Preview

Safety and Risk of Pharmacotherapy

Advanced search

ON THE SAFETY OF ANTIBACTERIAL DRUGS USED IN PEDIATRICS

Abstract

The safety of application of different groups of antibacterial drugs in pediatrics among children is discussed in this article. The analysis was made of spontaneous reports in the national database for 2012, containing information about serious adverse reactions (AR) on antibiotics in the pediatric population. In addition to evaluating the overall structure of serious AR and their distribution to system organ classes, the role of different pharmaco-therapeutic groups of antibacterial drugs in the development of adverse effects of pharmacotherapy was analyzed. Particular attention was drawn to «off-label» prescriptions; their frequency and structures. It was shown that antibiotics are common cause of serious AR among children, and their use as «off-label» prescribed drugs is an additional risk factor for such reactions.

About the Authors

A. R. Titova
Federal State Budget Institution «Informational-Methodological Center for the Expertise, Accounting and Analysis of Medical Products Circulation» under Roszdravnadzor
Russian Federation


E. Y. Pasternak
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», Ministry of Health of the Russian Federation
Russian Federation


I. L. Asetskaya
Federal State Budget Institution «Informational-Methodological Center for the Expertise, Accounting and Analysis of Medical Products Circulation» under Roszdravnadzor; Pirogov Russian National Research Medical University
Russian Federation


S. K. Zyryanov
Pirogov Russian National Research Medical University
Russian Federation


V. A. Polivanov
Federal State Budget Institution «Informational-Methodological Center for the Expertise, Accounting and Analysis of Medical Products Circulation» under Roszdravnadzor
Russian Federation


R. N. Alyautdin
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», Ministry of Health of the Russian Federation
Russian Federation


B. K. Romanov
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», Ministry of Health of the Russian Federation
Russian Federation


References

1. Shehab N., Patel P.R., Srinivasan A., Budnitz D.S. Emergency department visits for antibiotic-associated adverse events. Clin Infect Dis. 2008 Sep 15; 47(6): 735-43.

2. Neubert A., Dormann H., Weiss J., Egger T., Criegee-Rieck M., Rascher W., Brune K., Hinz B. The impact of unlicensed and off-label drug use on adverse drug reactions in paediatric patients. Drug Saf. 2004; 27(13): p.1059-67.

3. Horen B., Montastruc J.-L., Lapeyre-Mestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol. 2002; 54: 665-670.

4. Завидова С.С., Намазова-Баранова Л.С., Тополянская С.В. Клинические исследования лекарственных препаратов в педиатрии: проблемы и достижения. Педиатрическая фармакология. 2010, том 7, № 1, с. 6-14.

5. Naranjo C.A., Busto U., Sellers E.M., at al. A method for estimating the probability of adverse drug reactions // Clin Pharmacol Ther. - 1981. - Vol. 30. - P. 239-45.

6. Зырянов С.К., Белоусов Ю.Б. Использование лекарств в педиатрии: есть ли проблемы? Медицинские технологии. Оценка и выбор. 2011, №2, с.37-40.

7. WHO Collaborating Centre for Drug Statistics Methodology, Guidelines for ATC classification and DDD assignment 2014. Oslo, 2013.

8. The Uppsala Monitoring Centre, The WHO Adverse Reaction Terminology - WHO-ART. Terminology for coding clinical information in relation to drug therapy. WHO-ART guide, January 2014.

9. Воронцов И.М., Мазурин А.В. Пропедевтика детских болезней. - СПб.: Фолиант, 2009. - 1008 с.

10. В.К. Таточенко. Рациональная терапия ОРЗ. Лечащий врач. 2011. № 8.

11. Saullo F., Saullo E., Caloiero M., Menniti M., Carbone C., Chimirri S., Paletta L., Gallelli L. A questionnaire-based study in Calabria on the knowledge of off-label drugs in pediatrics. J Pharmacol Pharmacother. 2013 Dec; 4(Suppl 1): p.51-4.

12. Ferrajolo C., Capuano A., Trifirr G., Moretti U., Rossi F., Santuccio C. Pediatric drug safety surveillance in Italian pharmacovigilance network: an overview of adverse drug reactions in the years 2001 - 2012. Expert Opin Drug Saf. 2014 Sep; 13 Suppl 1: S9-20.

13. Aldea A., García Sánchez-Colomer M., Fernádez Quintana E., García Sáiz M. Paediatric adverse drug reactions reported to the Spanish Pharmacovigilance System from 2004 to 2009. Eur J Clin Pharmacol. 2012 Sep; 68(9): 1329-38.

14. Aagaard L., Weber C.B., Hansen E.H. Adverse drug reactions in the paediatric population in Denmark: a retrospective analysis of reports made to the Danish Medicines Agency from 1998 to 2007. Drug Saf. 2010 Apr 1; 33(4): 327-39.

15. Костылева М.Н. Оценка безопасности лекарственных средств, применяемых в многопрофильном педиатрическом стационаре. Автореферат диссертации на соискание ученой степени кандидата медицинских наук. Москва, 2013.

16. Pinar Yildirim, Ljiljana Majnaric, Ozgur Jlyas Ekmekci, Andreas Holzinger. Knowledge discovery of drug data on the example of adverse reaction prediction. BMC Bioinformatics 2014; 15(Suppl 6): S7.

17. Bellis J.R., Kirkham J.J., Thiesen S., Conroy E.J., Bracken L.E., Mannix H.L., Bird K.A., Duncan J.C., Peak M., Turner M.A., Smyth R.L., Nunn A.J., Pirmohamed M. Adverse drug reactions and off-label and unlicensed medicines in children: a nested case-control study of inpatients in a pediatric hospital. BMC Med. 2013 Nov 7; 11: p. 238.

18. Кутехова Г.В., Лепахин В.К., Романов Б.К. Выявление назначения лекарственных средств с нарушениями предписаний инструкции (off-label) в педиатрической практике. Ведомости НЦЭСМП. № 3, 2012, с.23-27.


Review

For citations:


Titova A.R., Pasternak E.Y., Asetskaya I.L., Zyryanov S.K., Polivanov V.A., Alyautdin R.N., Romanov B.K. ON THE SAFETY OF ANTIBACTERIAL DRUGS USED IN PEDIATRICS. Safety and Risk of Pharmacotherapy. 2015;(2):12-22. (In Russ.)

Views: 1265


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2312-7821 (Print)
ISSN 2619-1164 (Online)