{"id":3008,"date":"2012-12-27T17:50:56","date_gmt":"2012-12-27T15:50:56","guid":{"rendered":"http:\/\/www.ced.org.tr\/?p=3008"},"modified":"2012-12-27T17:50:56","modified_gmt":"2012-12-27T15:50:56","slug":"titck-endikasyon-disi-ilac-listesini-guncelledi","status":"publish","type":"post","link":"http:\/\/www.ced.org.tr\/?p=3008","title":{"rendered":"T\u0130TCK Endikasyon d\u0131\u015f\u0131 ila\u00e7 listesini g\u00fcncelledi"},"content":{"rendered":"

T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu www.iegm.gov.tr adresinden yay\u0131mlad\u0131\u011f\u0131 26.12.2012 tarihli duyuru ile Endikasyon D\u0131\u015f\u0131 \u0130la\u00e7 L\u0130stesinin g\u00fcncellendi\u011fini belirtti.<\/p>\n

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Endikasyon D\u0131\u015f\u0131 \u0130la\u00e7 Listesi G\u00fcncellenmi\u015ftir<\/strong><\/p>\n

Sa\u011fl\u0131k Uygulama Tebli\u011fi\u2019nin \u201c6.1.4. Maddesi 6. F\u0131kras\u0131 (a) bendi gere\u011fince 07.11.2012 tarihinde yay\u0131mlanan \u201cSa\u011fl\u0131k Bakanl\u0131\u011f\u0131ndan Ek Onaya Gerek Olmayan Endikasyon D\u0131\u015f\u0131 \u0130la\u00e7 Listesi\u201d g\u00fcncellenmi\u015ftir.<\/p>\n

\u201cSa\u011fl\u0131k Bakanl\u0131\u011f\u0131 Ek Onay\u0131 Al\u0131nmadan Kullan\u0131labilecek Endikasyon D\u0131\u015f\u0131 \u0130la\u00e7 Listeleri\u201dnden , \u201cB\u00f6l\u00fcm I Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 Ek Onay\u0131 Al\u0131nmadan Kullan\u0131labilecek Endikasyon D\u0131\u015f\u0131 Hematoloji-Onkoloji \u0130la\u00e7 Listesi\u201d 26.12.2012 tarihinden ge\u00e7erlidir.<\/p>\n

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END\u0130KASYON DI\u015eI \u0130LA\u00c7 KULLANIMI KILAVUZU<\/span><\/strong><\/div>\n
<\/strong><\/div>\n
<\/strong><\/div>\n
Ama\u00e7<\/strong><\/a>: <\/strong>Bu k\u0131lavuz, endikasyon d\u0131\u015f\u0131 (off label use) kullan\u0131lan veya \u015fahsi tedavi amac\u0131yla yurt d\u0131\u015f\u0131ndan getirilen ila\u00e7lar\u0131n t\u0131bbi, etik, hukuki, farmakoekonomik ve ak\u0131lc\u0131 kullan\u0131m\u0131 temin etmek amac\u0131yla haz\u0131rlanm\u0131\u015ft\u0131r.<\/div>\n
<\/strong><\/div>\n
Tan\u0131m<\/strong><\/a>: <\/strong>\u00dclkemizde onaylanm\u0131\u015f endikasyonlar\u0131n d\u0131\u015f\u0131nda ve\/veya standart dozlar\u0131n \u00fcst\u00fcnde ila\u00e7 kullan\u0131m\u0131 ile \u00fclkemizde hen\u00fcz ruhsatland\u0131r\u0131lmam\u0131\u015f ila\u00e7lar\u0131n \u015fahsi tedavi amac\u0131yla yurt d\u0131\u015f\u0131ndan getirtilerek kullan\u0131m\u0131 hususlar\u0131 \u201cendikasyon d\u0131\u015f\u0131 ila\u00e7 kullan\u0131m\u0131\u201d olarak adland\u0131r\u0131lmaktad\u0131r.<\/div>\n
<\/strong><\/div>\n
Genel esaslar<\/strong><\/a>:<\/div>\n
Endikasyon D\u0131\u015f\u0131 ila\u00e7 kullan\u0131m\u0131 i\u00e7in belirlenmi\u015f genel esaslar \u015funlard\u0131r:<\/div>\n
1- Onayl\u0131 endikasyon ve standart doz d\u00e2hilinde ila\u00e7la tedavisi m\u00fcmk\u00fcn olan hastal\u0131klar i\u00e7in endikasyon d\u0131\u015f\u0131 ila\u00e7 kullan\u0131m\u0131na izin verilmeyecektir. Ancak belirgin olarak farmakoekonomik avantaj tan\u0131yan tedavi se\u00e7eneklerinde hasta ve hekimin talebi de\u011ferlendirilir.<\/div>\n
2- Ba\u015fvurular, hastay\u0131 takip eden hekimin imza ve ka\u015fesini ta\u015f\u0131yacakt\u0131r. Hasta, hasta yak\u0131n\u0131, eczac\u0131 veya ba\u015fka \u015fah\u0131slarca ba\u015fvuru formlar\u0131 d\u00fczenlenemez.<\/div>\n
3- \u00d6ncelikle ilgili ilac\u0131n istenilen endikasyonda kullan\u0131m\u0131n\u0131n bilimsel y\u00f6nden uygun olup olmad\u0131\u011f\u0131n\u0131n Bakanl\u0131k\u00e7a de\u011ferlendirilecek, uygunluk onay\u0131ndan sonra re\u00e7ete yaz\u0131labilecektir.<\/div>\n
4-\u00a0\u00a0Bakanl\u0131ktan izin al\u0131nmadan endikasyon d\u0131\u015f\u0131 ila\u00e7 kullan\u0131m\u0131na ba\u015flan\u0131lm\u0131\u015f ise, geriye d\u00f6n\u00fck bu gibi durumlar i\u00e7in yap\u0131lacak ba\u015fvurular de\u011ferlendirilmeye al\u0131nmayacakt\u0131r.<\/div>\n
5-\u00a0Yukar\u0131daki \u015fartlara uyan ba\u015fvurular i\u00e7in gerekli belgeler:<\/div>\n
a)\u00a0\u201cEndikasyon D\u0131\u015f\u0131 \u0130la\u00e7 Kullan\u0131m\u0131 Talep Formu<\/strong>\u201d (Ek-1<\/a><\/strong>)<\/div>\n
b) Sa\u011fl\u0131k Kurulu Raporu veya \u0130la\u00e7 Kullan\u0131m Raporu \u00f6rne\u011fi<\/div>\n
c)\u00a0Hasta taraf\u0131ndan okunarak imzalanm\u0131\u015f genel \u201cBilgilendirilmi\u015f Hasta Olur Formu<\/strong>\u201d (Ek-2<\/a><\/strong>)<\/div>\n
\u00e7)\u00a0Literat\u00fcr(ler): Endikasyon d\u0131\u015f\u0131 ila\u00e7 kullan\u0131m\u0131 ba\u015fvurular\u0131 Bakanl\u0131k\u00e7a \u00e7\u0131kar\u0131lacak k\u0131lavuzlarda yer alan ila\u00e7lar i\u00e7in tan\u0131mlanm\u0131\u015f alanlarda yap\u0131lmas\u0131 gerekir. Tedavi s\u00fcreleri de yine bu k\u0131lavuzlarla d\u00fczenlenecektir. Bu k\u0131lavuzlarda tan\u0131mlanan alanlar haricinde kullan\u0131lmak istenen ilac\u0131n ilgili endikasyonda kullan\u0131m\u0131na dair literat\u00fcr eklenmelidir. Bu literat\u00fcrler \u00e7ok say\u0131da hastada olumlu sonu\u00e7lar\u0131n (sa\u011f kal\u0131m avantaj\u0131, morbiditeye yol a\u00e7an klinik bulgular\u0131n gerilemesi, vb.) kesin olarak g\u00f6sterildi\u011fi, spesifik ve bilimsel hakemli dergi veya kitaplardan al\u0131nm\u0131\u015f olmal\u0131d\u0131r. K\u0131s\u0131tl\u0131 say\u0131da hasta i\u00e7eren veya vaka takdimi (case report) \u015feklinde olan literat\u00fcr \u00f6rnekleri kabul edilmeyecektir.<\/div>\n
d)\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Epikriz (veya hastane \u00e7\u0131k\u0131\u015f \u00f6zeti) \u00f6rne\u011fi.<\/div>\n
6-\u00a0Ba\u015fvuru \u201cSa\u011fl\u0131k Bakanl\u0131\u011f\u0131 T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz\u00a0KurumuS\u00f6\u011f\u00fct\u00f6z\u00fc Mahallesi 2176. Sokak No:5 P.K. 06520 \u00c7ankaya\/ANKARA <\/strong>\u201d adresine veya internette\u00a0www.iegm.gov.tr<\/a> adresi arac\u0131l\u0131\u011f\u0131yla yap\u0131lacakt\u0131r.<\/div>\n
7-\u00a0\u00a0Uygulanan tedavi sonras\u0131 etkililik ve yan etki bak\u0131m\u0131ndan olumlu cevap al\u0131nan hastalarda tedaviye devam etmek istenir ise iznin son bir ay\u0131 i\u00e7inde ba\u015fvuru yap\u0131labilecektir. Ba\u015fvuruda hekim taraf\u0131ndan yeniden \u201cEndikasyon D\u0131\u015f\u0131 \u0130la\u00e7 Kullan\u0131m Talep Formu\u201d (Ek-1<\/a>) <\/strong>doldurulmayacak;\u00a0\u201cBilgilendirilmi\u015f Hasta Olur Formu (Ek-2<\/a>)\u201d ve<\/strong> \u201cEtkililik ve Yan Etki Geri Bildirim Formu (Ek-3<\/a>)\u201d <\/strong>doldurulmas\u0131 yeterli olacakt\u0131r.<\/div>\n
8-\u00a0\u00a0Bakanl\u0131k, talep edilen ilac\u0131n \u00f6zelli\u011fine g\u00f6re ek form veya belge isteyebilir;\u00a0\u00a0\u00a0 gerekti\u011finde hastal\u0131kla ilgili olarak yap\u0131lm\u0131\u015f \u00f6zel laboratuar tetkiklerinin sonu\u00e7lar\u0131n\u0131 da talep edebilir (kemik ili\u011fi biyopsisi, histopatoloji de\u011ferlendirme sonu\u00e7lar\u0131 gibi).<\/div>\n
9-\u00a0 Hastal\u0131\u011f\u0131n ilerlemesi, hastan\u0131n hayat\u0131n\u0131 kaybetmesi ve ciddi advers etkiler gibi tedavinin sonland\u0131r\u0131lmas\u0131n\u0131 gerektiren hallerde en ge\u00e7 5(be\u015f) i\u015fg\u00fcn\u00fc i\u00e7inde Bakanl\u0131\u011fa gerek\u00e7esiyle birlikte bildirimde bulunulacakt\u0131r.<\/div>\n
10-\u00a0 Hastal\u0131\u011f\u0131n ilerlemesi, hastan\u0131n hayat\u0131n\u0131 kaybetmesi, ila\u00e7 alerjisi gibi olumsuz bir durum geli\u015fmesine ba\u011fl\u0131 olarak tedavinin planlanan s\u00fcreden daha erken kesilmesi halinde; bedeli Sosyal G\u00fcvenlik Kurumlar\u0131nca \u00f6denmi\u015f olan ila\u00e7lar, tutanak kar\u015f\u0131l\u0131\u011f\u0131 bir kamu hastanesi eczanesine hasta yak\u0131n\u0131 taraf\u0131ndan teslim edilecek ve ayr\u0131ca Sosyal G\u00fcvenlik Kurumu ile T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu’na sorumlu eczac\u0131 taraf\u0131ndan yaz\u0131l\u0131 bilgi verilecektir.<\/div>\n
11-\u00a0Olumsuz sonu\u00e7lanan talepler i\u00e7in yap\u0131lacak itirazlar \u00fc\u00e7 ay ge\u00e7meden de\u011ferlendirmeye al\u0131nmayacakt\u0131r. Ancak yeni literat\u00fcr eklenmesi ve\/veya hastan\u0131n klinik verileriyle ilgili ek bilgi sunulmas\u0131 durumunda itiraz de\u011ferlendirilebilir.<\/div>\n
12-\u00a0Yeni ruhsat veya endikasyon ilavesi alm\u0131\u015f oldu\u011fu halde hen\u00fcz geri \u00f6demeye al\u0131nmam\u0131\u015f m\u00fcstahzarlar geri \u00f6deme listesine al\u0131n\u0131ncaya kadar \u015fahsi tedavi baz\u0131nda Bakanl\u0131\u011f\u0131m\u0131zca verilen kullan\u0131m izni yaz\u0131s\u0131yla \u00f6denir.<\/div>\n
13-\u00a0Endikasyon d\u0131\u015f\u0131 ila\u00e7 kullan\u0131m izni \u015fahsi (hasta baz\u0131nda) olup, hastan\u0131n i\u00e7inde bulundu\u011fu \u00f6zel klinik durum i\u00e7in verilir. Herhangi bir hasta i\u00e7in verilen izin; benzer te\u015fhis konulmu\u015f fakat farkl\u0131 klinik seyre sahip di\u011fer hastalara emsal te\u015fkil etmeyece\u011fi gibi, Bakanl\u0131\u011f\u0131n ila\u00e7la ilgili genel bir sa\u011fl\u0131k stratejisini de yans\u0131tmaz.<\/div>\n
14-\u00a0Bakanl\u0131k, hastan\u0131n ilerleyen veya de\u011fi\u015fen klinik durumundan dolay\u0131 s\u00f6z konusu izni iptal edebilir, doz ve uygulama s\u00fcresinde de\u011fi\u015fiklikler yapabilir.<\/div>\n
15-\u00a0Bu k\u0131lavuz kapsam\u0131na girmeyen m\u00fcteaddit ba\u015fvurular ve izinsiz endikasyon d\u0131\u015f\u0131 ila\u00e7 kullan\u0131m\u0131n\u0131n tespiti halinde Bakanl\u0131k\u00e7a\u00a05237 Say\u0131l\u0131 T\u00fcrk Ceza Kanunun 90. maddesi gere\u011fince i\u015flem yap\u0131lacakt\u0131r. <\/strong><\/div>\n
<\/strong><\/div>\n
Yasaklar<\/strong><\/a>: <\/strong>Bakanl\u0131k\u00e7a verilmi\u015f izinler do\u011frultusunda yap\u0131lan tedaviler ve bunlardan elde edilecek sonu\u00e7lar bilimsel yay\u0131n amac\u0131yla (vaka takdimi hari\u00e7) ve ila\u00e7 ruhsatland\u0131rma \u00e7al\u0131\u015fmalar\u0131na esas veri olarak kullan\u0131lamaz.<\/div>\n
Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 Ek Onay\u0131 Al\u0131nmadan Kullan\u0131labilecek \u00a0Endikasyon D\u0131\u015f\u0131 \u0130la\u00e7lar;<\/span><\/strong><\/span><\/div>\n
<\/p>\n
B\u00f6l\u00fcm I: Onkoloji \u2013 Hematoloji \u0130la\u00e7lar\u0131<\/span><\/a><\/span><\/strong><\/div>\n
B\u00f6l\u00fcm II: G\u00f6z \u0130la\u00e7lar\u0131<\/span><\/a><\/span><\/strong><\/div>\n
B\u00f6l\u00fcm III: Psikiyatri Alan\u0131nda Kullan\u0131lan \u0130la\u00e7lar<\/span><\/a><\/span><\/strong><\/div>\n
<\/p>\n
B\u00f6l\u00fcm IV:Dermatoloji \u0130la\u00e7lar\u0131<\/span><\/a><\/span><\/strong><\/div>\n

<\/span><\/strong><\/div>\n

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Ekler;<\/span><\/span><\/strong><\/span><\/span><\/div>\n
Ek – 1 Endikasyon D\u0131\u015f\u0131 \u0130la\u00e7 Kullan\u0131m\u0131 Talep Formu<\/strong><\/span><\/a><\/div>\n
Ek – 2 Bilgilendirilmi\u015f Olur Formu<\/strong><\/span><\/a><\/div>\n
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Ek\u00a0 -2(a) Paroksismal Nokturnal Hemoglobin\u00fcri (PNH) Hastalar\u0131nda Eculizumab Kullan\u0131m\u0131 \u0130\u00e7in Bilgilendirilmi\u015f Hasta Olur Formu<\/strong><\/span><\/a><\/div>\n
Ek\u00a0 -2(b) Atipik Hemolitik \u00dcremik Sendrom (aH\u00dcS) Hastalar\u0131nda Eculizumab Kullan\u0131m\u0131 \u0130\u00e7in Bilgilendirilmi\u015f Hasta Olur Formu<\/strong><\/span><\/a><\/div>\n
Ek\u00a0 -2(c)\u00a0Albumine Ba\u011fl\u0131 Paklitaksel Kullan\u0131m\u0131 \u0130\u00e7in Bilgilendirilmi\u015f Hasta Olur Formu<\/span> <\/strong><\/span><\/a> <\/strong><\/span><\/div>\n
Ek –\u00a02(d) \u00a0Bevacizumab Kullan\u0131m\u0131 i\u00e7in Bilgilendirilmi\u015f Hasta Onam Formu<\/strong><\/span><\/a> <\/strong><\/span><\/div>\n
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Ek –\u00a02(e) Tedavi Ba\u015flang\u0131c\u0131 i\u00e7in Natalizumab Hasta Bilgilendirme Formu<\/strong><\/span><\/a><\/div>\n
Ek – 2(f)\u00a0 24 Aydan 36 Aya Kadar Natalizumab Kullanan Hastalar i\u00e7in Bilgilendirme Formu<\/strong><\/span><\/a><\/div>\n
Ek –\u00a02(g) Lenalidomid Hasta Onam Formu<\/strong><\/span><\/a><\/div>\n
Ek – 2(h) Rit\u00fcksimab Eri\u015fkin\/\u00c7ocuk Hastalar \u0130\u00e7in Tedavi Bilgilendirme Onam Formu<\/strong><\/span><\/a><\/div>\n
Ek – 3 Etkililik ve Yan Etki Geri Bildirim<\/strong><\/span><\/a><\/div>\n
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Ek –\u00a04 Paroksismal Nokturnal Hemoglobin\u00fcri (PNH) Hastalar\u0131nda Eculizumab Kullan\u0131m\u0131 \u0130\u00e7in\u00a0A\u015f\u0131 Sertifikas\u0131<\/strong><\/span><\/a><\/div>\n
Ek –\u00a05 Atipik Hemolitik \u00dcremik Sendrom (aH\u00dcS) Hastalar\u0131nda Eculizumab Kullan\u0131m\u0131 \u0130\u00e7in\u00a0A\u015f\u0131 Sertifikas\u0131<\/strong><\/span><\/a><\/p>\n
<\/strong><\/span><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"

T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu www.iegm.gov.tr adresinden yay\u0131mlad\u0131\u011f\u0131 26.12.2012 tarihli duyuru ile Endikasyon D\u0131\u015f\u0131 \u0130la\u00e7 L\u0130stesinin g\u00fcncellendi\u011fini belirtti. \u00a0...<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[62],"tags":[],"class_list":["post-3008","post","type-post","status-publish","format-standard","hentry","category-sagliktan-haberler"],"aioseo_notices":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"jetpack-related-posts":[],"_links":{"self":[{"href":"http:\/\/www.ced.org.tr\/index.php?rest_route=\/wp\/v2\/posts\/3008","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/www.ced.org.tr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/www.ced.org.tr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/www.ced.org.tr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.ced.org.tr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3008"}],"version-history":[{"count":0,"href":"http:\/\/www.ced.org.tr\/index.php?rest_route=\/wp\/v2\/posts\/3008\/revisions"}],"wp:attachment":[{"href":"http:\/\/www.ced.org.tr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3008"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.ced.org.tr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3008"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.ced.org.tr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3008"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}