Tarillion Marie, Hertzsch Robert, Richter Angelika
Institute of Pharmacology, Pharmacy and Toxicology, Faculty of Veterinary Medicine, University of Leipzig, 04103 Leipzig, Germany.
Tierarzt Plus GmbH, 10115 Berlin, Germany.
Antibiotics (Basel). 2025 Apr 21;14(4):419. doi: 10.3390/antibiotics14040419.
Since 28 January 2022, veterinary medicinal products (VMPs) must be used in accordance with the conditions of the marketing authorisation (Regulation (EU) 2019/6, Article 106). This entails further restrictions on therapeutic freedom, for example, with regard to dose deviations. Off-label use is any use of a product that deviates from the Summary of Product Characteristics (SPCs). To date, there are no data available on the type and extent of off-label use on the basis of which the feasibility of the new regulation in Germany can be assessed. Therefore, a Germany-wide anonymous online survey was conducted as a quantitative cross-sectional study comprising 196 questions according to off-label use in dogs and cats. In quantitative terms, the survey was representative of 358 participants but limited due to the demographic characteristics of the participants. A total of 91.3% (326/357) veterinarians stated that they had used antibiotics off-label. Fusidic acid, chloramphenicol, tylosin, and florfenicol were most frequently reclassified with regard to animal species. Authorised drugs for cats and dogs such as amoxicillin/clavulanic acid, doxycycline, metronidazole, and fluoroquinolones, like enrofloxacin and marbofloxacin, were also used off-label, often with regard to indication and treatment duration. Although there are comparatively many antibacterial preparations available for cats and dogs, off-label use is common practice. In many cases, special circumstances of the individual case justify the off-label use of authorised preparations for cats and dogs. The survey results indicate that some dose revisions are recommended. Guidance for specific indications in cats and dogs could contribute to greater legal certainty in small animal practice with regard to the justification of off-label use.
自2022年1月28日起，兽用药品（VMPs）必须按照上市许可的条件使用（欧盟法规2019/6，第106条）。这对治疗自由度带来了进一步限制，例如在剂量偏差方面。超说明书用药是指产品的任何使用方式偏离了产品特性摘要（SPCs）。迄今为止，尚无关于超说明书用药的类型和程度的数据，据此无法评估德国新法规的可行性。因此，开展了一项全德范围的匿名在线调查，作为一项定量横断面研究，包含196个关于猫和狗超说明书用药的问题。从数量上看，该调查对358名参与者具有代表性，但由于参与者的人口统计学特征而受到限制。共有91.3%（326/357）的兽医表示他们曾超说明书使用抗生素。就动物种类而言，夫西地酸、氯霉素、泰乐菌素和氟苯尼考被重新分类的情况最为常见。猫和狗的获批药物，如阿莫西林/克拉维酸、多西环素、甲硝唑以及氟喹诺酮类药物，如恩诺沙星和马波沙星，也被超说明书使用，通常是在适应症和治疗时长方面。尽管有相对较多的猫和狗用抗菌制剂可供使用，但超说明书用药仍是常见做法。在许多情况下，个别病例的特殊情况证明了对猫和狗获批制剂进行超说明书使用的合理性。调查结果表明，建议进行一些剂量修订。针对猫和狗特定适应症的指南可能有助于在小动物医疗实践中，在超说明书使用合理性方面提高法律确定性。
