2018 № 6 Social significance of the use of medicines according to actual scientific data
Research rationale. The results of legislative changes in a healthcare system are reflected in social consequences based on indicators of achieving the treatment goals and the outcomes of diseases and, ultimately, the number of demographic and economic indicators. The scientific approach based on the data of high quality clinical, epidemiological, economical, and sociological researches is a tool to make a decision on the use of medicines that is implemented via normative documents. The urgent objective is to upgrade and harmonize these documents timely on the base of modern scientific achievements in order to obtain the most possible social outcome of pharmacotherapy of diseases.
Goal. To demonstrate social importance of the scientific approach to implementation of normative documents in the field of the use of medicines by the example of pharmacotherapy of various pathological conditions of high social significance.
Research methods. The general research methods (content-analysis, synthesis, generalization, formalization, etc) and the methods of comparative analysis are used. The current national and foreign normative documents, which regulate the use of medicines, were analyzed. Also analyzed are scientific publications in e-Library, Pubmed, Cochrane Library, Сlinicaltrials, Scopus databases and sites of biomedical journals on key queries reflecting the research topics.
Results. Results of implementation of the global programs on improving the efficiency of medicines use and the prospect proposals are presented by the authors of the article. These results will promote advancement of the normative documents which regulate the use of medicines, such as clinical recommendations, standards of medical care, manuals and guidelines on socially significant diseases treatment.
Conclusions. Translation of the relevant research data into a real clinical practice through improving the normative documents makes it possible to use fully the scientific outcomes for the benefit of population health in the country that brings health, social, and economic results.
Timely updating the normative documents in the field of the use of medicines is possible on the base of scientific analysis of current normative documents and publication on the outcomes of qualitative clinical researches with using the methodology for complex medicines assessment and, more generally, methodology for health technology assessment (HTA).
Organizational process of updating the normative documents can be carried out at various levels: national, regional, and local; while the local level provides more rapid implementation of the innovations in medical practice
2023 № 7 Comparative analysis of the standards of medical care for adults in the oncology profile approved before and after 2019 for the possibility of planning a program of state guarantees.
In the healthcare system in Russian Federation, in recent decades, standards of medical care have been formed, which are tabular forms indicating medical services, medicines, medical devices implanted in the human body, blood components and clinical nutrition (components), indicating average frequency indicators.
P u r p o s e – a comparative analysis of the standards of medical care for adults in the oncology profile, approved by orders of the Ministry of Health of Russia in the period from 2012 to 2018, and the standards developed on the basis of clinical guidelines and approved in the period from 2019 to 2022, with a view to the possibility of planning a state guarantee program based on them.
M a t e r i a l s a n d m e t h o d s . The comparison was performed by comparing the standards of medical care in the context of types of medical care, the conditions for providing medical care, localizations and nosological forms according to ICD‑10 blocks, types of medical interventions and assessing consistency with planning units of the state guarantees program.
R e s u l t s . The standards of medical care in the oncology profile, approved in the period from 2012 to 2018, were developed in the context of the types of medical interventions and were not coordinated either with the planning units of the state guarantees program or with the methods of payment by diagnosis-related group. The introduction of a methodology for the formation of standards of medical care based on clinical guidelines using standardized modules of medical care made it possible to revise the principle of the formation of standards for the oncology profile and harmonize them with the planning units of the state guarantees program and methods of payment
by diagnosis-related group.
F i n d i n g s . Structuring the process of developing medical care standards based on clinical guidelines and developing a methodology for their formation makes it possible to realize the economic function of medical care standards.
2017 № 8 Standards of medical care: whether they are mandatory for compliance with medical organizations?
In the Federal legislation of public health has stated that «medical care is organized and is … on the basis of standards of medical care…». The phrase «on the basis of standards of medical care» is interpreted differently in medical institutions, in connection with which the question often arises: «do I have to perform the standards of care, or they are Advisory in nature?». In the article the authors substantiate and prove that is currently approved in the prescribed manner the standards of care mandatory for medical organizations and doctors
2019 № 4 Amendments to the Federal law “On the basics of public health in the Russian Federation” on matters of clinical guidelines: what to do and what to expect medical organizations
The article deals with an analysis of certain provisions of the legislation on health care in connection with the changes made to the Federal law “on the basics of public health in the Russian Federation” on clinical guidelines.” In the context of the adopted changes, the authors consistently and clearly justify the obligation of medical organizations to comply with both the standards of medical care and the current clinical recommendations (treatment protocols). The sig- nificantly increased role of criteria for assessing the quality of medical care, approved by the Ministry of health of Russia, is emphasized and justified.
2017 № 9 The discussion about mandatory compliance with medical organizations standards of medical care
The authors in the order of discussion into details justify and prove that currently approved and put into effect in the prescribed manner the standards of medical care mandatory for medical organizations and doctors