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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher-id">farmaec</journal-id><journal-title-group><journal-title xml:lang="en">FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology</journal-title><trans-title-group xml:lang="ru"><trans-title>ФАРМАКОЭКОНОМИКА. Современная фармакоэкономика и фармакоэпидемиология</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2070-4909</issn><issn pub-type="epub">2070-4933</issn><publisher><publisher-name>IRBIS LLC</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">farmaec-57</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>Economic Review</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>Экономический обзор</subject></subj-group></article-categories><title-group><article-title>EVALUATION OF SAFETY OF DRUG THERAPY IN CLINICAL PRACTICE</article-title><trans-title-group xml:lang="ru"><trans-title>Оценка безопасности лекарственной терапии в клинической практике Костылева М.Н.1,2, Белоусов Ю.Б.2, Грацианская А.Н.1,2,</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Костылева</surname><given-names>М. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Kostyleva</surname><given-names>M. N.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Белоусов</surname><given-names>Ю. Б.</given-names></name><name name-style="western" xml:lang="en"><surname>Belousov</surname><given-names>Yu. B.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Грацианская</surname><given-names>А. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Gratsianskaya</surname><given-names>A. N.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Постников</surname><given-names>С. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Postnikov</surname><given-names>S. S.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru">ФГБУ «Российская детская клиническая больница» Минздрава РФ, Москва;&#13;
ГБОУ ВПО РНИМУ им. Н.И. Пирогова Минздрава РФ, Москва<country>Россия</country></aff><aff xml:lang="en">Russian Children's Clinical Hospital, Ministry of Health of the Russian Federation, Moscow;&#13;
The Russian National Research Medical University named after N.I. Pirogov of the Ministry&#13;
of Health of the Russian Federation, Moscow<country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru">ГБОУ ВПО РНИМУ им. Н.И. Пирогова Минздрава РФ, Москва<country>Россия</country></aff><aff xml:lang="en">The Russian National Research Medical University named after N.I. Pirogov of the Ministry of Health of the Russian Federation, Moscow<country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2014</year></pub-date><pub-date pub-type="epub"><day>22</day><month>03</month><year>2015</year></pub-date><volume>7</volume><issue>1</issue><fpage>27</fpage><lpage>32</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Kostyleva M.N., Belousov Y.B., Gratsianskaya A.N., Postnikov S.S., 2015</copyright-statement><copyright-year>2015</copyright-year><copyright-holder xml:lang="ru">Костылева М.Н., Белоусов Ю.Б., Грацианская А.Н., Постников С.С.</copyright-holder><copyright-holder xml:lang="en">Kostyleva M.N., Belousov Y.B., Gratsianskaya A.N., Postnikov S.S.</copyright-holder><license license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.pharmacoeconomics.ru/jour/article/view/57">https://www.pharmacoeconomics.ru/jour/article/view/57</self-uri><abstract><p>the present review is devoted to an actual problem of safety of pharmacotherapy in clinical practice; the particular attention is paid to the state of this problem in pediatrics. Information about pharmacovigilance is proposed; criteria of definition, methods of collecting (their advantages and limitations), account and analysis of the adverse reactions of drugs in post-marketing period are described. The off label use of drugs in children and a role of clinical pharmacologist in the adverse reactions of drugs monitoring in a hospital is discussed.</p></abstract><trans-abstract xml:lang="ru"><p>настоящий обзор посвящен актуальной проблеме безопасности фармакотерапии в клинической практике, отдельное внимание уделено состоянию проблемы в педиатрии. Предлагаются сведения о фармаконадзоре: описаны критерии определения, методы сбора (их преимущества и недостатки), учета и анализа нежелательных явлений лекарств на пострегистрационном этапе. Обсуждается проблема off label назначений лекарств у детей и роль врача-клинического фармаколога в организации мониторинга нежелательных явлений в условиях стационара.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>безопасность фармакотерапии</kwd><kwd>нежелатель- ные явления лекарств</kwd><kwd>педиатрия</kwd><kwd>мониторинг НПР</kwd><kwd>фармаконад- зор</kwd><kwd>методы фармаконадзора</kwd><kwd>клинический фармаколог</kwd><kwd>off-label назначения лекарств</kwd></kwd-group><kwd-group xml:lang="en"><kwd>safety of pharmacotherapy</kwd><kwd>adverse drug reactions</kwd><kwd>monitoring of drug safety</kwd><kwd>pediatrics</kwd><kwd>pharmacovigilance</kwd><kwd>methods of pharmacovigilance</kwd><kwd>clinical pharmacologist</kwd><kwd>off label use of drugs</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Безопасность лекарств и фармаконадзор. 2008; 1: 17; 2009; 1: 13.</mixed-citation><mixed-citation xml:lang="en">Bezopasnost' lekarstv i farmakonadzor. 2008; 1: 17; 2009; 1: 13.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Косенко В.В., Глаголев С.В. 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