Off-label medicines use: Complex problem of modern clinical practice [Назначение лекарственных препаратов по показаниям, не указанным в инструкции («off-label»): сложная проблема современной клинической практики]

World experience in off-label medicines use is presented in the article. Data on the history of changes in tactics and approaches to solve the problem of medicines off-label use in the USA and some European countries, as well as in the European Union as a whole, are presented. The reasons, why doctors should use medicines off-label, are discussed. The expert opinion on the conditions ensuring the maximum safety in off-label medicines use is presented. In particular, the validity of obtaining patient informed consent is discussed. The article does not apply to the Russian regulation regarding “off-label” therapy but describes the foreign practice related to off-label medicines use. In addition, the results of some recently completed randomized clinical trials evaluating the effects of direct oral anticoagulants are presented in order to demonstrate the need to clarify the effectiveness and safety of medicines used in certain clinical situations. The results of such studies clarify the indications for the drug use, which are subsequently entered into the summary of product characteristics. © 2020 Stolichnaya Izdatelskaya Kompaniya. All rights reserved

Position paper. The role of iron deficiency in patients with chronic heart failure and current corrective approaches

Further to the discussions, a position paper with the following main provisions was elaborated: 1. Iron Deficiency (ID) must be regarded as an independent clinically significant concomitant condition, with the prevalence reaching 50% among Chronic Heart Failure (CHF) patients in Russia. 2. According to observation studies iron deficiency in patients with CHF adversely affects functional performance and is associated with increased hospitalization rates and mortality. 3. ID must be excluded in all CHF patients, regardless of haemoglobin levels; the severity of ID should be evaluated. Blood ferritin concentration and transferrin saturation (TSAT, transferrin saturation coefficient) are currently optimal parameters for defining ID. 4. According to current data, therapy aimed only at increasing blood haemoglobin concentrations does not seem to have advantages in influencing the prognosis and clinical manifestations of CHF, while the elimination of ID in CHF patients leads to significant clinical benefits even in the absence of anaemia. 5. According to recently available data (the results of Randomized Clinical Trials, RCTs), the intravenous use of ferric carboxymaltose should be considered the most consistent approach for the treatment of ID in CHF patients. © 2020 Seoul National University. All rights reserved