Off-label structure of drugs prescription for children: An analysis of the Russian spontaneous reports database

The use of medicinal products (MP) with contraventions of officially approved instructions regulations (off-label), especially in pediatrics, is an actual problem of health care. This article studies MP off-label use structure in children and role of such drugs use in development of serious adverse reactions (AR), on the basis of Russian spontaneous reports database analysis. The results confirm that off -label MP prescription is an independent factor for AR developing risk. The study proved that spontaneous reports method is effective in studying of medicines use security problems and allows to develop recommendations that can significantly reduce the risk of pharmacotherapy complications, including in pediatric patients. © 2016, Pediatria Ltd. All rights reserved.

Authors
Titova A.R.1 , Asetskaya I.L.1 , Polivanov V.A.1 , Zyryanov S.K. 2 , Glagolev S.V.3
Journal
Pediatriya - Zhurnal im G.N. Speranskogo
Number of issue
6
Language
Russian
Pages
75-84
Status
Published
Link
External link
Volume
95
Year
2016
Organizations
  • 1 Monitoring Centre for efficient, safe and rational use of medicines, Center of Expertise and quality control of medical products of Roszdravnadzor, Moscow, Russian Federation
  • 2 People’s Friendship University of Russia, Medical Institute of People’s Friendship University of Russia, Moscow, Russian Federation
  • 3 Pharmacovigilance Department, Organization of state quality control of medical products of Roszdravnadzor, Russian Federation
Keywords
Children; Off-label drugs prescription; Pharmacovigilance; Serious adverse reaction; Spontaneous reports
Date of creation
19.10.2018
Date of change
19.10.2018
Short link
https://repository.rudn.ru/en/records/article/record/4398/
Share

Other records