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.

The results of identifying new risks for pharmacovigilance systems and databases in Russia, including the Roszdravnadzor's web-based pharmacovigilance system, are presented. The lack of information in the database on pharmacovigilance of the Eur asian Economic Union and problems with updating programs and using alternative systems were noted. Changes in RWD/RWE information in global pharmacovigilance over the past 5 years.Objectives. Identification of new risks associated with pharmacovigilance systems and databases in Russia. Materials and methods. The materials were obtained by interviewing 138 pharmacovigilance specialists and from regula tory legal acts, publications, computerized systems, and databases through open and authorized access. Sociological methods were used: survey in Telegram-group «Pharmacovigilance CIS» in October 2024 and information-analytical methods: user testing, review, and analysis of Russian and foreign systems and programs, including databases for pharmacovigilance, regu latory documentation, and bibliography.Results. 17 % of pharmacovigilance specialists use exclusively Russian software in their computerized systems and data bases, 29 % use only foreign software, 35 % use both Russian and foreign software, and 19 % find it difficult to classify their systems and programs as domestic or foreign. The results of user testing indicate that there are problems and risks with access ing Roszdravnadzor’s web-based pharmacovigilance system via foreign browsers in current versions of Windows, Android, MacOS, iOS, and Unix operating systems. The unified pharmacovigilance database of the Eurasian Economic Union as of No vember 5, 2024, contains no public access notifications. The composition of data in the global database, VigiBase, has changed over 5 years: the largest number of cases now relates to COVID-19 vaccines. Russian data were not included in EudraVigilance and VigiBase (from October 10, 2020), which does not allow them to be considered in the global analysis.Conclusion. New potential risks for computerized systems and databases for pharmacovigilance in Russia have been iden tified — loss of data and reduction in the quality of analysis.

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 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.

By Decision No. 81 of 19.06.2022, the Council of the Eurasian Economic Commission amended the Guideline on Good Pharmacovigilance Practices of the Eurasian Economic Union (EAEU GVP Guideline), the core regulatory document on pharmacovigilance requirements for the EAEU Member States. The amendment involved all critical pharmacovigilance processes, and its consequences are yet to be assessed.The aim of the study was to analyse the changes to the EAEU GVP Guideline effective since 06.12.2022. The author summarised information on the changes made to the EAEU GVP Guideline by Decision No. 81 of the Council of the Eurasian Economic Commission of 19.06.2022 “On Amendments to the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union”. He described the differences between the old and the new versions of the EAEU GVP Guideline. Having critically reviewed the updated regulatory document, the author commented on its positive and negative aspects. The review created a starting point for further analysis of the changes to the EAEU GVP Guideline. At the time of writing, there were no other published works assessing the significance of most of the changes for the pharmaceutical industry and designated pharmacovigilance organisations in the EAEU Member States. The author assessed their significance through the prism of the recent years’ events in Russia and the world, including the COVID-19 pandemic. In connection with the amended guideline coming into force in 2022, the author suggested a transitional standstill period for both the pharmaceutical industry and designated pharmacovigilance organisations. He offered further improvements for the guideline. The article may be of practical interest to pharmacovigilance specialists, heads of pharmaceutical organisations, and employees of regulatory authorities.

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.

The complexity of the treatment of atopic diseases, including bronchial asthma, atopic dermatitis, and chronic urticaria, in pediatric patients lies in the detrimental effect of first-line drugs (glucocorticoids) on children's health and in the low prevalence of types of biological preparations due to limited data on their efficacy and safety, especially for the child population. The work presents a review of data on therapy with biological preparations in various pathological conditions, their effectiveness and safety in the long term. The aim of the review is to summarize the data on the treatment of atopic diseases with biological preparations. Materials and methods. We identified putatively relevant studies by searching MEDLINE, SCOPUS, PubMed, and Google Scholar electronic databases over the past 7 years using the terms: bronchial asthma; chronic urticaria; atopic dermatitis; biological preparations; omalizumab; dupilumab; mepolizumab; safety; monoclonal antibodies; efficiency. Further, according to the inclusion and exclusion criteria, as well as the independent selection of all authors, the suitable sources were selected and the review was compiled. Results. At the moment, there are not enough long-term studies on this topic, especially in pediatric practice. However, the existing ones allow drawing a preliminary conclusion about the prospects for further study of this topic in the treatment of atopic diseases.

The article presents the results of analysis of the use of drugs in the first trimester of pregnancy from the point of view of safety to the fetus

This review presents information on pharmaceuticals that have the properties of inverse agonists. The article describes the features of the interaction of the ligand - receptor with constitutive conformational changes. Many of ligands, assumed to be neutral antagonists, behave as inverse agonists displaying negative efficacy in experimental systems. This suggests that their therapeutic actions may involve not only receptor blockade, but also the decrease of spontaneous receptor activity. Examples of inverse agonists that influence the processes of excitation of adrenergic, histaminergic, opioid and benzodiazepine receptors are presented. The existence of constitutive activity in vivo and its pathophysiological relevance are also discussed

Aztreonam is the only approved monocyclic β-lactam antibiotic for human use that is active against Gram-negative aerobes, primarily Pseudomonas аeruginosa. Aztreonam has been used for more than 35 years, and aztreonam lysine has been on the market for 15 years. Although the medicinal products show clinical and microbiological efficacy in severe infections and are significant for cystic fibrosis patients, little information is published on their safety. In the meantime, new data have accumulated.The aim of the study was to analyse the data on adverse reactions in patients of different age groups receiving aztreonam, collected in the safety monitoring databases VigiBase and Pharmacovigilance.Materials and methods: the data on adverse reactions associated with aztreonam, in any dosage form, from the individual case reports submitted to VigiBase (the database of the Uppsala Monitoring Centre) before 15.09.2021 and to Pharmacovigilance (the database for spontaneous reports in the Automated Information System of the Federal Service for Surveillance in Healthcare of the Russian Federation) before 05.10.2021.Results: the analysis of adverse reactions during the use of aztreonam for approved indications showed differences in frequency, types and severity of the adverse reactions amongst the age groups. The most common adverse reaction with aztreonam was cystic fibrosis referred to in 1828 reports (12.0%). It was recorded more often in patients aged 18–44 years (39.2%).Conclusions: the data obtained allowed the authors to identify a new safety signal for aztreonam, namely an increased risk of inefficacy or insufficient efficacy in cystic fibrosis considered an adverse reaction in the individual reports from the databases of spontaneous reports. Confirmation of the signal requires further monitoring.

In this article authors describe some existing methods of benefit / risk assessment.

This review presents information on pharmaceuticals that have the properties of inverse agonists. The article describes the features of the interaction of the ligand - receptor with constitutive conformational changes. Many of ligands, assumed to be neutral antagonists, behave as inverse agonists displaying negative efficacy in experimental systems. This suggests that their therapeutic actions may involve not only receptor blockade, but also the decrease of spontaneous receptor activity. Examples of inverse agonists that influence the processes of excitation of adrenergic, histaminergic, opioid and benzodiazepine receptors are presented. The existence of constitutive activity in vivo and its pathophysiological relevance are also discussed

By June 1, 2022, there were 38 prophylactic COVID-19 vaccines approved in 197 countries around the world. The ongoing approval of new vaccines and the accumulation of more than a year's worth of data on their use give particular importance to the consolidation and analysis of information on the safety of such vaccines.The aim of study was to analyse the information on adverse events after immunisation (AEFIs) with coronavirus vaccines in the individual case safety reports entered into the VigiBase database by June 1, 2022.Materials and methods: the author analysed safety reports retrieved from VigiBase through the VigiLyze interface in the expert access mode. The search was carried out using the generic keyword “Covid-19 vaccine” in combination with the trade names of all 38 coronavirus vaccines.Results: the article presents consolidated information on the number and content of the safety reports on COVID-19 vaccines. The author noted that the reports were characterised by a high level of information completeness and quality, which could be due to the fact that the main reporters were the countries with developed pharmacovigilance systems. The analysis of patient complaints showed that the reported symptoms of AEFIs coincided with the manifestations of side effects of the vaccines included in the package leaflets. The author carried out a review of the cases of serious AEFIs and the cases of adverse events of special interest requiring additional monitoring after immunisation. It revealed a positive correlation of individual vaccines with the cases of somnolence in post-COVID-19 patients.Conclusions: the data obtained on the global safety of coronavirus vaccines may be of practical interest to doctors, researchers, developers, and healthcare regulators.

The pharmacovigilance system aimed at ensuring the safety of medicines has been functioning in Russia since 1997. However, at the moment, an important part of this system, pharmacy organisations, is not sufficiently involved in pharmacovigilance activities. Pharmacy personnel may be not prepared to collect information on adverse reactions associated with the use of medicinal products and submit it to regulatory authorities. The reason is not only that their knowledge of pharmacovigilance is insufficient, but also that little attention is paid in the educational process to the development of dialectical thinking, which is necessary for successful problem-solving. The available literature does not cover the importance of dialectical thinking as a professional competency of a pharmacy employee sufficiently well.The aim of the study was to substantiate the need in the development of dialectical thinking in employees of pharmacy organisations in order to increase their participation in the pharmacovigilance system.Materials and methods: 166 employees of pharmacies in Kazan were surveyed on the implementation of pharmacovigilance in pharmacy organisations. The authors used Spearman’s rank correlation coefficient to assess the extent of association between the variables identified in the survey (pharmacy’s standing in the pharmacovigilance system, respondents’ competence in pharmacovigilance, their familiarity with pharmacovigilance documentation, adverse reaction reporting, and so forth).Results: the majority of respondents perceive the importance of pharmacies for the pharmacovigilance system as medium (46.99%) and low (17.47%); the same is true for the level of pharmacovigilance development in pharmacies (45.63 and 27.5% of the respondents respectively). According to the correlation analysis, pharmacy employees do not associate the level of pharmacovigilance development in their pharmacy with their competence, which is characteristic of a dialectical failure. Most respondents tend to exaggerate the role of executive authorities, medical organisations, and pharmaceutical companies in the pharmacovigilance system and underestimate the role of pharmacies and pharmacy staff (only 17.62% of the respondents assign this role to pharmacies), which may be the reason for failing to fulfil pharmacovigilance duties and passing the responsibility to other parties to the circulation of medicinal products.Conclusions: according to the consolidated results, pharmacy employees may not consider themselves to be leading implementers of legislative initiatives, causally related to the effectiveness of pharmacovigilance system as a whole. Consequently, there is a need to form dialectical thinking in pharmacy employees within the framework of educational programmes. It will contribute to the development of reflection on their efforts in ensuring the safety of medicines and increase the effectiveness of their participation in pharmacovigilance activities.

Omalizumab is one of the longest-used monoclonal antibodies and the first available treatment option for severe allergic asthma in patients aged 6 years and older. Its efficacy and safety were 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 registration of adverse events associated with the use of omalizumab.

In this article authors analyze the influence of a label on drugpackage on the risk of medication errors and propose methods of their prevention.Analysis of the corresponding data published by regulators EMA and FDA hasprovided an opportunity to find examples of phonetic and graphic similaritieswith drugs identification