DRUG SAFETY MONITORING SERVICE IN DEVELOPING ORGANIZATIONS / MANUFACTURERS OF DRUGS FOR VETERINARY USE

The danger of animal complications due to drug therapy increases the responsibility of developers/manufacturers for the safety of medicinal products for veterinary use, including those in civilian circulation. At the time of making a decision on the state registration of a drug, information obtained during its preclinical and clinical studies on undesirable reactions and side effects cannot be complete, since these studies are limited to a small number and similarity of experimental animals and a relatively short duration of experiments. In addition, with long-term use of the drug may be delayed adverse side reactions that can occur months and years after exposure of the drug to a living organism. Considering this, the pharmacovigilance system should function effectively in the producer (or developer) of the drug, the main task of which is monitoring monitoring of drug safety during the pre-registration period, tracking and analyzing data on the effect of the drug when it is in public circulation, and taking adequate measures to prevent adverse effects of drug therapy. As a result of the analysis, data on regulatory and methodological documents on the organization of monitoring the safety of pharmacological drugs were systematized, recommendations prepared with the provisions of international and domestic legislative regulatory and information documents related to the methodology of organizing pharmacovigilance and monitoring drug safety were prepared.

1. Astakhova A. V., Lepakhin V. K. Adverse side reactions and control of drug safety. M., 2004; 200. (In Russ.)

2. Braytseva E. V. Improving of monitoring of adverse side reactions to drugs: avtoref. dis. ... PhD. M., 2001; 18. (In Russ.)

3. Kukes V. G. Clinical pharmacology. M., 2006; 938. (In Russ.)

4. Reyhart D. V. Complications of pharmacotherapy. Adverse side drug reactions. M.: Litterra, 2007; 256. (In Russ.)

5. Revised drug strategy. Resolution of the 52nd session of the World Health Organization.WHA 52.19. Section 1. (4).

6. Order of the Ministry of Agriculture of Russia dated 10.24.2011 No. 376 "On approval of the form of a document containing the results of monitoring the safety of a medicinal product for veterinary use in order to confirm its state registration."

7. Order of the Ministry of Agriculture of the Russian Federation of 10.10.2011 No. 357 "On approval of the procedure for monitoring the safety of medicines for veterinary use, registration of side effects, serious adverse reactions, unforeseen undesirable reactions when using drugs for veterinary use and providing information about it."

8. ICH: E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting; E2E Pharmacovigilance Planning; E2F Development Safety Update Report.

9. Procedure for adherence of non-member countries to council acts related to the mutual acceptance of data in the assessment of chemicals. Annex to the Council Decisions ENV/MC/CHEM (98) 17.

10. The Rules Governing Medicinal Products in the European Union. Guidelines on Pharmacovigilance for Medicinal Products for Human Use. Volume 9, January 2007.