Yıl: 2021 Cilt: 10 Sayı: 2 Sayfa Aralığı: 166 - 175 Metin Dili: Türkçe DOI: 10.5336/pharmsci.2021-81086 İndeks Tarihi: 19-11-2021

Dünyada ve Türkiye’de Jenerik İlaç Kullanımı ile İlgiliGelişmeler

Öz:
Jenerik ilaç, referans alınan orijinal ilaç ile aynı etkin maddeyi aynı dozda aynı ya da benzer farmasötik şekilde içeren ve orijinal ilacın patent koruma süresi bittikten sonra üretilebilen ilaçtır. 1984 yılında yürürlüğe giren “Hatch-Waxman Hareketi” olarak bilinen “İlaç Fiyat Rekabeti ve Patent Yenileme Kanunu” ile jenerik ilaçların kullanımının yaygınlaşmasında, preklinik ve klinik faz çalışması koşulunun jenerik ilaçların ruhsat başvuru sürecinden çıkarılarak “kısaltılmış yeni ilaç başvurusu” hâline getirilmesi etkili olmuştur. Sınırlı sayıda sağlıklı gönüllü ile yapılan biyoyararlanım/biyoeşdeğerlik çalışmaları ile jenerik ilacın referans ile terapötik eşdeğer olduğunun gösterilmesi yeterli olarak kabul edilir. Bu nedenle daha düşük maliyet ile piyasaya çıkan jenerikler referans ilaçlara göre genellikle daha ucuzdur. Bu sayede jenerikler, sağlık hizmeti kalitesinden ödün vermeden ilaç harcamalarının azaltılmasına kritik katkı sağlar. Nitekim özellikle gelişmiş ülkelerde, jenerik ilaçların kullanımının yaygınlaştırılması ile ilaçların sağlık bütçesinde meydana getirdiği baskının azaltılması amaçlanmış ve bu doğrultuda özel politikalar uygulanmaya başlanmıştır. Jenerik kullanımının yaygınlaştırılmasında, uygulanan idari politikalarının yanısıra tüketicilerin, eczacıların ve hekimlerin jenerik ilaçlar ile ilgili algıları ve davranışları, tanıya ve ilaca ilişkin özellikler vb. faktörler de etkili olabilmektedir. Bu derlemede, jenerik ilaçlara yönelik temel bilgilere yer verilmesi ve farklı yerlerde kullanımı gittikçe yaygınlaşmakta olan bu ilaçlara ilişkin dünyadaki ve Türkiye’deki gelişmelerin sunulması amaçlanmıştır.
Anahtar Kelime:

Trends in Generic Drug Use in Turkey and in the World

Öz:
The generic drug contains the same active substance asthe referenced original drug, in the same dose, in the same or similarpharmaceutical form and can be produced after the patent protectionperiod of the original drug expires. With "The Drug Price Competi tion and Patent Term Restoration Act", informally known as the“Hatch-Waxman Act” in 1984, the requirement for pre-clinical andclinical phase studies was abolished in the approval process of gener ics. In this context, replacement of the former process with the "ab breviated new drug application" has streamlined the widespread useof generics. Generic drug is deemed as therapeutically equivalent toreference product by demonstrating bioequivalence through bioavail ability/bioequivalence studies conducted with a limited number ofhealthy volunteers. Therefore, generic drugs introduced to the marketwith lower costs are generally cheaper than reference drugs. In thisway, generic drugs make a critical contribution to reducing drug ex penditures without conceding healthcare quality. In fact, especiallyin developed countries, it was aimed to off-load the pressure causedby drug costs on the health budget via increasing the use of genericdrugs, and special policies have been implemented. Apart from ad ministrative policies, many factors including consumers’, pharma cists’, and physicians’ perceptions and behaviors about generics,diagnosis and drug-related characteristics, etc. can impact in spread ing the use of generic drugs. In this review, it was aimed to providefundamental information about generic drugs and present the devel opments in the world and in Turkey for these drugs which are be coming more widespread.
Anahtar Kelime:

Belge Türü: Makale Makale Türü: Derleme Erişim Türü: Erişime Açık
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APA Bayram D, Aydin V, VIZDIKLAR C, Akici A (2021). Dünyada ve Türkiye’de Jenerik İlaç Kullanımı ile İlgiliGelişmeler. , 166 - 175. 10.5336/pharmsci.2021-81086
Chicago Bayram Dilara,Aydin Volkan,VIZDIKLAR Caner,Akici Ahmet Dünyada ve Türkiye’de Jenerik İlaç Kullanımı ile İlgiliGelişmeler. (2021): 166 - 175. 10.5336/pharmsci.2021-81086
MLA Bayram Dilara,Aydin Volkan,VIZDIKLAR Caner,Akici Ahmet Dünyada ve Türkiye’de Jenerik İlaç Kullanımı ile İlgiliGelişmeler. , 2021, ss.166 - 175. 10.5336/pharmsci.2021-81086
AMA Bayram D,Aydin V,VIZDIKLAR C,Akici A Dünyada ve Türkiye’de Jenerik İlaç Kullanımı ile İlgiliGelişmeler. . 2021; 166 - 175. 10.5336/pharmsci.2021-81086
Vancouver Bayram D,Aydin V,VIZDIKLAR C,Akici A Dünyada ve Türkiye’de Jenerik İlaç Kullanımı ile İlgiliGelişmeler. . 2021; 166 - 175. 10.5336/pharmsci.2021-81086
IEEE Bayram D,Aydin V,VIZDIKLAR C,Akici A "Dünyada ve Türkiye’de Jenerik İlaç Kullanımı ile İlgiliGelişmeler." , ss.166 - 175, 2021. 10.5336/pharmsci.2021-81086
ISNAD Bayram, Dilara vd. "Dünyada ve Türkiye’de Jenerik İlaç Kullanımı ile İlgiliGelişmeler". (2021), 166-175. https://doi.org/10.5336/pharmsci.2021-81086
APA Bayram D, Aydin V, VIZDIKLAR C, Akici A (2021). Dünyada ve Türkiye’de Jenerik İlaç Kullanımı ile İlgiliGelişmeler. Literatür Eczacılık Bilimleri Dergisi, 10(2), 166 - 175. 10.5336/pharmsci.2021-81086
Chicago Bayram Dilara,Aydin Volkan,VIZDIKLAR Caner,Akici Ahmet Dünyada ve Türkiye’de Jenerik İlaç Kullanımı ile İlgiliGelişmeler. Literatür Eczacılık Bilimleri Dergisi 10, no.2 (2021): 166 - 175. 10.5336/pharmsci.2021-81086
MLA Bayram Dilara,Aydin Volkan,VIZDIKLAR Caner,Akici Ahmet Dünyada ve Türkiye’de Jenerik İlaç Kullanımı ile İlgiliGelişmeler. Literatür Eczacılık Bilimleri Dergisi, vol.10, no.2, 2021, ss.166 - 175. 10.5336/pharmsci.2021-81086
AMA Bayram D,Aydin V,VIZDIKLAR C,Akici A Dünyada ve Türkiye’de Jenerik İlaç Kullanımı ile İlgiliGelişmeler. Literatür Eczacılık Bilimleri Dergisi. 2021; 10(2): 166 - 175. 10.5336/pharmsci.2021-81086
Vancouver Bayram D,Aydin V,VIZDIKLAR C,Akici A Dünyada ve Türkiye’de Jenerik İlaç Kullanımı ile İlgiliGelişmeler. Literatür Eczacılık Bilimleri Dergisi. 2021; 10(2): 166 - 175. 10.5336/pharmsci.2021-81086
IEEE Bayram D,Aydin V,VIZDIKLAR C,Akici A "Dünyada ve Türkiye’de Jenerik İlaç Kullanımı ile İlgiliGelişmeler." Literatür Eczacılık Bilimleri Dergisi, 10, ss.166 - 175, 2021. 10.5336/pharmsci.2021-81086
ISNAD Bayram, Dilara vd. "Dünyada ve Türkiye’de Jenerik İlaç Kullanımı ile İlgiliGelişmeler". Literatür Eczacılık Bilimleri Dergisi 10/2 (2021), 166-175. https://doi.org/10.5336/pharmsci.2021-81086