Medicines In Ukraine Research Articles

Emergency and immediate medicine in Ukraine: organizational, legal, clinical aspects

February 25, 2022, Poltava State Medical University, Poltava, Ukraine ABSTRACTS WERE PUBLISHED IN THE ALPHABETICAL ORDER OF AUTHORS’ LAST NAMES

POSC269 Health Technology Assessment Implementation for Development of Basic Benefit Package in 2021 in Ukraine

The aim of the study is to determine the impact of health technology assessment (HTA) implementation for the basic benefit package to justify the medicines inclusion on the National list of essential medicines in Ukraine according to new legislation.

POSA277 Implemetation of HTA in Decision-Making Process of Selecting Essential Medicines in Ukraine

POSA277 Implemetation of HTA in Decision-Making Process of Selecting Essential Medicines in Ukraine

Про перспективи розвитку шкільної медицини в Україні

The article presents the history of the development of school medicine in Ukraine, the birth of national school hygiene as an independent science. It was emphasized that school medical services are very important both in maintaining the health of the younger generation and in providing the best conditions for its formation, health promotion, and prevention of pathological conditions. In 1922–1935, institutes of health care for children and adolescents and institutes for the protection of motherhood and childhood were opened in Ukraine for the scientific development of health care issues for schoolchildren and adolescents. In October 1922, the first Ukrainian State Institute for Maternal and Child Health was opened in Kharkiv, which is now called SI «Institute of Children and Adolescents Health Care of the National Academy of Medical Sciences of Ukraine». The Institute has become a leading research institution in Ukraine, which coordinates research on «Health Care of schoolchildren and adolescents», trains highly qualified personnel, publishes methodological and informational materials for implementation in practice, conducts scientific and practical conferences, and scientific symposiums on topical issues, including school medicine. According to the Resolution of the Cabinet of Ministers of Ukraine № 31 of January 20, 2021 «On approval of the Procedure for providing medical care to students of general secondary education» medical care for students is now provided by a medical worker who is a member of the educational institution. Ways to improve the organization of medical care for students in secondary schools for more effective development of school medicine, the expediency of using the resources of the SI «Institute of Children and Adolescents Health Care of the National Academy of Medical Sciences of Ukraine» are presented. Therefore, only the combined work of educational and health care institutions can provide the most favorable conditions for maintaining the health of students.

CHARACTERISTICS AND SUBSTANTIATION OF THE USE OF PELLETS AS A MODERN DOSAGE FORM ON THE MARKET OF UKRAINE

currently, omeprazole pellets are one of the most common pellet formulations on the pharmaceutical market of Ukraine (Gorobets, Matyash, Pekhenko & Barna, 2019). This medication is available in capsule form. Pellets are multi particular dosage forms that have several advantages over monoparticular dosage forms; therefore, pellets are promising oral delivery systems for active pharmaceutical ingredients (APIs). Pellets are used when the stability of the active substance changes with fluctuations in the pH of the environment, when irritation of the gastric mucosa is possible, to facilitate swallowing (especially important for patients with dysphagia, elderly patients, and children). When using polymers in the shell, it is possible to regulate the release in a certain part of the gastrointestinal tract, this allows you to get a point pharmacological effect. In addition, pellets can be of different sizes (from 0.1 to 2 mm), because of their shape, pellets exhibit abrasion resistance and are more fluid. Omeprazole is a synthetic substance. The active ingredient suppresses gastric acid secretion. In refers to the pharmaceutical group of proton pump inhibitors, it prescribes drugs in this group to treat active duodenal ulcers, gastric ulcers, gastro-oesophageal reflux disease (GERD), severe erosive esophagitis, pathological hypersecretory conditions, for example, Zollinger Ellison syndrome. Among the most commonly used methods for the production of pellets are: stage-by-stage spraying of solutions or suspensions (the second name is stage-by-stage layering); direct pelletization (the second name is extrusion-spheronization); spray drying and spray cooling of melts; agglomeration-spheronization. Unfortunately, at the moment, none of the Ukrainian manufacturers is manufactured enteric pellets on their own (they buy ready-made pellets), while there are medicines of both foreign and Ukrainian origin on the domestic market. The article contains an overview of pharmaceutical preparations as pellets, systematization of information on production methods, a review of omeprazole drugs as pellets, presented on the pharmaceutical market of Ukraine. The purpose of this study was to summarize the cases when the use of such a form as pellets is the most reasonable; make an overview of medicines in Ukraine containing pellets; summarize modern methods of pellet production.

Analysis of extemporal production trends in pharmacies for children

Medicines for children are insufficiently represented in pediatric dosages and appropriate dosage forms in the pharmaceutical market of Ukraine. Pediatricians are forced to prescribe children's medicines in dosages that are not available in the State Register of Medicines of Ukraine. Extemporaneously compounded medicines (ECM) are useful when a required dose or dose form is unavailable commercially, or is needed for individualised dosing.
 The aim of the study was to analysis a real data of the list of medicines which are produced in hospital and public pharmacies of Lviv region during 2020–2021.
 Methods. Content analysis of extemporal prescriptions for children, depending on the composition of the active pharmaceutical ingredient, dose and dosage form, comparative cost analysis of ECM and industrial medicines.
 In the hospital doctors prescribe ECМ in liquid forms (75%) – solutions for injection and in solid forms (25%) – dosed simple powders – 19%, dosed complex powders – 6%. It was determined the structure of ECM, which are produced in 6 studied pharmacies in 2020–2021. There are soft ECM 61.6% in dosage forms: ointments, creams, paste; liquid ECM are 28.3% in mixtures, solutions, mumbles; solid ECM are 8.3% in mono, combine powders, suppositories and 1.8% – other ECM: powders and nail polishs. There were highlighted unique recipes of ECM which analogues were not present in industrial dosage forms.
 We conducted analysis of the cost of children’s ECM in these pharmacies. It was determined that ECM cost were 40.5–305.6 UAH depending on the dosage form. The comparative analysis showed that ECM are in 2.2–4.9 times more cheaper for children compare with similar active ingredients in industrial medicines.
 ECMs are much more compliant for treatment in children and babies, they provide higher effect, safety, reduce dosing errors, especially at the inpatient stage, and continuation of therapy on an outpatient basis and more cost-effective for individual needs. The use of ECMs allows parents to properly dose them for children, to avoid errors in dosing, improper administration, which is extremely important to ensure the rational use of medicines in pediatric practice.

Novelties of the legislation on veterinary medicinal products

The article is devoted to the analysis of the latest innovations in the legislation on veterinary medicine, namely the regulation of the production, distribution and use of veterinary medicines. The adoption of the new Law of Ukraine “On Veterinary Medicine” is caused by the need to approximate the relevant national legislation with the legislation of the European Union to fulfill Ukraine’s international obligations under the Association Agreement. This law reflects the latest trends in the development of legislation on veterinary medicinal products in the European Union.
 The article pays attention to the strengthening of state regulation of production and distribution of veterinary medicines, in particular the introduction of licensing of imports, wholesale and retail sales of these medicines in Ukraine, due to the need to combat counterfeiting and veterinary medicinal products of dubious quality. It is also noted that the changes in the procedure of state registration of veterinary medicines provided by this law will on the one hand reduce the administrative burden on business due to the transition to indefinite state registration of veterinary drugs, and on the other hand new requirements for the registration dossier will improve the safety, quality and efficacy of veterinary medicinal products.
 New requirements for the use of antibiotics are analyzed. Attention is drawn to the fact that along with the regulation of the use of antibiotics in animal husbandry, it is also necessary to regulate in more detail the issues of control of the circulation of active substances (active pharmaceutical ingredients). The article also deals with the mechanism of veterinary pharmacovigilance, which is new for Ukraine. At the same time, it is necessary to study the practical experience of implementing the European model of pharmaco to improve the relevant legislation in Ukraine.

РЕТРОСПЕКТИВА ТА СУЧАСНИЙ СТАН ЛІКАРНЯНОЇ (ГОСПІТАЛЬНОЇ) ФАРМАЦІЇ В УКРАЇНІ

The current state of provision of medicines to the population of the country from the standpoint of government programs, Resolutions of the Cabinet of Ministers of Ukraine, Orders of the Ministry of Health on the purchase of medicines was considered. The development and improvement of hospital pharmacy during the years of Ukraine's independence were analyzed. The legal framework for the purchase of medicines and medical devices to provide health care facilities is considered. The history of formation and implementation of the Program of import substitution of medicines in Ukraine is retrospectively investigated, social and political, sanitary and epidemiological reasons of its non-fulfillment were considered, and also necessity of restoration of import substitution in modern conditions was proved.

Scientific and practical approaches to optimizing the pharmaceutical supply of pediatric palliative patients with paralytic syndromes

Today, palliative care (PC) as a system has a complex structure with stable orderliness, interrelated elements and subsystems. The problem of providing PD with an appropriate level and quality to the children population is particularly acute; it is due to differences in the duration of provision, the necessity to provide educational services, and the socialization of palliative children. At the same time, an important aspect in achieving an appropriate quality of life for children and their families related to health is the assessment of not only medical and social, but also pharmaceutical provision.
 The aim of the work is to substantiate the approaches to optimization of pharmaceutical support of pediatric palliative patients with paralytic syndromes.
 The study objects were data from medical records, theactual consumption of medicines by pediatric patients of the Kharkiv healthcare institution where palliative care was provided, as well as data on the state registration of medicines in Ukraine. During the study, clinical and anamnestic, sociological, and marketing methods were used.
 Based on the results of the analysis of clinical and anamnestic data and the overall assessment of symptoms in a sample group of palliative children with paralytic syndromes, which was 115 people, pathological conditions that led to frequent or permanent distress were identified. Among them, the spastic syndrome prevailed in 100% of cases, the pain syndrome in 66% of cases, the convulsive syndrome in 59%, respectively, and digestive disorders were observed in 82.6% of patients in the sample. It was found that a large proportions of drugs for pharmacological correction of symptoms in the sample of patients were formed by antiepileptic drugs, laxatives and centrally acting muscle relaxants. The results of the marketing analysis of a definite segment of the pharmaceutical market showed a rather limited range of drugs for pediatric dosage forms and concentrations, and it on average ranged from 3.1% to 25% in the pharmacotherapeutic groups studied.
 Thus, the results obtained prove the need to develop mechanisms for optimizing the pharmaceutical supply of pediatric palliative patients, in particular, expanding the range of medicines approved for use in pediatric practice.

Marketing analysis of influenza vaccines in Ukraine

Acute respiratory viral infections (ARVI) are highly prevalent, and it is especially dangerous during the COVID-19 pandemic. The most effective way to prevent the ARVI is vaccination. Aim. To analyze the pharmaceutical market of vaccines registered in Ukraine. Material and methods. The material of the study was data of the State Register of Medicines of Ukraine 2020, information on the results of the epidemic season of influenza and ARVI of the Center for Public Health of the Ministry of Health of Ukraine, declared wholesale prices for vaccines in Ukraine in December 2020. The methods of frequencyand descriptive analysis were used. Results and discussion. As a result of the structural analysis of ATC classification it was found that viral vaccines against influenza of J07B В group were presented at the pharmaceutical market. The frequency analysis revealed that there were 665.000 doses of vaccines of 4 trade names at the pharmaceutical market of Ukraine in 2020, all of them were of foreign production from France, the Netherlands, Great Britain, Korea. Among the vaccines purchased, 75 % were French-made vaccines. The cost of one vaccine dose ranged from 185.00 to 249.69 UAH. It was found that the number of vaccine doses purchased for the population during the study period (2016-2020) increased in 190 times. The population vaccination increased from 106683 to 238079 people, i.e. by 123 %. Conclusions. As a result of the research conducted it was found that in 2020-2021 there were 4 trade names of foreign vaccines at the pharmaceutical market of Ukraine. The cost of one dose of vaccines ranged from 185.00 tо 249.69 UAH.

The analysis of prolonged-release drugs at the Ukrainian pharmaceutical market

Aim. To analyze the range of prolonged-release dosage forms at the Ukrainian pharmaceutical market focusing on the pharmacotherapeutic groups that are insufficiently saturated with prolonged-release drugs, in particular to determine the proportion of non-steroidal anti-inflammatory drugs (NSAIDs). Materials and methods. The research was conducted in accordance with the data of the State Registry of Medicines of Ukraine and the АТС classification system. The methods of scientific analysis, in particular methods of grouping and comparison, marketing methods of analysis were applied. Results. The study of the assortment of prolonged-release drugs registered at the Ukrainian pharmaceutical market has been performed. The structure of the assortment by manufacturer, dosage forms, the АТС classification system has been analyzed. As a result of the study, it has been found that 202 trade names of prolonged-release drugs are registered in Ukraine. Most of them (196 names, 84 %) are medicines of foreign manufacturers. Prolonged-release drugs registered in Ukraine are mostly presented in the form of tablets and capsules, but tablets (72.77 %) are the largest part. The analysis of distribution of prolonged-release drugs by the ATC classification groups has shown that a significant number of prolonged-release drugs belongs to group N – Nervous system (80 trade names), and group C – Cardiovascular system (44 trade names). The share of group M – Musculoskeletal system, in particular prolonged-release NSAIDs, is insignificant (9 trade names). Conclusions. The marketing research of the prolonged-release drugs conducted allowed us to characterize the structure of the assortment of the Ukrainian market by pharmacotherapeutic groups, manufacturers and dosage forms. As a result of the research, the current assortment of prolonged-release NSAIDs has been determined.

The analysis of the pharmaceutical supply with medicines used in insect allergy therapy and approaches to the development of new medicines in the form of a gel for the local treatment

According to the World Allergy Organization, allergies occur in 10 % to 40 % of the world’s population. Currently, the number of such patients in Europe is about 150 million people. It is projected that in the next decade there will be more than 250 million people, 5 % of whom have a predisposition to insect allergies (IA).Aim. To analyze the range of drugs used in the local treatment of IA and approaches to the development of new domestic drugs in the form of a gel.Materials and methods. The scientific publications of domestic and foreign authors, data from official sites on the subject, ICD-10, materials of the State Register of Medicines of Ukraine, directory Compendium, Protocol for medical care for insect allergies, as well as methods of the system analysis, comparison, graphical, analytical and the content analysis were used.Results. The regimen of IA treatment has been studied depending on the severity (mild, moderate, severe, anaphylactic shock), which is given in the Protocol of medical care for insect allergies in accordance with the Order of the Ministry of Health of Ukraine from 03.07.2006 No.432. It is considered that IA is treated with the subgroup “D04A A – Antihistamines for topical application”, which has only 5 drugs (including release forms); among them 80 % of medicines are foreign, 60 % are produced in the form of a gel. It is very insufficient because of the fact that there are consequences of insect bites during the local therapy of children since constant scratching of the bite sites is a threat of infection of wounds and delay their healing.Conclusions. On the example of the pharmaceutical composition in the form of a gel, the expediency for developing new domestic drugs that are available compared to foreign ones for the local therapy in IA, and manifestations of allergic reactions to insect bites has been proven.

The impact of the COVID-19 pandemic on the financial sector in medicine: features of centralized state procurement of drugs and medical devices in Ukraine for the period 2018-2021

ABSTRACT. Coronavirus disease (COVID-19) has deeply impacted the global health care system, and the redistribution of funding for medical care violated the prevention and treatment of chronic non-communicable diseases, including hypertension, tuberculosis, and HIV. In 2020, centralized state procurement of medicines in Ukraine was for the first time conducted via the online platform Prozorro. Of the 483 items planned to be purchased, 375 items (78 %) were successfully contracted. In the current 2021, tenders were announced for the purchase of 555 of 562 items. In most fields of medicine, the drugs to be purchased are 100 % covered by tenders. The lowest percentage of coverage is observed for pulmonary arterial hypertension (66.67 %).
 In today’s complex environment, not only COVID-19 should be actively combated, but other diseases should be also kept in mind when carefully planning the funding of various fields of medicine through the analysis of data from previous years. The money saved can be used to eliminate the consequences of the COVID-19 pandemic, and to purchase the necessary medicines. The creation of a single database of drug residues in medical institutions (chatbot in the Telegram messenger) can be called a positive innovation. Control of drug residues and their adequate redistribution makes it possible to rationally use this resource without spending money on unnecessary purchases.
 In general, despite the medical and financial impact of COVID-19, Ukraine’s healthcare system continues to withstand pressure and change for the better. Further improvement of the system of centralized procurement of medicines will be able to overcome the problem of lack of necessary drugs.

Медична допомога дітям у навчальних закладах: стан, проблеми та перспективи розвитку

В статті проведено аналіз систем медичного забезпечення дітей шкільного віку, особливостей організації. Міжнародний досвід свідчить, що існують різні моделі медичного забезпечення дітей у навчальних закладах: відмінності щодо підпорядкування шкільної служби (структурам охорони здоров’я або освіти), фінансування, підготовки кадрів та найбільш — щодо профілактичної спрямованості: обсягу та терміну проведення профілактичних медичних оглядів. Всесвітня організація охорони здоров’я наголошує, що поки оптимальної моделі шкільної охорони здоров’я в світі не визначено. Загальними проблемами шкільної охорони здоров’я є недостатнє фінансування, нерівномірний доступ дітей до медичних послуг. Наведено стан медичного забезпечення школярів у країнах пострадянського простору, результати змін у галузі охорони здоров’я дітей, що стосувалися реформування системи санітарно-епідеміологічних закладів, модернізації їх функцій, створення нових вертикальних структур, функціями яких є розробка національних і регіональних програм щодо пропаганди здорового способу життя, медичної освіти та комунікаційна діяльність. Проаналізовано розвиток системи шкільної медицини в Україні з позиції «Концепції стандартів якості шкільних медичних послуг і компетенцій» Європейського союзу шкільної та університетської медицини. Окреслено перспективи шкільної медицини в Україні, а саме: потреба у розробці і запровадженні нової української моделі шкільної медицини, адаптованої до європейських стандартів, та інтегрування її у систему громадського здоров’я, що затверджено в Україні; оновлення нормативно-правової бази; розвиток кадрового потенціалу; формування нових професійних компетентностей медичних працівників шкільної медицини в Україні; посилення міжвідомчої взаємодії в питаннях допомоги збереження здоров’я дітям і підліткам, які навчаються.

Content analysis of the official documents on the turnover of counterfeit medicines in Ukraine in 2017–2020

The purpose of the work was to conduct a content analysis of the orders of the State Medicines Service on the prohibition of the circulation of counterfeit medicines and the information messages of law enforcement agencies in 2017–2020.
 The object of the study was the orders of the State Medicines Service on the prohibition of the circulation of counterfeit medicines, information messages of law enforcement agencies to identify the facts of clandestine production and counterfeiting, publications on the problems of it’s distribution. The study used the methods of content analysis, systematization and generalization.
 Тo prevent the circulation of counterfeit medicines in the countries of the world, various methods of countering counterfeiting are being introduced, however, only in Ukraine was the restriction of measures of state supervision (control) in the pharmaceutical sector introduced as an element of deregulation. In connection with this, it was investigated how such restrictions, which were introduced three times, has influenced the identification and distribution of counterfeit medicines.
 For the study, a methodology for content analysis of official documents on the circulation of counterfeit medicines in the country for 2017–2020 has been proposed. In most of the orders of the State Medicines Service, revealed signs of drug falsification were introduced, which related to the labeling of packages.
 The imposition of a moratorium on planned measures of state supervision had a negative impact on the work of quality control bodies of medicines to identify counterfeits. In 2010–2014 (before the introduction of the first moratorium) the State Medicines Service issued 326 orders prohibiting the circulation of counterfeit medicines, but after the introduction of the moratorium, the number of orders for 6 years decreased significantly – to 118. So, in 2020, the State Medicines Service issued only 4 orders to prohibit the circulation of counterfeit drugs (for comparisons in 2017 – 18), although law enforcement officers revealed 6 facts of clandestine production and counterfeit.
 According to the results of the study, it was established that it was necessary to unify and standardize the management documents of the State Medicines Service on the prohibition of the circulation of counterfeit medicines, and also indicated the feasibility of introducing «field screening» of the often counterfeited medicines, to establish the real part of counterfeit medicines. Information messages from law enforcement agencies should not be limited only to the facts of revealing clandestine proceedings, but also should contain the results of court decisions on these facts. It is advisable to intensify interaction with regulatory authorities in other countries for a more effective exchange of information on detected of counterfeit medicines.

Legal principles of public administration for the invention of innovative medicines: European experience

Formulation of the problem. The creation of innovative medicines is the key to increasing the competitiveness of the pharmaceutical sector of Ukraine’s economy. Going through European integration requires bringing Ukrainian legislation, which regulates various sectors of the economy, in line with European legislation. The study of the European experience of legal regulation of medicines development is characterized by relevance. The state of the problem research. Problems of innovative activity in the field of medicines creation are investigated in scientific works of such Ukrainian scientists as V. M. Pashkov, S. V. Glibko, Yu. V. Heorgievsky, O. G. Alekseev, and T. A. Kolyada. European authors who have studied scientific activity problems in pharmacy are Philip A. Hines, Rosanne Janssens, Rosa Gonzalez-Quevedo, Ralf Arno Wess, and Constantinos Ziogas, Ivana Silvia. The purpose of the study is to develop proposals for amendments to Ukrainian legislation governing public administration in the sphere of medicines creation, taking into account the European experience. Presenting main material. State regulation of the creation of innovative medicines in Ukraine and the European Union is carried out in the following areas. The first is the creation and financial support of research institutions that develop innovative medicines. Second, the identification of research that needs public financial support on a competitive basis. Public administration bodies shall establish the procedure for registration of medicinal products or obtaining a trade license for placing a medicinal product on the market. Legislation and bylaws define the conditions for licensing the production of medicines. The differences in the legal regulation of the creation of medicines under Ukrainian and European legislation are as follows. First, in the European Union, licenses for marketing medicines are issued by the European Medicines Agency. At the same time, in Ukraine, the registration of medicines is entrusted to the Ministry of Health of Ukraine. Secondly, in the European Union, licenses for medicines production are issued by the national authorities of the EU member states. At the same time, the issuance of such licenses in Ukraine belongs to the competence of the State Service for Medicines Trafficking and Drug Control. Conclusions and prospects for further research. The implementation of European legislation governing the development of medicines may consist of further amendments to Ukrainian legislation in the field of circulation of medicines. Firstly, to consolidate the medicines registration function to the State Service for Medicines Trafficking and Drug Control of Ukraine. Secondly, to define one of the service’s tasks as providing advice to medicines developers on clinical and preclinical trials and medicines registration. It is also necessary to assess the environmental risk due to the use of a new medicinal product during its registration.

Modern views on anthropometric variability of the upper airway (literature review)

Annotation. The versatility and complexity of the structure of the upper airway is the subject of research by researchers in various fields of medicine. In particular, the greatest attention is paid to infectious diseases, injuries and their consequences, congenital pathologies of the upper airway. However, to understand certain processes in the human body, in particular pathological, it is necessary to know which indicators of the upper airway should be considered normal and what can affect their value. The purpose of this work is to systematize information and acquaint with modern views on anthropometric variability of the upper airway. To achieve this goal, an analysis of literature sources not older than 10 years, included in the scientometric databases Scopus, Web of Science and Google Academy. A study of scientific papers has shown that the most effective and appropriate method of studying the indicators of the upper airway for further anthropometric analysis is a cephalometric study. The analysis of foreign literature showed the importance of the influence of such factors as sex, age, nationality and structural features of cranial and dental-maxillary parameters on the cephalometric parameters of the upper airway. In the analysis of the domestic literature, research performed in this direction was not found. Thus, conducting research to identify normative cephalometric indicators of the upper airway in the Ukrainian population, taking into account the experience of foreign scientists is a promising and relevant area of research for both theoretical and clinical medicine in Ukraine.

Interaction experience of medical rescue units with rescuers of the Republic of Poland and its implementation in Ukraine

Aim of research is to study the positive experience of the medical rescue units disaster medicine in cooperation with fire and rescue units in Poland and analyzing historical aspects of disaster medicine in Ukraine and the organization of interaction of the State Service of Ukraine for Civil Protection. A detailed analysis of the experience of medical rescue by disaster medicine units in cooperation with fire and rescue units in the Republic of Poland and the historical aspect of the creation of disaster medicine in Ukraine and the organization of its interaction by the State Civil Defense Service of Ukraine. Factors of positive and negative influence on results of activity are defined. Ukraine has borrowed the Polish experience of cooperation between disaster medicine units and fire rescue units, using exactly those provisions that will be most acceptable to it. Implementing of best practices contributes to the development of human potential, quality of public and social services, consolidation of society, solution of social problems. The key to the successful completion of the tasks of disaster medicine units and fire and rescue units for medical rescue is, in particular, adequate resources, improvement of practical skills and interaction in the process of providing first aid. The best practices of providing qualified medical care to victims of emergencies in each country are unique and reflect the specifics of its operation, so the implementation of the experience is appropriate to take into account the specifics of the development of a particular country. Keywords: medical rescue, emergencies, victims, organization of interaction, implementation of experience.

Клинические основы синдрома гипертонического криза на уровне первичного звена

Гипертонический криз представляет собой частое явление на уровне первичной медико-санитарной помощи. Одной из основных задач в диагностике и лечении гипертонического криза в экстренной медицине является дифференциация между гипертензивной ургентностью (неосложненным гипертоническим кризом) и неотложностью (осложненным гипертоническим кризом), основанная на наличии повреждения органа-мишени во втором случае. Адекватная стратификация, профилактика и регрессия повреждения, вызванного гипертоническим кризом, могут предотвратить появление новых долгосрочных событий. Состояния гипертензивной ургентности (неосложненного гипертонического криза) обычно не связаны с непосредственным риском для жизни, поэтому лечение может быть начато и даже завершено в амбулаторных условиях. Состояния гипертензивной неотложности (осложненного гипертонического криза) — это очень серьезные клинические ситуации, которые требуют госпитализации. При наличии тяжелой гипертонии у пациента, бессимптомной или с неспецифическими симптомами, следует предпринять осторожный терапевтический подход. При лечении состояний гипертензивной ургентности усилия медиков направлены как на снижение показателей артериального давления (как минимум 20 % от базовых показателей), так и на избегание внезапного и/или чрезмерного его снижения (необходимо сохранять зону пенумбры). Следовательно, быстродействующие препараты не следует использовать из-за риска возникновения ишемических событий. При состояниях гипертензивной неотложности выбор препарата должен быть индивидуальным, причем парентеральный путь его введения является наиболее распространенной формой. При отсутствии симптомов повреждения органов-мишеней большинство пациентов, вероятно, могут лечиться в амбулаторных условиях. Соблюдение четкой преемственности диагностико-терапевтических мероприятий на догоспитальном этапе и в стационаре является необходимым условием для реальной стабилизации данного состояния. Экстренные состояния, связанные с гипертоническим кризом, в Украине являются основными причинами обращения и/или вызова врача экстренной медицины (≈ 25–26 %). Гипертонический криз, первичное проявление или осложнение ранее диагностированной артериальной гипертензии, чаще всего может иметь место в виде резкого повышения артериального давления ≥ 180/120 мм рт.ст. (хотя клиника гипертонического криза иногда наблюдается и при меньших цифрах). Методы поиска литературы: база данных Scopus, Web of Science, MedLine, CyberLeninka, РИНЦ.

Analysis of the effectiveness of regulatory legal acts on counterfeiting of medicines in Ukraine

The problem of medicines counterfeiting is relevant for all countries of the world, without exception. At the same time, the effectiveness of combating the spread of counterfeit medicines (CM) in different countries, as well as the volume of counterfeited medical products, varies. Any state that aimed to ensure highly effective control over the circulation of medicines has to elaborate a comprehensive solution to this problem, primarily to adopt high-quality national legislation. The executive authorities should not only pay attention to neutralizing CM problem, but also take the most active part in this process. The primary role here should be played by law enforcement authorities. There is a need for coordinated work by law enforcement authorities to investigate the cases of falsified medicines and clandestine production, as well as by regulatory bodies to identify such products. It is also necessary to systematize the investigative and judicial practice on this issue, create an unified system for recording the facts of identifying the counterfeit drugs. The need for systematic monitoring and analysis of regulatory legal acts regarding the counteraction to the circulation of the CM in order to assess their effectiveness, as well as the adoption of appropriate measures by the authorized bodies, determine the relevance of the study.
 The aim of the work was to analyze the laws and regulations of CM adopted in Ukraine after the Declaration of Independence had been signed (1991), to assess their effectiveness in terms of bringing perpetrators to justice for pharmaceutical counterfeiting.
 Materials and methods. Scientific publications on the problem of CM, as well as the Laws of Ukraine and legal acts adopted by various authorities to combat the spread of falsified medicines, reports of law enforcement agencies, the General Prosecutor’s Office, the State Judicial Administration, court decisions included in the Unified State Register of Court Decisions (USRCD) under Article 321-1 of the Criminal Code of Ukraine. The analysis of the respective norms of the legislation adopted during 1991–2020 is carried out.
 Results. Having analyzed the reports of law enforcement agencies, the State Statistical Office, and the Prosecutor General’s Office, the authors established that none of the people who had been convicted under Article 321-1 of the Criminal Code of Ukraine, after the entry of the guilty verdict into force, was in places of deprivation of liberty. There are many information sources that provide various forms of statistics, but understanding them is quite a challenge. A large number of criminal proceedings have been investigated for a long time, and since the USRCD is inaccessible, and is available only for the pre-trial investigation bodies and the prosecutor’s office, it is impossible for a private person to get information regarding the end of the pre-trial investigation in certain cases.
 Conclusions. Despite the large quantity of regulatory legal acts adopted in Ukraine to prevent the spread of counterfeit medicines, the severity of the sanctions of Article 321-1 of the Criminal Code, which criminalizes the falsification and circulation of medicines, as well as the importance of medicines’ counterfeiting for public health, the effectiveness of measures to combat this phenomenon is dramatically low.