Drug safety is one of the priority areas of modern medicine and pharmacy. The statistics and accounting of adverse drug reactions represent a complex problem due to the fact that many adverse reactions remain unrecognized and also depend on the willingness of healthcare professionals to inform regulatory authorities about the occurred adverse reactions. The objective of this study was to create and assess the reliability of an electronic questionnaire aimed at evaluating healthcare professionals' understanding of the procedures for reporting adverse drug reactions. The study consisted of two phases: the first phase focused on the development of the questionnaire and evaluation of a draft version by an expert committee, while the second phase included pilot testing with 30 respondents. The final version of the electronic questionnaire consists of 23 questions. As a result of the two phases of development and validation, the electronic questionnaire demonstrates sufficient reliability and validity, suggesting its potential for future use.

Currently, there are no comprehensive studies to assess the causes of adverse reactions in terms of the use of omalizumab. The aim of the study was to conduct a comprehensive analysis of the causes of adverse reactions to omalizumab. Materials and methods. Based on these criteria, experts of medical organizations conducted a retrospective assessment of 300 cases of omalizumab use with registration of existing defects based on the data of primary medical documentation (inpatient records, outpatient records). By the method of a sociological survey of 100 doctors, the level of their awareness of the procedure for reporting adverse reactions of drugs and, in particular, omalizumab was studied. The data were processed using applied computer programs. Outcomes. The incidence of medical-organizational defects in safety monitoring of omalizumab was 591 per 100 cases overall. The highest frequency was observed in such defects as: "lack of analysis of identified adverse reactions and cases of ineffectiveness"; "lack of a plan for corrective and preventive measures in connection with the detection of cases of adverse drug reactions"; "violation of the deadlines for the transfer of notices". In the structure of defects in reporting and filling out notifications of adverse reactions of omalizumab by doctors of medical organizations, the leading positions are occupied by: the absence of indications of the presence of bad habits (drug addiction, alcohol abuse, smoking) in the patient; absence of indications of the patient's reaction to the drug; lack of information about the period of time that has elapsed from the administration of the drug to the onset of symptoms of an adverse reaction. The weakest points of professional awareness of doctors about the procedure for reporting adverse reactions of omalizumab are: awareness of the need and content of the analysis of the identified adverse reactions; on regulatory documents on the quality, efficacy and safety of medicines; on the notification scheme of the person responsible for monitoring the safety of the medicinal product.

Clinical practice guidelines suggest long-term use of oral anticoagulation in elderly patients. An increased risk of bleeding is associated with age, low body weight, limited renal function, and multiple comorbidities that may be exacerbated by anticoagulation therapy. There is currently very little relevant pharmacological and clinical data on direct oral anticoagulants (DOACs), especially in older geriatric patients. This is very relevant since pharmacokinetics and pharmacodynamics often differ significantly in this group of patients. Therefore, studying and understanding the pharmacokinetics and pharmacodynamics of DOACs in the elderly is necessary to achieve balance in anticoagulation strategies. We identified potentially relevant studies by searching the electronic databases PubMed, Web of Science, Cochrane Library, MEDLINE, and Google Scholar. Further, according to the inclusion and exclusion criteria, as well as independent selection, all the authors of this article selected sources that were suitable according to the criteria and compiled this review.

The article provides an overview of information on cases of adverse reactions with the use of semaglutide, reports of which are included in the database of the World Health Organization’s international drug monitoring program as of February 26, 2024. The study carries out an analysis of the safety indicators of semaglutide, which is a drug for the treatment of type 2 diabetes mellitus. However, the drug gained its popularity due to its ability to reduce appetite. Semaglutide has been registered in the Russian Federation since 2019, and there is not enough information about adverse reactions related to its use. Characterization of the structure of adverse reactions associated with the use of semaglutide includes data on various factors, such as gender, age of patients, the nature of their complaints, severity of outcomes, geographic distribution, and initiators of the reports. These data can serve as a theoretical basis for improving and customizing the pharmacovigilance and drug monitoring system in Russia and are of practical interest for doctors, researchers, and health care regulators.

Ensuring drug safety is one of the key areas of modern medicine and pharmacy. Recent studies and publications confirm the long-term effectiveness and safety of using benralizumab. However, when making clinical decisions, it is important to consider the risks associated with biological therapy in order to provide adequate consultations for patients and effectively monitor potential adverse reactions. This article examines serious and significant adverse reactions associated with the use of benralizumab, as well as an analysis of the World Health Organization's global database, VigiBase, regarding adverse reactions to benralizumab. The data obtained on adverse reactions serve as a theoretical basis for improving the pharmacovigilance and drug monitoring system in Russia, presenting significant practical value for physicians, researchers, and healthcare professionals.

The authors analyzed and described the main stages of organizing the clinical pharmacology service in a medical institution, the rules for organizing the activities of the office of a clinical pharmacologist, the recommended staffing standards for the office of a clinical pharmacologist, the standard of equipment for the office of a clinical pharmacologist, the rules for organizing the activities of the clinical pharmacology department, recommended staffing and equipment standards for the clinical pharmacology department, responsibilities of a clinical pharmacologist, documentation for organizing the clinical pharmacology service, as well as requirements for equipping a pharmacologist’s workplace. The work is of practical importance when organizing a clinical pharmacology service in a medical organization.

The purpose of the review is to analyze Russian and foreign literature sources on the effectiveness and safety of benralizumab in the treatment of moderate and severe bronchial asthma. Benralizumab is a humanized monoclonal antibody directed against the interleukin-5 receptor (IL-5R) subunit. Binding of benralizumab with the alpha chain of IL-5R leads to inhibition of hetero-oligomerization of alpha and beta subunits, thus preventing signal transduction and consequent proliferation of eosinophils and basophils and the cascade of events following it. Benralizumab significantly reduces annual asthma exacerbation rates and is well tolerated by patients with severe uncontrolled asthma. The efficacy and long-term adverse reactions of benralizumab therapy have not been sufficiently studied and require more detailed analysis.

The article is devoted to an analytical review of studies to assess the clinical safety of omalizumab. The analysis showed that targeted therapy using genetically engineered biological drugs, which include, in particular, omalizumab, is increasingly used in the treatment of allergic diseases. In general, most studies show the clinical efficacy of omalisamab in bronchial asthma, allergic rhinitis, anaphylactic conditions, allergic urticaria, both in adults and children. However, there are isolated reports that allow us to talk about individual restrictions in the use of this drug associated with adverse reactions. Anaphylactic reactions have been most commonly reported during the administration of omalizumab. There are reports that indicate itching and rashes on the skin as undesirable reactions. In children, dyspeptic disorders are a common complaint. Reliable data on the initiation of malignancy processes against the background of the use of omalizumab have not been established. Quite rarely, as adverse reactions, the authors note eosinophilic granulomatosis with polyangiitis and thromboembolic complications. The authors draw attention to the need for a thorough collection of allergic anamnesis in patients, a clear selection of the dose of the drug, and monitoring patients in the first hours after the administration of the drug. The analysis data are the theoretical basis for improving the system for ensuring the safety of medicines and notifying supervisory authorities of adverse reactions to the use of medicines.

Thrombosis ranks first among the leading causes of death worldwide and is a fatal risk factor for patients’ health. Rapid diagnosis and appropriate treatment are necessary. There are three categories of antithrombotic agents: antiplatelet agents, anticoagulants, and fibrinolytics. Anticoagulants are first-line therapy for the prevention and treatment of venous thrombi. Dabigatran etexilate is a direct thrombin inhibitor. The effectiveness of dabigatran has been demonstrated in several clinical studies for the prevention of venous thromboembolism in patients undergoing total hip or total knee arthroplasty, for the prevention of stroke in patients with non-valvular atrial fibrillation, and in the treatment of acute venous thromboembolism. Some studies have demonstrated that the use of dabigatran leads to an increased risk of bleeding. Therefore, the purpose of this review is to examine the safety of dabigatran in patients over 18 years of age. We identified potentially relevant studies by searching the electronic databases PubMed, Web of Science, Cochrane Library, MEDLINE, and Google Scholar. Further, according to the inclusion and exclusion criteria, as well as by means of independent selection, all the authors of this article selected the sources that were suitable according to the criteria and compiled this review.

Clinical pharmacology as a separate field of medicine has existed for over 40 years. Currently, the main part of the work of a clinical pharmacologist in a medical institution is the correct choice of an efficient and safe drug in the treatment of a disease in a particular patient using informative criteria for assessing the effectiveness and safety of pharmacotherapy. Comprehensive work to optimize pharmacotherapy, carried out at all stages of a medical institution, allows the clinical pharmacologist to contribute to enhancing the quality of medical care and improving the drug provision to patients. The authors analyzed the main areas of activity of clinical pharmacologists and various aspects of their activities.

The article provides an overview of information on cases of adverse reactions with the use of omalizumab, the reports of which are included in the database of the World Health Organization's international drug monitoring program in 6 years (selected period 01.01.2017-01.01.2024). An analysis of the safety indicators of omalizumab, which is the drug of choice in the treatment of a number of severe atopic diseases, was carried out. Despite the long-term use of the drug in medical practice (more than 15 years) and reports on its efficacy, there is insufficient information on adverse reactions during its use, especially in the Russian Federation, since long-term clinical monitoring has not been carried out. The obtained characteristics of the structure of adverse reactions to the use of omalizumab by gender, age of patients, nature of their complaints, severity of outcomes, geography and initiators of reports, constitute a theoretical basis for improving and fine-tuning the domestic system of pharmacovigilance and drug monitoring, and may also be of practical interest to doctors, researchers and health regulators. The first rank places in the structure of adverse reactions to omalizumab are occupied by: general disorders and reactions at the site of administration, disorders of the skin and subcutaneous tissue, disorders of the respiratory system, thoracic and mediastinal organs, injuries, intoxication and complications of procedures, disorders of the nervous system. In the overall structure of NR, serious adverse reactions to omalizumab accounted for 35,1%. The analysis showed that in the assessment of adverse reactions, a significant role is given to patients (their representatives), whose opinion is determined by subjective feelings and the level of awareness, so more attention should be paid to drug informing patients.

Infusion therapy (IT) is an essential tool for influencing homeostasis and an integral part of the complex treatment of urgent conditions and chronic diseases accompanied by fluid and electrolyte balance disorders. To this day the features of infusion therapy remain one of the most controversial and poorly studied topics, despite the centuries-old use of this method of treatment. Rational use of IT requires a clear understanding of the pathophysiological changes occurring in the patient’s body during acute and chronic pathology. Its main tasks are the elimination of volemic disorders, replenishment of circulating blood volume, restoration of microcirculation, as well as detoxification and elimination of hemocoagulation disorders. IT acquires particular importance as parenteral nutrition, with limited or excluded possibility of the enteral route of absorption of water, nutrients, and drugs. In the work, the authors focused on clinical and laboratory diagnostics and possible options for correcting acid-base, energy, fluid, and electrolyte disorders. The sequence of actions when prescribing IT is presented in detail; the criteria for calculating the volume of therapy and the initial selection of colloids or crystalloids for a specific clinical situation are considered.

Relevance. Chronic idiopathic urticaria (CIU) is a disease that affects 20 % of people for more than 5 years. One out of five patients has tachyphylaxis, and traditional therapy is not effective. In addition, a problem of predictable adverse effects is the increasing growth in cases refractory to therapy, as well as a decrease in the quality of life of patients. The aim of the work is to study modern methods of chronic idiopathic urticaria treatment.

In modern algorithms of arterial hypertension treatment, the main strategic approach aimed at increasing the therapy effectiveness is the use of fixed combinations (FC) of two antihypertensive drugs at the start of therapy and of three drugs (preferably in one tablet) when it is necessary to intensify pharmacotherapy. Starting therapy with two drugs in one tablet (FC) is recommended for more than 70 % of patients. The article provides up-to-date information on the choice of a fixed combination for the treatment of patients with arterial hypertension (AH) according to modern national and international recommendations. The place of a fixed combination of ramipril and amlodipine among antihypertensive drugs in achieving the goal of treating patients with arterial hypertension was determined. The advantages of the fixed combination of ramipril and amlodipine due to the wide range of indications and its effectiveness for patients with hypertension in combination with chronic kidney disease (CKD) and metabolic syndrome are discussed. The distinctive properties of the fixed combination of ramipril and amlodipine are emphasized: it allows achieving target values of blood pressure (BP), improves adherence to treatment, reduces the frequency of prescribing additional antihypertensive drugs, and increases patient satisfaction with treatment. In patients with diabetes mellitus and metabolic syndrome, the fixed combination of ramipril and amlodipine allows achieving target values of blood pressure, promotes adherence to treatment, reduces heart rate, improves biochemical parameters of lipid and carbohydrate metabolism and functional kidney indicators. Ramipril, along with perindopril, is widely prescribed for patients with arterial hypertension, and its combination with amlodipine can be considered the method of choice in arterial hypertension patients with diabetes mellitus, chronic kidney disease, and metabolic syndrome.

Cardiovascular diseases are the leading cause of death worldwide. Dyslipidemia is one of the most significant modifiable risk factors for the CVD development and potentiation. The main drugs in the treatment of dyslipidemia in modern clinical practice are statins, although there are other effective hypolipidemic drugs that are gaining popularity, such as ezetimibe, proprotein convertase subtilisin/kexin type inhibitors - PCSK9 inhibitors, antisense oligonucleotide (pelacarsen), small interfering RNA - siRNA (inclisiran), and some others. In real clinical practice, the most effective approach to achieve LDL-C targets is adding ezetimibe to a statin (simvastatin, atorvastatin, rosuvastatin, etc.), rather than titrating the statin dose to the maximum possible. The addition of siRNA to statin therapy resulted in a stable, significant reduction in LDL levels by an average of 50% in all groups compared with statin monotherapy.

The purpose of the review is to analyze Russian and foreign literature sources on safety of using omalizumab in the treatment of moderate to severe bronchial asthma and chronic idiopathic urticaria in children. Omalizumab is one of the longest used monoclonal antibodies and the first available treatment option for severe atopic asthma in patients aged 6 years and older. Its efficacy and safety have been established in several randomized controlled trials, leading to its final registration over 15 years ago. In most cases, long-term treatment with omalizumab is safe and does not increase the risk of adverse reactions. However, over the years, there has been a trend towards an increase in the number of registrations of adverse reactions associated with the use of omalizumab. Long-term adverse reactions with omalizumab therapy are not sufficiently studied and require more detailed analysis, despite reports of an association between omalizumab and some adverse events. There are very few reports of adverse reactions when taking omalizumab in children in the Russian Federation. Further study of the safety of omalizumab and monitoring of its delayed adverse reactions is required.

In recent years, the use of off-label drugs (the use of drugs for indications not approved by state regulatory bodies, and also not mentioned in the instructions for use) has become widespread in the pediatric population. For a long time, clinical trials in the pediatric population were considered difficult to conduct due to ethical issues, leading to frequent off-label drug use. Off-label drug use remains an important public health problem, especially in children with rare diseases or diseases not responding to standard treatment. The purpose of the review is to analyze foreign literature sources on the use of biological preparations outside the instructions. The use of drugs outside the instructions (off-label) is a topical issue in the clinical practice of doctors of various specialties, and this is especially in demand in pediatric practice. This is due to the fact that a registered drug may have a successful experience in adults, but at the same time not have official approval for use in children. The need to use drugs outside the instructions for use, as a rule, occurs in patients with severe, chronic, life-threatening pathology. Further studies analyzing their efficacy, safety, and cost-benefit ratio are needed to expand the use of biological therapy in the pediatric population.

Diseases associated with blood clotting disorders are one of the most common problems of a modern person and, accordingly, of the attending physician. Since apixaban is the drug of choice for the treatment of thrombosis and prevention of strokes and embolism, the practitioner needs to be aware of the pharmacological properties and safety of apixaban in special groups of patients. This article provides updated information on the safety of apixaban in patients with kidney disease. We identified potentially relevant studies by searching the electronic databases MEDLINE, Scopus, PubMed, Google Scholar, and the Cochrane Database of Systematic Reviews from January 2022 to November 2023 using the terms: apixaban, anticoagulants,thrombosis, stroke, embolism, kidney disease, chronic kidney disease, therapy, safety, efficacy,adverse effects, clinical trials. Then, according to the inclusion and exclusion criteria, as well as by means of independent selection, all the authors of this article selected the sources meeting the criteria and compiled this review. Recent data show high safety of apixaban, supporting its use as a first-line treatment for thrombosis in patients with kidney diseases.

Age-related macular degeneration (AMD) is one of the leading causes of low vision and blindness worldwide for people over age 60. By 2040, the number of people living with macular degeneration is expected to reach 288 million due to the exponential acceleration of population aging. A decline in visual functions caused by AMD has a significant economic impact in all countries. Besides aging, there are other multiple heterogenic risk factors associated with AMD: gender, environmental condition, lifestyle, genetic characteristics, chronic inflammatory processes in the human body, level of education, etc. It is important for the ophthalmologist to be aware of modifiable risk factors and thus to collect a comprehensive medical history, interact with patients using motivational interviewing and to involve promptly other healthcare specialists into the patient management strategy. Etiopathogenesis of AMD is still not entirely understood. However, it is known that the major pathways include age-related alterations of retinal pigment epithelium (RPE) cells, oxidative stress, dysregulated lipid metabolism, inflammation, hemodynamic changes, and neovascularization. Carotenoids lutein and zeaxanthin are natural compounds with a proven efficacy in reducing AMD progression, which have been demonstrated to act as medications for patients with early AMD stages. The micro- encapsulated formula offers such an advantage as gradual and controlled release of active substances. Keywords: age-related macular degeneration, risk factors, etiopathogenesis, carotenoids, lutein, zeaxanthin, microcapsules. For citation: Maksimov M.L., Oganezova J.G., Kanner I.D., Voznesenskaya A.A. Carotenoids in the treatment of age-related macular degeneration: a drug delivery system does matter. Russian Journal of Clinical Ophthalmology. 2023;23(1):60–65 (in Russ.). DOI: 10.32364/2311-7729-2023-23-1-60-65.