Регуляторные исследования и экспертиза лекарственных средств (Aug 2023)
Pharmacy Compounding Regulation in the German Pharmaceutical Market. Part 2. Organisational Features (Review)
Abstract
INTRODUCTION. The Russian Federation has decided to restore the system of compounding pharmacies as an element of the critical national healthcare infrastructure and pharmaceutical supply chain. To improve Russian regulatory practices, develop novel advanced approaches to pharmacy compounding and quality control, and implement these approaches, it is necessary to study relevant good compounding practices applied in healthcare systems of other countries.AIM. The study aimed to analyse the German experience in the organisation and regulation of pharmaceutical compounding to suggest recommendations for the development and implementation of Russian guidelines on good compounding and dispensing practices.DISCUSSION. This work continues a comprehensive study that delves into the current provisions of German legislation governing the system of good compounding practices. This article examines the differences between approaches to compounding by medical and pharmaceutical specialists. According to the findings, compounding by medical specialists is guided by the “free practice of medicine” principle and is subject to minimal regulatory oversight. All pharmacy organisations operate as compounding pharmacies, thereby enhancing the physical accessibility of compounded medicinal products to the population. The authors highlight the features of a process-based quality assurance system encompassing production process controls and quality control methods for compounded medicinal products. Additionally, the authors discuss the applicability of rapid test methods to compounding. In accordance with the German concept of good pharmacy practices, a compounding pharmacy may use the available validation, qualification, and verification tools in the pharmaceutical development of compounded medicinal products and may outsource its internal quality control function. Using the concept of risk ranking, compounding pharmacies may design their own sampling programmes. The article describes approaches to and requirements for organising the evaluation of compounding prescriptions. In Germany, compounding pharmacies may independently assign shelf lives to the compounded medicinal products they produce.CONCLUSIONS. Some German solutions are of considerable practical importance and are applicable to the development and implementation of Russian guidelines on good compounding and dispensing practices. In particular, pharmacy organisations may outsource the quality control of their compounded medicinal products. Additionally, pharmacies can conduct the full-scale pharmaceutical development of compounding technologies and quality control methods (including rapid test methods) using the validation, qualification, and verification tools available to drug manufacturers. Moreover, pharmacy organisations may independently assign shelf lives to the compounded medicinal products they produce. Finally, pharmacy organisations may design their individual sampling programmes.
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