Incidence of Unlicensed And Off-Label DrugUse in Breast Cancer Therapy İn Turkey:Assessment of Legislative and Regulatory Policy

BUYUKOKUROGLU, Mehmet Emin; AKBULAT, Akif; KERMAN, Saim; KOCKAYA, Güvenc; VURAL, İ. Mert; TANYERİ, Pelin

Incidence of Unlicensed And Off-Label DrugUse in Breast Cancer Therapy İn Turkey:Assessment of Legislative and Regulatory Policy

Pelin Tanyeri, (Sakarya Üniversitesi Tıp Fakültesi, Farmakoloji Anabilim Dalı, Sakarya, Türkiye)

Güvenc Kockaya, (Sağlık Ekonomisi ve Politikaları Derneği, Ankara, Türkiye)

Mehmet Emin Buyukokuroglu, (Sakarya Üniversitesi Tıp Fakültesi, Farmakoloji Anabilim Dalı, Sakarya, Türkiye)

İ. Mert Vural, (Türkiye İlaç ve Tıbbi Cihaz Kurumu, Ankara, Türkiye)

Akif Akbulat, (Türkiye İlaç ve Tıbbi Cihaz Kurumu, Ankara, Türkiye)

Saim Kerman (Türkiye İlaç ve Tıbbi Cihaz Kurumu, Ankara, Türkiye)

Sakarya Tıp Dergisi

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Yıl: 2018 Cilt: 8 Sayı: 4 Sayfa Aralığı: 847 - 853 Metin Dili: İngilizce İndeks Tarihi: 21-04-2021

Incidence of Unlicensed And Off-Label DrugUse in Breast Cancer Therapy İn Turkey:Assessment of Legislative and Regulatory Policy

Öz:

Objective The aim of the study is to evaluate the use of off-label or unlicensed medicines in breast cancer for understanding of Turkey’s perspective. ( Sakarya Med J 2018, 8(4):847-853 )Materials and MethodsThis study involved patients (n=1317) with metastatic breast cancer with tumors ErbB-2 positive who received trastuzumab or other medicine application off-label use. Results It was seen the Marmara Region had the highest application percentage (33.26 %) and it was continued the Central Anatolia Region (27.79 %). Evaluated on the base of cities Istanbul, Ankara and Izmir had the most applications with 29.6 %, 19.2 % and 15.7 % respectively. University hospitals were created the most of the applications, other applications were from education and research hospitals and private hospitalsConclusion This may be caused from the fact that university hospitals accept severe patients who may need off-label medicines.

Anahtar Kelime:

Türkiye’de Meme Kanseri Tedavisinde Ruhsatsız ve Endikasyon Dışı İlaç Kullanım Sıklığı: Yasama Ve Düzenleme Politikasının Değerlendirilmesi

Öz:

Amaç Bu çalışmanın amacı, Türkiye’de meme kanseri tedavisinde ruhsatsız ve endikasyon dışı ilaç kullanımını değerlendirmektir.( Sakarya Tıp Dergisi 2018, 8(4):847-853 ). Gereç veYöntem Bu çalışmaya trastuzumab veya diğer endikasyon dışı ilaç kullanımı için başvuruda bulunmuş ve ErbB-2 pozitif tümörleri olan metastatikmeme kanseri hastaları (n = 1317) alındı. Bulgular Marmara Bölgesi en yüksek başvuru yüzdesine (% 33,26) sahipdi bunu İç Anadolu Bölgesi (% 27,79) izledi. En fazla başvuru sırasıylaİstanbul (% 29,6) Ankara (% 19,2) ve İzmir (% 15,7)illerinden yapıldı. En çok üniversite hastanelerinden başvurular vardı, diğer başvurular ise eğitim ve araştırma hastaneleri ve özel hastane lerden geliyordu.Sonuç Bu durum, üniversite hastanelerinin endikasyon-dışı ilaç kullanımına ihtiyaç duyabilecek hastaları daha fazla kabul etmesinden kaynakla nabilir.

Anahtar Kelime:

Belge Türü: Makale Makale Türü: Araştırma Makalesi Erişim Türü: Erişime Açık

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APA	TANYERİ P, KOCKAYA G, BUYUKOKUROGLU M, VURAL İ, AKBULAT A, KERMAN S (2018). Incidence of Unlicensed And Off-Label DrugUse in Breast Cancer Therapy İn Turkey:Assessment of Legislative and Regulatory Policy. , 847 - 853.
Chicago	TANYERİ Pelin,KOCKAYA Güvenc,BUYUKOKUROGLU Mehmet Emin,VURAL İ. Mert,AKBULAT Akif,KERMAN Saim Incidence of Unlicensed And Off-Label DrugUse in Breast Cancer Therapy İn Turkey:Assessment of Legislative and Regulatory Policy. (2018): 847 - 853.
MLA	TANYERİ Pelin,KOCKAYA Güvenc,BUYUKOKUROGLU Mehmet Emin,VURAL İ. Mert,AKBULAT Akif,KERMAN Saim Incidence of Unlicensed And Off-Label DrugUse in Breast Cancer Therapy İn Turkey:Assessment of Legislative and Regulatory Policy. , 2018, ss.847 - 853.
AMA	TANYERİ P,KOCKAYA G,BUYUKOKUROGLU M,VURAL İ,AKBULAT A,KERMAN S Incidence of Unlicensed And Off-Label DrugUse in Breast Cancer Therapy İn Turkey:Assessment of Legislative and Regulatory Policy. . 2018; 847 - 853.
Vancouver	TANYERİ P,KOCKAYA G,BUYUKOKUROGLU M,VURAL İ,AKBULAT A,KERMAN S Incidence of Unlicensed And Off-Label DrugUse in Breast Cancer Therapy İn Turkey:Assessment of Legislative and Regulatory Policy. . 2018; 847 - 853.
IEEE	TANYERİ P,KOCKAYA G,BUYUKOKUROGLU M,VURAL İ,AKBULAT A,KERMAN S "Incidence of Unlicensed And Off-Label DrugUse in Breast Cancer Therapy İn Turkey:Assessment of Legislative and Regulatory Policy." , ss.847 - 853, 2018.
ISNAD	TANYERİ, Pelin vd. "Incidence of Unlicensed And Off-Label DrugUse in Breast Cancer Therapy İn Turkey:Assessment of Legislative and Regulatory Policy". (2018), 847-853.

APA	TANYERİ P, KOCKAYA G, BUYUKOKUROGLU M, VURAL İ, AKBULAT A, KERMAN S (2018). Incidence of Unlicensed And Off-Label DrugUse in Breast Cancer Therapy İn Turkey:Assessment of Legislative and Regulatory Policy. Sakarya Tıp Dergisi, 8(4), 847 - 853.
Chicago	TANYERİ Pelin,KOCKAYA Güvenc,BUYUKOKUROGLU Mehmet Emin,VURAL İ. Mert,AKBULAT Akif,KERMAN Saim Incidence of Unlicensed And Off-Label DrugUse in Breast Cancer Therapy İn Turkey:Assessment of Legislative and Regulatory Policy. Sakarya Tıp Dergisi 8, no.4 (2018): 847 - 853.
MLA	TANYERİ Pelin,KOCKAYA Güvenc,BUYUKOKUROGLU Mehmet Emin,VURAL İ. Mert,AKBULAT Akif,KERMAN Saim Incidence of Unlicensed And Off-Label DrugUse in Breast Cancer Therapy İn Turkey:Assessment of Legislative and Regulatory Policy. Sakarya Tıp Dergisi, vol.8, no.4, 2018, ss.847 - 853.
AMA	TANYERİ P,KOCKAYA G,BUYUKOKUROGLU M,VURAL İ,AKBULAT A,KERMAN S Incidence of Unlicensed And Off-Label DrugUse in Breast Cancer Therapy İn Turkey:Assessment of Legislative and Regulatory Policy. Sakarya Tıp Dergisi. 2018; 8(4): 847 - 853.
Vancouver	TANYERİ P,KOCKAYA G,BUYUKOKUROGLU M,VURAL İ,AKBULAT A,KERMAN S Incidence of Unlicensed And Off-Label DrugUse in Breast Cancer Therapy İn Turkey:Assessment of Legislative and Regulatory Policy. Sakarya Tıp Dergisi. 2018; 8(4): 847 - 853.
IEEE	TANYERİ P,KOCKAYA G,BUYUKOKUROGLU M,VURAL İ,AKBULAT A,KERMAN S "Incidence of Unlicensed And Off-Label DrugUse in Breast Cancer Therapy İn Turkey:Assessment of Legislative and Regulatory Policy." Sakarya Tıp Dergisi, 8, ss.847 - 853, 2018.
ISNAD	TANYERİ, Pelin vd. "Incidence of Unlicensed And Off-Label DrugUse in Breast Cancer Therapy İn Turkey:Assessment of Legislative and Regulatory Policy". Sakarya Tıp Dergisi 8/4 (2018), 847-853.