DOI: 10.15690 / vsp.v18i3.2032

A.V. Matveev1, 2, A.E. Krasheninnikov1, E.A. Egorova2, E.I. Konyaeva2, K.N. Koryanova3
1 National Research Center for Pharmacovigilance, Moscow, Russian Federation
2 Medical Academy. S.I. Georgievsky as a part of the Crimean Federal University them. IN AND. Vernadsky, Simferopol, Republic of Crimea, Russian Federation
3 Pyatigorsk Medical and Pharmaceutical Institute – a branch of the Volgograd State Medical University, Pyatigorsk, Russian Federation

The most common clinical symptoms in pediatric patients requiring intervention are pain and hyperthermia. According to the results of epidemiological studies, diseases associated with hyperthermia in children of preschool age (3-6 years) are recorded up to 3-6 times a year. In the United States, the number of medical visits for fever in children exceeds 25 million per year. In the Russian Federation, the frequency of visits to a pediatrician with symptoms of hyperthermia in children is 1/3 of the total number of cases, and in the autumn-winter period it reaches 90%. The safety of drug use is determined by the pharmacovigilance procedure carried out by authorized organizations.

In accordance with the recommendations of experts from the World Health Organization (WHO), the main group of drugs for relieving pain symptoms and hyperthermic reactions in children are non-opioid analgesics (the term “analgesics-antipyretics” is often used in Russian medical literature). According to the mechanism of their action, they can be attributed to representatives of a broader group – non-steroidal anti-inflammatory drugs (NSAIDs). According to some estimates, children in the Russian Federation receive about 30 million courses of antipyretic drugs a year.

However, despite the high efficiency, the use of drugs of this group in pediatric practice is not absolutely safe and may be accompanied by the development of adverse reactions (AD) of varying severity. And here the organization of pharmacovigilance and the procedure for reporting adverse drug reactions is especially important. The development of complications of pharmacotherapy may have regional characteristics due to differences in the use of drugs, patient adherence to treatment, genetic factors and the functioning of the system for reporting the development of HP, and also differ from the data obtained as a result of clinical trials, strictly limited by inclusion criteria and study duration. A regional pharmacovigilance center has been operating in the Republic of Crimea since 1995, and since 2010 an electronic system for storing information on the development of HP has been used. The procedure for pharmacovigilance and organization of reporting of adverse drug reactions in accordance with the rules adopted in the country. The activity of reporting by Crimean doctors is at the level of countries with a developed pharmacovigilance system (300–500 reports per 1 million population per year), while the structure of NR for NSAIDs in the region has not been analyzed previously.

A study was conducted to study the development of adverse reactions in children associated with the use of non-steroidal anti-inflammatory drugs.

The results of a retrospective analysis of maps – notifications registered in the Republic of Crimea for 2010–2018. NR on NSAIDs in pediatric patients showed that the development of complications of pharmacotherapy in most cases is associated with the appointment of ibuprofen and paracetamol drugs.

The main clinical manifestations of NR NSAIDs were immediate hypersensitivity reactions. Cases of irrational prescription of drugs in children with disregard of the requirements of the officially approved UTI of the drug (prescription of acetylsalicylic acid, metamizole sodium, nimesulide and ketorolac) were found.