Abstract
The quantitative reduction of the manufacturing pharmaceutical organizations significantly lowers public accessibility to medicinal preparations manufactured by pharmacies. The aim of this research has is the analysis of the normative legal standards regulating the industrial production and the pharmaceutical manufacture of infusion medicinal preparations in the territory of the Russian Federation. Materials and methods: The research has been carried out by the analysis of the current legislative and normative acts by means of documentary observation and content analysis. Results and discussion. Hereby the review has been done of the main acts along with normativelegal documentation regulating the industrial production and the pharmaceutical manufacture of infusion medicines such as federal laws, regulations of the Government of the Russian Federation, the State Pharmacopeia (Editions XI and XIII), orders of the Ministry of Health of the Russian Federation, etc. It has been established that in the Russian Federation there has been developed and currently functioning the system of mandatory requirements to industrial production and quality control of infusion medicinal preparations produced by manufacturing enterprises. At the same time, despite the restrictions on the pharmaceutical manufacture of the aseptic medicines registered in the Russian Federation, the pharmaceutical organizations implement manufacture of the medicines which are not produced industrially. That makes it possible to provide an individual dosage of ingredients and take into account patients’ individual characteristics. The normative legal regulation system for the pharmaceutical manufacture significantly differs from the similar system for the industrial production. The scientific discussion on the implementation of the international Rules of Good Manufacturing Practices (GMP) into pharmaceutical activities has not arrived at a unanimous organizational and technological opinion because of essentially different purposes, a diverse range of the undertaken tasks and dissimilar economic opportunities of pharmaceutical organizations and manufacturing enterprises. Conclusion: The currently existing normative legal regulation system for the industrial production and the pharmaceutical manufacture of infusion medicines in the Russian Federation is aimed at providing the national health services’ needs of necessary remedies for infusion therapy. At the same time, the pharmaceutical manufacture does not oppose the industrial production, but quite the contrary, expands public accessibility to such preparations for treatment in emergency or urgent cases and also during routine treatment of patients.
Highlights
Infusion therapy is one of the major remedial measures widely taken both in rendering medical aid in emergency or urgent cases and during routine treatment of patients
The carried out content analysis of available medical literature has revealed that intensive therapy is prescribed for sudden acute illnesses, pathoses, exacerbation of the chronic diseases threatening lives of patients who are in demand of emergency aid and for routine treatment purposely for elimination or relief of manifestations of a disease or diseases or conditions of patients, restoration or improvement of their healths, working capacity and quality of life
As infusion medicinal preparations (MP) belong to pharmaceutical dosage forms for parenteral application, special demands must be made to their quality and safety
Summary
Infusion therapy is one of the major remedial measures widely taken both in rendering medical aid in emergency or urgent cases and during routine treatment of patients. In the Russian Federation, pharmacy organizations are prohibited from manufacturing registered medicinal preparations (MP). Their production activities are carried out only in respect of MP, not produced by the pharmaceutical industry, or manufactured, taking into account the individual dosages of incoming ingredients and other personalized features of patients. The imposed restrictions caused the quantitative reduction of the pharmacies manufacturing MP in the Russian Federation Such pharmacies, as a rule, are functional divisions of treatment-and-prophylactic organizations and represent the significant section in the system of drug supply defining the efficiency and quality of the national medical care [1, 2]. We are of the opinion that the decline in volumes of the pharmaceutical organizations’ production activities leads to the pharmacies’ staff reduction and threatens the elimination of a huge layer of the qualified pharmaceutical personnel, along with the loss of prestige of the chief academic subject “Pharmacy” and the profession of Qualified Pharmaceutical Chemist
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