{"id":3421,"date":"2020-05-19T14:11:07","date_gmt":"2020-05-19T12:11:07","guid":{"rendered":"https:\/\/avepharma.eu\/?page_id=3421"},"modified":"2022-02-14T15:08:30","modified_gmt":"2022-02-14T14:08:30","slug":"bezpecnost-liekov","status":"publish","type":"page","link":"https:\/\/avepharma.eu\/en\/bezpecnost-liekov\/","title":{"rendered":"Drug safety"},"content":{"rendered":"[vc_row][vc_column][vc_column_text]<strong>DRUG SAFETY\u00a0 \/ Bezpe\u010dnos\u0165 liekov<\/strong><\/p>\n<p>V nasleduj\u00facich riadkoch si m\u00f4\u017eete pre\u010d\u00edta\u0165 u\u017eito\u010dn\u00e9 inform\u00e1cie o v\u00fdzname a priebehu oznamovania ne\u017eiaducich \u00fa\u010dinkov liekov.<\/p>\n<p><strong>\u010co znamen\u00e1 bezpe\u010dnos\u0165 liekov (farmakovigilancia = FV)?<\/strong><\/p>\n<p>Farmakovigilancia predstavuje s\u00fahrn v\u0161etk\u00fdch \u010dinnost\u00ed, ktor\u00e9 prostredn\u00edctvom nepretr\u017eit\u00e9ho zberu a vyhodnocovania \u00fadajov o ne\u017eiaducich \u00fa\u010dinkoch prispievaj\u00fa k poznaniu st\u00e1le podrobnej\u0161ieho a presnej\u0161ieho bezpe\u010dnostn\u00e9ho profilu lieku. Dostatok a aktualiz\u00e1cia inform\u00e1ci\u00ed nielen o kladn\u00fdch \u00fa\u010dinkoch lieku, ale aj o ich negat\u00edvach, \u010di obmedzeniach\u00a0 pom\u00e1ha v spr\u00e1vnom pou\u017eit\u00ed lieku a t\u00fdm aj v \u010do najefekt\u00edvnej\u0161ej a najbezpe\u010dnej\u0161ej lie\u010dbe pacientov. Za vykon\u00e1vanie uveden\u00fdch \u010dinnost\u00ed nes\u00fa zodpovednos\u0165 dr\u017eitelia registr\u00e1cie liekov a ich opr\u00e1vnen\u00ed z\u00e1stupcovia (v\u00e4\u010d\u0161inou ide o farmaceutick\u00e9 spolo\u010dnosti), respekt\u00edve miestne a medzin\u00e1rodn\u00e9 org\u00e1ny. V\u00fdznamn\u00fa \u00falohu v\u00a0 z\u00edskavan\u00ed prvotn\u00fdch inform\u00e1ci\u00ed zohr\u00e1vaj\u00fa samotn\u00ed zdravotn\u00edcki pracovn\u00edci, lek\u00e1rnici a pacienti. Aj v\u010faka ich hl\u00e1seniam je mo\u017en\u00e9 st\u00e1le bezpe\u010dnej\u0161ie pou\u017e\u00edvanie liekov. .<\/p>\n<p><strong>Pre\u010do je FV potrebn\u00e1?<\/strong><\/p>\n<p>Lieky m\u00f4\u017eu pred\u013a\u017ei\u0165 \u017eivot a zlep\u0161i\u0165 jeho kvalitu. Cie\u013eom liekov je br\u00e1ni\u0165 pr\u00ed\u010din\u00e1m a mechanizmom ochoren\u00ed, ALE!<br \/>\nZ\u00e1rove\u0148 maj\u00fa aj v men\u0161ej \u010di v\u00e4\u010d\u0161ej miere vplyv aj na in\u00e9 \u010dasti organizmu, alebo vstupuj\u00fa do interakcie s fyziologick\u00fdmi procesmi, pr\u00edpadne s in\u00fdmi liekmi, \u010di ide o s\u00fahru okolnost\u00ed s in\u00fdmi skryt\u00fdmi \u2013 nediagnostikovan\u00fdmi ochoreniami a\u00a0preto v\u017edy bud\u00fa existova\u0165 \u013eudia, na ktor\u00fdch liek, ktor\u00fd m\u00f4\u017ee u\u017e\u00edva\u0165 bezpe\u010dne aj mili\u00f3n \u013eud\u00ed, nebude \u00fa\u010dinkova\u0165 alebo jeho \u00fa\u010dinok bude negat\u00edvny.<\/p>\n<p>Neexistuje \u00faplne \u201ebezpe\u010dn\u00fd\u201c liek!<\/p>\n<p>Chemick\u00fd alebo fyzick\u00fd z\u00e1sah do fungovania organizmu v\u017edy obn\u00e1\u0161a ur\u010dit\u00e9 riziko! Takmer bez v\u00fdnimiek ka\u017ed\u00fd liek m\u00f4\u017ee ma\u0165 svoje ved\u013eaj\u0161ie \u00fa\u010dinky.<\/p>\n<p>Pozadie ved\u013eaj\u0161\u00edch \u00fa\u010dinkov: Interakcie liekov s organizmom, in\u00fdmi liekmi, v\u00fd\u017eivov\u00fdmi doplnkami a rastlinn\u00fdmi prepar\u00e1tmi. T\u00e1to interakcia je d\u00f4sledkom najm\u00e4 toho, \u017ee liek \u00fa\u010dinkuje nielen v po\u017eadovanom mieste, ale aj v in\u00fdch org\u00e1noch, \u010d\u00edm m\u00f4\u017ee sp\u00f4sobova\u0165 nepr\u00edjemn\u00e9, alebo aj nebezpe\u010dn\u00e9 ved\u013eaj\u0161ie \u00fa\u010dinky.<\/p>\n<p>V\u0161etky lieky nach\u00e1dzaj\u00face sa v distrib\u00facii v r\u00e1mci svojho v\u00fdvoja pre\u0161li nieko\u013ek\u00fdmi sk\u00fa\u0161kami\/klinick\u00fdmi testmi, ktor\u00fdch cie\u013eom bolo potvrdenie ich \u00fa\u010dinnosti a z\u00e1rove\u0148 bezpe\u010dnosti. S d\u013a\u017ekou pou\u017e\u00edvania v\u0161ak rastie aj po\u010det os\u00f4b, ktor\u00e9 liek u\u017e\u00edvaj\u00fa a tak sa m\u00f4\u017eu odhali\u0165 aj ne\u017eiaduce \u00fa\u010dinky, ktor\u00e9 sa v pr\u00edpade m\u00e1lopo\u010detn\u00fdch sk\u00fa\u0161obn\u00fdch skup\u00edn doteraz neobjavili, alebo m\u00f4\u017ee d\u00f4js\u0165 k tomu, \u017ee predt\u00fdm zriedkavo pozorovan\u00e9 ved\u013eaj\u0161ie \u00fa\u010dinky sa prejavia \u010dastej\u0161ie.<\/p>\n<p><strong>Pre\u010do je potrebn\u00e9 ved\u013eaj\u0161ie \u00fa\u010dinky ozn\u00e1mi\u0165?<\/strong><\/p>\n<p>Dr\u017eitelia registr\u00e1cie liekov, alebo aj ich opr\u00e1vnen\u00e9 osoby s povolen\u00edm k distrib\u00facii, ako aj zdravotn\u00edcky person\u00e1l po celom svete, teda aj v Slovenskej republike, s\u00fa z\u00e1konn\u00fdmi predpismi viazan\u00ed k tomu, aby behom cel\u00e9ho \u017eivotn\u00e9ho cyklu produktov akt\u00edvne sledovali ich pr\u00edpadn\u00e9 ne\u017eiaduce \u00fa\u010dinky (z\u00e1kon \u010d.\u00a0 362\/2011 Z.z.).<\/p>\n<p>Z\u00e1rove\u0148 je v ich vlastnom z\u00e1ujme, aby akt\u00edvnym sledovan\u00edm svojich liekov umo\u017enili ich \u010do naj\u00fa\u010dinnej\u0161ie a najbezpe\u010dnej\u0161ie pou\u017eitie a to s vyu\u017eit\u00edm v\u0161etk\u00fdch dostupn\u00fdch inform\u00e1ci\u00ed.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Ak\u00fdm sp\u00f4sobom je mo\u017en\u00e9 ved\u013eaj\u0161\u00ed \u00fa\u010dinok hl\u00e1si\u0165?<\/strong><\/p>\n<p>Ak po\u010das u\u017e\u00edvania na\u0161ich liekov zist\u00edte ne\u017eiaduci alebo ved\u013eaj\u0161\u00ed \u00fa\u010dinok, alebo sa o nie\u010dom takom dozviete, vypl\u0148te pros\u00edm formul\u00e1r, ktor\u00fd si m\u00f4\u017eete stiahnu\u0165 a vytla\u010di\u0165 z na\u0161ej webovej str\u00e1nky a odo\u0161lite n\u00e1m ho sp\u00e4\u0165 jedn\u00fdm z nasleduj\u00facich sp\u00f4sobov:<\/p>\n<ul>\n<li>e-mailom<\/li>\n<li>po\u0161tou<\/li>\n<li><a href=\"https:\/\/avepharma.eu\/wp-content\/uploads\/2020\/05\/hlasenie_podozrenia_na_neziaduci_ucinok_lieku_avepharma.doc\" target=\"_blank\" rel=\"noopener noreferrer\">Formul\u00e1r pre hl\u00e1senie ne\u017eiaducich \u00fa\u010dinkov (. doc)<\/a><\/li>\n<\/ul>\n<p>Ak ste lek\u00e1r alebo lek\u00e1rnik a m\u00e1te ak\u00fako\u013evek ot\u00e1zku v s\u00favislosti s aplik\u00e1ciou lieku, obr\u00e1\u0165te sa pros\u00edm na n\u00e1s s d\u00f4verou. V pr\u00edpade ot\u00e1zok kontaktujte n\u00e1\u0161ho spolupracovn\u00edka<\/p>\n<p>Telef\u00f3n: +421915080566\u00a0 alebo linka pre nahl\u00e1senie ved\u013eaj\u0161\u00edch \u00fa\u010dinkov &#8230;&#8230;. linka pre rie\u0161enie s\u0165a\u017enost\u00ed na kvalitu (z\u00e1znamn\u00edk).<\/p>\n<p>E-mail:\u00a0\u00a0 avepharma@avepharma.eu<\/p>\n<p>&nbsp;<\/p>\n<p><strong>\u010co sa stane s\u00a0 Vami zaslan\u00fdm hl\u00e1sen\u00edm?<\/strong><\/p>\n<p>Vyplnen\u00fd formul\u00e1r ozn\u00e1menia alebo dotazn\u00edk sa dostane do r\u00fak kontaktnej osoby zodpovednej za bezpe\u010dnos\u0165 liekov v spolo\u010dnosti AvePharma, s.r.o.. Po predbe\u017enom vyhodnoten\u00ed a zdokumentovan\u00ed sa inform\u00e1cie post\u00fapia do strediska pre bezpe\u010dnos\u0165 liekov\u00a0 u v\u00fdrobcu. Centr\u00e1la zhroma\u017e\u010fuje ozn\u00e1menia o ved\u013eaj\u0161\u00edch \u00fa\u010dinkoch prich\u00e1dzaj\u00face z viacer\u00fdch kraj\u00edn sveta do jednotnej datab\u00e1zy, \u010d\u00edm je k dispoz\u00edcii ve\u013ek\u00e9 mno\u017estvo inform\u00e1ci\u00ed k tomu, aby bolo mo\u017en\u00e9 nepretr\u017eite vyhodnocova\u0165 a revidova\u0165 \u00fa\u010dinnos\u0165 a bezpe\u010dnos\u0165 na\u0161ich produktov a v pr\u00edpade potreby vykona\u0165 opatrenia v z\u00e1ujme bezpe\u010dn\u00e9ho pou\u017eitia.<\/p>\n<p>V pr\u00edpade obd\u0155\u017eania ak\u00e9hoko\u013evek hl\u00e1senia o ne\u017eiaducom \u00fa\u010dinku lieku je na\u0161a spolo\u010dnos\u0165 povinn\u00e1 t\u00fato inform\u00e1ciu post\u00fapi\u0165\u00a0 v spracovanej podobe \u010falej\u00a0 pr\u00edslu\u0161n\u00fdm org\u00e1nom.<\/p>\n<p><strong>S\u00favisiace z\u00e1kony:<\/strong><\/p>\n<p>Nov\u00fa legislat\u00edvu v oblasti farmakovigilancie (doh\u013eadu nad bezpe\u010dnos\u0165ou liekov) ur\u010duje Nariadenie (EU) \u010d. 1235\/2010, ktor\u00fdm sa upravuje Nariadenie (EK) \u010d. 736\/2004, Smernica \u010d. 2010\/84\/EU, ktorou sa upravuje Smernica \u010d. 2001\/83\/EK, Vykon\u00e1vacie nariadenie Eur\u00f3pskej komisie \u010d. 520\/2012 a aktu\u00e1lna verzia z\u00e1kona \u010d. 362\/2011 Z.z. o liekoch a zdravotn\u00edckych pom\u00f4ckach Vopred V\u00e1m \u010fakujeme za odoslan\u00e9 ozn\u00e1menia, ktor\u00fdmi napom\u00e1hate pri identifik\u00e1cii ne\u017eiaducich udalost\u00ed a zberu d\u00e1t a prispievate k roz\u0161\u00edreniu v\u0161eobecnej farmakovigilan\u010dnej slu\u017eby spolo\u010dnosti AvePharma, s.r.o.<\/p>\n<p>&nbsp;<\/p>\n<p>(Vami poskytnut\u00e9 \u00fadaje a inform\u00e1cie spravujeme d\u00f4verne pod\u013ea predpisov.)[\/vc_column_text][\/vc_column][\/vc_row]\n","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_column_text]DRUG SAFETY\u00a0 \/ Bezpe\u010dnos\u0165 liekov V nasleduj\u00facich riadkoch si m\u00f4\u017eete pre\u010d\u00edta\u0165 u\u017eito\u010dn\u00e9 inform\u00e1cie o v\u00fdzname a priebehu oznamovania ne\u017eiaducich \u00fa\u010dinkov liekov. \u010co znamen\u00e1 bezpe\u010dnos\u0165 liekov (farmakovigilancia = FV)? Farmakovigilancia predstavuje s\u00fahrn v\u0161etk\u00fdch \u010dinnost\u00ed, ktor\u00e9 prostredn\u00edctvom nepretr\u017eit\u00e9ho zberu a vyhodnocovania \u00fadajov o ne\u017eiaducich \u00fa\u010dinkoch prispievaj\u00fa k poznaniu st\u00e1le podrobnej\u0161ieho a presnej\u0161ieho bezpe\u010dnostn\u00e9ho profilu lieku. Dostatok a [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/avepharma.eu\/en\/wp-json\/wp\/v2\/pages\/3421"}],"collection":[{"href":"https:\/\/avepharma.eu\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/avepharma.eu\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/avepharma.eu\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/avepharma.eu\/en\/wp-json\/wp\/v2\/comments?post=3421"}],"version-history":[{"count":6,"href":"https:\/\/avepharma.eu\/en\/wp-json\/wp\/v2\/pages\/3421\/revisions"}],"predecessor-version":[{"id":3643,"href":"https:\/\/avepharma.eu\/en\/wp-json\/wp\/v2\/pages\/3421\/revisions\/3643"}],"wp:attachment":[{"href":"https:\/\/avepharma.eu\/en\/wp-json\/wp\/v2\/media?parent=3421"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}