Farger Michaela Veronika, Eule Johanna Corinna
Klinik für kleine Haustiere, Ophthalmologie, Freie Universität Berlin.
Kleintierpraxis am Aischbach.
Tierarztl Prax Ausg K Kleintiere Heimtiere. 2022 Apr;50(2):82-91. doi: 10.1055/a-1789-2762. Epub 2022 May 6.
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.
市场上专门批准用于猫的眼科药物很少，导致经常使用批准用于人类的药物。在德国，药品的管理、调配或处方受药品法（《药品法》（AMG））以及兽医实践中药房的规定（《兽医诊所药房条例》（TÄHAV））的监管。本研究的目的是收集有关猫眼部疾病的发生情况和频率的数据，并评估超说明书用药的必要性频率。制定了基于证据的最佳治疗方案，并就其在德国的可行性进行了审查。
对来自柏林自由大学“小动物诊所”以及德国南部一家小动物诊所的876只患有眼部问题的猫的数据进行了评估（2015年1月1日至2018年12月31日）。随后，分析了德国批准药物和/或超说明书用药的理论可及性。
基于925次眼科检查做出了1198例诊断。最常见的疾病包括结膜炎、角膜炎、葡萄膜炎、高血压性视网膜病变和青光眼。这些疾病中有885/1198（73.9%）需要治疗，相当于722/925（78.1%）例。根据循证数据，所有患者都有可能接受治疗。在225/722（31.2%）的病例中，可以使用相关的专门批准药物进行治疗。在497/722例（68.8%）病例中需要超说明书用药。在需要超说明书用药的497例病例中，481例（96.8%）可以使用批准用于人类的药物，28例（5.6%）可以超说明书使用其他兽药，60例（12.2%）可以使用特别生产的药物。在总共36/722例（5%）病例中，在当前监管框架下无法提供最佳护理。
根据治疗必要性的规定，德国猫的眼科治疗在监管框架内是可行的。在本研究中，5%的患者无法获得最佳医疗护理。要填补这一差距，需要额外批准兽医眼科药物以及研发新型活性剂和兽药。
