IntroductionIn Turkey, pharmacovigilance began in 1985. A fully structured adverse drug reaction (ADR)-reporting system was established with the publication of the first pharmacovigilance regulation in 2005. Subsequent regulation published in 2014 brought further improvements to the system.ObjectiveIn this study, we aimed to analyse the ADR-reporting pattern in the context of the first pharmacovigilance legislation in Turkey.MethodsWe analysed ADR reports submitted to the Turkish Pharmacovigilance Center (TUFAM) from 2005 to 2014 with respect to reporting rate (RR), patient characteristics, type of the ADRs, suspected drugs, source of the report and the profession of the reporter.ResultsThe annual RR increased gradually over the study period. RRs for females were greater than those for males. RRs were highly correlated with age. Most commonly reported ADRs were skin and subcutaneous tissue disorders. Most commonly suspected drugs were antineoplastic and immunomodulating agents. There was no remarkable change in reporting pattern of ADRs, patient characteristics or classes of suspected drugs over the years. The most common source of reports was spontaneous reporting. Contribution of the reports from studies increased gradually. Most of the reports were reported by physicians. RRs by pharmacists increased substantially over the years.ConclusionThis study showed that the annual RR increased gradually over the 9-year study period. This increase was neither due to an increased reporting of a specific group of ADRs or drugs, nor to an increased reporting in a specific group of patients. There was a general increase in RR in parallel to pharmacovigilance activities.Electronic supplementary materialThe online version of this article (doi:10.1007/s40801-015-0054-1) contains supplementary material, which is available to authorized users.
Türkiye'de tianeptinin kötüye kullanım risk yönetimi: Ulusal bir tecrübe Amaç: Major depresif atakların tedavisinde kullanılan tianeptin, herhangi bir ilaç veya alkol bağımlılığı veya kötüye kullanımı öyküsü olanlarda bağımlılık potansiyeli olan ve yapısal olarak trisiklik antidepresanlara benzerlik gösteren, ancak farmakolojik olarak farklı özelliklere sahip bir ilaçtır. Bu çalışmada, Türkiye'de tianeptinin kötüye kullanım potansiyelinden doğan güvenlik problemlerini ve alınan risk yönetimi önlemlerini değerlendirmeyi amaçladık. Yöntemler: Tianeptinin kötüye kullanımıyla ilgili yan etki bildirimleri ve bu ajanla ilgili alınan risk yönetimi önlemleri, Türkiye İlaç ve Tıbbi Cihaz Kurumu Uygulama Yazılımı, Sağlık Bilgileri Enstitüsü (IMS) değerleri, Uppsala İzleme Merkezi (Vigiflow) ve Türkiye İlaç Takip Sistemi kullanılarak retrospektif olarak değerlendirildi. Bulgular: 2011 ve 2012 yıllarında tianeptinin kötüye kullanımı sonucu meydana gelen üç ölüm vakası ve Risk Yönetimi Dairesi'ne tianeptinin kötüye kullanımıyla ilgili yan etki bildirimlerinin artması neticesinde tianeptin, Türkiye'de 2012 yılının Ekim ayında kontrole tabi ilaçlar listesine dahil edilmiştir. Sonuç: Tianeptin, diğer trisiklik antidepresanlara göre bazı avantajlara sahip olmasına rağmen, bağımlılık potansiyeli açısından özellikle herhangi bir ilaç veya alkol bağımlılığı veya kötüye kullanımı öyküsü olan hastalarda dikkatle izlenmelidir.
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