OFF LABEL USE OF HUMAN DRUGS IN VETERINARY SMALL PRACTICE IN REPUBLIC OF NORTH MACEDONIA

Abstract

“Off-label use” is defined as the use of a medicinal product that is not in accordance with the summary of the product characteristics, which includes the use of a medicine. for unapproved species, disease, route of administration, or dosage. This is widespread practice in veterinary medicine, especially “off-label use” of human-approved drugs for the treatment of small animals. The data was collected from a private veterinary practice in North Macedonia. Veterinarians were asked to collect data on every off-label prescription or application of human drugs during a 3-month period. In both cats and dogs, oral antibacterial drugs were the most prescribed drugs, and oral application of amoxiclav was most commonly used in both species. The reasons all over the world why veterinarians frequently use “off-label” drugs from human medicine may be different: low price, no medicines available for treatment of a specific condition, more suitable drug formula. Antibacterial drugs are the number one ‘off-label use’ drug in small animal practice in our country, and these data are similar to results from other countries. The main concern for off-label use of human drugs in veterinary medicine is the risk to public health, especially off-label use of antimicrobial drugs and potential impacts on public health due to antimicrobial resistance. the findings of this study indicate that in small animal veterinary practice in North Macedonia, the off-label use of human medicinal products, particularly antibacterial drugs, remains a widespread and routine clinical practice. Clearer professional guidelines and better regulation are needed to provide veterinarians with clear and standardized protocols, thereby justifying the use of human drugs.