Abstract
The aim. To develop conceptual framework of the strategy for a reasonable transition from original to generic medicines by complex implementation of proper bioequivalence studies and sufficient therapeutic drug monitoring management.
 Materials and methods. To conduct the study, we used the lists of medicines included in the state reimbursement program “Dostupny Liky” (Affordable Medicines), and materials of reports on medicines public procurement provided on the website of the Ministry of Health of Ukraine and the National Health Service of Ukraine, as well as information data on the results of studies of the quality and effectiveness of these drugs provided by the Rx-Index website. In the course of the study, the methods of logical analysis, SWOT analysis, and statistical evaluation of results, Kingdon’s Policy Streams Approach and the method of flowcharts construction were used. The concept of evidence-based medicine substitution formation in Ukraine was designed applying the Policy Streams Approach.
 Results. The analysis of public procurement programs for drugs for the period 2018–2020, as well as the analysis of drugs included in the new list under the “Dostupny Liky” (Affordable Medicines) program, carried out in the course of the study, showed that the level of evidence of data on assessing their effectiveness remains low. At the same time, more than 1.5 billion UAH (~ 50 mln USD) is spent annually on the purchase of such drugs and reimbursement of their cost, and the question of the optimal selection and monitoring of pharmacotherapy with these drugs remains open. A structural model has been developed, in which three basic levels are identified: provision of regulatory and financial components, executive and the level of implementation of the results. The SWOT-analysis of the strengths and weaknesses, as well as external opportunities and threats for the implementation of the conceptual framework made it possible to substantiate the advantages and reveal the possibilities of attracting clinical centers of universities and research institutions to the implementation of the concept. A framework for the interaction of a research center with health care institutions in the implementation of therapeutic drug monitoring was developed for low-income and low-middle income countries on the example of Ukraine. Distribution of responsibilities was proposed and the basic principles of interaction between performers of therapeutic drug monitoring were highlighted.
 Conclusions. Based on the results of the analysis of the evidence of the quality and effectiveness of drugs included in public procurement and in reimbursement programs, the key problems of organizing pharmaceutical provision of an appropriate level of quality for a number of chronic diseases requiring lifelong therapy were identified. The conceptual framework of evidence-based original medicines substitution to generic counterparts have been formed; and the ways of its implementation in the conditions of scarce financial resources on the example of Ukraine have been substantiated
Highlights
The quality of patient treatment depends directly on the medicines used, their dosage, and the therapy regimen chosen
Materials and methods Analysis was carried out based on the collected information from the lists and reports of public procurement of the Ministry of Health of Ukraine (MOH) [21], data and reports about functioning of “Dostupny Liky” (Affordable Medicines) program from the National Health Service of Ukraine (NHSU) [22, 23], and
In this context, it is important to note that, in contrast to these existing generic substitution policies in the world, our proposed conceptual framework is aimed at comprehensively solving the problem of evidence-based generic substitution of original drugs that require additional attention by combining proper BE studies and therapeutic drug monitoring (TDM)
Summary
The quality of patient treatment depends directly on the medicines used, their dosage, and the therapy regimen chosen. The selection of effective pharmacological therapy for human diseases is a very complex task, and the key factor for its solving is proper pharmaceutical support, which includes original medicines, generic medicines (generics), and biosimilars (generic versions of original biotechnological medicines) [1]. This is especially true for medicines with a so-called narrow therapeutic index when the permissible deviation from the effective dose is very small [2, 3].
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