Availability of drugs for the treatment of cats with ocular diseases in Germany - Discrepancy between theory and reality

Abstract

Only a few ophthalmologics specifically approved for cats are available on the market leading to frequent use of drugs approved for humans. In Germany, the administration, dispense or prescription of pharmaceuticals is regulated by the pharmaceuticals law ('Arzneimittelgesetz' (AMG)) as well as the regulation concerning pharmacies in veterinary practice ('Verordnung über tierärztliche Hausapotheken' (TÄHAV)). The aim of this study was to collect data concerning the occurrence and frequency of feline eye diseases and to evaluate the frequency of the necessity for extra-label drug use. Evidence-based, optimal treatment schemes were generated and reviewed with regard to their feasibility in Germany. Data from 876 cats with ocular problems of the "Small Animal Clinic", Freie Universität Berlin as well as a small animal practice in Southern Germany were evaluated (01.01.2015-31.12.2018). Subsequently, the theoretical accessibility for approved agents and/or extra-label drug use in Germany was analyzed. 1198 diagnoses were based on 925 ophthalmic examinations. The most common diseases include conjunctivitis, keratitis, uveitis, hypertensive retinopathy and glaucoma. 885/1198 (73.9 %) of these diseases required treatment, which equates to 722/925 (78.1 %) cases. For all patients, treatment would have been possible according to evidence-based data. In 225/722 (31.2 %) cases, treatment with the pertaining, specifically approved agents would have been possible. Extra-label drug use would have been necessary in 497/722 cases (68.8 %). Of the 497 cases necessitating extra-label use, pharmaceuticals approved for humans would have been available for 481 cases (96.8 %), extra-label use of other veterinary pharmaceuticals would have been possible in 28 cases (5.6 %) and in 60 cases (12.2 %) especially manufactured drugs could have been employed. In a total of 36/722 cases (5 %), optimal care would not have been possible in the context of the current regulatory framework. Based on regulations concerning therapeutic necessity, the ophthalmologic therapy of cats in Germany is possible within the regulatory framework. In the present study, 5 % of the patients could not receive optimal medical care. The closure of this gap demands additional approval of veterinary ophthalmic drugs as well as the research and development of novel active agents and veterinary pharmaceuticals.