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Management and economics of pharmacy (MEP) is the disciplinary scientific complex that combines achievements from such fields of knowledge as management, economics, sociology, marketing, logistics, psychology, systems theory, purpose of which is to find the most effective ways to provide pharmaceutical care to population. Object of studying management and economics of pharmacy is sphere of circulation of pharmaceutical products, as well as mechanisms of interaction in pharmaceutical market. Management and economics of pharmacy is the discipline that studies economic and managerial activities of subjects of medicine circulation. The subject of management and economics of pharmacy is the subjects of circulation of medicines that perform pharmaceutical activities, economic relations between them and external environment, in addition, objects, processes and phenomena that form basis of their activities in pharmaceutical market. Purpose of studying Management and economics of pharmacy is to obtain various information and knowledge, as well as practical skills in field of organization, planning, control, analysis, accounting and other activities of subjects of medicine circulation for provision of high-quality pharmaceutical care.
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The following approaches are used in study of Management and economics of pharmacy : logistics – subject of MEP is considered as a set of commodity, as well as information flows connecting with them; it provides an opportunity to significantly improve economic activities of subjects of circulation of medicines by improving end-to-end material flow; Marketing - defines subject of MEP as means of satisfying potential and real consumers in medicines and other products of pharmacy range; provides for study of activities of subjects of circulation of medicines in full relationship with situation of pharmaceutical market and consumer behavior; Institutional - subject of MEP is set of institutions and organizations of pharmaceutical market, implemented in order to structure economic and social interactions; System - sees subject of MEP as combination of interrelated and interdependent subsystems, united by common goal, reveals its integrative properties, external and internal links; Modeling - provides an opportunity to study processes and systems that form subject of MEP by studying and building their models (graphical, conceptual, formal, and others). When studying subject of MEP, other methods of cognition are also used: historical, logical, sociological, statistical, economic-mathematical, etc.
Health is one of highest human benefits, without which many other benefits, opportunity to enjoy other rights (choice of profession, freedom of movement, etc.) can lose their value. Constitution of World Health Organization defines health as a state of complete physical, mental and social well-being, and not merely as an absence of disease or infirmity. Right to health and medical care is referred in article 12 of « I nternational Covenant on economic, social and cultural rights » (of1966 ).
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Public health protection is set of measures of various nature (economic, social, legal, scientific, sanitary and epidemiological, etc.) aimed at supporting and strengthening health of each person for purpose of active long-term life, as well as providing him with medical care in case of loss of health. Human health depends on socio-economic conditions, life support systems, mental state, satisfaction with living conditions in every country. Quality of pharmaceutical care affects health and life of each individual and well-being of society as a whole.
Слайд 6: Regulatory framework
Constitution of the Russian Federation Federal laws Federal Law “On basics of protecting health of citizens in Russian Federation" November 21, 2011 N 323-FL Federal Law “On sanitary and epidemiological well-being of population " March 30, 1999 N 52-FL Federal Law “On circulation of medicines " April, 12, 2010 N 61-FL Federal Law “On narcotic medicines and psychotropic s ubstances" January, 01, 1998 N 3-FL Resolution s of Government of the Russian Federation Resolution of Government of the Russian Federation № 1081 22.12.2011 « On licensing of pharmaceutical activities ». Decree of Government of Russian Federation 21.10.2019 N 2406 « On approval of list of vital and essential medicines »
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Orders of Ministry of Health of the Russian Federation Order of Ministry of Health of the Russian Federation of 31.08.2016 N 647n "On approval of rules of good pharmacy practice of medicines for medical use” Order of Ministry of Health of the Russian Federation of 31.08.2016 N 646n "On approval of rules of good practice of storage and transportation of medicines for medical use” Order of Ministry of Health of Russian Federation 14. 01. 201 9 N 4 n “On approval of procedure for prescribing medicines, prescription forms for medicines, procedure for filling out these forms, their accounting and storage” Order of Ministry of Health and Social Development Russian Federation 08.23.2010 N 706n “On approval of rules for storage of medicines”
Слайд 8: Constitution of Russian Federation
Article 4. Everyone has right to health protection and medical care. Medical care in state and municipal health care institutions is provided to citizens free of charge at expense of relevant budget, insurance premiums. In Russian Federation, there are Federal programs for protection and promotion of public health, measures are being taken to develop state, municipal, and private health systems, and activities that promote human health, physical culture and sports, and environmental and sanitary-epidemiological well-being are being encouraged.
Protection of citizens' health is set of measures of political, economic, legal, social, cultural, scientific, medical, sanitary-hygienic and anti-epidemic nature aimed at preserving and strengthening physical and mental health of each person, maintaining his long-term active life, providing him with medical care in case of loss of health. This Federal law regulates relations of citizens, public authorities and local governments, economic entities, subjects of state, municipal and private health systems in field of health protection of citizens. Laws of subjects of Russian Federation, normative legal acts of local governments shall not limit rights of citizens in field of health protection established by this Federal law.
Слайд 10: Federal Law № 52-FL “On sanitary and epidemiological well-being of population"
This Federal law is aimed at ensuring sanitary and epidemiological well-being of population as one of main conditions for realization of constitutional rights of citizens to health protection and favorable environment. Sanitary and epidemiological well-being of population is state of health of population, human habitat, in which there is no harmful impact of environmental factors on person and provide favorable conditions for his life.
Слайд 11: Federal Law № 61-FL “On circulation of medicines"
This Federal law governs relations arising in connection with development, preclinical research, clinical research, expertise, state registration, standardization and quality control, production, manufacture, storage, transportation, import into Russian Federation, export from Russian Federation, advertising, sale, transfer, use and destruction of medicines. This Federal law establishes priority of state regulation of safety, quality and effectiveness of medicines in their circulation.
Слайд 12: Federal Law № 3-FL “On narcotic medicines and psychotropic substances "
This Federal law establishes legal basis of state policy in trafficking of narcotic medicines, psychotropic substances and their precursors, as well as in field of combating their illegal trafficking in order to protect health of citizens, state and public security.
Слайд 13: Resolution of Government of Russian Federation № 1081 from 22.12.2011 « On licensing of pharmaceutical activities »
This Resolution of Government of Russian Federation establishes procedure for licensing pharmaceutical activities carried out by legal entities, including organizations of wholesale trade of medicines, pharmaceutical organizations, veterinary pharmaceutical organizations.
Слайд 14: Decree of Government of Russian Federation from 21.10.2019 № 2406 « On approval of list of vital and essential medicines »
This d ecree of Government of Russian Federation approves list of vital and essential medicines for medical use. This medicines should be in every pharmacy. This list includes about 500 international non-generic names of medicines.
Слайд 15: Order of Ministry of Health of Russian Federation 14. 01. 201 9 N 4 n “On approval of procedure for prescribing medicines, prescription forms for medicines, procedure for filling out these forms, their accounting and storage”
This order of Ministry of health of Russian Federation establishes rules for prescribing of medicines
Слайд 16: Order of Ministry of Health and Social Development of Russian Federation № 706n “On approval of rules for storage of medicines”
This order establishes requirements to premises for storage of medicines and rules of storage according to physical and chemical properties of medicines
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Pharmaceutical care is activity aimed at : providing population with goods of pharmacy range provision of scientific and advisory services to medical personnel and individual citizens on selection of most effective and safe medicines, methods of their storage, use, etc.
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Subsystems of pharmaceutical care control and supervision of farmaceutical activities state standardization, registration, certification of medicines industrial production and pharmacy manufacturing of medicines bringing goods from manufacturer to consumer information and advice continuing pharmaceutical edu cation consumer protection
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Pharmaceutical activity is activity carried out by wholesale trade enterprises and pharmacy organizations in field of circulation of medicines, including wholesale and retail trade of medicines, manufacture of medicines