In the recent years, complications of drug therapy are an important medical problem. Data on adverse drug reactions (ADRs) in older patients were analyzed. The object of the study was notification cards for NR received from medical organizations (MO) of Irkutsk region for a five-year period. The Narangio scale was used to assess the causality (SST) between ADR and LS. Of the 1068 ADR notifications in patients over 60 years of age, 2/3 (705) are presented with ADR notifications in women, 363 (34.0 %) – in men. The presence of background diseases was registered in 940 notifications (88.0 %). There were no gender differences except for a higher incidence of chronic obstructive pulmonary disease in men (7.2 % and 3.5 %, respectively, p < 0.05) and diabetes mellitus in women (14.0 % and 3.5 %, respectively, p < 0.05). ARs for antibacterial agents amounted to 31.8 %, drugs for the treatment of cardiovascular diseases – 10.5 %, cases of therapeutic inefficiency – 5.4 %. The ADR data statement was in line with the recommended form of 76 %. The most common filling defect was incomplete patient information. The validity of the Narango PSS was high. The deadlines for reporting data were observed in 93 %. For effective interaction in the pharmacovigilance system, it is necessary for each MO to constantly inform about the procedure for pharmacovigilance, types of ADRs, the rules for their detection and the timing of data reporting. The work should be supervised by a trained specialist.

In recent years, complications of drug therapy are an important medical problem. Data on adverse drug reactions (ADR) in patients of older age groups were analyzed. The object of the study was notification cards for unwanted reactions received from medical organizations of the Irkutsk region for period 2009-2020 years. The Narangio scale was used to assess the causality between ADR and medicines. Of the 1021 ADR notifications in patients over 65 years of age, 2/3 (668) are presented with ADR notifications in women, 353 (34,6%) in men. The presence of background diseases was registered in 915 notifications (89,6%). There were no gender differences except for a higher incidence of chronic obstructive pulmonary disease in men (7,2 and 3,5% respectively, p<0,05) and diabetes mellitus in women (14 and 3,5% respectively, p<0,05). ADRs for antibacterial agents amounted to 31,8%, drugs for the treatment of cardiovascular diseases - 10,5%, cases of therapeutic inefficiency - 5,1%. The ADR data statement was in line with the recommended form of 76%. The most common filling defect was incomplete patient information. The validity of the Narango causation was high. The deadlines for reporting data were observed in 89,1%. For effective interaction in the pharmacovigilance system, it is necessary in each medical organization to constantly inform about the procedure for pharmacovigilance, types of ADRs, the rules for their detection and the timing of data reporting. The work should be supervised by a trained specialist.

INTRODUCTION. National pharmacy compounding is a priority for providing the population with medicinal products, particularly the medicinal products lacking in the Russian Federation. Investigating opportunities to improve the operation of compounding pharmacies in the Russian Federation remains essential, especially in the context of the developing personalised approach to treatment, growing practice of orphan drug development, and import substitution needs.AIM. This study aimed to identify the factors driving the development of compounding pharmacies under the current conditions.MATERIALS AND METHODS. The study focused on the Russian regulatory framework for pharmacy compounding, as well as the range of dosage forms and administration routes of the medicinal products that had been produced and packaged by the compounding pharmacies in Irkutsk in 2021–2023.RESULTS. This study showed a demand for compounded medicinal products among both healthcare providers and patients. These medicinal products covered a traditional range of compounded medicines, including custom formulae, medicines for paediatrics and geriatrics, stock preparations, and pharmacy-packaged items. In 2021–2023, the mean annual production of Irkutsk pharmacy organisations amounted to ~500,000 units of compounded medicinal products, with a variety of doses and dosage forms. The medicinal products were compounded using ~100 different active substances and over 20 approved medicinal products. This study examined the evolution of Russian pharmacy compounding legislation. The key aspects included the establishment of a pharmaceutical quality system for compounded medicinal products, the extension of shelf life for specific dosage forms, and the authorisation to use medicinal products approved in the Eurasian Economic Union in compounding. The study showed that the main factors driving the operation of compounding pharmacies were the ongoing regulatory framework transformation and the transition from standardised treatment to personalised medicine. The main impediments for compounding pharmacies included the lack of state support, the ban on compounding medicinal products produced by pharmaceutical companies, the shortage of skilled staff, the inadequate supply of equipment (first of all, production machinery), the poor availability of active substances and excipients in small packages, and the challenges associated with regulatory control and oversight over the quality of compounded medicinal products.CONCLUSIONS. Further stimulation of the active development of compounding pharmacies requires further investigation into their operation in other regions, which will help to develop legal arrangements for the federal and regional state support of compounding pharmacies, procure up-to-date materials and equipment, and train the staff for compounding pharmacies.

In paediatrics, it is a common practice to use pharmaceuticals outside the approved Summary of Product Characteristics (i.e. off-label). According to the literature, up to 45% of inpatient paediatric prescriptions and 10–20% of outpatient ones are for off-label uses. It is essential to analyse such uses, as it helps medical practitioners act reasonably and professionally. The aim of the study was to explore the possibility of using spontaneous reports to assess the risks of the off-label use of cardiac medicinal products in children in the Irkutsk region. Materials and methods . The authors analysed 25 reporting forms on adverse drug reactions (ADRs) in paediatric cardiac patients from the database of the Regional Centre for Drug Safety Monitoring of the Irkutsk Region and regional data from the Automated Information System (AIS) of the Federal Service for Surveillance in Healthcare of the Russian Federation (Roszdravnadzor) submitted in 2009–2020. The inclusion criterion for reporting forms was a causal relationship between the off-label use of a medicinal product and the ADR that was scored as “possible” or higher on the Naranjo probability scale. Results . According to the reporting forms, the off-label use of cardiac medicinal products in children was associated with ADRs, such as angiooedema, cutaneous symptoms, and bronchospasm. The majority of ADRs (84%) were considered severe. The medicinal products were prescribed for heart failure, arterial hypertension, and cardiac arrhythmias. The majority of ADR reports (75%) were submitted by inpatient medical organisations. Conclusions . The analysis of spontaneous ADR reporting databases is a simple and informative method for studying the safety of medicinal products. It is necessary to raise awareness of ADRs associated with off-label prescribing amongst paediatric cardiologists in order to reduce the incidence of ADRs. The following contributions will improve the quality of medical care: all parties involved with pharmaceuticals should adhere to good pharmacovigilance practices, medical practitioners should be actively involved in treatment safety monitoring, and the professional training curricula of paediatric cardiologists and paediatricians should include specific units on the practical functioning of pharmacovigilance.

Scientific relevance. Since statins are widely used to prevent cardiovascular diseases, the control of statin-related complications is essential from both medical and social perspectives. Aim. The study aimed to analyse unsolicited reports on adverse drug reactions (ADRs) to control the safety of statin therapy.Materials and methods. The study analysed information on ADRs observed during statin treatment from the reporting forms submitted by medical organisations in Irkutsk to the database of the Regional Centre for Drug Safety Monitoring of the Irkutsk Region in 2011–2022. The causal relationship between ADRs and statin therapy was assessed using the Naranjo scale. Results. The database contained 1068 ADR reporting forms; 12 (1.1%) were spontaneous reports of statin-related complications, including 4 cases (33.4%) of myalgia, 7 cases (58.3%) of myalgia with moderately elevated transaminase levels (3–5 times the upper limit of normal), and 1 case of rhabdomyolysis that required statin discontinuation. In all cases, a reduction in the statin dose resulted in a regression in the clinical symptoms of ADRs. Most ADRs were observed in women with comorbidities (diabetes mellitus, obesity, and hypothyroidism), but the small sample size prevented the authors from testing the identified differences for statistical significance. Conclusions. According to the study results, statins have a reliable safety profile. Adequate and patient-specific selection of statin doses and ADR prevention are important responsibilities of clinical practitioners.

There are a number of factors that contribute to the accelerated rate of aging, one of which is physical activity. The increasing proportion of elderly and senile people in the Russian Federation requires urgent implementation of the elderly generation subprogram within the framework of the Demography federal project. In this regard, the problems of maintaining health and the development of methodological approaches to assessing the health of people in the older age group are especially significant.Objective: evaluation of anthropometry, stabilometry and biochemical parameters in the dynamics of Nordic walking in elderly womenMaterials and methods: 30 women were examined, mean age 69.0 (63.0–71.5) years. Examination by a therapist and a neurologist, biochemical blood tests, stabilometry, anthropometry, osteodensitometry (ODM) were carried out. Training loads of Nordic walking (NW) for 3 months were carried out according to the generally accepted method 3 times a week.Results: According to the biochemical analysis of blood, a statistically significant increase in the level of phosphorus and alkaline phosphatase (AP), total protein, as well as a decrease in the level of calcium and total cholesterol were revealed. When considering anthropometry data, there was a statistically significant decrease in body weight, BMI, body fat mass according to the Durnin — Womersley method, SBP and an increase in the cardiovascular index. According to the results of computer stabilometry — a statistically significant increase in the average position of the CP in the sagittal plane with open and closed eyes.Conclusion: 1. The use of NW as a training factor to achieve active longevity in the elderly leads to an improvement in the functioning of the cardiovascular system, due to a statistically significant decrease in body weight, a decrease in SBP by an average of 15 mm Hg. art., as well as the level of total cholesterol. 2. With regular NW exercises for 3 months, the functional stability indicators in the sagittal plane are corrected both with open and closed eyes.

In the Russian Federation, a substantial proportion of the population (39.3–75.7%) opts for self-treatment. Self-administration of prescription medicinal products, particularly antibiotics, can lead to serious adverse drug reactions (ADRs). The safety of medicines in circulation relies upon the proper functioning of the pharmacovigilance system, both in general and in the case of self-medication ADRs.The aim of the study was to analyse data on the serious ADRs attributed to self-treatment with antibiotics and reported to the Regional Centre for Drug Safety Monitoring of the Irkutsk Region, as well as on the pharmacovigilance problems associated with self-treatment.Materials and methods: the study analysed the suspected ADR reporting forms from the database accumulated by the Regional Centre for Drug Safety Monitoring of the Irkutsk Region in 2011–2019. The inclusion criteria for the reporting forms were full completion and a Naranjo probability score categorising antibiotic–ADR causality at least as “possible”.Results: of the total 2325 reports in the database, 790 (34%) were on the ADRs associated with the use of antibiotics. Of these, 222 reported serious ADRs caused by self-medication. The largest number of ADRs (126) was recorded in patients aged 40–70 years; the proportion of women (60.32%) was significantly higher than the proportion of men (39.68%). Hospitalisation was required for 23 patients with serious adverse events. In 80% of the studied cases, patients justified the need for self-prescription of antibiotics with cough (which they regarded as acute bronchitis), but their presumptive diagnosis coincided with that established in the hospital only in 47.83% of the cases. The reports of ADRs during self-treatment with antibiotics were mainly received from hospitals (205 cases), and much less often from outpatient clinics and directly from patients (9 and 8 cases, respectively). There were no reports from pharmacy organisations; and it may be assumed that their employees did not take active part in reporting.Conclusions: the use of antibiotics for self-medication can lead to serious ADRs; therefore, the medicinal products of this class should be used only as directed by a doctor. To reduce the incidence of ADRs, it is necessary to raise awareness of the population and medical specialists conducting antibiotic therapy. The quality of medical care will benefit from proper performance of pharmacovigilance activities by all parties to the circulation of medicines, active involvement of patients in treatment safety monitoring, inclusion of specific sections on practical functioning of the pharmacovigilance system into the training curricula of pharmaceutical professionals, and creation of a feedback system connecting pharmacovigilance organisations to medical ones and other subjects of the circulation of medicines.

This paper presents the results of the work of the Regional Centre for Monitoring the Safety of Pharmaceuticals in the Irkutsk Region functioning under the aegis of the Federal Service for Surveillance in the Sphere of Circulation of Pharmaceuticals. The analysis is carried out on the basis of the ecological monitoring of adverse reactions to antibacterial drugs. The sample involved 343 cases registered by specialists in the Irkutsk region medical institutions. The gender and age characteristics of the patients experiencing mani-festations of drug toxicity are provided. The clinical manifestations of the complications that developed un-der the influence of chemical antimicrobial factors are systematized. The characteristic symptoms that are predominantly manifested by skin and gastrointestinal tract lesions are described. The groups of antibacte-rial drugs exhibiting the highest risk of complications are identified. The drug monitoring showed that a large number of adverse reactions are associated with two drug classes, i.e., beta-lactam antibiotics and fluo-roquinolones (57% cases). The analysis of the effects of cephalosporins and "protected" penicillins re-vealed a high incidence of adverse reactions to ceftriaxone. Key factors reducing the effectiveness of anti-microbial therapy in urinary tract infections are revealed, including a long history of the disease, the pres-ence of two or more urinary tract pathogens, the concomitant infection of upper and lower sections of the urinary tract.

Questions of replacement of original medicines with generic are discussed. The sintesation of identical medicine is a complex challenge from the technological point of view. It is caused by distinctions in production of substances, influence of the variable pharmaceutical factors giving change of the size of particles, a different amorphous forms, a deviation of structure and quantitative content of impurity. Auxiliary substantion characteristics of a production process of ready dosage forms matter. Data on pharmacokinetic equivalence of each generic to original are necessary. For carrying out pharmacotherapy original medicine which receive as a result of the researches executed under the regulated protocol needs data on comparative therapeutic efficiency and shipping the generic of drugs.

The place of nonsteroid resolvents (NPVS) in treatment of a postoperative pain syndrome is considered. Safety issues of a nimesutid in comparison with other NPVS are discussed. The conclusion is drawn that nimesutid - a preparation with very favorable combination of powerful analgetic, anti-infLammatory action and good tolerance. CLinicaL trials and a wide experience of application of a nimesutid aLLow to consider that it is a choice preparation for treatment of postoperative pain of average and moderate intensity.he place of nonsteroid resolvents (NPVS) in treatment of a postoperative pain syndrome is considered. Safety issues of a nimesutid in comparison with other NPVS are discussed. The conclusion is drawn that nimesutid - a preparation with very favorable combination of powerful analgetic, anti-infLammatory action and good tolerance. CLinicaL trials and a wide experience of application of a nimesutid aLLow to consider that it is a choice preparation for treatment of postoperative pain of average and moderate intensity.

To study the probable negative influence of the complex remedy Tireoton on the reproductive function of the laboratory animals the following tests have been carried out, namely the probable occurrence of embryo-toxicity, teratogenicity, foetotoxicity and its influence on the postnatal development of the laboratory animals progeny. The experiments have been carried out of the white Wistar rats. It has been established that the Tireoton at the doses of 75 and 750 mg/ kg has no embryotoxic, teratogenic and fetotoxical effect. The introduction of the Tireoton at the dose of 750 mg/kg since 6th to 19th day of pregnancy does not influence on the postnatal development of white rats progeny.

The influence of the complex plant remedy (Urtica dioica L., Polygonum aviculare L., Achillea millefolium L., Zingiber officinalis L., Cinnamomum cassia L.) on the morphofunctional state of the liver in rats with ethanol-induced hepatitis was studied. The liver injury was simulated with 40% ethanol introduction to rats in dose of 10.0 ml/kg for 7 days. The extract of the complex remedy was administered to animals in dose of 200 ml/kg for 14 days. The findings showed that the tested remedy inhibited the development of microcirculatory impairments, decreased the intensity of inflammatory infiltration and diminished the amount of hepatocytes subjected to adipose and cloudy degeneration as well as to necrotic changes. The increased amount of hypertrophied and binuclear hepatocytes in the area of the portal tract and central vein testifies reparation processes in the liver of the rats treated with the tested plant extract.

The influence of the plant composition on the functional state of rat hepatic mitochondria and biochemical indices of energy metabolism was studied. Experiments were carried out on 42 white Wistar rats. The application of the plant composition increases contingency between oxidation and phosphorylation, as well as coefficients of respiratory stimulation and respiratory control by 17 % (р < 0.05) and 15 % (р < 0.05) respectively as compared to the control group. The tested herbal medicine increases the ATP content by 29 % (р < 0.05) and improves the activity of pyruvate kinase and H+-ATPase by 1.9 and 1.2 times respectively which indicates a partial restoration of energy metabolism in hepatocytes. The results of the research allow us to recommend the plant compositionfor its further study as a potential prospective hypolipidemic remedy for non-alcoholic fatty liver disease.

The results of work on identification and registration of complications of medicinal therapy in medical institutions of the Irkutsk region showed that that the frequency of undesirable medicinal reactions in patients made from 10 to 30 %. The standard scheme of antibacterial therapy results in resistance of pathogenetic flora. Hospital patients have great possibility of being infected with microorganisms, the so-called hospital strains (bacteria). The drug safety monitoring showed the necessity of the policing of prescribing of cardiovascular, antibacterial and antiglaucoma drugs.

The purpose of the present review to submit the analysis of a current state of a problem of postoperative anesthesia and to systematize data on analgetichesky efficiency of nonsteroid anti-inflammatory preparations (NPVP). Safety issues of a ketorolak in comparison with other NPVР are discussed. The conclusion that ketorolak - a preparation with very favorable combination of powerful analgetic action and good tolerance is drawn. Clinical trials and a wide experience of application of a ketorolak allow to consider that it is a choice preparation for treatment of postoperative pain of average and moderate intensity.

Questions of replacement of original medicines with generic are discussed. The sintesation of identical medicine is a complex challenge from the technological point of view. It is caused by distinctions in production of substances, influence of the variable pharmaceutical factors giving change of the size of particles, a different amorphous forms, a deviation of structure and quantitative content of impurity. Auxiliary substantion characteristics of a production process of ready dosage forms matter. Data on pharmacokinetic equivalence of each generic to original are necessary. For carrying out pharmacotherapy original medicine which receive as a result of the researches executed under the regulated protocol needs data on comparative therapeutic efficiency and shipping the generic of drugs.

To study the probable negative influence of the complex remedy Tireoton on the reproductive function of the laboratory animals the following tests have been carried out, namely the probable occurrence of embryo-toxicity, teratogenicity, foetotoxicity and its influence on the postnatal development of the laboratory animals progeny. The experiments have been carried out of the white Wistar rats. It has been established that the Tireoton at the doses of 75 and 750 mg/kg has no embryotoxic, teratogenic and fetotoxical effect. The introduction of the Tireoton at the dose of 750 mg/kg since 6th to 19th day of pregnancy does not influence on the postnatal development of white rats progeny.

The 95 cases of adverse drug reactions in children were registered in the Centre of Drug Safety Monitoring of Irkutsk Region from 2009 to 2015. In 21.4 % of cases, the coexistent affections developed. Children were allergic three times more often than adults. In 14.7 % of cases severe allergic reactions were registered. Most often allergies occurred after taking immunotropic (62.2 %), antimicrobial (16.2 %) and nonsteroidal anti-inflammatory drugs (10.8 %). 10.5 % of cases concerned inefficient drug use in children under 3 years; and 36.8 % of cases concerned children aged 3 to 18 years. The following risk factors of inefficient antibiotic therapy in children with urinary system infections were determined: the duration of the disease up to 5 years, isolation of two or more infectious agents and concomitant infections of upper and lower urinary tract. Adverse drug reaction occurred more often when more than three drugs were prescribed at the same time. Such cases were generally registered in patients with infectious diseases and epilepsy. Risk of adverse reaction increased with the off-label drug use. Introduction of monitoring methods and prediction algorithms allowing to reveal with high probability and to prevent adverse drug reactions in children improved efficiency and quality of pharmacotherapy

The 95 cases of adverse drug reactions in children were registered in the Centre of Drug Safety Monitoring of Irkutsk Region from 2009 to 2015. In 21.4 % of cases, the coexistent affections developed. Children were allergic three times more often than adults. In 14.7 % of cases severe allergic reactions were registered. Most often allergies occurred after taking immunotropic (62.2 %), antimicrobial (16.2 %) and nonsteroidal anti-inflammatory drugs (10.8 %). 10.5 % of cases concerned inefficient drug use in children under 3 years; and 36.8 % of cases concerned children aged 3 to 18 years. The following risk factors of inefficient antibiotic therapy in children with urinary system infections were determined: the duration of the disease up to 5 years, isolation of two or more infectious agents and concomitant infections of upper and lower urinary tract. Adverse drug reaction occurred more often when more than three drugs were prescribed at the same time. Such cases were generally registered in patients with infectious diseases and epilepsy. Risk of adverse reaction increased with the off-label drug use. Introduction of monitoring methods and prediction algorithms allowing to reveal with high probability and to prevent adverse drug reactions in children improved efficiency and quality of pharmacotherapy