The paper presents the current views on the methodological principles of standards in the health care of Ukraine, such as branch standards, that defined by law. The Ukrainian law “On amendments to the Basic Laws of Ukraine on health care”, 2011 (paragraph 14-1) defined the place of doctor’s records in branch standards of health care. Thus, a system of standards in health care includes state norms and branch standards, the last include standard of health care, clinical protocol, material-technical list and doctor’s records. In legislative and in practical aspects the integration process of the formulary system in Ukrainian health care system was launched, particularly in its standardization subsystem of health care. The impetus for the integration served the transition to a modern methodology of clinical protocols development and medical standards on the principles of evidence-based medicine, which began in 2009 with the approval of the methodic recommendations and creation of the unified clinical protocols of medical care according to Decree of Ministry of Health of Ukraine. The question of the establishment of the State register of medicines and unified clinical protocols of medical care based on evidence-based medicine was discussed. It was determined that the only sources of their creation are clinical guidelines and primary and secondary sources of evidence-based components of the medicine. An important source of evidence-based medicine is a tertiary clinical guideline, which plays an important role. Clinical practice guideline is a statement that is designed using a particular methodology, which aims to help doctor and patient in making decisions on rational interventions in specific clinical situations. Basic components of unified clinical protocol sections are “Primary prevention”, “Diagnostics”, “Treatment”, “Rehabilitation”, “Secondary prevention”. So, the chapter «Treatment» in the part of conservative therapy for rational pharmacotherapy is guided by reference the provisions of the State register of medicines and the Unified clinical protocol of health care that is developed on the principles of evidence-based medicine, such as the treatment of hypertension, ischemic stroke and others, served as a reliable source for the choice of drugs to the State register of medicines. On the same basis of evidence-based medicine doctor’s records and local protocols are created at the level of public health institution. The harmonization of the regulations of these documents is ensured by the only scientific evidences of the efficiency of medical interventions and medicines that are in the primary, secondary and especially in tertiary sources of evidence-based medicine, t. e. in clinical guidelines. Formulary system of medicine supply and system of standardization of medical care, which are formed by normative acts of medical care (medical standards and clinical protocols) create a system of standards in public health field, namely they are branch standards that is determined legislatively. The unity of both these systems is provided by single methodical principles of their creation on the basis of evidence-based medicine (primary, secondary, tertiary sources of literature) which guarantee reliability of efficiency, security and economic accessibility of pharmacotherapy.
branch standards, medicinal form, clinical protocol, evidence-based medicine
«Bulletin of problems biology and medicine» Issue 3 part 1 (110), 2014 year, 330-333 pages, index UDK 616. 274:351. 77
