{"id":3669,"date":"2020-01-21T22:45:34","date_gmt":"2020-01-21T22:45:34","guid":{"rendered":"https:\/\/malmed.gov.mk\/?p=3669"},"modified":"2020-01-21T22:45:46","modified_gmt":"2020-01-21T22:45:46","slug":"%d1%81%d0%bb%d0%b5%d0%b4%d0%b5%d1%9a%d0%b5-%d0%bd%d0%b0-%d0%b1%d0%b5%d0%b7%d0%b1%d0%b5%d0%b4%d0%bd%d0%be%d1%81%d1%82","status":"publish","type":"post","link":"https:\/\/malmed.gov.mk\/sq\/%d1%81%d0%bb%d0%b5%d0%b4%d0%b5%d1%9a%d0%b5-%d0%bd%d0%b0-%d0%b1%d0%b5%d0%b7%d0%b1%d0%b5%d0%b4%d0%bd%d0%be%d1%81%d1%82\/","title":{"rendered":"V\u00ebzhgimi i siguris\u00eb"},"content":{"rendered":"<p><strong>Si t\u00eb v\u00ebzhgohet siguria e barnave t\u00eb regjistruara?<\/strong><\/p>\n\n\n\n<p>Bari konsiderohet i sigurt n\u00ebse p\u00ebrfitimi i pritsh\u00ebm tejkalon rrezikun e mundsh\u00ebm nga shfaqja e reaksioneve t\u00eb pad\u00ebshiruara gjat\u00eb p\u00ebrdorimit t\u00eb tij.  \u00c7do bari mund t\u00eb shkaktoj\u00eb efekte an\u00ebsore. Megjithat\u00eb, \u00ebshht\u00eb e r\u00ebnd\u00ebsishme t\u00eb theksohet se n\u00eb shumic\u00ebn e pacient\u00ebve, p\u00ebrdorimi i barnave kalon pa manifestimin e reaksioneve serioze t\u00eb pad\u00ebshiruara.<\/p>\n\n\n\n<p>N\u00eb periudh\u00ebn para-publicitetit (bari para se t\u00eb dal\u00eb n\u00eb treg), hulumtime t\u00eb gjera jan\u00eb duke u realizuar: studime paraklinike t\u00eb kafsh\u00ebve dhe prova klinike t\u00eb njer\u00ebzve.<br>Studimet klinike jan\u00eb kryer n\u00eb p\u00ebrputhje me protokolin e m\u00eb parsh\u00ebm t\u00eb definuar dhe t\u00eb njejt\u00ebt jan\u00eb t\u00eb dizajnuara p\u00ebr t\u00eb vler\u00ebsuar p\u00ebrfitimin e marr\u00ebdh\u00ebnies\/ rrezik gjat\u00eb p\u00ebrdorimit t\u00eb barnave gjat\u00eb terapis\u00eb p\u00ebr indikacione specifike n\u00eb nj\u00eb popullat\u00eb t\u00eb p\u00ebrcaktuar t\u00eb pacient\u00ebve. Provat klinike kryhen rrept\u00ebsisht t\u00eb p\u00ebrcaktuara dhe n\u00eb kushte specifike:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>t\u00eb anketuarit jan\u00eb zgjedhur posa\u00e7\u00ebrisht p\u00ebr at\u00eb studim me kritere t\u00eb rrepta t\u00eb p\u00ebrcaktuara (gjinia, mosha, p\u00ebrkat\u00ebsia etnike, pirja e duhanit, n\u00eb p\u00ebrgjith\u00ebsi nuk ka s\u00ebmundje dhe n\u00eb t\u00eb nj\u00ebjt\u00ebn koh\u00eb nuk p\u00ebrdorin barna t\u00eb tjera, etj.),<\/li><li>numri i t\u00eb anketuarve dhe koh\u00ebzgjatja e studimit jan\u00eb t\u00eb kufizuara,<\/li><li>t\u00eb anketuarit monitorohen vazhdimisht gjat\u00eb studimit.<\/li><\/ul>\n\n\n\n<p>N\u00eb fund t\u00eb prov\u00ebs klinike, jan\u00eb t\u00eb njohura reagimet e shpeshta an\u00ebsore. Bari mund t\u00eb regjistrohet n\u00ebse v\u00ebrtetohet cil\u00ebsia e tij, efikasiteti dhe siguria, dmth n\u00ebse konfirmohet marr\u00ebdh\u00ebnie p\u00ebrfitimi pozitiv \/ rreziku n\u00eb koh\u00ebn e regjistrimit (efikasiteti terapeutik dhe rreziqet e caktuara t\u00eb manifestuara si efekte an\u00ebsore, jan\u00eb t\u00eb pranueshme n\u00eb momentin e caktuar). Pas regjistrimit, bari futet n\u00eb qarkullim dhe fillon t\u00eb p\u00ebrdoret n\u00eb praktik\u00ebn rutinore klinike, te nj\u00eb num\u00ebr i madh i pacient\u00ebve n\u00eb kushte t\u00eb pakontrolluara. Kjo do t\u00eb thot\u00eb q\u00eb momenti kur barnat miratohen p\u00ebr qarkullim ende nuk \u00ebsht\u00eb p\u00ebrcaktuar siguria e p\u00ebrgjithshme e profilit t\u00eb tyre, n\u00eb t\u00eb v\u00ebrtet\u00eb, ka informacione jo t\u00eb plota p\u00ebr efektet e rralla an\u00ebsore, reaksione q\u00eb manifestohen pas p\u00ebrdorimit t\u00eb gjat\u00eb t\u00eb barnave, mungojn\u00eb informacionet p\u00ebr bashk\u00ebveprimet e mundshme, rezistenca, potenciali p\u00ebr shfaqjen e gabimeve mjek\u00ebsore gjat\u00eb p\u00ebrdorimit t\u00eb barnave, p\u00ebrdorimin e tyre p\u00ebr indikacione e cila nuk \u00ebsht\u00eb miratuar dhe nuk \u00ebsht\u00eb specifikuar n\u00eb udh\u00ebzimet e barnave (off label use), abuzimi dhe keqp\u00ebrdorimi, p\u00ebrdorimi i barnave te kategorit\u00eb specifike t\u00eb pacient\u00ebve (f\u00ebmij\u00eb, t\u00eb moshuar, gra shtatz\u00ebna, n\u00ebna infermiere, pacient\u00eb me s\u00ebmundje shoq\u00ebruese: \n(f\u00ebmij\u00eb, t\u00eb moshuar, gra shtatz\u00ebna, gjidh\u00ebn\u00ebse, pacient\u00eb me s\u00ebmundje shoq\u00ebruese: d\u00ebshtimi i m\u00ebl\u00e7is\u00eb, veshkat, zemra etj).<br>P\u00ebr t\u00eb gjitha k\u00ebto arsye, dhe ve\u00e7an\u00ebrisht p\u00ebr shkak t\u00eb ndryshimit t\u00eb madh nga p\u00ebrdorimi i barnave n\u00eb kushte rrept\u00ebsisht t\u00eb kontrolluara \ngjat\u00eb koh\u00ebs t\u00eb provave klinike n\u00eb lidhje me aplikimin e barnave n\u00eb praktik\u00ebn rutin\u00eb t\u00eb p\u00ebrditshme n\u00eb klinik\u00eb n\u00eb popullat\u00ebn e p\u00ebrgjithshme,<\/p>\n\n\n\n<p><strong>Disiplina baz\u00eb shkencore q\u00eb mund\u00ebson v\u00ebzhgimin e barnave dhe mbledhjen e informatave t\u00eb sigurta p\u00ebr to \u00ebsht\u00eb farmakovigjilenca<\/strong><\/p>\n\n\n\n<p>Farmakovigjilenca \u00ebsht\u00eb proces i:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>V\u00ebzhgimit t\u00eb p\u00ebrdorimit t\u00eb barit n\u00eb praktik\u00ebn e p\u00ebrditshme me \u00e7ka mund\u00ebsohet identifikimi i reaksioneve m\u00eb par\u00eb t\u00eb paidentifikuara, t\u00eb papritshme dhe t\u00eb pad\u00ebshiruara, ose ndryshime n\u00eb karakterin (natyr\u00ebn, seriozitetin, frekuenc\u00ebn) n\u00eb reaksionet e pad\u00ebshiruara tanim\u00eb t\u00eb p\u00ebrcaktuara,<\/li><li>vler\u00ebsimitt\u00eb rrezikut dhe p\u00ebrfitimit nga p\u00ebrdorimi i barnave me q\u00ebllim t\u00eb caktohen masat q\u00eb duhet t\u00eb nd\u00ebrmerren, n\u00ebse \u00ebsht\u00eb e nevojshme, q\u00eb t\u00eb p\u00ebrmir\u00ebsohet siguria gjat\u00eb p\u00ebrdorimit t\u00eb barit,<\/li><li>sigurimit t\u00eb informatave p\u00ebr punonj\u00ebsit sh\u00ebndet\u00ebsor\u00eb dhe pacient\u00ebve, me q\u00ebllim t\u00eb arrihet p\u00ebrdorim i sigurt dhe efikas i barnave, v\u00ebzhgimi i ndikimit dhe rezultatet nga masat e nd\u00ebrmarra.<\/li><\/ul>\n\n\n\n<p>Burimi i informatave q\u00eb shfryt\u00ebzohen n\u00eb farmakovigjilenc\u00eb:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>paraqitja spontane e reaksioneve t\u00eb pad\u00ebshiruara t\u00eb barnave nga ana e punonj\u00ebsve sh\u00ebndet\u00ebsor\u00eb dhe pacient\u00ebve,<\/li><li>studime klinike dhe epidemiologjike,<\/li><li>literatur\u00eb mjek\u00ebsore<\/li><li>informata nga industria farmaceutike,<\/li><li>informata nga trupa t\u00eb tjer\u00eb rregullator\u00eb n\u00eb bot\u00eb,<\/li><li>regjistra (vdekjesh, morbiditetesh, shtatz\u00ebn\u00ebsish etj).<\/li><\/ul>\n\n\n\n<p>Informatat nga k\u00ebto burime po testohen dhe analizohen holl\u00ebsisht, dhe mund t\u00eb na drejtojn\u00eb n\u00eb ekzistenc\u00ebn e pap\u00ebrcaktuarparaprakisht t\u00eb reaksionit t\u00eb ri t\u00eb pad\u00ebshiruar t\u00eb baritspecifik, ta v\u00ebrtetojn\u00eb frekuenc\u00ebn e ndryshuar t\u00eb paraqitjes s\u00eb reaksionit t\u00eb pad\u00ebshiruar tashm\u00eb t\u00eb p\u00ebrcaktuar nga bari specifik, identifikimin e reaksionit t\u00eb pad\u00ebshiruesh\u00ebm q\u00eb paraqitet vet\u00ebm te nj\u00eb num\u00ebr i caktuar i pacient\u00ebve, zbulimin e interaksioneve, gabimeve t\u00eb mundshme mjek\u00ebsore, keqp\u00ebrdorim, p\u00ebrdorimi i gabuar etj. \nMasa rregullatore nga shkaqete siguris\u00eb: \nAgjencia e Barnave dhe Pajisjeve Mjek\u00ebsore (MALMED) pas vler\u00ebsimit t\u00eb t\u00eb dh\u00ebnave t\u00eb evidentuara dhe identifikimin e njohurive t\u00eb reja lidhur me sigurin\u00eb e barnave, mund t\u00eb marr\u00eb masa me t\u00eb cilat do t\u00eb siguroj\u00eb se bari do t\u00eb p\u00ebrdoret n\u00eb m\u00ebnyr\u00ebn me t\u00eb cil\u00ebn do t\u00eb pak\u00ebsohet rreziku dhe do t\u00eb rritet p\u00ebrfitimi prej tij. \n\n\nZakonisht k\u00ebto masa p\u00ebrfshijn\u00eb ndryshime n\u00eb informatat p\u00ebr sigurin\u00eb n\u00eb raportin p\u00ebrmbledh\u00ebs p\u00ebr ve\u00e7orit\u00eb e barit dheudh\u00ebzuesin e p\u00ebrdorimit, si dokumente baz\u00eb t\u00eb barit:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>n\u00eb kuptimin e dh\u00ebnies s\u00eb v\u00ebrejtjeve t\u00eb reja t\u00eb r\u00ebnd\u00ebsishme dhe masa t\u00eb kujdesit dhe reaksioneve t\u00eb pad\u00ebshiruara,<\/li><li>kund\u00ebrindikacione t\u00eb reja (p.sh. nuk u jepet grave shtatz\u00ebna, f\u00ebmij\u00ebve ose situatave t\u00eb paqarta mjek\u00ebsoreetj.)<\/li><li>ulja e doz\u00ebs s\u00eb rekomanduar,<\/li><li>kufizimi i p\u00ebrdorimit t\u00eb barit (si terapi dyt\u00ebsore, p\u00ebrjashtimi gjat\u00eb s\u00ebmundjes specifike ose grupeve t\u00eb pacient\u00ebve te t\u00eb cil\u00ebt bari administrohet, ndryshohet n\u00eb baz\u00eb t\u00eb m\u00ebnyr\u00ebs s\u00eb dh\u00ebnies s\u00eb barnave, p.sh. NR i R etj.)<\/li><\/ul>\n\n\n\n<p>Nga ana e MALMED-it mund t\u00eb realizohen edhe masa t\u00eb tjera rregullatore n\u00eb menaxhimin e rrezikut, paras\u00ebgjithash p\u00ebr pak\u00ebsimin e rrezikut, e n\u00eb raste t\u00eb rralla, edhe t\u00ebrheqjes s\u00eb p\u00ebrkohshme t\u00eb lejes p\u00ebr l\u00ebshimin e barit n\u00eb qarkullimp\u00ebr arsye sigurie dhe t\u00ebrheqja e barit nga tregu, kur do t\u00eb shihet se rreziku i mundsh\u00ebm e tejkalon p\u00ebrfitimin e pritur gjat\u00eb p\u00ebrdorimit t\u00eb r\u00ebndomt\u00eb t\u00eb barit.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>\u041a\u0430\u043a\u043e \u0441\u0435 \u0441\u043b\u0435\u0434\u0438 \u0431\u0435\u0437\u0431\u0435\u0434\u043d\u043e\u0441\u0442\u0430 \u043d\u0430 \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0438\u0440\u0430\u043d\u0438\u0442\u0435 \u043b\u0435\u043a\u043e\u0432\u0438? \u041b\u0435\u043a\u043e\u0442 \u0441\u0435 \u0441\u043c\u0435\u0442\u0430 \u0437\u0430 \u0431\u0435\u0437\u0431\u0435\u0434\u0435\u043d \u0434\u043e\u043a\u043e\u043b\u043a\u0443 \u043e\u0447\u0435\u043a\u0443\u0432\u0430\u043d\u0430\u0442\u0430 \u043a\u043e\u0440\u0438\u0441\u0442 \u0433\u043e \u043d\u0430\u0434\u043c\u0438\u043d\u0443\u0432\u0430 \u043f\u043e\u0442\u0435\u043d\u0446\u0438\u0458\u0430\u043b\u043d\u0438\u043e\u0442 \u0440\u0438\u0437\u0438\u043a \u043e\u0434 \u043f\u043e\u0458\u0430\u0432\u0430 \u043d\u0430 \u043d\u0435\u0441\u0430\u043a\u0430\u043d\u0438 \u0440\u0435\u0430\u043a\u0446\u0438\u0438 \u043f\u0440\u0438 \u043d\u0435\u0433\u043e\u0432\u0430\u0442\u0430 \u0443\u043f\u043e\u0442\u0440\u0435\u0431\u0430. \u0421\u0435\u043a\u043e\u0458 \u043b\u0435\u043a \u043c\u043e\u0436\u0435 \u0434\u0430 \u043f\u0440\u0435\u0434\u0438\u0437\u0432\u0438\u043a\u0430 \u043d\u0435\u0441\u0430\u043a\u0430\u043d\u0430 \u0440\u0435\u0430\u043a\u0446\u0438\u0458\u0430. \u0421\u0435\u043f\u0430\u043a, \u0432\u0430\u0436\u043d\u043e \u0435 \u0434\u0430 \u0441\u0435 \u0438\u0441\u0442\u0430\u043a\u043d\u0435 \u0434\u0435\u043a\u0430 \u043a\u0430\u0458 \u043f\u043e\u0432\u0435\u045c\u0435\u0442\u043e \u043f\u0430\u0446\u0438\u0435\u043d\u0442\u0438, \u0443\u043f\u043e\u0442\u0440\u0435\u0431\u0430\u0442\u0430 \u043d\u0430 \u043b\u0435\u043a\u043e\u0442 \u043f\u043e\u043c\u0438\u043d\u0443\u0432\u0430 \u0431\u0435\u0437 \u043c\u0430\u043d\u0438\u0444\u0435\u0441\u0442\u0430\u0446\u0438\u0458\u0430 \u043d\u0430 \u0441\u0435\u0440\u0438\u043e\u0437\u043d\u0438 \u043d\u0435\u0441\u0430\u043a\u0430\u043d\u0438 \u0440\u0435\u0430\u043a\u0446\u0438\u0438. \u0412\u043e [&hellip;]<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3669","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/posts\/3669","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/comments?post=3669"}],"version-history":[{"count":0,"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/posts\/3669\/revisions"}],"wp:attachment":[{"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/media?parent=3669"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/categories?post=3669"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/malmed.gov.mk\/sq\/wp-json\/wp\/v2\/tags?post=3669"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}