Off-Label Use of Antibiotics in Small Animal Medicine—A Germany-Wide Anonymous Online Survey

<b>Background/Objectives:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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. <b>Conclusions:</b> 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.

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Publication Details

Journal
Antibiotics
Published
2025-04-21
DOI
https://doi.org/10.3390/antibiotics14040419
Citations
1
Primary Topic
Pharmaceutical studies and practices
Type
article
Field-Weighted Citation Impact
3.49
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article

Off-Label Use of Antibiotics in Small Animal Medicine—A Germany-Wide Anonymous Online Survey

Robert Hertzsch, Angelika Richter, Marie Tarillion
1 citations
Antibiotics
Pharmaceutical studies and practices
3.49
article

Off-Label Use of Antibiotics in Small Animal Medicine—A Germany-Wide Anonymous Online Survey

Robert Hertzsch, Angelika Richter, Marie Tarillion
article en
1 citations

Abstract

<b>Background/Objectives:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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. <b>Conclusions:</b> 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.

AntibioticsVol. 14(4)
Institut für Tier-, Natur- und Umweltethik (DE), Leipzig University (DE)
Peace, Justice and strong institutions
Openalex Percentile: Top 10%
Pharmaceutical studies and practices
3.49
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Off-Label Use of Antibiotics in Small Animal Medicine—A Germany-Wide Anonymous Online Survey — Robert Hertzsch, Angelika Richter, et al. · Antibiotics (2025) | TGRS Research Map | TGRS