Rome IV criteria of functional gastrointestinal diseases in evaluation of drugs interchangeability: through the eyes of a clinical pharmacologist

The article analyses the factors likely leading to the lack of interchangeability of generic drugs for patients with functional gastrointestinal disorders (FGID). It substantiates the need for improvement of the legal basis and regulatory framework underlying drugs circulation in the Russia. Based on the modern classification of FGIDs, laid down in the article, and according to Rome IV criteria the authors formulated major concerns related to the reliability of non-adaptive assessment parameters of generics interchangeability. The article looks into genetically determined differences in the functional activity of the stomach and bowel in healthy people and people with FGIDs that preclude extrapolation of already established interchangeability to the population of patients with FGIDs. The article also highlights potential interaction of drugs that are prescribed to patients with FGIDs either for the treatment of the underlying disease or co-morbidities. It was shown that Rome IV criteria can be used (to a limited extent) in therapeutic equivalence studies of generic drugs used either as primary or concomitant medications in patients with FGIDs.

функциональные расстройства, Римские критерии IV, взаимозаменяемость, воспроизведенные лекарственные средства, синдром раздраженной кишки, functional disorders, Rome IV criteria, interchangeability, generic drugs, irritable bowel syndrome

1. Federal Law of the Russian Federation of 12.04.2010, No. 61-FZ «On Circulation of Medicines». Available from: http://www.consultant.ru/document/cons_doc_LAW_99350 (in Russian).

2. Bukatina TM, Pasternak EYu, Romanov BK, Alyautdin RN, Lepakhin VK, Kazakov AS, et al. Information on the decisions of foreign regulatory authorities. Safety and Risk of Pharmacotherapy 2017; 5(1): 39–43 (in Russian).

3. Scientific substantiation, development and improvement of methodology for assessment of medicinal products interchangeability. Research report (intermediate). FSBI «SCEEMP» of the Ministry of Health of Russia; advisors: Romanov BK, Prokofiev AB, Yagudina RI; prepared by: Alyautdin RN, Zhuravleva MV. Moscow; 2015. 274 p. No. SR 115111740009. Deposited in CITIS on 16.02.2016, No. IKRBS 216021650027 (in Russian).

4. Moiseev SV. Cordarone or amiodarone in the treatment and prevention of arrhythmias? Clinical Pharmacology and Therapy 2010; 19(3): 18–22 (in Russian).

5. Nardi R, Masina M, Cioni G, Leandri P, Zucceri P. Generic—equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or of knowledge? Part 2. Misconceptions, doubts and critical aspects when using generic drugs in the real world. Italian Journal of Medicine 2014; 8(2): 88–98.

6. Reshetko OV, Lutsevich KA. Individual bioequivalence: concept, research and variability (a review). Pharmaceutical Chemistry Journal 2009; 43(8): 3–8 (in Russian).

7. Lewek P. Generic drugs: The benefits and risks of making the switch. J Fam Pract 2010; 59(11): 634–40.

8. EUDRAGIT®. Acrylic polymers for solid oral dosage forms. Available from: http://www.rofarma.com/allegati/97.pdf.

9. Sun H, Liu D, Li Y, Tang X, Cong Y. Preparation and in vitro/in vivo characterization of enteric-coated nanoparticles loaded with the antihypertensive peptide VLPVPR. Int J Nanomedicine 2014; 9(1): 1709–16.

10. Chourasia MK, Jain SK. Pharmaceutical approaches to colon targeted drug delivery systems. J Pharm Pharm Sci. 2003; 6(1): 33–66.

11. Drossman AD. Rome IV — Functional GI disorders: disorders of gut-brain interaction. Gastroenterology 2016; 150(6): 1257–61.

12. Van Oudenhove L, Levy RL, Crowell MD, Drossman DA, Halpert AD, Keefer L, et al. Biopsychosocial aspects of functional gastrointestinal disorders: how central and environmental processes contribute to the development and expression of functional gastrointestinal disorders. Gastroenterology 2016; 150(6): 1355–67.

13. Camilleri M, Bueno L, Andresen V, De Ponti F, Choi MG, Lembo A. Pharmacologic, pharmacokinetic, and pharmacogenomic aspects of functional gastrointestinal disorders. Gastroenterology 2016; 150(6): 1319–31.

14. Itopride. Registration certificate. Available from: https://goo.gl/QviFuK.

15. Chuchalin AG, Hohlov AL, eds. Federal guidance on the use of drugs (formulary system). Issue XVIII. Moscow: Vidoks; 2017 (in Russian).

16. Poynard T, Regimbeau C, Benhamou Y. Meta-analysis of smooth muscle relaxants in the treatment of irritable bowel syndrome. Aliment Pharmacol Ther. 2001; 15(3): 355–61.

17. Ruepert L, Quartero AO, de Wit NJ, van der Heijden GJ, Rubin G, Muris JW. Bulking agents, antispasmodics and antidepressants for the treatment of irritable bowel syndrome. Cochrane Database Syst Rev. 2011 Aug 10; (8): CD003460.

18. Serebrova SYu. Comparative clinical pharmacology of modern proton pump inhibitors. Dr. Med. Sci [dissertation]. Moscow; 2009 (in Russian).

19. Scientific substantiation, development and improvement of methodology for assessment of medicinal products interchangeability. Research report (intermediate). FSBI «SCEEMP» of the Ministry of Health of Russia; advisors: Romanov BK, Prokofiev AB, Yagudina RI; prepared by: Alyautdin RN, Zhuravleva MV. Moscow; 2016. 365 p. No. SR 115111740009. Deposited in CITIS on 26.01.2017, No. IKRBS 217012640056-0 (in Russian).