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