Heart failure is a complex clinical syndrome caused by an impaired pumping function of the heart muscle, etiologically associated with cardiovascular disease and, in the vast majority of cases, requiring complex therapeutic regimens and simultaneous prescription of several drugs. To date, we know several classes of drugs (including those used for heart failure) which can induce development/progression of heart failure in both patients with left ventricular dysfunction, and in patients who do not have cardiovascular diseases. The aim of the study was to analyse and systematize data on development mechanisms, as well as methods of prevention and treatment of drug-induced heart failure when using diff erent groups of drugs. It has been established that drug-induced heart failure is most often associated with the use of calcium channel blockers (verapamil, diltiazem, nifedipine), beta-blockers, antiarrhythmic drugs (disopyramide, fl ecainide, propafenone, amiodarone, ibutilide, dofetilide, dronedarone), anthracyclines (doxorubicin) and other antitumor drugs (trastuzumab, bevacizumab, infl iximab), hypoglycemic drugs (thiazolidinediones, saxagliptin, alogliptin), and nonsteroidal anti-infl ammatory drugs, including selective cyclooxygenase-2 inhibitors. The study revealed various mechanisms of heart failure development following drug treatment. In some patients, heart failure development is associated with the cardiotoxic eff ect of a particular drug, in others with adverse eff ects on hemodynamics. Much depends on risks of developing heart failure, including specifi c risks attributable to groups of drugs and individual drugs. The identifi cation of drugs that can contribute to the development/ progression of heart failure, and possible clinical manifestations of drug-induced heart failure, as well as provision of timely information to physicians, and engagement of clinical pharmacologists with the aim of optimizing treatment of patients can facilitate timely diagnosis, treatment and prevention of drug-induced heart failure. 

Drug-induced fatty liver disease (DIFLD) covers a group of adverse drug reactions whose prevalence accounts for about 10% of all adverse reactions. The aim of this review was to analyse and summarise data on medicines that can potentially lead to the development of DIFLD, as well as on the pathophysiological mechanisms of its development, methods of its diagnosis, treatment, and prevention. The analysis of scientifi c literature showed that most often this complication occurred following the use of amiodarone, methotrexate, tamoxifen, valproic acid, and some other medicines. It was demonstrated that the main risk factors for developing DIFLD are comorbidity/polymorbidity and mitochondrial dysfunction. Due to the lack of pathognomonic clinical manifestations of DIFLD the best approach to making diagnosis is to obtain a thorough medical history, including medication history, to use RUCAM and Naranjo scales, to analyse a number of blood chemistry parameters (alanine transaminase, aspartate transaminase, bilirubin, alkaline phosphatase), and, if necessary, to perform liver biopsy. Whenever DIFLD is observed in a patient, it is necessary, if possible, to discontinue the use of the medicine that caused the adverse reaction, or to lower its dose and to exclude the factors that may potentially aff ect the patient’s condition. The following measures will help healthcare professionals to prevent and detect DIFLD in a timely manner: observing the requirements of the patient information leafl et, taking into account any comorbidity and potential adverse drug interactions, as well as regular monitoring of the condition of patients taking medicines with known hepatotoxic eff ects.

Abstract. The paper discusses specific features of acute respiratory infections (ARI) progression in patients with comorbidity. The relevance of this study is accounted for by severe progression of ARIs in this group of patients, as well as by specific considerations of combining causal treatment of infections with life-long treatment of chronic diseases.

The aim of the study was to use a clinical case to substantiate an optimal treatment strategy for influenza and associated complications in a comorbid patient.

Results: the analysis of the clinical case showed that an unfavourable course of ARI in the patient was due to the lack of timely antiviral therapy, adverse effects of paracetamol during statin therapy, exposure to pneumonia pathogen degradation products, general intoxication, and immune response. The compromised medical history contributed to the development of severe complications. The paper proposes a strategy for selecting the most eff ective and safe approach to the treatment of ARIs in a comorbid patient.

Conclusions: ARIs in patients with chronic diseases entail increased risks of complications that may arise both due to specific characteristics of the infection and unfavourable combination of drugs. Treatment regimens for infl uenza and other ARIs in comorbid patients should be eff ective and timely. Early antiviral treatment is especially important in patients with comorbidity. When choosing a treatment regimen, it is necessary to assess potential benefi ts of pharmacotherapy as well as associated risks, including those related to previously prescribed medicines. 

The Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union oblige developers and marketing authorisation holders to implement a pharmacovigilance system that has to be described in the pharmacovigilance system master file (PSMF). Analysis of public sources revealed lack of data describing the creation of a PSMF. Therefore, the creation of a PSMF and keeping it up to date may prove challenging for pharmacovigilance specialists.

The aim of the study was to identify information needs of pharmacovigilance specialists by carrying out a sociological survey.

Materials and methods: the authors used information analysis methods (review and analysis of regulatory documents and scientific literature) and sociological methods (a questionnaire for pharmacovigilance specialists).

Results: the analysis helped to identify the following master file sections that present problems for specialists: sources of safety data; annexes to the master file; quality system; changes in the pharmacovigilance system that may result in an additional request from the competent authorities, etc.

Conclusions: the authors identified the most relevant topics for additional training: “Pharmacovigilance system documents” and “Pharmacovigilance system master file”. The results of the study are helpful for elaboration and updating of additional training programmes for pharmacovigilance specialists. 

Depression associated with somatic diseases ranks high among other depressive disorders and has a number of specifi c clinical features as compared to classic depression.

The aim of the study was to analyse specifi c features of comorbid depression clinical course, its diagnosis, and methodology for the selection of psychopharmacotherapy—using a clinical case as an example.

Results: the authors carried out a detailed retrospective clinical analysis of medical records of long-term (over three years) dynamic monitoring of a patient with comorbid vascular depression. They explored the tactics of selecting pharmacotherapy for anxiety-depressive disorder given the underlying chronic cerebral ischemia, atherosclerosis of brachiocephalic arteries, аrterial hypertension, and atherosclerotic cardiosclerosis. The primary focus was on specifi c aspects of vascular depression pharmacotherapy that were governed by a diverse clinical picture of comorbid personality disorders, dynamic transformation of somatic, neurological, and psychic symptoms and syndromes in a patient. The paper highlights the need for alignment of scientifi c and methodological approaches to assessment of potential risks associated with the use of psychotropic medicines.

Conclusions: the choice of rational psychopharmacotherapy for vascular depression should be governed by the data on the drug effi cacy for the prevailing clinical symptoms, by the age and gender characteristics of the patient, by compensation status of organs and systems, as well as by genetic, personal, and social characteristics that aff ect the disease progression. The use of a comprehensive multidisciplinary approach to the diagnosis and treatment of comorbid personality disorders, as well as implementation of personalised medicine methodology in clinical practice in order to assess the patient’s condition as infl uenced by changes in his/her somatic, neurological, psychic status and the results of psychological testing, will increase the effi cacy and safety of treatment. 

Experts of the Department for Evaluation of Medicinal Products’ Safety of the Scientific Centre for Expert Evaluation of Medicinal Products analysed administrative decisions of foreign regulatory authorities on the recall of medicines and/or the need to amend the prescribing information due to changes in their safety profile. The analysis helped to identify 11 administrative decisions that contain information on the following medicines registered in Russia: ranitidine, nizatidine, famotidine, pantoprazole, ondansetron, domperidone.