{"id":15699,"date":"2026-08-24T12:46:50","date_gmt":"2026-08-24T12:46:50","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=15699"},"modified":"2026-08-24T12:46:50","modified_gmt":"2026-08-24T12:46:50","slug":"rupture-de-stock-de-bicafres-1000-mg-comprime-gastro-resistant-recommandation-de-remplacement-par-des-preparations-magistrales","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=15699","title":{"rendered":"Rupture de stock de Bicafres 1000 mg, comprim\u00e9 gastro-r\u00e9sistant : recommandation de remplacement par des pr\u00e9parations magistrales"},"content":{"rendered":"<p>Le m\u00e9dicament Bicafres 1000 mg comprim\u00e9 gastro-r\u00e9sistant (bicarbonate de sodium), indiqu\u00e9 dans le traitement de l\u2019acidose m\u00e9tabolique chez les adultes et adolescents de 14 ans et plus atteints d\u2019insuffisance r\u00e9nale chronique, fait l\u2019objet d\u2019une rupture de stock de plusieurs mois. Le laboratoire Th\u00e9radial, titulaire du m\u00e9dicament, pr\u00e9voit une remise \u00e0 disposition d\u00e9but avril 2027. L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) publie, \u00e0 titre exceptionnel et temporaire, une recommandation permettant d\u2019assurer la continuit\u00e9 des traitements.<\/p>\n<p>En cas d\u2019indisponibilit\u00e9 de Bicafres 1000 mg, les pharmaciens sont autoris\u00e9s \u00e0 d\u00e9livrer, sans nouvelle ordonnance, une pr\u00e9paration magistrale de bicarbonate de sodium en g\u00e9lules non gastro-r\u00e9sistantes dos\u00e9es \u00e0 500 ou 1000 mg. Ils doivent informer les patients de ce remplacement, des diff\u00e9rences de forme pharmaceutique (g\u00e9lules non gastro-r\u00e9sistantes versus comprim\u00e9s gastro-r\u00e9sistants) et remettre une fiche d\u2019utilisation adapt\u00e9e au dosage. Les m\u00e9decins prescripteurs doivent \u00eatre inform\u00e9s sans d\u00e9lai de ce changement afin de mettre en place un suivi biologique (dosage des bicarbonates, pH sanguin, ionogramme sanguin) dans les deux semaines suivant l\u2019instauration du traitement de substitution, la diffusion du principe actif pouvant diff\u00e9rer de celle de la forme gastro-r\u00e9sistante.<\/p>\n<p>Les patients sont invit\u00e9s \u00e0 ne pas modifier leur traitement sans avis m\u00e9dical, \u00e0 respecter la posologie prescrite et \u00e0 consulter rapidement en cas d\u2019effets ind\u00e9sirables (naus\u00e9es, maux de t\u00eate, fatigue, \u0153d\u00e8mes des chevilles, soif intense) ou de sympt\u00f4mes inhabituels. Parall\u00e8lement, des mesures compl\u00e9mentaires sont \u00e0 l\u2019\u00e9tude, notamment l\u2019importation de m\u00e9dicaments \u00e9quivalents au Bicafres 1000 mg comprim\u00e9 gastro-r\u00e9sistant, afin de s\u00e9curiser l\u2019approvisionnement. Cette situation illustre un dispositif de gestion de rupture de stock mobilisant l\u2019ANSM, le laboratoire exploitant et les pharmaciens d\u2019officine, avec un encadrement sp\u00e9cifique des substitutions pour un m\u00e9dicament utilis\u00e9 dans la prise en charge d\u2019une complication de l\u2019insuffisance r\u00e9nale chronique.\u00a0(contenu r\u00e9sum\u00e9 par l&rsquo;IA)<a href=\"https:\/\/ansm.sante.fr\/actualites\/rupture-de-stock-de-bicafres-1000-mg-comprime-gastro-resistant-recommandation-de-remplacement-par-des-preparations-magistrales\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a>\u200b<\/p>","protected":false},"excerpt":{"rendered":"<p>Le m\u00e9dicament Bicafres 1000 mg comprim\u00e9 gastro-r\u00e9sistant (bicarbonate de sodium), indiqu\u00e9 dans le traitement de l\u2019acidose m\u00e9tabolique chez les adultes et adolescents de 14 ans et plus atteints d\u2019insuffisance r\u00e9nale [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3852,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"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":"","footer-sml-layout":"","ast-disable-related-posts":"","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-5)","background-image":"","background-repeat":"repeat","background-position":"center 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