Інформація призначена тільки для фахівців сфери охорони здоров'я, осіб,
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"Child`s Health" (62) 2015. Тематический выпуск "Детская гастроэнтерология"

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Study of problems of provision with medicines to the patients with celiac disease based on pharmaceutical law

Authors: Shapovalova V.A., Vasyna Yu.V., Shapovalov V.V. (Jr.), Shapovalov V.V. (prof.), Kovalyova K.I.
Kharkiv Medical Academy of Postgraduate Education, Ukraine

Categories: Pediatrics/Neonatology

Sections: Clinical researches

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Keywords

pharmaceutical law, celiac disease, medicines, extemporaneous formulation, control regime.

Introduction. In 2005. World Gastroenterology Organisation, it was noted that 1% of the world's population suffer from celiac disease and can not eat cereals such as wheat, rye, barley and oats, as well as foods that contain them. Celiac disease - is one of the most common genetic disease that affects the small intestine and leads to malabsorption of nutrients from food.
Based on the above, the purpose of our study was to investigate the problems of drugs celiac disease based on pharmaceutical law.
Materials and methods. Materials were scientific sources on the prevalence of celiac disease in the world, studied and summarized recipes of extemporaneous formulations, which used for the treatment of dermatological diseases. To achieve this goal used legal and documentary analysis.
The results of the study. Celiac disease (or gluten enteropathy) is a chronic autoimmune disease that affects the digestive tract of genetically predisposed individuals who have an intolerance to the basic protein cereals – gluten. The major symptoms of celiac disease – polymorphic disorders of the gastrointestinal tract, but in 65-85% of cases there extraintestinal manifestations which displace the aforementioned symptoms. These manifestations of dermatitis herpetiformis of the Duhring refers to the typical of cutaneous manifestations of celiac disease, as well as various types of eczema. Found that systemic treatment of cutaneous manifestations of celiac disease involves the use of drugs sulfone series - diafenilsulfon (dapsone, Avlosulfon, Dimotsifon, Diutsifon), but with little effect of the drug is used glucocorticoid medications for regular use (prednisolone, dexamethasone, triamcinolone). Carried out by the research showed that the number of sulfone drugs, namely diafenilsulfon, Ukraine does not have and none of the above drugs in the country is not registered. In Ukraine, you can buy only the drug dapsone, and only through a network of online pharmacies. After examining the range of medicines that are used in the treatment of cutaneous manifestations of celiac disease (namely, preparations for external use), the authors found that the pharmaceutical market in Ukraine is not enough finished drugs that could fully satisfy the need for them to solve the problem of individual patient intolerance of components. Therefore, the authors drew attention to the extemporaneous preparations (EP), which combine in a single dosage form different active pharmaceutical ingredients (APIs), taking into account the individual characteristics of each patient (age, sex, body weight, concomitant diseases, etc.). After considering the range of extemporaneous compounding the authors selected and offered effective and accessible (subject to the availability of the API) extemporaneous recipe, which includes sulfur (showing keratolytic and antiparasitic action); salicylic acid (antiseptic); resorcinol (antibacterial and antifungal agent); streptocid (antimicrobial agent); boric acid (preservative exhibiting fungistatic action); prednisolone (hormonal agent, has anti-allergic, and protivovospaltelnym desensitizing effect); zinc sulfate (antiseptic). In addition, the authors developed a manual for medical use and defined control regime of the extemporaneous formulation.
Conclusions. The authors studied the problem of drugs with celiac disease based on the pharmaceutical law. Offered an alternative EP, which can used in complex therapy of cutaneous manifestations of celiac disease, defined by its mode of control and designed instruction for medical use. Implementation of the proposed extemporaneous prescriptions in the practice of healthcare facilities will expand the range of drugs used for the treatment of cutaneous manifestations of celiac disease, improve the quality of health-pharmaceutical care, taking into account the individual characteristics of each patient, as well as provide the opportunity to organize the order of treatment with EP on the stage of prescription, manufacturing and the supply of pharmacies in accordance with the requirements of the medical and pharmaceutical legislation.

Bibliography

1. Avtor'ske pravo 58295, Ukrayina. Broshura. Orhanizatsiyno-pravovi osnovy prypynennya farmatsevtychnoyi diyal'nosti z obihu ekstemporal'nykh likars'kykh zasobiv: metod. rekom. / [Vasina Yu.V., Shapovalova V.O., Shapovalov V.V., Koval'ova K.I]. – Kharkiv, 2014. – S9
2. Vasina Yu. V. Farmatsevtychne pravo: istorychni aspekty rozpodilu likars'kykh zasobiv za nomenklaturno-pravovymy hrupamy na zasadakh farmatsevtychnoho zakonodavstva, sudovoyi farmatsiyi ta dokazovoyi farmatsiyi / Yu. V. Vasina // Ukrayins'kyy zhurnal klinichnoyi ta laboratornoyi medytsyny. – 2010. – T. 5, # 2. – S. 4–9.
3. Vasina Yu.V. Istorychni aspekty stanovlennya rezhymu kontrolyu za obihom bezretsepturnykh likars'kykh zasobiv. Pochatok rozvytku ekstemporal'noyi retseptury / Yu.V. Vasina // Farmatsevtychne pravo v bezpechnomu samolikuvanni. Likars'ki zasoby, yaki vidpuskayut'sya bez retsepta likarya. – Kh.: «Skorpion», 2010. – Hl. 1. – S. 7-10
4. Vasina Yu.V. Standartyzatsiya ta orhanizatsiya vyrobnytstva likars'kykh zasobiv: predmetno-kil'kisnyy oblik ekstemporal'nykh likars'kykh zasobiv riznykh klasyfikatsiyno-pravovykh hrup v zakladakh okhorony zdorov"ya / Yu.V.Vasina // Ukrayins'kyy visnyk psykhonevrolohiyi. – 2013. T.21, vyp. 2(75), dodatok. S. 18-21.
5. Vasina Yu.V. Sudova farmatsiya: pidvyshchennya rivnya derzhavnoho kontrolyu u vprovadzhenni ekstemporal'noyi retseptury dlya rozv"yazannya problemy protydiyi obihu fal'syfikovanykh likars'kykh zasobiv / Yu.V. Vasina, V.O. Omel'chenko // Farmatsevtychnyy zhurnal. – 2011. - #2. – S. 39-42.
6. Vse o tseliakii: vrachi dlya vrachey (post-reliz) [Elektronnyiy resurs] // Ukrainskiy meditsinskiy vestnik Therapia. – 2011. vyip. 12 (64). - Rezhim dostupa k dokumentu: http://s98088.cdn3.setup.ru/u/73/2201645ef411e28234f9c431933b38/-/%D0%92%D1%81%D0%B5%20%D0%BE%20%D1%86%D0%B5%D0%BB%D0%B8%D0%B0%D0%BA%D0%B8%D0%B8.pdf
7. Holovatyuk T.O. Tseliakiya. Informatsiya dlya bat'kiv [Elektronnyy resurs] / T.O. Holovatyuk // I.B.I.S. – 24.06.2003. – Rezhym dostupu do dokumentu: http://www.ibis-birthdefects.org/start/ukrainian/uceliak2.htm
8. Gubskaya E.Yu. Pravda i vyimyislyi o tseliakii [Elektronnyiy resurs] // Ukrainskiy meditsinskiy vestnik Therapia. – 2007. vyip. 2 (12). - Rezhim dostupa k dokumentu: http://therapia.ua/therapia/2007/02/pravda-i-vymysly-o-czeliakii
9. Gubskaya E.Yu. Sovremennaya klassifikatsiya i nomenklatura glyutenzavisimyih zabolevaniy [Elektronnyiy resurs] // Zdorov’ya UkraYini. – 2014. - Rezhim dostupa k dokumentu: http://i.gubskaya.in.ua/u/39/e793ba197811e4bc2d7900c55aa83f/-/Gubskaya_%D0%B7%D0%B4%D0%BE%D1%80%20%D1%83%D0%BA%D1%80_2014.pdf
10. Dermatit gerpetiformniy (Hvoroba DyurInga) [Elektronnyiy resurs] // Zdorove Ukrainyi. – 2013. - Rezhim dostupa k dokumentu: http://www.health-ua.org/archives/directories/194.html
11. Ob'em prodazh preparatov dlya lecheniya glyutenovoy bolezni (tseliakii) uvelichitsya bolee chem v 10 raz k 2023 g. [Elektronnyiy resurs] // Apteka.ua (online). – 16.01.2015. - Rezhim dostupa k dokumentu: http://www.apteka.ua/article/320242
12. Spravochnaya aptek [Elektronnyiy resurs] - Rezhim dostupa k dokumentu: http://www.spravka-apteka.com.ua 
13. Shapovalov V. V. Farmatsevtychne pravo Ukrayiny: rozpodil likars'kykh zasobiv za nomenklaturno-pravovymy hrupamy / V. V. Shapovalov, Yu. V. Vasina, V. O. Omel'chenko // Zbirnyk naukovykh prats' spivrobitnykiv NMAPO imeni P.L. Shupyka. – 2011. – Vyp. 20, kn. 3. – S. 419–423.
14. «Shire» priobretaet prava na preparat dlya lecheniya tseliakii [Elektronnyiy resurs] // Apteka.ua (online). – 07.01.2008. - Rezhim dostupa k dokumentu: http://www.apteka.ua/article/5981
15. Celiac disease. WGO - OMGE: Practice guidelines// World Gastroenterology News, Vol.10, Issue 2, 2005, Suppl.1-8- P.1-8
16. Joseph A Murray. The widening spectrum of celiac disease /American Journal of Clinical Nutrition, - 1999 - 69:3 - Р.354-365

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