ANALYSIS OF THE STATE OF THE SUPPLY OF UKRAINIAN POPULATION WITH CHONDROPROTECTIVE MEDICATIONS

Conduct systematic analysis of the state of the supply of Ukraine with medications with chondroprotective activity. The Unified Clinical Protocol of Primary, Secondary (specialized) Medical Care allows doctors to control the state of a patient at every stage of illness and guarantees the effective treatment and prophylaxis of the locomotor system (LMS) pathologies. As a result of the chondroprotective medication range analysis it was determined that the pharmaceutical market of Ukraine is represented by 40 trade names of medications. The top market share of chondroprotective medications in Ukrainian market belongs to the foreign producers (52.5%), while domestic medications occupy 47.5%. In general the nomenclature of Ukrainian medications is provided by 6 manufacturing companies. Three pharmaceutical companies are the leaders producing 5 names of medications each (12.5% each): Pharmaceutical company “Zdorovye” (Kharkiv), PrJSC “Fitofarm” (Bakhmut, formerly Artemivsk, Donetsk region), JSC “Farmak” (Kyiv). Out of 40 trade names the medications are mainly produced: as coated tablets – 12 medications (30%), as solutions for injections – 11 items (27.5%), as capsules – 7 (17.5%), as soft dosage forms – 6 medicines (15%), and powders for oral administration – 4 items (10%) [1]. KEYWORDS

Health Problems of the 10th revision, among all the LMS disorders osteoarthrosis (OA, M15-M19 by ICD-10) is one of the most widely spread degenerative-dystrophic disorders, which comprises the most complicated socio-economic and medical problem. According to the WHO about 4% of the population of the Earth suffers from OA, which in 10% of cases is the actual cause of disabilities. The attack rate of adult population of working age since 2008 has been increasing by an average of 4.3% yearlyfrom 80.8 to 91.2%; in the population over working age the growth by 1.9% has been indicatedfrom 157.6 to 166.8% [2,3].
According to the ICD-10 the terms "osteoarthrosis", "arthrosis", "osteoarthritis" are synonyms and only differ by the local classifications depending on the country where applied. The term "osteoarthrosis" is mainly used in Ukraine, while "osteoarthritis" is more common for Europe and the USA. OA ranks first among the disorders of rheumatic profile (60-80%) and has a tendency of incidence growth among the youth. According to the WHO, OA of knee joints is among five main reasons of the incapacity to work in women, and among tenin men. OA is one of the main reasons of early incapacitation and disabilities, being second in this regard only to the ischemic heart disease (IHD) [4,5].
In the USA 39 million of arthritis patients see a doctor yearly, with over 500 thousand of them being hospitalized. Further, the costs associated with medical care comprise 15 billion dollars, while the total economic losses -65 billion dollars. Prognostic statistical data show that by 2020 the incidence of arthritis might comprise about 60 million people, i.e. almost 20% of the population, 11 million of which might become disabled, unless the situation is intervened into [6,7].
According to the official statistics of diseases registered in the health care organizations within the last several years, the statistical insights and social importance of musculoskeletal system (MSS) and connective tissue disorders in Ukraine looks as follows.
As for official statistics, 26.614,512 cases were registered in 2017 for the first time, 4.65% of which comprised the MSS and connective tissue disorders, i.e. 2878 cases per 100,000 population.
OA is the most widely spread MSS disorder in Ukraine. According to the official statistical data the OA incidence in Ukraine comprises 2200,6 cases per 100,000 population. The OA incidence in population (6.43%) increases with age and reaches maximum values (13.9%) in individuals over 45 years of age. The occurrence among men and women of working and retirement age also varies. In men it is 32% less (423.1), than in women (558.8). In people of working age it is 2.7 times less (338.9) than in retired individuals (931.1) [8,9].
According to the National Institute for Strategic Studies of the Ministry of Health of Ukraine the share of bone fractures among all traumatic injuries comprised 86.4% in 2016, which was equal to 3,500 patients per 100,000 population. The number of patients that were losing the working capacity reached 1,58 million people (or 3.6% of all the population of Ukraine). The greater part of fractures was provoked by MSS disorders. The carried out analysis of fractures in adults between 18 and 75 years of age (among which the most numerous group (40%) comprised the patients between 40 and 59 years) showed that in the vast majority of cases (51.31%) the injuries were home accidents, the second in frequency were injuries sustained in the street (29.98%), while 10.18% patients sustained injuries as a result of road accidents. The most common fracture localizations were in various segments of upper and lower extremities (41.1 and 54.0 % respectively), while concomitant injuries were registered in 15.9% of cases. The most frequent fractures of upper extremities were humerus fractures (23.1%); in addition, concerning the fractures of specified localizations, the highest frequency was characteristic of patients older than 60, which might be due to the decrease of strength characteristics of bone tissue in patients of the indicated age group [10,11].
According to the research carried out by the National Institute for Health and Care Excellence (NICE), 2,5 million of women and 900,000 of men among the population in Ukraine are affected by osteoporosis (OP). 50% of the patients become disabled as a result of the disease, and 20%die. Fractures comprise one of the most serious OP complications. The bone mass loss depends on the gender: in womenwith the speed of 0.75-2.4% per year, and in men -0.4-1.2%. In addition, the process starts in women at the age of 35 years, while in menafter 50 years. The OP incidence among women after menopausal period comprises 14% at the age of 50-59 years, 22%at 60-69 years of age, 39%between 70 and 79 years of age, and 70%at the age of 80 and over. Thus, about 80% of OP patients are women, and in people over 50 years of age, in one case of two women and in one of eight men, there is a high probability of fracture occurrence [12].
Given the expected increase in life expectancy within the next coming years the increase in the number of osteoporotic fracture incidence will be observed. Thus, by 2035 the number of proximal femoral fractures is expected to grow by 36% in men and by 43% in women [13].
Purpose of the research is to determine the level of the supply of the population of Ukraine with chondroprotective medicines based on the data from marketing and pharmacoeconomic analysis.
Material and methods. The current research was carried out using the system approach. The MSS incidence was analyzed based on the official statistical data. The data from the State Register of Medications, information resources and official websites of pharmaceutical companies were used for the marketing analysis. The marketing data on market prices for medications were used for the price indices analysis. The indices of price variations, liquidity and solvency adequacy were calculated to assess the accessibility of chondroprotective medications.
Research results. The complex therapy of locomotor system disorders never goes without medications with chondroprotective activity. Today the range of medications with chondroprotective activity of domestic and foreign production is fairly broadly represented in the pharmaceutical market of Ukraine [14,15].
Medications used for the LMS disorders treatment must comply with the guidelines of the Unified Clinical Protocol, which is created in accordance with the Methods for the development and implementation of medical standards (unified clinical protocols) of medical aid on the evidence-based medicine principles, approved by the Order of the Ministry of Health of Ukraine of 28.09.2012 № 751 "On the creation and implementation of medical and technological documents on the medical aid standardization in the system of the Ministry of Health of Ukraine". Such organizations as NICE and SIGN (Scottish Intercollegiate Guidelines Network), as well as the National Osteoporosis Guideline Group (NOGG), being based on the evidence-based medicine principles, have determined the optimal ways of the LMS pharmacotherapy management [16].
Depending on the rate of response the medications used in the LMS disorders treatment are classified into the fast-acting and slow-acting ones. SYSADOA (Symptomatic Slow Acting Drugs for OsteoArthritis), such as glucosamine, chondroitin sulfate, diacerein, hyaluronic acid, show symptomatic effect and low toxicity (Table 1) [17,18]. • Glucosaminoglycan-peptide complex; • Extract of marine organisms Development of slow acting anti-inflammatory and structurally modifying agentschondroprotectorsis the doubtless achievement of modern pharmacotherapy [19,20].
The prescription of combined medications is preferred in clinical practice, which, on the one hand, allows achieving the additive effect in treatment, and increasing the treatment compliance, on the other hand. On prescription of combination medications the glucosaminoglycan synthesis by chondrocytes in increased by 96.6% compared to 32% in case of monotherapy. Application of combination medications treatment (glucosamine + chondroitin) objectively increases the number and sizes of chondrocytes per unit area of joint cartilage [21,22].
We have carried out analysis of average retail prices of chondroprotective medications, which are registered in Ukraine and are represented in pharmacy institutions. The research on the pricing policy of chondroprotective medications in Kharkiv pharmacies was conducted during the period of 01.06 to 01.07 2019.
The range of medications with chondroprotective activity in pharmacy chains of Kharkiv city are represented by 40 trade names (Tables 2, 3).  The results of the analysis have shown that the top market share of chondroprotective medications in Ukrainian market belongs to the foreign drugs (52.5%), while domestic medications occupy 47.5%. In general, the nomenclature of Ukrainian medications is provided by 6 companies. The leaders of domestic production are 3 pharmaceutical companies, producing 5 names of medications each (12.5% each): Pharmaceutical company "Zdorovye" (Kharkiv), PrJSC "Fitofarm" (Bakhmut, formerly Artemivsk, Donetsk region), JSC "Farmak" (Kyiv). Among the foreign producers the greatest shares belong to: Germany and Austria -10% each, and the USA -7.5%. France, India, Switzerland and Romania occupy 5% each respectively.

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We have carried out the analysis of the prices of chondroprotective medications liquidity by calculating the liquidity coefficient Сliq: where Pmaxmaximal price; Pminminimal price. The solvency adequacy coefficient was calculated: Analysis of the range of medications with chondroprotective activity has shown that the largest share is represented by combination chondroprotective medications, containing the combination of chondroitin sulfate with glucosamine, which occupy 35% (14 trade names) of the market. Medications that contain active ingredients from the group of NSAIDs comprise 10% (4 trade names), and other medications -10%. Monotherapy medications with Chondroitin sulfate as an active ingredient comprise 27,5% (11 trade names), while monotherapy medications with Glucosamine as an active ingredient -17,5% (7 trade names). Conclusions.
1. The LMS disorders comprise one of the main reasons for the incapacity to work and physical disability of population. These disorders cause the impairment of quality of life and carry significant financial treatment expenses.
2. The Unified Clinical Protocol of primary, secondary (specialized) care allows doctors to control the state of a patient at any stage of illness and guarantees the effective treatment and prophylaxis of LMS disorders. At the same time, the long-term treatment with chondroprotective medications according to the doctor's indications might show the desired effect and allow improving the patient's quality of life.
3. Analysis of the range of chondroprotective medications has shown that the majority of drugs are represented by coated tablets (30%) and solutions for injections (27.5%). In addition, the majority of medications (52.5%) are of foreign production. analysis of the range of medications with chondroprotective activity that the greatest share is represented by combination medications that contain the combination of chondroitin sulfate with glucosamine -35%. Monotherapy medications from the group М01АХ25 Chondroitin sulfate comprise 27.5%, and from the group M01AX05 Glucosamine -17.5%