MONITORING OF SOFT DRUGS WITH CORTICOSTEROIDS FOR USE IN PEDIATRIC PRACTICE

Abstract

Introduction. During the last decade in all countries increase the number of people with allergic diseases. Three leaders among of allergic genesis forms allergic rhinitis, asthma and atopic dermatitis.

Atopic dermatitis is a genetically caused chronic allergic inflammation of the skin which has a typical clinical picture, accompanied by itching and immediate respiratory manifestations of allergy, allergic rhinoconjunctivitis and atopic asthma. The problem of this disease has extremely socially value, according to official statistics; about 20% of Ukrainians suffer from this disease. For the last ten years, there has been a gradual increase of the incidence and spreading of atopic dermatitis among children up to 14 years. For the first time, atopic dermatitis appears in the age of five ‒ 85% of cases, up to one year ‒ 60% and up to six months ‒ in 45% of cases. According to official data and Allergic Children's pulmonary service of the Department of Health Care in 2015 year the prevalence of atopic dermatitis were 32.26 per 10,000 children in Kyiv. According to this statistics the total number of children are 1876, including first discovered cases ‒ 676 and children under 14 years ‒ 1473 (figure at 10,000 ‒ 29.7).

According to treatment protocol, steroids are used as monotherapy or in combination with antiseptics, antibiotics and antimicrobial agents at different stages of atopic dermatitis. They exhibit anti-inflammatory, anti-allergic and immunosuppressive action and affect the body's metabolism.

Today the pharmaceutical market ofUkrainehas a large number of available drugs for the treatment of skin diseases. Therefore, analysis of drugs of D07 “Corticosteroids for the application in dermatology” by dosage forms, active pharmaceutical ingredients, manufacturers of and indications are highly important for usage in pediatric practice.

Investigation methods.  Materials for the study served as a public electronic and paper sources of the information as to drug registration inUkraine, instructions for medical usage of drugs, for basic methods were used: systematic reviews, marketing, statistical and graphical analysis methods.

Results and discussion. As of 1 February 2016 assortment of drugs D07 «Corticosteroids for the application in dermatology" according to the State Register of medicines in Ukraine are 108 trade names, of which 37% ‒ Ukrainian and 63% ‒ foreign production.

Imported dermatological drugs supply to Ukrainian market from different countries such as Germany (23.5%), Switzerland (17.6%), Croatia (16.2%), India (10.3%), the Netherlands (8.8 %), Russia (7.4%), the United Kingdom and Jordan (5.9%), Poland (2.9%) and Hungary (1.5%).

The range of Ukrainian drugs agents are represented by eleven of the applicant: OOO "VALEANT Pharmaceuticals" (13 products), LLC "Pharmaceutical company" Health "(7), Pharmaceutical Company PJSC" Darnitsa "(5), JSC" Kievmedpreparat "(4),  PJSC "Farmak" (3),  PJSC "Fitofarm" and Joint Ukrainian-Spanish company "Sperco Ukraine" (2), JSC "Himfarmzavod" Red star ", JSC SPC" Borschagovsky CPP ", LLC" DCT "Pharmaceutical factory" and LLC "FL" Biopharma" (1 drug).

The group D07 includes drugs in a variety of dosage forms: ointments, creams, emulsions, skin solutions, sprays, aerosols, lotions, ointments and gels fat.

During segmentation topical corticosteroids for the dosage form has been found that ointments occupy 46.3% and 38.9% creams and form the bulk of the range. Other formulations up 2.8%, gel 0.9% drugs.

Among active pharmaceutical ingredients clobetasol (15 products), mometasone (14) and hydrocortisone (13) occupy a leading positions. Particular attention should be paid to betamethasone, which is part of the 34 drugs, 21 of them ‒ in combination with other substances and 13 ‒ mono-drugs.  Among the APIs that are represented inUkraine, drugs domestic production, recorded only one ‒ flumetazon and drugs for four API: aklometazonom, fluticasone, beclomethasone and prednicarbate have not analogues in Ukrainian production. Therefore, it is very important expansion of domestic production of drugs with these pharmaceutical ingredients.

As the first signs of atopic dermatitis occur even in early childhood, it is important to segment drugs with corticosteroids by age restrictions. In pediatrics can be used 81 drugs which are registered inUkraine, which is 3/4 of the total assets of the group that used under close medical supervision (due to the structural features of the child's skin and side effects of corticosteroids). Other drugs are not used because of their contraindications for children, without adequate study drugs or lack of data on studies in pediatric patients. Pharmaceutical market ofUkrainedoesn’t have domestic production of medicines for children 1, 3, 6 months and 3 years.

Conclusions. A monitoring group D07 «Corticosteroids for the application in dermatology" was studied for the country of manufacture, dosage forms, active pharmaceutical ingredients and the usage in pediatric patients. It was established that most of the study group in Ukraine is occupied by imported drugs, including the leading countries such as: Germany (23.5%), Switzerland (17.6%) and Croatia (16.2%). Among Ukrainian manufacturers a dominant position is occupied by company LLC "Valeant Pharmaceuticals" (32.5% drugs).

During segmentation of  topical corticosteroids for the dosage form has been found that the ointments and creams form takes the bulk of the range (85.2%). Among AFI occupies a significant share of betamethasone (31.5%) in both mono and combination of drugs. Equally common are drugs containing hydrocortisone (12%), mometasone (13%) and clobetasol (13.9%).

It is relevant to increase the range of dermatological drugs wit corticosteroids in domestic production.