Opat\u0159en\u00ed pro minimalizaci rizik\u00a0maj\u00ed za c\u00edl usnadnit informovan\u00e1 rozhodnut\u00ed pro podporu minimalizace rizika p\u0159i p\u0159edepisov\u00e1n\u00ed, v\u00fddeji a\/nebo pou\u017e\u00edv\u00e1n\u00ed l\u00e9\u010div\u00e9ho p\u0159\u00edpravku. P\u0159i pou\u017eit\u00ed rutinn\u00edch opat\u0159en\u00ed pro ka\u017ed\u00fd l\u00e9\u010div\u00fd p\u0159\u00edpravek (viz GVP modul V), maj\u00ed b\u00fdt dal\u0161\u00ed aktivity pro minimalizaci rizik pou\u017eity pouze v p\u0159\u00edpad\u011b, \u017ee jsou pova\u017eov\u00e1ny za nezbytn\u00e9 pro bezpe\u010dn\u00e9 a \u00fa\u010dinn\u00e9 pou\u017eit\u00ed l\u00e9\u010div\u00e9ho p\u0159\u00edpravku a maj\u00ed b\u00fdt vyvinuty a poskytov\u00e1ny vhodn\u011b kvalifikovan\u00fdmi osobami.<\/p>\n
Dal\u0161\u00ed opat\u0159en\u00ed pro minimalizaci rizik se mohou \u0161iroce li\u0161it v \u00fa\u010delu, pl\u00e1nu, c\u00edlov\u00e9 skupin\u011b a slo\u017eitosti. Tato opat\u0159en\u00ed mohou b\u00fdt pou\u017eita jako n\u00e1vod pro v\u00fdb\u011br vhodn\u00e9ho pacienta s vy\u0159azen\u00edm pacient\u016f, u kter\u00fdch je pou\u017eit\u00ed kontraindikov\u00e1no, pro podporu monitorov\u00e1n\u00ed b\u011bhem l\u00e9\u010dby, kter\u00e1 je d\u016fle\u017eit\u00e1 s ohledem na v\u00fdznamn\u00e1 rizika a\/nebo l\u00e9\u010dbu ne\u017e\u00e1douc\u00ed reakce.<\/p>\n
Dal\u0161\u00ed opat\u0159en\u00ed pro minimalizaci rizik, kter\u00e1 je mo\u017en\u00e9 zv\u00e1\u017eit krom\u011b b\u011b\u017en\u00fdch opat\u0159en\u00ed, v\u010detn\u011b eduka\u010dn\u00edch program\u016f.<\/p>\n
Eduka\u010dn\u00ed materi\u00e1ly jsou dodate\u010dn\u00e1 opat\u0159en\u00ed pro minimalizaci rizik (aRMM) a obvykle zahrnuj\u00ed eduka\u010dn\u00ed materi\u00e1l(y) zam\u011b\u0159en\u00fd(\u00e9) na minimalizaci d\u016fle\u017eit\u00e9ho rizika a\/nebo maximalizaci pom\u011bru riziko-p\u0159\u00ednos l\u00e9\u010div\u00e9ho p\u0159\u00edpravku. Obsah eduka\u010dn\u00edho materi\u00e1lu m\u00e1 b\u00fdt pln\u011b v souladu s aktu\u00e1ln\u00ed schv\u00e1lenou informac\u00ed o p\u0159\u00edpravku pro l\u00e9\u010div\u00fd p\u0159\u00edpravek, tj. souhrnem \u00fadaj\u016f o p\u0159\u00edpravku (SPC), p\u0159\u00edbalovou informac\u00ed (PI) a \u00fadaji na obalu a m\u00e1 sp\u00ed\u0161e p\u0159id\u00e1vat ne\u017e replikovat informace v SPC a PI.<\/p>\n
P\u0159\u00edklady eduka\u010dn\u00edch program\u016f doporu\u010den\u00e9 pro pl\u00e1n \u0159\u00edzen\u00ed rizik zahrnuj\u00ed: eduka\u010dn\u00ed materi\u00e1ly (pro zdravotnick\u00e9 odborn\u00edky, pacienty nebo obchodn\u00ed z\u00e1stupce), p\u0159\u00edmou komunikaci se zdravotnick\u00fdmi pracovn\u00edky (Direct HCP Communication, DHPC), program \u0159\u00edzen\u00e9ho p\u0159\u00edstupu, program prevence po\u010det\u00ed a syst\u00e9m \u0159\u00edzen\u00e9 distribuce.<\/p>\n
EDUKA\u010cN\u00cd MATERI\u00c1LY p\u0159ipraven\u00e9 pro p\u0159\u00edpravky skupiny Polpharma<\/p>\n
Eduka\u010dn\u00ed materi\u00e1ly zam\u011b\u0159en\u00e9 na minimalizaci d\u016fle\u017eit\u00e9ho rizika a\/nebo maximalizaci pom\u011bru riziko-p\u0159\u00ednos l\u00e9\u010div\u00e9ho p\u0159\u00edpravku. Eduka\u010dn\u00ed materi\u00e1ly mohou b\u00fdt ve form\u011b: informa\u010dn\u00edho dopisu\/sd\u011blen\u00ed, terapeutick\u00e9ho n\u00e1vodu, dotazn\u00edku (nap\u0159. dotazn\u00edk hodnot\u00edc\u00ed znalosti o rizic\u00edch souvisej\u00edc\u00edch s pou\u017eit\u00edm l\u00e9\u010div\u00e9ho p\u0159\u00edpravku), informa\u010dn\u00ed bro\u017eury, pohotovostn\u00ed karty pacienta a speci\u00e1ln\u00edch \u0161kolic\u00edch program\u016f.<\/p>\n
<\/p>\n
Podrobn\u00e9 informace o p\u0159\u00edprav\u011b a implementaci dal\u0161\u00edch opat\u0159en\u00ed pro minimalizaci rizik, v\u010detn\u011b eduka\u010dn\u00edch materi\u00e1l\u016f, jsou pops\u00e1ny v pokynech pro spr\u00e1vnou farmakovigilan\u010dn\u00ed praxi (GVP): Modul V – Risk Mamagement System and Module XVI – Risk Minimization Measures.<\/p>\n","protected":false},"excerpt":{"rendered":"
OPAT\u0158EN\u00cd PRO MINIMALIZACI RIZIK PRO L\u00c9\u010cIV\u00c9 P\u0158\u00cdPRAVKY SKUPINY POLPHARMA Opat\u0159en\u00ed pro minimalizaci rizik\u00a0maj\u00ed za c\u00edl usnadnit informovan\u00e1 rozhodnut\u00ed pro podporu minimalizace rizika p\u0159i p\u0159edepisov\u00e1n\u00ed, v\u00fddeji a\/nebo pou\u017e\u00edv\u00e1n\u00ed l\u00e9\u010div\u00e9ho p\u0159\u00edpravku. P\u0159i pou\u017eit\u00ed rutinn\u00edch opat\u0159en\u00ed pro ka\u017ed\u00fd l\u00e9\u010div\u00fd p\u0159\u00edpravek (viz GVP modul V), maj\u00ed b\u00fdt dal\u0161\u00ed aktivity pro minimalizaci rizik pou\u017eity pouze v p\u0159\u00edpad\u011b, \u017ee jsou pova\u017eov\u00e1ny […]<\/p>\n","protected":false},"author":1,"featured_media":51,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"acf":[],"_links":{"self":[{"href":"https:\/\/polpharma.pl\/int\/cz\/wp-json\/wp\/v2\/pages\/102"}],"collection":[{"href":"https:\/\/polpharma.pl\/int\/cz\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/polpharma.pl\/int\/cz\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/polpharma.pl\/int\/cz\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/polpharma.pl\/int\/cz\/wp-json\/wp\/v2\/comments?post=102"}],"version-history":[{"count":13,"href":"https:\/\/polpharma.pl\/int\/cz\/wp-json\/wp\/v2\/pages\/102\/revisions"}],"predecessor-version":[{"id":801,"href":"https:\/\/polpharma.pl\/int\/cz\/wp-json\/wp\/v2\/pages\/102\/revisions\/801"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/polpharma.pl\/int\/cz\/wp-json\/wp\/v2\/media\/51"}],"wp:attachment":[{"href":"https:\/\/polpharma.pl\/int\/cz\/wp-json\/wp\/v2\/media?parent=102"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}