Aim. To analyze the range of metformin hydrochloride medicines registered at the pharmaceutical market of Ukraine for the treatment of type II diabetes mellitus.Materials and methods. When conducting the analysis the data of the State Register of Medicines of Ukraine, namely, reference resources, in particular the Compendium drug reference book, unified clinical protocols for the treatment of type II diabetes in adults, were used as research materials. In the course of the study, documentary, analytical, mathematical-statistical and logical data generalization methods were used. Graphical and tabular methods with explanations and conclusions were used to visually present the research results. The analysis of the structure of the assortment of metformin hydrochloride medicines wascarried out taking into account trade names of the drugs, countries producing these drugs, dosage forms and the composition of the drugs.Results. According to the results of the study, the ratio of metformin hydrochloride medicines of domestic and foreign production has been found. It has been determined that 65 % of the total range consists of foreign-made drugs, mainly from India (37 %) and France (15 %). When studying the structure of the assortment of metformin hydrochloride medicines of domestic production, 6 manufacturers have been identified; among them 40 % of the domestic assortment is manufactured by Farmak JSC. In addition, the list of metformin hydrochloride medicines made by domestic manufacturers from in bulk tablets of foreign (mainly Indian) production has been detailed. It has been found that all metformin hydrochloride medicinesare available in the form of solid dosage forms, mainly in the form of coated tablets (75 % of the total amount of drugs), in three doses.Conclusions. Based on the analysis, it has been found that more than 160 metformin hydrochloride medicines are registered in Ukraine; the vast majority of them are of foreign production. It has been determined that most domestic manufacturers produce metformin hydrochloride medicines from foreign-made tablets in bulk.Key words: market analysis; type II diabetes mellitus; metformin hydrochloride; assortment.
The aim of the study was to monitor the physical availability and socio-economic affordability of metformin hydrochloride medicines, which are used for the treatment of type II diabetes mellitus. Materials and methods. Medical and technological documentation on the standardization of medical care for patients with type II diabetes, data from the State Register of Medicinal Products of Ukraine, software complex “Apteka” of the company “Morion” and data from the pharmaceutical market research analytical company “Pharmstandard” of the company “Morion” were used as research materials to determine indicators of physical availability and socio-economic affordability of metformin HCL medicines for the treatment of type II diabetes. Documentary, analytical methods, the method of marketing research and the method of logical summarization of data were used during the research. Results. According to the results of the analysis of the medical and technological documentation on the standardization of medical care for diabetes mellitus (DM) type II and the State Register of Medicines of Ukraine, a number of characteristics were formed for Metformin HCL pharmaceuticals, namely: tablets or film-coated tablets in a dose of 500 mg, which are manufactured: Ukrainian manufacturers (full cycle of production); Ukrainian manufacturers of tablets in bulk (primary and secondary packaging) and foreign manufacturers. The specified characteristics became the basis for the further selection of several metformin HCL medicines in terms of determining their indicators of physical availability and socio-economic affordability. When determining the physical availability of metformin HCL medications, it was established that Ukrainian-made pharmaceuticals (full production cycle) are presented in the wholesale chain of the pharmaceutical market in full. According to the socio-economic indicator of the solvency adequacy of payment capacity, among the metformin HCL pharmaceuticals, the most economically justified are the Ukrainian-made pharmaceuticals, which are made from tablets in bulk according to the full production cycle. Only 1 medicine was singled out among foreign-made ones, which has the lowest indicator of solvency adequacy for various categories of the population. Conclusions. Monitoring of indicators of physical availability and socio-economic affordability of metformin HCL medicines showed that the most economically justified for able-bodied people and people of retirement age is the use of the Ukrainian-made pharmaceuticals (full cycle and production from tablets in bulk) for the treatment of type II DM)
The aim of the study is to study approaches to the formation of legislation in the field of the online retail selling (distance selling) of medicines in the EU with further development of areas for improvement of phar-maceutical legislation of Ukraine. Materials and methods. During the research, scientific methods were used, in particular, system-analytical, content analysis, comparative legal, graphic, etc. Results. The main provisions of the EU Directives 2000/31/EU “On some legal aspects of information services, in particular, electronic commerce, in the internal market” (Directive on electronic commerce) and EU Directive 2001/83 EU “On the Community code relating to medicinal products for human use”, the Council of Europe Convention “On counterfeiting medical products and similar involving threats to public health”, Implementing Regulation of the EU Commission No. 699/2014 of June 24, 2014, as well as the Law of Ukraine “On Electronic Commerce”, “On medicines”, Resolution of the Cabinet of Ministers of Ukraine (CMU) of March 23, 2020 No. 220, of November 30, 2016 No. 929 and others. Conclusions. The main directions of improving the current legislation of Ukraine in the field of the online retail selling of medicines are proposed. The necessity to supplement the Regulation “On the State Service of Ukraine for Medicines and Drug Control” (Resolution of the Cabinet of Ministers of Ukraine of November 30, 2016 No. 929) with certain norms has been substantiated. In particular, to impose on this state body the obligation to register business entities that plan to sell drugs using information and communication means, as well as maintain their Register
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