ADVERSE EFFECTS OF ANTIMICROBIAL VETERINARY MEDICINAL PRODUCTS LISTED IN THE EUROPEAN UNION DATABASE

Following the new version of the Law of Ukraine "On Veterinary Medicine" (from February 4, 2021 No. 1206-IX), the rules for carrying out the procedure for veterinary pharmacovigilance have been adopted, which was determined by the order of the Ministry of Agrarian Policy and Food of Ukraine No. 1397 "On the approval of certain normative legal acts on the circulation of veterinary medicinal products" dated 07.20.2023. Although the entry into force of these documents has been postponed for one year from the date of termination or cancellation of the martial law. However, the Agency for Veterinary Medicines and Feed Additives is working on preparing for implementing the requirements of these documents into practice. With the information about possible adverse reactions, mostly caused by antiparasitic and antimicrobial veterinary medicinal products, we have investigated the types and number of reports caused by antimicrobial veterinary medicinal products recorded in the database of the European Medicines Agency (EMA). Among the antimicrobial agents, products containing substances belonging to the classes of tetracyclines, penicillins, and fluoroquinolones were selected as the object of research. It was established that they account for the largest shares in sales volumes of these antimicrobial veterinary medicinal products, according to the results of the nine-year monitoring. The analysis of adverse reactions of the above-mentioned groups of antimicrobial veterinary medicinal products, manufactured abroad, which are authorized in Ukraine, in relation to the target species of animals, was carried out. The types and number of adverse reactions in the database are not constant, since the continuous process of monitoring them, so our analysis refers to reports as of 07/31/2024. The 100 authorized antimicrobial veterinary medicinal products were analyzed, among which the smallest number of reports was for products that were derivatives of the tetracycline class—slightly more reports related to amoxicillin trihydrate, which belongs to the class of penicillins. The largest number of reports of adverse reactions is associated with products containing marbofloxacin and enrofloxacin, which represent the class of fluoroquinolones. The analysis of reports and types of adverse reactions in the EMA database showed that reports of adverse effects on animals and humans were recorded for 52 antimicrobial veterinary medicinal products. Only for products containing chlortetracycline hydrochloride and tetracycline hydrochloride, no such data have been found in the database at this time. The number of adverse reaction reports doesn't reflect their frequency and prevalence, since their number depends on the duration of the monitoring period, which is determined by the antimicrobial veterinary medicinal product life cycle duration. The number of reports, of course, does not correspond to the number of animals affected by the administration of antimicrobial products. First of all, it depends on the animal species for which there are products indicated, as well as the number of animals that could be in contact with sick animals, depending on the characteristics of their keeping conditions. The conclusions formulated in the article should be taken into account by marketing authorization holders qualified persons responsible for veterinary pharmacovigilance practical application upon the entry into force of regulatory documents adopted for the functioning of the veterinary pharmacovigilance system in Ukraine, taking into account the stated requirements and provisions.