antibioticsАнтибиотики и ХимиотерапияAntibiot Khimioter = Antibiotics and Chemotherapy0235-2990ООО «Издательство ОКИ»10.37489/0235-2990-2023-68-11-12-49-58antibiotics-1098Research ArticleКЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯ И ПРАКТИКАGUIDELINES FOR PRACTITIONERSМетодология создания системы управления рисками возникновения межлекарственных взаимодействийMethodology for Creating a Risk Management System for Drug-Drug Interactionshttps://orcid.org/0000-0001-5594-4859ТаубэА. А.TaubeA. A.

Таубэ Александра Альбертовна — к. фарм. н., научный сотрудник, доцент кафедры экономики и управления

Москва

Aleksandra A. Taube — Ph. D. in Pharmaceutics, Researcher, Associate Professor of the Department of Economics and Management

Moscow

https://orcid.org/0000-0002-9198-8661ЖуравлеваМ. В.ZhuravlevaM. V.

Журавлева Марина Владимировна — д. м. н., профессор; профессор кафедры клинической фармакологии и пропедевтики внутренних болезней

Москва

Marina V. Zhuravleva — D. Sc. in Medicine, Professor; Professor of the Department of Clinical Pharmacology and Propaedeutics of Internal Diseases

Moscow

ФГБУ «Научный центр экспертизы средств медицинского применения» Минздрава РоссииРоссияScientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian FederationRussian FederationФГБУ «Научный центр экспертизы средств медицинского применения» Минздрава России; Первый московский государственный медицинский университет им. И. М. Сеченова Минздрава России (Сеченовский Университет)РоссияScientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation; I. M. Sechenov First Moscow State Medical University (Sechenov University)Russian Federation2023251220236811-124958Copyright © Таубэ А.А., Журавлева М.В., 20242024Таубэ А.А., Журавлева М.В.Taube A.A., Zhuravleva M.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.antibiotics-chemotherapy.ru/jour/article/view/1098

Межлекарственные взаимодействия (DDI) являются серьёзной причиной госпитализации, отвечая за 16,6% случаев, когда причиной был ADR, и около 1% всех госпитализаций. Полипрагмазия получает всё более широкое распространение. Так шведское популяционное исследование лиц в возрасте ;;;75 лет показало, что распространённость полипрагмазии увеличилась с 27% в 1988 г. до 54% в 2001 г. и до 65% в 2006 г. Цель. Анализ баз данных по DDI и последующая оценка возможности их применения для управления рисками фармакотерапии в РФ и ЕАЭС. Результаты. Охарактеризованы основные базы данных по DDI. Определена степень несогласованности данных по количеству DDI, степени тяжести и клиническим рекомендациям. Сформулированы основные требования, предъявляемые к полноте информации в базах данных. Выявлено, что необходимо гармонизировать подходы к предоставлению информации о DDI, а также потребность в создании локальных баз данных для нужд медицинских организаций. Создана программа для ЭВМ, предназначенная для минимизации рисков возникновения DDI в клинической практике, для экспертных и научных целей. Заключение. Базы данных и программы по DDI имеют различные цели, различный набор данных о DDI с различной степенью доказательств, различия в оценке степени тяжести, вероятности возникновения, клинических рекомендациях по терапии и коррекции DDI. Вариабельность сведений обусловлена отсутствием единой системы оценки тяжести и вероятности наступления потенциальных негативных последствий DDI; различными целями при создании; разницей в бюджетах при создании. Такая ситуация приводит к избыточности предупреждений и усталости врачей от незначимых или недоказанных DDI. На основании выявленных требований к локальным базам данных создана и получила свидетельство о государственной регистрации программа для ЭВМ для моделирования рациональной фармакотерапии при инфекциях нижних дыхательных путей.

Drug-drug interactions (DDIs) are a major cause of hospital admissions, accounting for 16.6% of ADRs and about 1% of all hospital admissions. Polypharmacy is on the rise, with a Swedish population-based study of people aged ;;;75 years showing that the prevalence of polypharmacy increased from 27% in 1988 to 54% in 2001 and to 65% in 2006. The aim of the study was to analyze the databases on DDI and to assess the possibility of their use in managing the risks of pharmacotherapy in the Russian Federation and the EAEU. Results. The main DDI databases are characterized. The degree of inconsistency in data on the number of DDI, severity and clinical recommendations was determined. The basic requirements for the completeness of information in databases are formulated. The necessity to harmonize approaches to providing information about DDI, as well as the need to create local databases for medical organizations were revealed. A computer program has been created to minimize the risks of DDI in clinical practice, for expert and scientific purposes. Conclusions. Databases and programs for DDI have different goals, a different set of data on DDI with varying degrees of evidence, differences in assessment of severity, likelihood of occurrence, clinical recommendations for treatment and correction of DDI. The variability of information is due to the lack of a unified system for assessing the severity and likelihood of potential negative consequences of DDI; different purposes for creation; difference in budgets at creation. This situation leads to warning redundancy and physician fatigue from insignificant or unproven DDIs. Based on the identified requirements for local databases, a computer program for modeling rational pharmacotherapy for lower respiratory tract infections was created and received a certificate of state registration. 

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The authors declare that there are no conflicts of interest present.