The use of antimicrobial medicines in human and veterinary medicine has led to the problem of the development of acquired antimicrobial resistance, which causes a global threat. Were described principles of tetracyclines and sulfonamides use, which are the most common among antimicrobial substances in veterinary medicinal products for the treatment of infectious diseases of food-producing and domestic animals. The aim. To substantiate the clinical relevance of antimicrobial veterinary medicinal products containing tetracyclines and sulfonamides+trimethoprim in veterinary medicine. Materials and methods. Research materials: sales reports of antimicrobial veterinary medicinal products in Ukraine for 2015–2019, EU countries, and the USA. Methods used: written and electronic survey; bibliosemantic, analytical and generalization. Results and discussion. As a result of the annual monitoring for 2015–2019 sales volumes in Ukraine, it was determined that tetracyclines (29.5–37.91 %) and sulfonamides + trimethoprim (12.1–18.7 %) were most often used in the composition of veterinary medicines. The same trend regarding the use of these classes of antimicrobials exists in many countries around the world. Factors determining the clinical relevance of these groups of substances are based on the criteria for their selection. The principle proposed by the EMA for the choice of antimicrobial veterinary medicinal products is based on the following criteria: categories of target animal species; treatment indications; the route of administration; the type of pharmaceutical formulation; the choice of a dosage regimen. Following this principle was substantiated the feasibility of tetracyclines and sulfonamides+trimethoprim use in veterinary medicine. By pharmacokinetic and pharmacodynamic parameters evaluated the rationality of the choice of antimicrobial veterinary medicines. Conclusions. The study revealed clinical efficacy and safety of tetracyclines and sulfonamides+trimethoprim as Veterinary Critically Important Antimicrobial Agents of Category D “Prudence”

The problem of tackling antimicrobial resistance to antimicrobial agents on a global scale is of great importance over the last few years. Governments of many countries and professional organizations developed a lot of legislative orders, requirements, and guidelines concerning this problem based on a ‘One-Health’ approach. Surveillance of the development of acquired antimicrobial resistance and monitoring the circulation of antimicrobials in veterinary practice and medicine is one of the steps to address this problem. The main goal of this study was the assignment of the veterinary medicine specialists' tasks in the implementation of the “Procedure for the use of antimicrobial veterinary medicinal products”, 2021. (hereinafter “Procedure”). National Agency of veterinary medicinal products and feed additives (hereinafter Agency) during the last six years is collecting annual sales data on antimicrobial veterinary medicinal products in food-producing and domestic animals in accordance with Chapter 6.9. of the Terrestrial Animal Health Code, 2018. The Agency must inform all the stakeholders about the problems revealed in this study because they are of great importance for the prudent use of antimicrobial agents and implementation of the requirements of the “Procedure”. Results of the antimicrobials sales reports monitoring in 2020 revealed an increase in the parts of macrolides (14%) and fluoroquinolones (15,2%), which are classified as critical antimicrobials of categories C and B, respectively According to the European Center for Disease Prevention and Control, the European Food Safety Authority and the European Medicines Agency (ECDC / EFSA / EMA, 2021), a statistically significant positive relationship was found between the consumption of fluoroquinolones to Salmonella spp., іn poultry and the resistance of isolated from poultry Salmonella spp. to fluoroquinolones and a significant association with Campylobacter jejuni resistance in humans. Therefore, the use of these categories of antimicrobials should be substantiated by veterinarians. Monitoring data do not allow us to state that all antimicrobials sold have been used, but the increase in their share is a matter of concern taking into account the requirements set out in the "Procedure for the use of antimicrobial medicinal products". The article formulates the tasks to be performed by veterinary specialists to implement the requirements for the use of antimicrobial veterinary medicinal products set out in the "Procedure", approved by the order of the Ministry of Economy of Ukraine № 1177-21 of 30.12.2021.

The procedure for manufacture, sale and rational use of antimicrobial veterinary medicinal products in veterinary medicine must comply with the national legislation, namely the Law of Ukraine “On Veterinary Medicine”. Only authorized in Ukraine veterinary medicinal products have been used in veterinary medicine as required with the recommendations stated in package leaflet, labeling and summary of the product characteristic. The article describes main principles of monitoring process sales turnover of antimicrobial veterinary medicinal products during period of study 2015-2018. On the suggestion of the World Organization for Animal Health (OIE) at the beginning of 2016 Ukraine started collecting annual sales data (for the previous year) on antimicrobial veterinary medicinal products in food-producing and domestic animals in accordance with the Chapter 6.9. of the Terrestrial Animal Health Code, 2016; 2018. The main goal of this study was the implementation of OIE recommendations in monitoring process by the assessment of sales patterns of antimicrobials, their influence on prudent use, in compliance with Ukrainian National Action Plan Tackling Antimicrobial Resistance, 2019. The study was conducted during four 12-month periods (from January 1 to December 31) during 2015-2018. The data in questionnaires reports were received from marketing authorization holders and distributors and collected as suggested by OIE. The specification of the amounts of the antimicrobials annual sales during 2015-2018 according route of administration and antimicrobial classes in [kg] and [%] of active ingredient were presented. The study revealed the main high-selling classes of antimicrobials (Tetracyclines, Penicillins and Sulfonamide+Trimethoprim); the commonly used route of administration (oral ~ 90 %) and part of veterinary critically important and important antimicrobials in total sales amounts of all antimicrobial veterinary medicinal products. Macrolides occupied the main part (10,2 %) in veterinary critically important antimicrobial medicinal products; part of Aminoglycosides was ~ 4 %; Fluoroquinolones – among 2,5 - 7,14 % and part of Cephalosporins was less than 1% during all years of the study. This study can be considered as the first step towards implementation a national monitoring system for rational and prudent use of antimicrobials in veterinary medicine.

У статті представлена модель дослідження безпеки при післяреєстраційному використанні протимікробних ветеринарних лікарських засобів в контексті вимог ветеринарного фармаконагляду. Найбільш поширеними заходами, які сприяють дослідженню безпеки застосованих протимікробних ветеринарних лікарських засобів є моніторинг і налагоджена система звітності за їх використанням в створеній виробником/власником реєстраційного посвідчення корпоративній системі ветеринарного фармаконагляду,  яка підтверджена інформативною базою даних.

The goal of this study was to continue the implementation of the OIE recommendations for monitoring sales amounts of antimicrobial veterinary medicinal products. The subject of the study were intramammary antimicrobial veterinary medicinal products, which were used to treat and prevent mastitis in cows. The problem of diagnostic, treating, and preventing mastitis is crucial for farms, as mastitis is a multifactorial disease that can cause significant economic losses. One of the principal factors in the development of mastitis is the invasion of pathogens, which causes subclinical and clinical infections of the udder. Antimicrobials for intramammary use has been a significant advance in the treatment of this disease, in both the lactation and dry-off periods. The study was conducted over four periods (from January 1 to December 31) during 2016-2019. The data were obtained through a written survey of marketing authorization holders and distributors and evaluated by qualitative and quantitative indices. Characteristics of annual sales amounts during 2016-2019 are presented by classes of antimicrobial substances in «kg» and «%» of active ingredients, as well as in defined daily DDDvet and course DCDvet doses for 1000 animals. Intramammary antimicrobial veterinary medicinal products occupied (0.06-0.44) % part among all antimicrobials sold. The classes of antimicrobial substances that are most often sold (penicillins, aminoglycosides, tetracyclines) were determined and were shown the differences in their use in the composition of products intended for lactating and dry cows. Mass fractions were also determined, and daily DDDvet and course DCDvet doses per 1000 animals were calculated, which allowed revealing particular trends in sales of antimicrobial veterinary medicinal products for intramammary administration. The defined course doses for the products intended for lactating cows were 5 times higher, than for the products used in the dry-off period.  First-generation and third-generation cephalosporins and fluoroquinolones were among the critically important veterinary medicinal products, but their sales were not annual. Cephalosporins of all generations and fluoroquinolones are characterized by a tendency to decrease in sales amounts, which testify to their prudent use following the National Action Plan to Combat Antimicrobial Resistance, 2019. This study is maintenance of the national monitoring system implementation for the rational and prudent use of antimicrobial products in veterinary medicine.