Veteriner Hekimliğinde Farmakovijilans ve Etik İlaç Kullanımı
Özet
Farmakovijilans, ilaç güvenliğinin sağlanması, yan, istenilmeyen ve beklenilmeyen etkilerinin izlenilmesi amacıyla geliştirilen bir bilim dalıdır. Genel olarak beşeri hekimlikle başlatılan farmakovijilans uygulamaları, ilaçların pazarlama sonrasında güvenliğinin izlemesini, yan etkilerin tespitini ve risklerin en aza indirilmesini amaçlamaktadır. Bu amaçla hem öngörülen hem de nadir ters reaksiyonların belirlenmesi, ilaç etkileşimlerinin ortaya koyulması ve farmakolojik mekanizmaların aydınlatılması gibi görevleri bulunmaktadır. Veteriner farmakovijilans ise, bu amaçları hayvan sağlığına uyarlayarak, veteriner hekimlikte kullanılan tıbbi maddelerin güvenli ve etkin kullanılmasını hedeflemektedir. Yalnızca hayvanlarda ortaya çıkabilecek advers ilaç reaksiyonlarını değil, aynı zamanda gıda güvenliği, halk sağlığı ve çevresel etkileri de inceleyen çok fonksiyonlu bir disiplindir. Ters ilaç etkilerinin sistematik bir şekilde sınıflandırılması yapılarak, türlere göre değişen farmakokinetik/farmakodinamik ayrımlar ile genetik ve çevresel faktörler gözetilerek risk–yarar durumunu ortaya koyar. Türkiye’de veteriner farmakovijilans, Sağlık Bakanlığı Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK) tarafından yürütülmektedir. Yürütülen bu sistem, Veteriner Tıbbi Ürünlerin Kayıt Edilmesine İlişkin Teknik Gerekliliklerin Uyumlaştırılması Konusunda Uluslararası İş Birliği ve Avrupa Birliği standartlarına entegredir. İlaçların etik kullanılmasının, farmakovijilansın esas hedefleriyle direkt olarak bağlantılı olduğu bilinmektedir. Etik kullanım, sadece hayvan sağlığını korumakla kalmayıp, aynı zamanda ilaç ve gıda güvenliği, halk sağlığının korunması ve çevresel güvenliği de garanti eder. Farmakovijilansın etkin bir şekilde uygulanması noktasında, denetleyici kurumlar, ilaç firmaları, veteriner hekimler ve ilaç araştırma-geliştirme kuruluşları arasındaki doğru ve aktif bilgi paylaşımı, etkin gözlemleme programları ve farmakoepidemiyolojik çalışmaların rolü önemlidir. Yakın gelecekte, dijital bilgi paylaşımları ve yapay zekâ programları kullanılarak risk değerlendirmelerinin yapılması ve uluslararası veri ağları sayesinde, veteriner farmakovijilansın kapsamı genişletilerek ilaçların ters reaksiyonlarının oluşumunu engellenebilecek, etik ilkeler kapsamında ilaç güvenliğinin artırılmasına katkıda bulunabilecektir. Sonuç olarak, veteriner hekimliğinde farmakovijilans ve etik ilaç kullanımının, veteriner hekimler ve hayvan sağlığını ilgilendiren personellerin bilimsel, güvenli ve sorumlu uygulamalarını destekleyen stratejik bir öneme sahip olduğu düşünülmektedir.
Pharmacovigilance is a scientific discipline developed to ensure drug safety and monitor adverse, unexpected and undesirable effects. Pharmacovigilance procedures, which generally originate in human medicine, aim to monitor the safety of medicines after they have been placed on the market, identify adverse effects and minimise risks. For this purpose, its responsibilities include identifying both expected and rare adverse reactions, identifying drug interactions and elucidating pharmacological mechanisms. Veterinary pharmacovigilance, by applying these objectives to animal health, aims to ensure the safe and effective use of medicinal products in veterinary medicine. Pharmacovigilance is a multidisciplinary field that examines not only adverse drug reactions that may occur in animals but also food safety, public health and environmental effects. By systematically classifying adverse drug reactions, it identifies the risk–benefit situation by taking into account species-specific pharmacokinetic and pharmacodynamic differences, as well as genetic and environmental factors. Veterinary pharmacovigilance in Turkey is carried out by the Turkish Medicines and Medical Devices Agency (TİTCK) under the Ministry of Health. This system is integrated with the standards of the International Cooperation on the Harmonisation of Technical Requirements for the Registration of Veterinary Medicinal Products and the European Union. Ethical use of medicines is known to be directly linked to the core objectives of pharmacovigilance. Ethical use not only safeguards animal health but also ensures the safety of medicines and food, as well as protecting public health and the environment. In terms of the effective application of pharmacovigilance, the role of accurate and active information sharing between regulatory authorities, pharmaceutical companies, veterinary professionals and pharmaceutical research and development organisations, as well as effective monitoring programmes and pharmacoepidemiological studies, is significant. In the future, the scope of veterinary pharmacovigilance will be expanded to prevent adverse drug reactions by conducting risk assessments using digital data-sharing platforms and artificial intelligence programmes, and through international data networks, thereby contributing to the enhancement of drug safety in accordance with ethical principles. In conclusion, it is considered that pharmacovigilance and the ethical use of medicines in veterinary medicine are of strategic importance in supporting scientific, safe and responsible practices among veterinarians and other personnel involved in animal health.
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