УДК: 616.831-005.1:614.271-036-085].001.57

Левицька Оксана Романівна. Клініко-фармацевтичне обґрунтування концептуальної моделі медикаментозного забезпечення хворих з гострими порушеннями мозкового кровообігу : дис. ... д-ра фарм. наук. : [спец.] 15.00.01, 22 / О. Р. Левицька. - Львів, 2021. - 399 с. - Бібліогр.: с. 335-399 (562 назви).

Досліджено клініко-епідеміологічні особливості та споживання лікарських засобів (ЛЗ) при гострих порушеннях мозкового кровообігу (ГПМК); ринок антиагрегантів і статинів; асортимент та відшкодування цін клопідогрелю і
симвастатину в рамках урядової програми «Доступні ліки»; економічну доступність ЛЗ для фармакотерапії ішемічного інсульту (İİ) та проведено їх експертну оцінку; фармакоекономічну оцінку подвійної антитромбоцитарної терапії при гострому малому İİ. Систематизовано дані доказової медицини стосовно тромболітичної, антитромбоцитарної та статинотерапії при İİ. Визначено конкурентоспроможність тенектеплази стосовно альтеплази. Проведено кількісну оцінку клінічних індикаторів якості медичної допомоги при İİ, пов`язаних з використанням ЛЗ та оцінку якості життя осіб, які перенесли ГПМК. Створено модель оптимізації медикаментозного забезпечення та модель управління якістю медичної допомоги хворим з ГПМК в частинвармакотерапії.

     Вступ. У структурі вітчизняного фармацевтичного ринку упродовж останніх років спостерігається незначне збільшення кількості фармацевтичних, у т.ч. аптечних закладів, проте внаслідок жорсткої конкуренції між суб’єктами підприємництва збиткові АЗ змушені припиняти свою діяльність, поступаючись місцем потужним аптечним мережам. Вітчизняні дослідники проводили аналіз фізичної доступності фармацевтичної допомоги до і після адміністративно-територіальної реформи, а також перспектив розвитку цієї допомоги жителям нечисленних і віддалених населених пунктів на прикладі Одеської області, рівня концентрації аптечних закладів в Україні, організаційних особливостей фармацевтичного забезпечення населення Тернопільської області. На даний час в Україні сформовано новий адміністративно-територіальний устрій базового рівня, що загалом налічує 136 районів, які складаються з 1469 об’єднаних територіальних громад (ОТГ). Львівська область є доволі великою адміністративно-територіальною одиницею вищого рівня західного регіону України. Вона поділяється на 7 районів, до складу яких входить 73 ОТГ. Тому дослідження особливостей структури та локалізації фармацевтичних закладів у розрізі нового адміністративно територіального устрою районного рівня Львівщини є актуальним.
         Мета роботи. Встановити організаційні особливості фармацевтичного забезпечення населення Львівської області з урахуванням нового її адміністративно-територіального устрою.

       Introduction. There has been a slight increase in the number of pharmaceutical establishments (PEs) in the structure of the domestic pharmaceutical market in recent years, but due to fierce competition between businesses, unprofitable PEs are forced to cease their activities, giving way to powerful pharmacy networks. Given that Lviv region, which consists of 7 districts and 73 amalgamated territorial communities (ATG) is a fairly large administrative-territorial unit of the western region of Ukraine, the study of the structure and localization of pharmaceutical establishments is relevant. 

           The aim. To establish organizational peculiarities of pharmaceutical supply of the population of Lviv oblast taking into account its new administrative-territorial structure. 

            Material & methods. Research materials: License registers for the production of drugs (medicines) (in pharmacies), wholesale and retail trade of drugs, industrial production of drugs and the right to engage in economic activities in the circulation of drugs, psychotropic substances and precursors as of 01.11.2021, Order of the Cabinet of Ministers of Ukraine from 12.06.2020 № 718-r «About definition of administrative centers and approval of the territories of territorial communities of Lviv oblast», statistical data on the population of Lviv oblast. Methods of information search, system analysis, comparison and generalization have been used. 

            Results & discussion. It has been found out that there are 6 pharmaceutical manufacturers and 1345 PEs in the region, including 15 pharmacy warehouses, 1093 pharmacies and 237 pharmacy points. All pharmacy warehouses and 46,8 % of holders of licenses for retail trade of drugs operate in Lviv district, in particular 86,7 % of pharmacy warehouses and 35,2 % of pharmacies and pharmacy points operate in Lviv ATG. 37 pharmacies have a license to manufacture drugs, 67,6 % of them are also concentrated in Lviv district, and 56,8 % operate in Lviv. 21 pharmacies have a license to carry out economic activities on the circulation of narcotic drugs, psychotropic substances and precursors, providing 6 out of 7 districts and only 16,4 % of ATG. In the structure of PEs 42,0 % are private limited companies, 25,1 % - private enterprises, 24,6 % - individual entrepreneurs, 8,3 % - communal enterprises, 0,1 % - joint stock companies. 86,4 % of PEs operate in cities, the rest - in rural areas. On average, there are 1868 people per PE in the oblast. This indicator is the highest in Drohobych (1503), slightly lower - in Lviv and Stryi (1805 and 1829 respectively) districts. In Sambir, Zolochiv, Chervonohrad and Yavoriv districts one PE serves 2092, 2104, 2179 and 2225 people respectively. By clustering, the differentiation of administrative-territorial units of Lviv oblast by the provision of PEs to their residents has been carried out. 

            Conclusions. A number of peculiarities of the infrastructure of pharmaceutical organizations providing pharmaceutical supply to the residents of Lviv region, in particular: 6 or 5,0 % of 119 pharmaceutical manufacturers in Ukraine operate in the region with national average indicator of 5, and the number of PEs is 57,9 % higher than the national average indicator (852); all holders of licenses for wholesale trade of drugs (3,7 % of 406 such licensees in Ukraine) operate in one (Lviv) of the seven districts under the new administrative-territorial structure of the region; the share of production pharmacies, which are present in all districts, but only in slightly more than one-fifth of ATG, is 2,8 % of the number of pharmacies and pharmacy points, which is twice as high as the average in Ukraine; this indicator is the highest (28,6 %) in Chervonohrad, and the lowest (14,3 %) - in Zolochiv districts. Two thirds of production pharmacies are concentrated in Lviv district, and more than half of them operate in Lviv; economic activities on the circulation of narcotic drugs, psychotropic substances and precursors are carried out by 1,6 % of pharmacies in 6 out of 7 districts and only in 16,4 % of ATGs, which is 0,2 % less than the national average indicator; more than half of such pharmacies are concentrated in the Lviv district, and almost half - in the regional centers; pharmaceutical supply of the population of Lviv oblast is provided by business entities of various organizational and legal forms of management, the absolute minority (8,3 %) of which are communal enterprises. It has been found out that the provision of PEs to the population in the oblast is 1,7 % higher than the national average indicator (1900 people per PE), but in rural areas of the region only 13,6 % of pharmacies and pharmacy points are functioning, which is almost twice lower than the average in Ukraine (26,0). It has been shown that the cluster «High provision of PEs to the population» includes Drohobych district, «Medium provision of PEs to the population» includes three districts (Lviv, Stryi and Sambir), «Low provision of PEs to the population» also includes three districts (Zolochiv, Chervonograd and Yavoriv).

Introduction. Epilepsy is one of the most common neurological diseases in the world and requires appropriate medical treatment. The Global Burden of Epilepsy Report estimates that there are 13 million disability adjusted life years due to epilepsy each year. Epilepsy is an important medical, social and economic problem of modern society, the solution of which is often based on the use of antiepileptic drugs. According to the State Strategy for the implementation of the state policy of providing the population with medicines for the period until 2025, the cost of medicines is an important factor that ensures their financial availability for the population. This determined the relevance of this stage of the research.Material & methods. Materials: information about purchase prices (Pp) for antiepileptic drugs of wholesale pharmaceutical enterprises (WPE 1, WPE 2 and WPE 3), which at the time of the study were in the TOP-3 in terms of the volume of drug supplies to pharmacies.  Methods: information search, comparison, analysis, generalization, determination of the cost of defined daily dose (DDD). The study period was February 2023. Results & discussion. It was found that at the time of the research, the TOP-3 WPE offered 105 assortment items (AI) of 11 international non-proprietary names of antiepileptic drugs in their price lists, taking into account the dosage forms and doses. By studying the DDD Pp of antiepileptic drugs AI, it was established that the largest number of AI with the lowest DDD Pp was offered by WPE 1 – 34 AI (or 32.38% of the total number of analyzed drugs). At the same time, in 26 AI (24.76%) offered by WPE 2, the cost of DDD was lower than that of competitors. The most valuable were the offers of WPE 3. It was found that among the 36 AI of pregabalin, the lowest DDD Pp was inherent in 15 and 8 AI, offered by WPE 1 and WPE 2, respectively. The price range of AI pregabalin DDD ranged from UAH 18.60 ("Pregabalin-Darnytsia", capsules 300 mg No. 21, PJSC Pharmaceutical company Darnytsia (Ukraine), the lowest price offer of WPE 1) to UAH 58.28 ("Galara", capsules 75 mg No. 14, WORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. (Turkey), the highest price offer of WPE 3).  The calculated values of Cliq ranging from 0.002 to 0.17 and Iаv from 5.68% to 17.21% for AI of pregabalin indicate a high level of competition and relative economic availability of the analyzed antiepileptic drugs in the studied segment of the wholesale market. At the same time, using the matrix projection of the integrated Sliq / Iav analysis, 7 or 19.44% of pregabalin AI were determined, which were the most economically available in the TOP-3 offers of the WPE. Conclusion. A situational analysis of the economic availability of antiepileptic drugs was carried out on the example of assortment offers of the TOP-3 wholesale pharmaceutical enterprises of Ukraine.

Introduction. Epilepsy, as a chronic non-infectious disease of the brain, affects according to some data about 50 million, according to others - about 65 million people worldwide. Epilepsy can be treated with antiepileptic drugs (AEDs), diet therapy, and surgery. AEDs are drugs of various origin, which are used to prevent or reduce (in intensity and frequency) seizures, their corresponding equivalents (loss or disturbance of consciousness, behavioral and autonomic disorders, etc.), which are observed during periodically occurring attacks of various forms of epilepsy. The peculiarity of the treatment of epilepsy is the need for regular daily intake of AEDs for many years, including at least 3-5 years after the cessation of seizures. The number of patients forced to take AEDs during whole life reaches 15%. Material & methods. The sources of information were: domestic and foreign web resources, the State Register of Medicines of Ukraine (for searching of AEDs) (as of February 1, 2023), registers of drugs which are subjects to reimbursement under the medical guarantee program. The several methods were used in the research, such as: information search, comparison, analysis, generalization, marketing.  Results & discussion. The analytical study of AEDs showed that in Ukraine as of February 1, 2023, were registered 325 trade names (TN) of AEDs, which represented 16 international non-propriatory names (INN). About half (48.85%) of the researched assortment is made by pregabalin-based medicines. Almost one-eighth parts of the assortment (12.92% each) is taken by lamotrigine and levitiracetam TN. In total, drugs of these three INNs make up about 72% of the nomenclature of AEDs. The distribution of the studied assortment by dosage forms type showed that the absolute majority of AEDs was represented by capsules (51.08%) and tablets (45.23%).  It was established that three-quarters (75.38%) of the nomenclature of AEDs are drugs of foreign production. They are represented by 65 companies from 23 countries of the world. Among them, the vast majority (88.57%) are produced by one company, a tenth part (10.20 %) – by two-three manufacturers, and three TN of Pregabalin euro (1.22 %) – by 13 enterprises. As for domestic medicines, they are represented by 13 manufacturers, and 9 out of 10 (93.75%) of their products are made by one, and the rest by two companies. High production activity regarding AEDs is characteristic of enterprises from India (16.67% of manufacturers, Index of Production Activity (IPA) = 26.28%) and Ukraine (16.67% of manufacturers, IPA = 22.96%). Among foreign enterprises, the highest production activity has Dr. Reddy's Laboratories Limited, India (IPA = 6.63%), and among Ukrainian manufacturers - LLC "Pharma Start" (IPA = 3.83%). As a result of the data analysis of 5 Registers of medicines, the prices of which are subject to reimbursement under the program of state guarantee program of medical care of the population for 2021-2023, an increase in the number of AEDs INN from 3 to 4 was found. The analysis of the latest Register as of August 10, 2023 showed that it included 31 TN of these drugs (lamotrigine – 18, carbamazepine – 10, valproic acid – 2 and phenytoin – 1). At the same time, patients with epilepsy can receive 10 medicines free of charge, with a surcharge of up to 10% of the cost - 1 medicine, with a surcharge of 10-20% - 4 medicines, 21-30% - 10 medicines, 31-40% - 2 medicines and in within 41-50% - 4 medicines. Conclusion.  Separate components of the marketing complex regarding antiepileptic drugs registered in Ukraine and their role in the context of the program of state guarantee program of medical care of the population were studied.