Sector of pharmacovigilance, antibiotic resistance and clinical documentation

Employees in the Sector:

Nataliia Viktorivna Ostapiv – Head of the Sector;
Zaruma Liubov Yevhenivna, PhD in Pharmacy – Senior Researcher;
Yuskiv Ihor Dmytrovych, Doctor of Veterinary Sciences, Professor – Senior Researcher;
Ponomaryova Svitlana Anatoliivna – Senior Researcher.

The employees of the sector conduct scientific expertise of the materials of the registration dossiers of Part IV “Preclinical and Clinical Documentation” for veterinary medicinal products and biocides, with the aim of their state registration, re-registration and amendments to the documentation.

In cooperation with the State Service of Ukraine on Food Safety and Consumer Protection, the Sector’s staff annually conducts a standardised survey of registration certificate holders and distributors of antimicrobial veterinary medicinal products to collect and analyse data on their production and use in Ukraine. This monitoring is carried out in accordance with the requirements of the World Organisation for Animal Health (WOAH, originally established as OIE) within the framework of the Global Action Plan on Antimicrobial Resistance and the National Action Plan on Antimicrobial Resistance. The survey data are calculated using standardised WOAH methods. The prepared annual report is entered into the ANIMUSE Global Database, which is unified for all WOAH member countries.

In addition, the sector’s employees carry out veterinary pharmacological supervision of the production and circulation of veterinary medicines in Ukraine. Thus, according to the Law of Ukraine “On Veterinary Medicine”, veterinary pharmacological surveillance is a scientific and practical activity to identify, evaluate, study and prevent adverse reactions or other problems associated with the use of veterinary medicines. The main objective of the monitoring is to improve the safety of veterinary medicinal products on the domestic market, with particular attention to adverse reactions or other undesirable effects on humans or animals associated with the use of veterinary medicinal products.

First of all, pharmacovigilance measures involve collecting information on the side effects of veterinary drugs (including in case of their off-label use), investigating the validity of their withdrawal period from the animal body, and assessing potential risks to the environment.

In cooperation with the Ministry of Agrarian Policy and Food of Ukraine, the sector’s employees participated in the development of the Procedure for Veterinary Pharmacovigilance, which is harmonised with VICH GL42, GL35, GL30 standards; Regulation (EU) 2019/6 and national requirements in the system of circulation of veterinary medicines.

The sector employs are highly qualified researchers who regularly improve their professional level at pan-European trainings and seminars. In particular, they participated in:

• training “Antimicrobial sales and use surveillance system and assessment of veterinary medicine products containing antimicrobials” (ANMV, Fougères, France);
• training under the BTSF programme on “Prevention and control of antimicrobial resistance in the context of the global One Health programme, covering both veterinary and public health” (Kyiv);
•  training BTSF ANTIMICROBIAL RESISTANCE “One Health” (Malaga, Spain);
• TAIEX Multi-country Workshop on antimicrobial resistance (AMR) for ENI regions (Amman, Jordan).

The results of the sector’s work are highlighted in scientific reports and articles, as well as in the materials of methodological recommendations.