Monitoring of adverse reactions on medicines in children in the Russian federation

Objective of the research - to study safety of medicinal preparations (MP) for children by analyzing a Roszdravnadzor national database of spontaneous reports (SR). This study includes a retrospective analysis of 467 primary SR on severe adverse reactions (AR) in children recorded to database in 2015. Children of preschool age have higher risk of medical therapy complications. Most frequently, skin and whole body (38,7% and 21,1%, respectively) were involved in the pathological process. Unexpected AR were identified in children in 10,8% of cases. They were often caused by antimicrobial system action drugs (43,8%) and drugs for nervous system treatment (26,1%). SR method allows to obtain new information about MP safety in the pediatric population, and to develop measures to reduce risks of medical therapy. © 2017, 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
3
Language
Russian
Pages
152-159
Status
Published
Link
External link
DOI
10.24110/0031-403X-2017-96-3-152-159
Volume
96
Year
2017
Organizations
  • 1 Center of Monitoring of efficacy, safety and rational use of medicines, Informational-Methodological Center for the Expertise, Accounting and Analysis of Medical Products Circulation of Roszdravnadzor, Russian Federation
  • 2 People’s Friendship University of Russia, Medical Institute of People’s Friendship University of Russia, Russian Federation
  • 3 Department of pharmacovigilance organization, Bureau of organization of state quality control of medical products of Roszdravnadzor, Moscow, Russian Federation
Keywords
Adverse reactions; Children; Medicinal preparations; Spontaneous reports
Date of creation
19.10.2018
Date of change
19.10.2018
Short link
https://repository.rudn.ru/en/records/article/record/6077/
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