Safety for the use of antimicrobial veterinary medicinal products in the context of veterinary pharmacovigilance

  • Yu. M. Kosenko State Scientific-Research Control Institute for Veterinary Medicinal Products and Feed Additives, Lviv, Ukraine
  • N. V. Ostapiv State Scientific-Research Control Institute for Veterinary Medicinal Products and Feed Additives, Lviv, Ukraine
  • L. E. Zaruma State Scientific-Research Control Institute for Veterinary Medicinal Products and Feed Additives, Lviv, Ukraine
Keywords: antimicrobial veterinary medicinal products, veterinary pharmacovigilance, safety/lack of expected efficacy, pharmacovigilance system master file, qualified person responsible for pharmacovigilance, adverse effect

Abstract

Current approaches to the responsible and prudent use of antimicrobial veterinary medicinal products involve monitoring of their efficacy and safety, which is ensured by the set up and maintained state veterinary pharmacovigilance system. It is well known that antimicrobials, as well as other veterinary medicinal products, can have both positive and unfavourable or unintended effect on the animal’s health, as well as human health after the exposure to their use. Also, the use of antimicrobial veterinary medicinal products requires following the measures of the OIE, WHO and FAO to combat the acquired antimicrobial resistance. In the view of the importance of the safety problem and the prevention of the development of the acquired antimicrobial resistance, the antimicrobial veterinary medicinal products were selected as the object of this study.

The main goal of the study was to present the model of the marketing authorization holder activity in the pharmacovigilance system master file.

Veterinary pharmacovigilance is a set up system for the assessment the safety and efficacy of a veterinary medicinal products, which determines the benefit/risk ratio for their use in veterinary medicine. The pharmacovigilance system is implemented in such a way that the key principles of pharmacovigilance are integrated into national policy, namely would be regulated by the Law of Ukraine "On Veterinary Medicine". Legislative documents regulating the activities of specialists in the pharmacovigilance system in the EU Member States are the Directive 2001/82, Council Regulation (EC) No 726/2004, amended by the Regulation Council of the EU No.1235/2010 of 15.12.2010 and Regulation (EU) 2019/6. The International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) develops guidelines to facilitate the harmonization of regulatory requirements in EU Member States, the USA, Japan and other countries in the world. Ukraine is also the Member of VICH Cooperation and the general principles of the VICH GL24,29,30,35,42 are basic for the implementation in the national veterinary pharmacovigilance system.

The veterinary pharmacovigilance system requires coordinated activities, first of all, from the manufacturer/marketing authorization holder of the antimicrobial veterinary medicinal products (in the context of quality, efficiency and safety), placing them to the market, distribution through wholesale and retail networks and use under the supervision of veterinary doctors. Marketing authorisation holders shall designed one or more qualified persons who can carry tasks for maintaining and implementing the pharmacovigilance system master file.

The obtained data for the suspected adverse reactions of antimicrobial veterinary medicinal product would be systematized, described in the form of reports (linear or periodically updated safety report) and collected in the form of the pharmacovigilance system master file. The reports would be submitted to the Sector of Pharmacovigilance and Antimicrobial Resistance for the assessment with any other information relevant to detecting a change to the benefit-risk balance of an antimicrobials, including appropriate information on post-marketing surveillance studies.

The identified model of safety research on the example of antimicrobial veterinary medicinal products will allow marketing authorization holders to maintain and implement the veterinary pharmacovigilance system which comply with the requirements of legislative documents.

The veterinary pharmacovigilance system will help to increase the responsibility of manufactures/marketing authorization holders, veterinary medicine doctors, and animal owners in the use of antimicrobials and prevent the unfavourable or unintended adverse reaction in any animal and human exposed to the product or environmental incident observed following their administration.

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Published
2019-09-18
How to Cite
Kosenko, Y. M., Ostapiv, N. V., & Zaruma, L. E. (2019). Safety for the use of antimicrobial veterinary medicinal products in the context of veterinary pharmacovigilance. Scientific and Technical Bulletin оf State Scientific Research Control Institute of Veterinary Medical Products and Fodder Additives аnd Institute of Animal Biology, 20(2), 446-457. https://doi.org/10.36359/scivp.2019-20-2.57