Publication: Güvenlilik kaynaklı ek izlem ve geri çekme uygulamalarının ilaç tüketimine yansımasının araştırılması
Abstract
Amaç: İlaçların advers etki bildirim sayılarının artırılması ve daha güvenli kullanılabilmesi için ek izlem işlemi, riski yüksek olan ilaçlarda ise geri çekme işlemi uygulanabilmektedir. Bu çalışmada ulusal ve uluslararası sağlık otoritelerince ek izleme tabi ilaç (EKİTİ) ve güvenlik gerekçesiyle geri çekme işlemlerine tabi tutulmuş ilaçların (GÇİ) özelliklerinin belirlenerek bu işlemlerinin sonuçlarının ilaç tüketimine yansımasının araştırılması amaçlandı. Gereç ve Yöntem: İki bölümden oluşan bu çalışmanın ilk bölümünde Türkiye ve Avrupa’da yayımlanan EKİTİ listelerindeki ilaçlar ve bu ülkelerin yanı sıra ilgili diğer yurtdışı sağlık otoriterince GÇİ işlemi uygulanan ilaçlar değerlendirildi. İkinci bölümde EKİTİ ve GÇİ’lerin tüketim verilerini nasıl etkilediği IQVIA-Türkiye’den sağlanan 14.07.2014-14.01.2024 arasındaki veriler üzerinden incelendi. Bulgular: Türkiye ve Avrupa’da ek izlem listesinde yer alan 83 ilacın %60,2’sinin başlangıçta, %39,8’inin sonradan EKİTİ uygulamasına alındığı belirlendi. EKİTİ’lerin TİTCK’da medyan 34 ay (IQR: 10-110,5), %38,6’sının ise 5 yıldan fazla listede kaldığı belirlendi. ATC-1 düzeyinde en sık “L” (%44,6), “J” (%12,1) ve “C” (%7,3) grubu ilaçlar ile karşılaşıldı. İlaçların %21,6’sı yetim, %42,1’i ise biyoteknolojik ilaç idi. Beş GÇİ’nin Türkiye’de yurtdışına göre 0,6±0,5 yıl sonra işleminin yapıldığı görüldü. Tüketim verisi incelenen sekiz ilaçta (dört EKİTİ ve bir kardeşi; bir GÇİ ve iki kardeşi) istatistiksel olarak anlamlı değişiklikler gözlendi. Sonuç: Bu çalışmada EKİTİ’ler arasında antineoplastik, immünomodülatör ve anti-infektifler gibi reçetelenme oranı yüksek ilaçların fazla olduğu ve tüketimlerinin EKİTİ sonrasında genel olarak belirgin biçimde etkilenmediği görüldü. GÇİ sonrasında kardeşlerinin tüketim ve maliyetinin azalma yönünde etkilendiği gösterilmiştir. Bu işlemlerin yaratabileceği tüketimle ilgili sorunlar konusunda daha detaylı çalışmalara ihtiyaç vardır.
Objective: Additional monitoring is implemented to increase adverse event reporting and promote safer use of medicines, while withdrawal procedures are applied for high-risk drugs. This study aimed to identify the characteristics of drugs subjected to additional monitoring (AMDs) or withdrawn due to safety concerns (WDs) by national and international health authorities, and to investigate how these regulatory actions are reflected in drug consumption. Materials and Methods: This two-part study first evaluated the drugs listed as AMDs in Turkey and Europe, as well as those withdrawn by these and other international regulatory authorities. In the second part, the impact of AMD and WD status on drug consumption was assessed using IQVIA-Turkey data covering the period from July 14, 2014 to January 14, 2024. Results: In 83 drugs listed as AMDs both in Turkey and Europe, 60.2% were designated as AMDs from launch, while 39.8% underwent AMD status later. In Turkey, AMD status persisted for a median of 34 months (IQR: 10–110.5), with 38.6% remaining on the list for >5 yrs. The most common drug groups at the ATC-1 level were “L” (44.6%), followed by “J” (12.1%), and “C” (7.3%). Biotechnological drugs constituted 42.1% and 21.6% of AMDs were orphan drugs. In five WDs, Turkey withdrew 0.6 ± 0.5 yrs. later than international counterparts. Significant changes were found for eight drugs with consumption data (4 AMDs and 1 analogue; 1 WD and 2 analogues). Conclusion: This study found that drugs under additional monitoring often included widely prescribed agents such as antineoplastics, immunomodulators, or anti-infectives, yet their overall consumption remained largely unchanged. In contrast, although limited in number, withdrawals were associated with measurable changes in consumption and cost of therapeutic alternatives. Further research is warranted to elucidate broader implications of these regulatory interventions.
Objective: Additional monitoring is implemented to increase adverse event reporting and promote safer use of medicines, while withdrawal procedures are applied for high-risk drugs. This study aimed to identify the characteristics of drugs subjected to additional monitoring (AMDs) or withdrawn due to safety concerns (WDs) by national and international health authorities, and to investigate how these regulatory actions are reflected in drug consumption. Materials and Methods: This two-part study first evaluated the drugs listed as AMDs in Turkey and Europe, as well as those withdrawn by these and other international regulatory authorities. In the second part, the impact of AMD and WD status on drug consumption was assessed using IQVIA-Turkey data covering the period from July 14, 2014 to January 14, 2024. Results: In 83 drugs listed as AMDs both in Turkey and Europe, 60.2% were designated as AMDs from launch, while 39.8% underwent AMD status later. In Turkey, AMD status persisted for a median of 34 months (IQR: 10–110.5), with 38.6% remaining on the list for >5 yrs. The most common drug groups at the ATC-1 level were “L” (44.6%), followed by “J” (12.1%), and “C” (7.3%). Biotechnological drugs constituted 42.1% and 21.6% of AMDs were orphan drugs. In five WDs, Turkey withdrew 0.6 ± 0.5 yrs. later than international counterparts. Significant changes were found for eight drugs with consumption data (4 AMDs and 1 analogue; 1 WD and 2 analogues). Conclusion: This study found that drugs under additional monitoring often included widely prescribed agents such as antineoplastics, immunomodulators, or anti-infectives, yet their overall consumption remained largely unchanged. In contrast, although limited in number, withdrawals were associated with measurable changes in consumption and cost of therapeutic alternatives. Further research is warranted to elucidate broader implications of these regulatory interventions.