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The Committee for Veterinary Medicinal Products (CVMP) has identified that certain first-line veterinary antibiotics, which have been on the market for years, have outdated dosages according to current scientific knowledge. This has led to the fact that, in clinical practice, they are not always used in accordance with the authorized Summary of Product Characteristics (SPC).
The emergence of bacterial resistance has changed the sensitivity of pathogens, making it necessary to re-evaluate and update dosage to limit the selection of resistant bacteria. Frequently, current doses are insufficient to effectively treat the indicated bacterial diseases, which has led veterinarians to use higher doses than those recommended in the SPC, based on clinical evidence and sensitivity patterns. However, Regulation (EU) 2019/6 prohibits the use of medicinal products outside the authorized conditions (Article 106(1)), preventing the modification of doses without re-evaluation.
Updating dosing requires data on dose determination, safety, field efficacy, tolerance in target species and, where relevant, withdrawal times, ecotoxicity, and user safety. Marketing authorization holders often lack the resources to conduct these studies, which could reduce the availability of first-line antibiotics, negatively impacting animal health and encouraging over-reliance on more critical antibiotics.
The CVMP has developed a discussion paper to find ways to adjust dosages while maintaining the efficacy of these drugs and avoiding the selection of resistant bacteria. A working group (ADRA) has been established to develop a list of antibiotics requiring revision and dosage adjustment, scheduled to be published in early 2025.
Until then, it is recommended to use antibiotics with adequate dosing and avoid those with insufficient dosing, to ensure effective treatments and limit the selection of resistant bacteria.
November 26, 2024/ National Plan against Antibiotic Resistance (PRAN)/ Spain.
https://www.resistenciaantibioticos.es
