A Multifaceted Evaluation of National Off-label Neurology Applications/Ulusal Endikasyon Disi Noroloji Basvurularinin Cok Yonlu Degerlendirilmesi

• Published in: Türk nöroloji dergisi Vol. 26; no. 3; p. 235
• Main Authors: Yurtogullari, Sukran, Rahmanlar, Hanife, Alkan, Ali, Bayar, Banu, Gursoz, Hakki, Adatepe, Nurten Uzun
• Format: Journal Article
• Language: English
• Published: Galenos Yayinevi Tic. Ltd 01.09.2020
• Subjects: Diagnosis; Dosage and administration; Drug therapy; Laws, regulations and rules; Nervous system agents; Nervous system diseases; Off label prescribing; Practice; Turkey
• ISSN: 1301-062X; 1309-2545
• DOI: 10.4274/tnd.2020.37791

Objective: Off-label drug use (OLDU) of neurologic diseases is approved by a regulatory authority, the Turkish Medicines and Medical Devices Agency (TMMDA) in Turkey. It was aimed to investigate the most common neurologic drugs relevant to off-label prescribing and the most prescribed diagnosis, demographic and medical characteristics of patients with OLDU applications in Turkey. Materials and Methods: Four years "TMMDA"s electronic OLDU application records, 9,758 applications in total, were evaluated retrospectively. Information regarding patients' demographic characteristics, diagnoses, ordered drugs, and institutions were evaluated. Results: The most OLDU applications were mostly made in 2015, the majority of which were associated with neurodegenerative diseases. The mean age of the patients was 41.6 years and 65% were female. Some 62.1% of off-label drug application patients' age range was found as 18-64 years. The most common applications were from the Marmara region with 36% and neurology clinics of university hospitals with 81%. Multiple sclerosis (MS) was the most common diagnosis and the most frequently used group of drugs was disease-modifying drugs used in the treatment of MS. Conclusion: Based on the four-year survey of OLDU applications for adult neurologic patients showed that unlicensed drug prescriptions were high. There are very few studies on the result of OLDU applications in neurology worldwide. We believe that this study will be a guide to neurologists with off-label application processes and the results in our country and will make a significant contribution to the literature. Keywords: Off-label drug use, neurologic diseases, multiple sclerosis, chronic migraine Amaç: Nörolojik hastaliklarda endikasyon disi ilaç kullanimi Türkiye'de düzenleyici otorite olan Türkiye Ilaç ve Tibbi Cihaz Kurumu (TITCK) tarafindan onaylanmaktadir. Bizde bu çalisma ile ülkemizde endikasyon disi en sik reçetelenen nörolojik ilaçlar ve tanilarin saptanmasini, bu tedavileri alan hastalarin demografik ve medikal özelliklerini arastirmayi amaçladik. Gereç ve Yöntem: TITCK'nin dört yillik elektronik endikasyon disi kayitlari (toplam 9,758 basvuru) retrospektif olarak degerlendirilmistir. Hastalarin demografik özellikleri, tanilari, reçetelenen ilaçlar, kurumlari incelenmistir. Bulgular: En sik endikasyon disi basvuru 2015 yilinda yapilmistir ve basvurularin çogunlugu nörodejeneratif hastaliklarla iliskilidir. Hastalarin yas ortalamasi 41,6 ve %65'ini kadinlar olusturmaktadir. Endikasyon disi basvuru yapilan hastalarin %62, 1'inin yas araligi 18-64 olarak saptanmistir. En sik basvurular %36 ile Marmara Bölgesi'nden ve %81 ile üniversite hastanesi nöroloji kliniklerinden yapilmistir. Multipl skleroz (MS) en yaygin basvuru yapilan tanidir ve en sik basvuru yapilan ilaç grubu da MS tedavisinde kullanilan hastalik modifiye edici ilaçlardir. Sonuç: Eriskin nöroloji alaninda yapilan dört yillik endikasyon disi basvurular incelendiginde ruhsatsiz ilaç basvurularinin yüksek oldugu saptandi. Dünya çapinda çok az sayida nöroloji endikasyon disi ilaç kullanim sonuçlari ile ilgili çalisma bulunmaktadir. Biz bu çalismamizla ülkemizde yapilan endikasyon disi basvuru süreçleri ve sonuçlari ile kilavuz oldugumuzu ve literatüre önemli katki sagladigimizi düsünmekteyiz. Anahtar Kelimeler: Endikasyon disi ilaç kullanimi, nörolojik hastaliklar, multipl skleroz, kronik migren