A study of safe drug use in children in the Russian Federation: a review of the national spontaneous reporting database
The article tells about the safety of drug use in the pediatric population based on a review of the national spontaneous reporting database of serious adverse effects in children. Along with the assessment of the overall structure of serious adverse reactions, their grouping into the system organ classes was studied in detail; the role of different groups of drugs in pharmacotherapeutic complications in children was analyzed. The article demonstrated a high incidence of unexpected adverse effects in children and an increased risk ofserious side effects of therapy in case of uncontrolled self-medication. The results showed the effectiveness of the method of spontaneous reporting in the identification of problems related to the efficient and safe use of medicines, which is a priority area for the functioning of the national pharmacovig-ilance system.