Research оn healthcare oxygen measures during the COVID-19 pandemic: latest trends and current priorities

Medical oxygen is a critically needed medicine in the treatment of coronavirus disease. During out breaks of the COVID-19 pandemic, the needs of health care institutions for medical oxygen increase by 5-6 times. The issue of the reliable functioning of the oxygen supply system of health care institutions during the COVID-19 pandemic is extremely urgent and requires systematic research. The purpose of the work was to conduct research on measures to provide oxygen to health care facilities during the COVID-19 pandemic, to establish risk factors in its production and supply, and to determine priority directions for guaranteeing the ability to provide medical assistance in the treatment of coronavirus disease. The methods of systematic approach, bibliographic, information search, marketing analysis, as well as generalization and analysis were used during the research. The study showed that medical use of oxygen as a medicine, oxygen produced by medical devices, and technical oxygen was allowed at the state level. Domestic manufacturers produce medical oxygen that meets all regulatory requirements for medicinal products. In Ukraine, 36 drugs based on medical oxygen are registered, the production of which is carried out by 26 enterprises that have licenses for the production of medicinal products. During the pandemic, it was allowed for medical use of technical oxygen, which should meet the quality indicators of medical oxygen. The use of oxygen, which is produced by medical devices, which include oxygen generators and oxygen concentrators, which must meet the requirements of the Technical Regulations, became a significant measure for the expansion of oxygen therapy. During the implementation of all measures to provide oxygen, there are risks of a national and branch nature, as well as specific risks associated with the characteristics of different types of oxygen (oxygen as a medicine, oxygen produced by medical devices, technical oxygen). The identified list of risks and their analysis in the provision of oxygen to health care facilities during the COVID-19 pandemic will provide an opportunity to develop the concept of general risk assessment and risk management processes to guarantee the ability to provide adequate medical care in the treatment of coronavirus diseas

Marketing research of the range of medicinal products based on salts of natural origin

As a source of supply of a balanced complex of salts in pharmaceutical practice, sea water (MW), sea salt (MS), obtained by the method of ordinary evaporation, or salt solutions made from standardized raw materials are used. Deep seawater (SW), typically pumped from depths greater than 200 m, contains a wealth of trace elements, including magnesium, calcium, potassium, chromium, selenium, zinc, and vanadium. Due to this, SW has the potential of a source and raw material for the creation of medicinal products for human health. The purpose of the work was to research the assortment of preparations based on salts of natural origin and analyze the segment of such products on the pharmaceutical market of Ukraine as of June 2022. The research was conducted on the basis of data from the State Register of Medicinal Products of Ukraine, the Morion information search program, and the classification system of the ATS electronic resource Compendium.online. Methods of structural, statistical and graphic analysis were applied in the work, and their generalization and systematization was carried out. It was established that on the pharmaceutical market of Ukraine, the segment of medicines, medical products and cosmetics, the source of active substances of which is SW and/or SS, is represented by 150 trade names. It was determined that by type of registration, the most common are medical products (51%) and cosmetics (42%), only 7% of registered drugs are registered. Manufacturers use sea water obtained from the deep water basins of the Adriatic, Aegean, Mediterranean Seas, Atlantic Ocean, Kankal Bay, sea water of Gullmarsfjorden. Domestically produced drugs of the investigated market segment occupy a share of 57%. Among the importing countries, the leaders are Croatia (9%) and Poland (5%). The analysis of the nomenclature established that the most common medicinal form of the drugs are nasal sprays (78%). The obtained data show that as the active substance of saline solutions, manufacturers declare SS (56% of the nomenclature) and SW (53%), however, not all products contain information about the source of origin of SS/SW. It was determined that there are no products on the pharmaceutical market of Ukraine based on the SW and SS of the Black and Azov seas, which is the basis for research and the creation of new drugs of domestic production

Validating the predictive ability of the 2MACE score for major adverse cardiovascular events in patients with atrial fibrillation: results from phase II/III of the GLORIA-AF registry

The 2MACE score was specifically developed as a risk-stratification tool in atrial fibrillation (AF) to predict cardiovascular outcomes. We evaluated the predictive ability of the 2MACE score in the GLORIA-AF registry. All eligible patients from phase II/III of the prospective global GLORIA-AF registry were included. Major adverse cardiac events (MACEs) were defined as the composite outcome of stroke, myocardial infarction and cardiovascular death. Cox proportional hazards were used to examine the relationship between the 2MACE score and study outcomes. Predictive capability of the 2MACE score was investigated using receiver-operating characteristic curves. A total of 25,696 patients were included (mean age 71 years, female 44.9%). Over 3 years, 1583 MACEs were recorded. Patients who had MACE were older, with more cardiovascular risk factors and were less likely to be managed using a rhythm-control strategy. The median 2MACE score in the MACE and non-MACE groups were 2 (IQR 1-3) and 1 (IQR 0-2), respectively (p < 0.001). The 2MACE score was positively associated with an increase in the risk of MACE, with a score of & GE; 2 providing the best combination of sensitivity (69.6%) and specificity (51.6%), HR 2.47 (95% CI, 2.21-2.77). The 2MACE score had modest predictive performance for MACE in patients with AF (AUC 0.655 (95% CI, 0.641-0.669)). Our analysis in this prospective global registry demonstrates that the 2MACE score can adequately predict the risk of MACE (defined as myocardial infarction, CV death and stroke) in patients with AF. Clinical trial registration:. Unique identifiers: NCT01468701, NCT01671007 and NCT0193737

Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry

Background and purpose: Prospectively collected data comparing the safety and effectiveness of individual non-vitamin K antagonists (NOACs) are lacking. Our objective was to directly compare the effectiveness and safety of NOACs in patients with newly diagnosed atrial fibrillation (AF). Methods: In GLORIA-AF, a large, prospective, global registry program, consecutive patients with newly diagnosed AF were followed for 3 years. The comparative analyses for (1) dabigatran vs rivaroxaban or apixaban and (2) rivaroxaban vs apixaban were performed on propensity score (PS)-matched patient sets. Proportional hazards regression was used to estimate hazard ratios (HRs) for outcomes of interest. Results: The GLORIA-AF Phase III registry enrolled 21,300 patients between January 2014 and December 2016. Of these, 3839 were prescribed dabigatran, 4015 rivaroxaban and 4505 apixaban, with median ages of 71.0, 71.0, and 73.0 years, respectively. In the PS-matched set, the adjusted HRs and 95% confidence intervals (CIs) for dabigatran vs rivaroxaban were, for stroke: 1.27 (0.79–2.03), major bleeding 0.59 (0.40–0.88), myocardial infarction 0.68 (0.40–1.16), and all-cause death 0.86 (0.67–1.10). For the comparison of dabigatran vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 1.16 (0.76–1.78), myocardial infarction 0.84 (0.48–1.46), major bleeding 0.98 (0.63–1.52) and all-cause death 1.01 (0.79–1.29). For the comparison of rivaroxaban vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 0.78 (0.52–1.19), myocardial infarction 0.96 (0.63–1.45), major bleeding 1.54 (1.14–2.08), and all-cause death 0.97 (0.80–1.19). Conclusions: Patients treated with dabigatran had a 41% lower risk of major bleeding compared with rivaroxaban, but similar risks of stroke, MI, and death. Relative to apixaban, patients treated with dabigatran had similar risks of stroke, major bleeding, MI, and death. Rivaroxaban relative to apixaban had increased risk for major bleeding, but similar risks for stroke, MI, and death. Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01468701, NCT01671007. Date of registration: September 2013

Anticoagulant selection in relation to the SAMe-TT2R2 score in patients with atrial fibrillation. the GLORIA-AF registry

Aim: The SAMe-TT2R2 score helps identify patients with atrial fibrillation (AF) likely to have poor anticoagulation control during anticoagulation with vitamin K antagonists (VKA) and those with scores >2 might be better managed with a target-specific oral anticoagulant (NOAC). We hypothesized that in clinical practice, VKAs may be prescribed less frequently to patients with AF and SAMe-TT2R2 scores >2 than to patients with lower scores. Methods and results: We analyzed the Phase III dataset of the Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF), a large, global, prospective global registry of patients with newly diagnosed AF and ≥1 stroke risk factor. We compared baseline clinical characteristics and antithrombotic prescriptions to determine the probability of the VKA prescription among anticoagulated patients with the baseline SAMe-TT2R2 score >2 and ≤ 2. Among 17,465 anticoagulated patients with AF, 4,828 (27.6%) patients were prescribed VKA and 12,637 (72.4%) patients an NOAC: 11,884 (68.0%) patients had SAMe-TT2R2 scores 0-2 and 5,581 (32.0%) patients had scores >2. The proportion of patients prescribed VKA was 28.0% among patients with SAMe-TT2R2 scores >2 and 27.5% in those with scores ≤2. Conclusions: The lack of a clear association between the SAMe-TT2R2 score and anticoagulant selection may be attributed to the relative efficacy and safety profiles between NOACs and VKAs as well as to the absence of trial evidence that an SAMe-TT2R2-guided strategy for the selection of the type of anticoagulation in NVAF patients has an impact on clinical outcomes of efficacy and safety. The latter hypothesis is currently being tested in a randomized controlled trial. Clinical trial registration: URL: https://www.clinicaltrials.gov//Unique identifier: NCT01937377, NCT01468701, and NCT01671007

The Changing Landscape for Stroke\ua0Prevention in AF: Findings From the GLORIA-AF Registry Phase 2

Background GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke. Phase 2 began when dabigatran, the first non\u2013vitamin K antagonist oral anticoagulant (NOAC), became available. Objectives This study sought to describe phase 2 baseline data and compare these with the pre-NOAC era collected during phase 1. Methods During phase 2, 15,641 consenting patients were enrolled (November 2011 to December 2014); 15,092 were eligible. This pre-specified cross-sectional analysis describes eligible patients\u2019 baseline characteristics. Atrial fibrillation disease characteristics, medical outcomes, and concomitant diseases and medications were collected. Data were analyzed using descriptive statistics. Results Of the total patients, 45.5% were female; median age was 71 (interquartile range: 64, 78) years. Patients were from Europe (47.1%), North America (22.5%), Asia (20.3%), Latin America (6.0%), and the Middle East/Africa (4.0%). Most had high stroke risk (CHA2DS2-VASc [Congestive heart failure, Hypertension, Age  6575 years, Diabetes mellitus, previous Stroke, Vascular disease, Age 65 to 74 years, Sex category] score  652; 86.1%); 13.9% had moderate risk (CHA2DS2-VASc = 1). Overall, 79.9% received oral anticoagulants, of whom 47.6% received NOAC and 32.3% vitamin K antagonists (VKA); 12.1% received antiplatelet agents; 7.8% received no antithrombotic treatment. For comparison, the proportion of phase 1 patients (of N = 1,063 all eligible) prescribed VKA was 32.8%, acetylsalicylic acid 41.7%, and no therapy 20.2%. In Europe in phase 2, treatment with NOAC was more common than VKA (52.3% and 37.8%, respectively); 6.0% of patients received antiplatelet treatment; and 3.8% received no antithrombotic treatment. In North America, 52.1%, 26.2%, and 14.0% of patients received NOAC, VKA, and antiplatelet drugs, respectively; 7.5% received no antithrombotic treatment. NOAC use was less common in Asia (27.7%), where 27.5% of patients received VKA, 25.0% antiplatelet drugs, and 19.8% no antithrombotic treatment. Conclusions The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in Asia and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701

ФІНАНСОВІ ВАЖЕЛІ ТА НАСЛІДКИ ІМПЛЕМЕНТАЦІЇ СВІТОВОГО ДОСВІДУ БІЗНЕС-ДІЯЛЬНОСТІ У ВІТЧИЗНЯНИЙ ТУРИСТИЧНИЙ РИНОК

The article describes the main indicators of the tourist services market in Ukraine and the world, comparing the dynamics of costs and revenues from international tourism; the model of structural restructuring of the tourist services market of Ukraine in the conditions of globalization of the economy is proposed, and the necessity of institutionalization of business activity in the field of international tourism is substantiated, in particular, different variants of strategic alliances that are alternative to Ukrainian tourism business activity are considered. It is proved that at the moment the tourism sector has become indispensable in the lives of a large part of the world’s population, as tourist flows have increased more than 50 times in recent years. In addition, at the beginning of the XXI century the sphere of rest for the volume of income took the third place among the leading sectors of the global economy. According to the World Travel & Tourism Council the share of the tourism industry in 2018 is approximately 10 % of global GDP (according to the forecasts the proportion will reach 11% to 2026), 6.0 % of the world export, that is 0.1% more than in 2017 and in accordance 0.6 % more than in 2016. It is determined that financial resources from tourist flows serve as an important tool for capacity building and economic growth of the world’s leading countries. World experience has substantiated that the creation of a tourism product with high added value is the key to growth of business activity in the tourism business segment, tourism market development, involvement of related industries (financial services, insurance, transport, communications) in the implementation of tourism services.The SWOT analysis shows that Ukraine has a strong potential for the most types of tourist and recreational activities, the use of which is significantly limited by a number of restrictions, to overcome which it should be chosen a clear strategy that would take full account of the use of the strengths of the phenomenon under study. Since the strategic priority of Ukraine’s integration into the world economic space and the reform of the domestic economy is a reorientation to efficiently functioning forms of management, we consider it advisable to start strengthening domestic competitive position in the field of international tourism just on the side of the implementation of world experience in business activities in this area.Охарактеризовано основні показники ринку туристичних послуг в Україні та світі, проведено порівняльну динаміку витрат і доходів від міжнародного туризму; запропоновано модель структурної перебудови ринку туристичних послуг України за умов глобалізаційного розвитку економіки, а також обґрунтовано необхідність інституціоналізації бізнес-діяльності у сфері міжнародного туризму, зокрема розглянуто різні варіанти стратегічних альянсів, які є альтернативними для української туристичної бізнес-діяльності. Доведено, що на даний момент туристичний сектор став незамінним у житті значної частини жителів світу, оскільки туристичні потоки за останні роки зросли більш ніж у 50 разів. Крім того, на початку XXI століття сфера відпочинку за обсягом доходу посіла третє місце серед провідних галузей світової економіки. За даними Всесвітньої ради з питань подорожей і туризму, частка туристичної галузі 2018 року становить приблизно 10 % від світового ВВП (за прогнозами, частка досягне 11 % до 2026-го); 6,0 % світового експорту, що на 0,1 % більше ніж 2017-го і відповідно на 0,6 % більше, ніж 2016 року. Визначено, що фінансові ресурси від туристичних потоків слугують важливим інструментом для нарощення реалізації потенціалу та економічного зростання провідних країн світу. Світовий досвід обґрунтував, що створення туристичного продукту з високою доданою вартістю є запорукою зростання бізнес-активності в сегменті туристичного бізнесу, розвитку туристичного ринку, залученню суміжних галузей (фінансові послуги, страхування, транспорт, зв’язок) до реалізації туристичних послуг. Проведений SWOT-аналіз засвідчує, що Україна має потужний потенціал для здійснення більшості видів туристично-рекреаційної діяльності, використання якого суттєво лімітується низкою обмежень, для подолання яких слід обрати чітку стратегію, яка б найбільш повно враховувала використання сильних сторін досліджуваного явища. Оскільки стратегічним пріоритетом інтеграції України у світовий економічний простір і реформування вітчизняного господарства є переорієнтація на ефективно функціонуючі форми господарювання, вважаємо за доцільне розпочати посилювати вітчизняні конкурентні позиції у сфері міжнародного туризму саме щодо імплементації світового досвіду бізнес-діяльності в цю сферу

Development of Micellar System for the Decontamination of Organophosphorus Compounds to Clean Technological Equipment

An analysis of composition of commercially available cleaning products, used in pharmaceutical enterprises today, was carried out, based on which it was found that they do not guarantee effective cleaning of equipment from organophosphorus compounds. It was concluded that the development of new composition of the cleaning agent, which effectively decontaminates organophosphorus compounds from surfaces of the equipment, is a pressing issue for ecologically safe manufacture of products containing substances of organophosphorus nature.A new system of micellar inactivation of active pharmaceutical ingredients of organophosphorus nature was developed. We conducted a study into the destruction of methylparathion by using the micellar system, which includes water, cetylpyridine chloride, hydrogen peroxide and boric acid. A concentration of cetylpyridine chloride, at which the largest constant of first-order reaction rate occurred, was established. It is shown that adding the activator, boric acid, increases the reaction rate by 2.5 times.Based on these studies, the composition of a model cleaning agent for cleaning technological equipment was proposed. An assessment of internal risks for quality of production stations when producing medicinal agent based on organophosphorus compounds in the form of eye drops was carried out. Production station was given the highest rating of internal risk – 3.We carried out an analysis of risks for cleaning reactor for preparing solutions RVD-630 in case of using the micellar system developed to decontaminate from residues of active pharmaceutical ingredients of organophosphorus nature.The obtained results might be used for devising the concept of validation of cleaning the reactor in the preparation of solutions. This is an important step in providing cleanliness of technological equipment under conditions of producing medicines based on organophosphorus compounds as active pharmaceutical ingredients at operating pharmaceutical enterprises