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Regulatory and legal status of clinical guidelines and their role in the quality control of medical care in countries of the European Union, North America and Asia

https://doi.org/10.17749/2070-4909.2019.12.3.239-245

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Abstract

Introduction. In 2016-2018, the approaches to the development and use of clinical guidelines in the Russian Federation underwent substantial changes. As part of this work, legal aspects of clinical guidelines were modified. The present review, conducted on behalf of the Ministry of Health, is aimed to analyze the international experience regarding the clinical guidelines standards and identify possible obstacles and risks for their implementation.

Materials and methods. We reviewed documents and publications related to the development and implementation of clinical guidelines in 2016-2017 in 12 countries from Europe, Asia and North America known for their well established health care systems. The search for publications has been conducted with the help of the PubMed bibliographic database and the Google search engine, using the following requests: «clinical practice guidelines legal status», «clinical practice guidelines + name of the country». The results were updated to 2019.

Results. In most of the 12 countries, the clinical guideline development process is coordinated at the national level. However, the implementation of these guidelines by medical professionals is not mandatory, although it is often supported by the regulations of the national health system.

Conclusion. The development and implementation of clinical guidelines in the Russian Federation is consistent with the international experience: the development of clinical guidelines is coordinated at the federal level in agreement with the principles of evidence-based medicine; the implementation of guidelines are not mandatory, however, medical organizations and health professionals are expected to provide the medical care by considering the clinical guidelines, approved by the Scientific and Practical Council of the Ministry of Health.

 

 

About the Authors

V. K. Fedyaeva 
Center for Healthcare Quality Assessment and Control of the Ministry of Healthcare of the Russian Federation; Russian Presidential Academy of National Economy and Public Administration, Federal State Educational Institution of Higher Professional Education
Russian Federation

Deputy Head of the Department of Medical Support for Standardization, Center for Healthcare Quality Assessment and Control, Ministry of Health of the Russian Federation; Researcher at the Laboratory of Health Technology Assessment of the Institute for Applied Economic Research, Russian Presidential Academy of National Economy and Public Administration

SCOPUS Author ID 57189502826



U. N. Dmitrieva 
Center for Healthcare Quality Assessment and Control of the Ministry of Healthcare of the Russian Federation
Russian Federation
Leading Specialist, Department of Medical Support for Standardization


N. I. Juravleva 
Center for Healthcare Quality Assessment and Control of the Ministry of Healthcare of the Russian Federation
Russian Federation
Chief Specialist, Department of Medical Support for Standardization


N. I. Juravlev 
Center for Healthcare Quality Assessment and Control of the Ministry of Healthcare of the Russian Federation
Russian Federation
Specialist at the Department of Medical Support of Standardization


M. Yu. Kovaleva 
Center for Healthcare Quality Assessment and Control of the Ministry of Healthcare of the Russian Federation
Russian Federation
Leading Specialist


A. S. Korobkina 
Center for Healthcare Quality Assessment and Control of the Ministry of Healthcare of the Russian Federation
Russian Federation
Chief Specialist, Department of Medical Support for Standardization


O. A. Sukhorukikh 
Center for Healthcare Quality Assessment and Control of the Ministry of Healthcare of the Russian Federation; Research Institute of Finance, Ministry of Finance of the Russian Federation
Russian Federation

Head, Department of Medical Support for Standardization, Center of Healthcare Quality Assessment and Control, Ministry of Health of the Russian Federation, Laboratory Assistant-Researcher, Health Care Finance Center at the Research Financial Institute, Ministry of Finance of the Russian Federation

SCOPUS Author ID 57201486113



A. A. Pashkina
Center for Healthcare Quality Assessment and Control of the Ministry of Healthcare of the Russian Federation
Russian Federation
Leading Specialist, Department of Medical Support for Standardization


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For citation:


Fedyaeva  V.K., Dmitrieva  U.N., Juravleva  N.I., Juravlev  N.I., Kovaleva  M.Y., Korobkina  A.S., Sukhorukikh  O.A., Pashkina A.A. Regulatory and legal status of clinical guidelines and their role in the quality control of medical care in countries of the European Union, North America and Asia. FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology. 2019;12(3):239-245. (In Russ.) https://doi.org/10.17749/2070-4909.2019.12.3.239-245

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ISSN 2070-4909 (Print)
ISSN 2070-4933 (Online)