f2, no deixen de ser preocupants les declaracions de C\u00e9sar Hern\u00e1ndez (Cap del Departament de Medicaments d&#8217;\u00das Hum\u00e0 de l\u2019AEMPS), publicades recentment, a les quals expressa que els medicaments homeop\u00e0tics sense indicaci\u00f3 terap\u00e8utica podrien passar a ser de prescripci\u00f3 m\u00e8dica (encara que no queda expl\u00edcitament reflectit en el projecte d&#8217;Ordre que ens ocupa).<\/p>\n<p>El fet que un medicament homeop\u00e0tic no reivindiqui una indicaci\u00f3 terap\u00e8utica concreta, forma part dels fonaments d&#8217;aquesta terap\u00e8utica, ja que el medicament no es tria en funci\u00f3 de la malaltia concreta que pateix el pacient, si no en funci\u00f3 dels s\u00edmptomes i signes que el pacient individualment presenta, el seu estat general i les modalitats, entre altres factors que es tenen en compte en la semiologia homeop\u00e0tica. No obstant aix\u00f2, molts medicaments homeop\u00e0tics sense indicaci\u00f3 terap\u00e8utica tenen una f\u00e0cil aplicaci\u00f3 en problemes menors de salut, i en la meva modesta opini\u00f3, un farmac\u00e8utic format en homeopatia, pot aconsellar-los amb seguretat i efic\u00e0cia quan els s\u00edmptomes indiquen clarament la seva utilitzaci\u00f3. Per exemple, est\u00e0 de sobres provat que a una persona que ha sofert un cop sense majors conseq\u00fc\u00e8ncies que la conseg\u00fcent inflamaci\u00f3 i hematoma, l&#8217;administraci\u00f3 d\u2019Arnica montana en gr\u00e0nuls a la 9CH li ajudar\u00e0 a alleujar el dolor i a resoldre molt m\u00e9s r\u00e0pidament la inflamaci\u00f3 i l&#8217;hematoma; tamb\u00e9 \u00e9s f\u00e0cil determinar que el medicament homeop\u00e0tic que precisa una persona que acudeix per un refredat incipient el s\u00edmptoma principal del qual \u00e9s abundant mucositat l\u00edquida, irritant, que produeix picors i irritaci\u00f3 en els orificis i base del nas i el llavi superior, sense plorera o amb plorera no irritant per als ulls, \u00e9s Allium cep. Aquests s\u00f3n solament dos exemples dels molts que podrien posar-se. Crec personalment que seria lamentable i un greu greuge comparatiu, que un farmac\u00e8utic franc\u00e8s, per posar un exemple, pogu\u00e9s indicar medicaments homeop\u00e0tics simples en s\u00edmptomes menors i no pogu\u00e9s fer el mateix un farmac\u00e8utic espanyol.<\/p>\n<p>***<\/p>\n<p>En los \u00faltimos d\u00edas se ha publicado el proyecto de la Orden Ministerial que regular\u00e1 el procedimiento de petici\u00f3n de registro de los medicamentos homeop\u00e1ticos, de fabricaci\u00f3n industrial, que actualmente se comercializan al amparo de la disposici\u00f3n transitoria segunda del Real Decreto 2208\/1994, por el que se regulaban los medicamentos homeop\u00e1ticos de uso humano de fabricaci\u00f3n industrial, para adecuarlos a lo estipulado en el RD 1345\/2007, por el que se regula el procedimiento de autorizaci\u00f3n, registro y condiciones de dispensaci\u00f3n de los medicamentos de uso humano fabricados industrialmente.<\/p>\n<p>Ante la diversidad de noticias e interpretaciones que est\u00e1n apareciendo en los medios, cabe decir que esta normativa cabe valorarla en principio como positiva, pues resolver\u00e1 una situaci\u00f3n an\u00f3mala de transitoriedad que se ven\u00eda arrastrando desde hace casi 20 a\u00f1os. Cabe decir tambi\u00e9n que la industria de medicamentos homeop\u00e1ticos y los propios farmac\u00e9uticos comunitarios, ven\u00eda pidiendo desde hace largo tiempo esta normalizaci\u00f3n, ya que garantizar\u00e1 un mejor acceso a estos medicamentos en \u00f3ptimas condiciones de seguridad y calidad. El registro definitivo de los medicamentos homeop\u00e1ticos permitir\u00e1 la creaci\u00f3n de una lista de los mismos que podr\u00e1n integrarse en las bases de datos de medicamentos, y, en un futuro, el registro de nuevos medicamentos que ya llevan comercializ\u00e1ndose desde hace a\u00f1os en otros pa\u00edses europeos.<\/p>\n<p>Uno de los caballos de batalla para que este proyecto salga a la luz ha sido la regulaci\u00f3n de tasas ya que en el anterior borrador (2088) se propon\u00eda un pago de tasas por cada diluci\u00f3n de un mismo medicamento, lo que aumentaba de forma exponencial el coste de registro de los medicamentos por parte de los laboratorios y lo hac\u00eda inviable. En el documento actual, se propone una sola tasa por cepa, lo que es m\u00e1s adecuado y coherente con los propios textos de la Ley 29\/2006 de Garant\u00edas y Uso Racional de los Medicamentos y el propio RD 1345\/2007.<\/p>\n<p>Seg\u00fan el texto del proyecto las exigencias para cada solicitud de registro de estos medicamentos ser\u00e1n las que marcan las directrices en todos los pa\u00edses de la UE, pero ser\u00eda deseable que tambi\u00e9n coincidan los criterios de evaluaci\u00f3n de las solicitudes. Sin embargo, no dejan de ser preocupantes las declaraciones de C\u00e9sar Hern\u00e1ndez (Jefe del Departamento de Departamento de Medicamentos de Uso Humano de la AEMPS), publicadas recientemente, en las que expresa que los medicamentos homeop\u00e1ticos sin indicaci\u00f3n terap\u00e9utica podr\u00edan pasar a ser de prescripci\u00f3n m\u00e9dica (aunque no queda expl\u00edcitamente reflejado en el proyecto de Orden que nos ocupa).<\/p>\n<p>El hecho de que un medicamento homeop\u00e1tico no reivindique una indicaci\u00f3n terap\u00e9utica concreta, forma parte de los fundamentos de esta terap\u00e9utica, ya que el medicamento no se elige en funci\u00f3n de la enfermedad concreta que padece el paciente, si no en funci\u00f3n de los s\u00edntomas y signos que el paciente individualmente presenta, su estado general y las modalidades, entre otros factores que se tienen en cuenta en la semiolog\u00eda homeop\u00e1tica. Sin embargo, muchos medicamentos homeop\u00e1ticos sin indicaci\u00f3n terap\u00e9utica tienen una f\u00e1cil aplicaci\u00f3n en problemas menores de salud, y en mi modesta opini\u00f3n, un farmac\u00e9utico formado en homeopat\u00eda, puede aconsejarlos con seguridad y eficacia cuando los s\u00edntomas indican claramente su utilizaci\u00f3n. Por ejemplo, est\u00e1 de sobras probado que a una persona que ha sufrido un golpe sin mayores consecuencias que la consiguiente inflamaci\u00f3n y hematoma, la administraci\u00f3n de Arnica montana en gr\u00e1nulos a la 9CH le ayudar\u00e1 a aliviar el dolor y a resolver mucho m\u00e1s r\u00e1pidamente la inflamaci\u00f3n y el hematoma; tambi\u00e9n es f\u00e1cil determinar que el medicamento homeop\u00e1tico que precisa una persona que acude por un resfriado incipiente cuyo s\u00edntoma principal es abundante mucosidad l\u00edquida, irritante, que produce picores e irritaci\u00f3n en los orificios y base de la nariz y el labio superior, sin lagrimeo o con lagrimeo no irritante para los ojos, es Allium cepa. Estos son solo dos ejemplos de los muchos que podr\u00edan ponerse. Creo personalmente, que ser\u00eda lamentable y un grave agravio comparativo, que un farmac\u00e9utico franc\u00e9s, por poner un ejemplo, pudiera indicar medicamentos homeop\u00e1ticos simples en s\u00edntomas menores y no pudiera hacer lo mismo un farmac\u00e9utico espa\u00f1ol.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Davant la not\u00edcia que el Ministeri de Sanitat regular\u00e0 el perm\u00eds als productes homeop\u00e0tics, Maria Jos\u00e9 Alonso, vocal de Plantes Medicinals i Homeopatia del COFB, ha escrit el seg\u00fcent article. \u00a0 En els \u00faltims dies s&#8217;ha publicat el projecte de l&#8217;Ordre Ministerial que regular\u00e0 el procediment de petici\u00f3 de registre [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4514,"comment_status":"open","ping_status":"open","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":"default","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 center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[23,489],"tags":[2153],"class_list":["post-4506","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-destacats","category-opinions-del-collegi","tag-homeopatia"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.4 - 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