The current state of the segment of industrial pharmacies with the right to manufacture aseptic drugs in the Central Federal District of Russia

Abstract


The aim of the study was to examine the current state and prospects of development of production pharmacies in Russia, as well as their readiness for the manufacture of cardioplegic solutions according to a specific prescription for providing cardiac surgery. The analysis of the Roszdravnadzor license registry data and a survey of institutions in the Central Federal District revealed that only a few number of pharmacies have the necessary conditions and resources for aseptic production. Major barriers include lack of components, equipment, qualified personnel and regulatory constraints. The need for regulatory changes and the introduction of modern manufacturing standards, including the use of international experience in compounding, and quality control in the activities of pharmacies with prescription and production departments to improve the availability of drugs in cardiac surgery is noted. The availability of drugs for cardiac surgery can be improved by implementing regulatory changes and modern manufacturing standards, including international compounding experience and quality control in the activities of pharmacies with prescription and production departments.

About the authors

Maria N. Denisova

N. A. Semashko National Research Institute of Public Health, Moscow, Russia

Email: denisova@nriph.ru

Daria N. Pasko

Russian Research Center of Surgery named after Academician B. V. Petrovsky, Moscow, Russia

Email: dasha.pasko@mail.ru

Anastasia A. Sinitsyna

N. A. Semashko National Research Institute of Public Health, Moscow, Russia; I. M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia

Email: sinitsyna_a_a@staff.sechenov.ru

Ernest G. Naneishvili

I. M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia

Email: ernestnaneishvili@gmail.com

References

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  4. Ovod A. I., Novikova M. D. Pharmaceutical market of cardioplegic drugs and features of their application in Russia. Medical & pharmaceutical journal «Pulse». 2021;23(9):169—182. doi: 10.26787/nydha-2686-6838-2021-23-9-169-182.
  5. Petrov A. Yu., Airo I. N., Berezhnaya E. S. et al. Problems of extemporaneous manufacture of dosage forms in pharmacy organizations as a form of personalized pharmacy in the Russian Federation and abroad. Medicine. Sociology. Philosophy. Applied research. 2022;(6):77—84. (In Russ.)
  6. Klyshko N. K., Shchava S. P., Furgal A. A. et al. Cardioplegia and myocardial protection in adult cardiac surgery: current trends. Russian Journal of Cardiology and Cardiovascular Surgery. 2020;13(2):108—113. doi: 10.17116/kardio202013021108

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