Compounding pharmacy regulations: experience of the Latvian pharmaceutical market
https://doi.org/10.17749/2070-4909/farmakoekonomika.2024.189
Abstract
The article aims to examine technological, organizational and regulatory aspects of drug quality and safety assurance system, as well as peculiarities in civil circulation of extemporaneous drugs in Latvian pharmaceutical market to improve approaches for statutory regulation of this special and socially significant type of activity of pharmaceutical organizations. This work continues a series of articles about compounding pharmacy practice in different world healthcare systems.
About the Authors
D. D. Mamedov
Saint Petersburg State Chemical and Pharmaceutical University
Russian Federation
Russian Federation
Devi D. Mamedov – Junior Researcher, Laboratory of Regulatory Relations and Good Practices.
14 lit. A Professor Popov Str., Saint Petersburg 197022
D. S. Yurochkin
Saint Petersburg State Chemical and Pharmaceutical University
Russian Federation
Russian Federation
Dmitriy S. Yurochkin – Researcher, Laboratory of Regulatory Relations and Good Practices.
14 lit. A Professor Popov Str., Saint Petersburg 197022
D. D. Zelikova
Saint Petersburg State Chemical and Pharmaceutical University
Russian Federation
Russian Federation
Daria D. Zelikova – Laboratory Assistant, Laboratory of Regulatory Relations and Good Practices.
14 lit. A Professor Popov Str., Saint Petersburg 197022
S. E. Erdni-Garyaev
Saint Petersburg State Chemical and Pharmaceutical University
Russian Federation
Russian Federation
Sergey E. Erdni-Garyaev – Senior Lecturer, Chair of Physical and Colloidal Chemistry.
14 lit. A Professor Popov Str., Saint Petersburg 197022
Z. M. Golant
Saint Petersburg State Chemical and Pharmaceutical University
Russian Federation
Russian Federation
Zakhar M. Golant – PhD (Econ.), Head of Laboratory of Regulatory Relations and Good Practices.
14 lit. A Professor Popov Str., Saint Petersburg 197022
I. A. Narkevich
Saint Petersburg State Chemical and Pharmaceutical University
Russian Federation
Russian Federation
Igor A. Narkevich – Dr. Pharm. Sc., Professor, Rector; WoS ResearcherID: C-1131-2014.
14 lit. A Professor Popov Str., Saint Petersburg 197022
References
1. Mamedov D.D., Yurochkin D.S., Golant Z.M., et al. Past, current and future of legal regulation of drugs compounding in the Russian Federation. Pharmacy & Pharmacology. 2023; 11 (3): 176–92 (in Russ.). https://doi.org/10.19163/2307-9266-2023-11-3176-192.
2. Fisenko V.S., Farrakhov A.Z., Mamedov D.D., et al. Review of judicial practice in relation to public procurement of extemporal drugs for 2012–2022. Vestnik Roszdravnadzora /bulletin of Roszdravnadzor. 2023; 5: 19–30 (in Russ.).
3. Narkevich I.A., Fisenko V.S., Golant Z.M., et al. Basis for forming a unified harmonizad system of regulation in the fields of compounding pharmacies: monograph. Saint Petersburg: Mediapapir; 2023: 292 pp. (in Russ.).
4. Mamedov D.D., Yurochkin D.S., Leshkevich A.A., et al. Compounding pharmacy regulations: experience of the North American pharmaceutical market. FARMAKOEKONOMIKA. Sovremennaya farmakoekonomika i farmakoepidemiologiya / FARMAKOEKONOMIKA. Modern Phar- macoeconomics and Pharmacoepidemiology. 2023; 16 (1): 80–6 (in Russ.). https://doi.org/10.17749/2070-4909/farmakoekonomika. 2022.155.
5. Mamedov D.D. The concept of good practice in the compounding of drugs in Germany. In: Modern world, nature and man: collection of materials of the XXII International Scientific and Practical Conference (Kemerovo, October 10, 2023). Kemerovo: Kemerovo State Medical University; 2023: 294–302 (in Russ.).
6. Pharmaceutical Law. Available at: https://likumi.lv/ta/en/en/id/43127 (accessed 10.04.2023).
7. Procedures for the licensing of pharmaceutical activity. Available at: https://likumi.lv/ta/en/en/id/238458 (accessed 10.04.2023).
8. State Agency of Medicines. Republic of Latia. Available at: https://www.zva.gov.lv/en (accessed 10.04.2023).
9. Regulations regarding operating of pharmacies. Available at: https://likumi.lv/ta/en/en/id/207397 (accessed 10.04.2023).
10. Kiseļova O., Mauriņa В., Šidlovska V., Zvejnieks J. The extent of extemporaneous preparation and regulatory framework of extemporaneous compounding in Latvia. Medicina. 2019; 55 (9): 531. https://doi.org/10.3390/medicina55090531.
11. Kiseļova O. Availability of extemporaneous preparations in pharmacies in Latvia: a quantitative and qualitative assessment of the situation and future perspectives. Available at: https://dspace.rsu.lv/jspui/bitstream/123456789/7730/1/2022-02_Kiseljova-Olga_DTS%2B_IPD-1888.pdf (accessed 10.04.2023).
12. Regulations regarding manufacture and storage of prescription forms, as well as writing out and storage of prescriptions. Available at: https://likumi.lv/ta/en/en/id/104228 (accessed 10.04.2023).
13. Regulations regarding procedures for the labelling of medicinal products and the requirements to be set for the package leaflet of medicinal products. Available at: https://likumi.lv/ta/en/en/id/126348 (accessed 10.04.2023).
14. Regulations regarding the principles for the determination of the price of medicinal products. Available at: https://likumi.lv/ta/en/en/id/120074 (accessed 10.04.2023).
15. Regulations regarding the procedures for the manufacture and control of medicinal products, the requirements for the qualification and professional experience of a qualified person and the procedures for the issuance of the certificate of good manufacturing practice to a medicinal product manufacturing undertaking. Available at: https://likumi.lv/ta/en/en/id/134261 (accessed 10.04.2023).
16. Zariņa O.P. Hopi's statements on the market for medicines in the EU are not true. Available at: https://sejas.tvnet.lv/6212030/olita-zarinap-apina-izteikumi-par-zalu-tirgu-es-neatbilst-patiesibai (in Latvian) (accessed 10.04.2023).
17. Procedures regarding the distribution and quality control of medicinal products. Available at: https://likumi.lv/ta/en/en/id/159645 (accessed 10.04.2023).
18. DAC/NRF. Available at: https://dacnrf.pharmazeutische-zeitung.de/ (in German) (accessed 10.04.2023).
19. USP Compounding Compendium. Available at: https://www.usp.org/products/usp-compounding-compendium (accessed 10.04.2023).
20. Australian Pharmaceutical Formulary. Available at: https://apf.psa.org.au/ (accessed 10.04.2023).
21. Fagron. Formulary. Available at: https://fagron.com/formulary/overview/?q= (accessed 10.04.2023).
22. EudraGMDP. Available at: http://eudragmdp.ema.europa.eu/ (accessed 10.04.2023).
23. Procedures for importing and distributing active substances. Available at: https://likumi.lv/ta/en/en/id/257857 (accessed 10.04.2023).
24. Kiselova O., Maurina B., Sidlovska V., Rogovska I. Trends of extemporaneous drug prescription in Latvia in 2017. Int J Pharm Comp. 2019; 23 (3): 245–9.
25. Criteria for the location of pharmacies and pharmacy branches. Available at: https://likumi.lv/ta/en/en/id/234279 (accessed 10.04.2023).
26. Official statistics portal. Available at: https://stat.gov.lv/en (accessed 10.04.2023).
27. Operational strategy of the State Agency of Medicines for the years 2017–2019. Available at: https://www.zva.gov.lv/sites/default/files/inline-files/ZVA%20Strategija-2017-2019-20180102.pdf (in Latvian) (accessed 10.04.2023).
28. Operational strategy of the State Agency of Medicines for the years 2020–2022. Available at: https://www.zva.gov.lv/sites/default/files/inlinefiles/Strategija%202020-2022.pdf (in Latvian) (accessed 10.04.2023).
29. PIC/S guide to good practices for the preparation of medicinal products in healthcare establishments. Available at: https://www.vvc.gov.lv/en/international-law/pics-guide-good-practices-preparationmedicinal-products-healthcare-establishments (accessed 10.04.2023).
30. Farrakhov A.Z., Solomatina T.V., Mamedov D.D., et al. Fundamentals of forming a strategy for the development of the segment of manu- facturing and dispensing of medicines in the Russian Federation. Vestnik Roszdravnadzora /bulletin of Roszdravnadzor. 2023; 6: 6–17 (in Russ.).
Review
For citations:
Mamedov D.D., Yurochkin D.S., Zelikova D.D., Erdni-Garyaev S.E., Golant Z.M., Narkevich I.A. Compounding pharmacy regulations: experience of the Latvian pharmaceutical market. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2024;17(1):106-117. (In Russ.) https://doi.org/10.17749/2070-4909/farmakoekonomika.2024.189
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