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在塞尔维亚共和国,人用药物批准适应证外使用于犬的治疗。

Off label use of human approved drugs in treatment of dogs in the Republic of Serbia.

机构信息

University of Novi Sad, Department of Veterinary Medicine, Faculty of Agriculture, Trg Dositeja Obradovica 8, 21 000 Novi Sad, Serbia.

University of Novi Sad, Center for Medical and Pharmaceutical Investigations and Quality Control/Department of Pharmacy, Faculty of Medicine, Hajduk Veljkova 3, 21000 Novi Sad, Serbia.

出版信息

Pol J Vet Sci. 2021 Sep;24(3):399-407. doi: 10.24425/pjvs.2021.138731.

Abstract

Since drug companies are driven by the need to produce profit they are unwilling to make large investments in the development of new drugs if there is no market large enough to justify such investment. For this reason, veterinarians face a major obstacle - the veterinary drug market is not very profitable, which sometimes leads to not having a licensed drug available for treatment in veterinary practice. In this case, the cascade procedure allows veterinarians to, under certain circumstances, prescribe human approved drugs. The aim of our study was to analyze the pattern of human approved drugs prescription for 150 medical records of dogs participating in the survey. The results show that antimicrobial agents were the most commonly prescribed drugs for animals (50%) of all human approved drugs, and beta-lactams (38.6%) were the most widely used antibiotic classes. The most common general conditions for therapeutic use of antimicrobials in this study were digestive, skin and respiratory disorders. Our study shows that the frequency of bacterial culture, susceptibility testing and cytology was very low. Even though the off-label use of human approved drugs in animal practice is regulated by law, the results of this study indicate the need for more specific strategies and guidelines for such use. This may represent a potential for improvement by raising veterinarians' awareness toward more prudent use of human drugs.

摘要

由于制药公司的驱动力是盈利,因此如果没有足够大的市场来证明投资是合理的,它们就不愿意在新药开发上投入大量资金。出于这个原因,兽医面临着一个主要障碍——兽药市场利润不高,这有时导致兽医实践中没有经过许可的药物可供治疗。在这种情况下,级联程序允许兽医在某些情况下为动物开处方人类批准的药物。我们的研究目的是分析在参与调查的 150 份狗的医疗记录中,人类批准的药物处方模式。结果表明,在所有人类批准的药物中,抗菌药物是最常用于动物的药物(50%),而β-内酰胺类(38.6%)是使用最广泛的抗生素类别。在本研究中,抗菌药物治疗的最常见一般条件是消化、皮肤和呼吸道疾病。我们的研究表明,细菌培养、药敏试验和细胞学检查的频率非常低。尽管动物实践中人类批准药物的标签外使用受到法律监管,但这项研究的结果表明,需要制定更具体的策略和指南来规范此类使用。通过提高兽医对人类药物更谨慎使用的意识,这可能代表着一种改进的潜力。

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