Drivers of Pharmaceutical Compounding: Regional Experience Analysis Using Irkutsk Pharmacy Organisations as a Case Study

INTRODUCTION. National pharmacy compounding is a priority for providing the population with medicinal products, particularly the medicinal products lacking in the Russian Federation. Investigating opportunities to improve the operation of compounding pharmacies in the Russian Federation remains essential, especially in the context of the developing personalised approach to treatment, growing practice of orphan drug development, and import substitution needs.

AIM. This study aimed to identify the factors driving the development of compounding pharmacies under the current conditions.

MATERIALS AND METHODS. The study focused on the Russian regulatory framework for pharmacy compounding, as well as the range of dosage forms and administration routes of the medicinal products that had been produced and packaged by the compounding pharmacies in Irkutsk in 2021–2023.

RESULTS. This study showed a demand for compounded medicinal products among both healthcare providers and patients. These medicinal products covered a traditional range of compounded medicines, including custom formulae, medicines for paediatrics and geriatrics, stock preparations, and pharmacy-packaged items. In 2021–2023, the mean annual production of Irkutsk pharmacy organisations amounted to ~500,000 units of compounded medicinal products, with a variety of doses and dosage forms. The medicinal products were compounded using ~100 different active substances and over 20 approved medicinal products. This study examined the evolution of Russian pharmacy compounding legislation. The key aspects included the establishment of a pharmaceutical quality system for compounded medicinal products, the extension of shelf life for specific dosage forms, and the authorisation to use medicinal products approved in the Eurasian Economic Union in compounding. The study showed that the main factors driving the operation of compounding pharmacies were the ongoing regulatory framework transformation and the transition from standardised treatment to personalised medicine. The main impediments for compounding pharmacies included the lack of state support, the ban on compounding medicinal products produced by pharmaceutical companies, the shortage of skilled staff, the inadequate supply of equipment (first of all, production machinery), the poor availability of active substances and excipients in small packages, and the challenges associated with regulatory control and oversight over the quality of compounded medicinal products.

CONCLUSIONS. Further stimulation of the active development of compounding pharmacies requires further investigation into their operation in other regions, which will help to develop legal arrangements for the federal and regional state support of compounding pharmacies, procure up-to-date materials and equipment, and train the staff for compounding pharmacies.

1. Mamedov DD, Yurochkin DS, Golant ZM, Fisenko VS, Alekhin AV, Narkevich IA. Past, current and future of legal regulation of drugs compounding in the Russian Federation. Pharmacy and Pharmacology. 2023;11(3):176–92 (In Russ.). https://doi.org/10.19163/2307-9266-2023-11-3-176-192

2. Narkevich IA, Fisenko VS, Golant ZM, Yurochkin DS, Mamedov DD, Erdni-Garyaev SE, Leshkevich AA. Basis for forming a unified harmonized

3. Smekhova IE, Ladutko YuM, Kalinina OV. Extemporal manufacture of medicines: problems and solutions. Bulletin of Pharmacy. 2021;(1):48–52 (In Russ.). https://doi.org/10.52540/2074-9457.2021.1.48

4. Moroz TL, Ryzhova OA. The problem of the availability of intra-pharmaceutical drugs (on the example of the Irkutsk region). Remedium. 2020;(10):54–7 (In Russ.). https://doi.org/10.21518/1561-5936-2020-10-54-57

5. Fisenko VS, Farrakhov AZ, Solomatina TV, Alekhin AV, Yurochkin DS, Erdni-Garyaev SE, Mamedov DD, Golant ZM. Monitoring of compounding pharmacies in the Russian Federation. Bulletin of Roszdravnadzor. 2023;(3):22–33 (In Russ.). EDN: XZJIJT

6. Erdni-Garyaev SE, Mamedov DD, Yurochkin DS, Zelikova DD, Golant ZM, Fisenko VS, Narkevich IA. Pharmacy compounding regulation in the German pharmaceutical market. Part 1. Basic regulatory provisions (review). Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation. 2024;14(1):91–109 (In Russ.). https://doi.org/10.30895/1991-2919-2024-14-1-91-109

7. Alekhin AV, Erivantseva TN, Ryazhenov VV, Lyskov NB, Alekhina NA, Kuznetsova MM. New role of extemporaneous manufacturing in regulating drug products access onto the market. Pharmacy and Pharmacology. 2023;11(2):161–72 (In Russ.). https://doi.org/10.19163/2307-9266-2023-11-2-161-172

8. Watson CJ, Whitledge JD, Siani AM, Burns MM. Pharmaceutical compounding: a history, regulatory overview, and systematic review of compounding errors. J Med Toxicol. 2021;17(2):197–217. https://doi.org/10.1007/s13181-020-00814-3

9. van der Schors T, Amann S, Makridaki D, Kohl S. Pharmacy preparations and compounding. Eur J Hosp Pharm. 2021;28(4):190–2. https://doi.org/10.1136/ejhpharm-2020-002559

10. Daniels R, Thoma K. Apothekenrezeptur und -defektur. Herstellung von Arzneimitteln und Körperpflegemitteln. Stuttgart: Deutscher Apotheker Verlag; 2021.

11. Korol LA, Egorova SN, Kudlay DA, Krasnyuk II, Sologova SS, Korol VA, Smolyarchuk EA, Sadkovskii IA, Mandrik MA. Modern extemporaneous formulation in the geriatric care management: current opportunities and future challenges. A review. Therapeutic Archive. 2022;94(8):1020–7 (In Russ.). https://doi.org/10.26442/00403660.2022.08.201805

12. Sineva, TD, Narkevich IA. Pediatric dosage forms: international requirements for the development and quality. Moscow: GEOTAR-Media; 2019 (In Russ.) https://doi.org/10.33029/9704-5255-4-DLF-2019-1-144

13. Sotnikova LI, Loskutova EE, Kurashov MM, Egiazarian EA, Lagutkina TP. Structural analysis and assessment of the rationality of prescribing drugs in pediatric practice. Medical & Pharmaceutical Journal “Pulse”. 2023;25(5):89–95 (In Russ.). https://doi.org//10.26787/nydha-2686-6838-2023-25-5-89-95

14. Fisenko VS, Solomatina TV, Farrakhov AZ, Yurochkin DS, Mamedov DD, Golant ZM. Analysis of the conditions and development of ways to improve the system of training of pharmaceutical and medical workers aimed at developing the potential of compounding pharmacies in the Russian Federation. Bulletin of Roszdravnadzor. 2023;(4):29–42 (In Russ.). EDN: CYOTYR

15. Kochkina EO, Verlan NV, Kovalskaya GN, Tolstikova TV. Off-label prescribing in paediatric cardiology: regulatory aspects and safety assessment by spontaneous reporting. Safety and Risk of Pharmacotherapy. 2023;11(1):52–62 (In Russ.). https://doi.org/10.30895/2312-7821-2023-11-1-52-62