Off-Label Drug Use in Pediatric Practice: Unsolved Problems
https://doi.org/10.15690/pf.v12i3.1355
Abstract
The widespread «off-label» drug use and the prescribing of unlicensed medicines in pediatric practice is a major health problem. The authors discuss actual regulatory and legal issues of «off-label» drug use in children in the US, Europe and Russia. The results of different population-based studies from many countries, showing the structure and frequency of «off-label» drug use in children, are summarized in this article. It is shown that such practice increases the risk of adverse drug reactions. The authors offer practical recommendations for a safer use of drugs in pediatric practice. The priority issue is conducting high quality clinical trials with the participation of children, improving national pharmacovigilance and the monitoring of off-label drug use, developing pediatric formularies, improving doctors’ knowledge and awareness of safety and efficacy of medicines in pediatric population.
About the Authors
A. R. Titova
Informational-Methodological Center for the Expertise, Accounting and Analysis of Medical Products Circulation under Roszdravnadzor
Russian Federation
Moscow
Russian Federation
Moscow
I. L. Asetskaya
Informational-Methodological Center for the Expertise, Accounting and Analysis of Medical Products Circulation under Roszdravnadzor;
Pirogov Russian National Research Medical University
Russian Federation
Moscow
Russian Federation
Moscow
S. K. Zyryanov
Pirogov Russian National Research Medical University
Russian Federation
Moscow
Russian Federation
Moscow
V. A. Polivanov
Informational-Methodological Center for the Expertise, Accounting and Analysis of Medical Products Circulation under Roszdravnadzor
Russian Federation
Moscow
Russian Federation
Moscow
References
1. Wittich C. M., Christopher M., Burkle C. M., Lanier W. L. Ten common questions (and their answers) about off-label drug use. Mayo Clin Proc. 2012 Oct; 87 (10): 982–90.
2. Pugeat M., Ducluzeau P. H. Insulin resistance, polycystic ovary syndrome and metformin. Drugs. 1999; 58 (Suppl. 1): 41–6; discussion 75–82.
3. Баев О. Р., Васильченко О. Н., Кан Н. Е., Клименченко Н. И., Митрохин С. Д., Тетруашвили Н. К., Ходжаева З. С., Шмаков Р. Г., Дегтярёв Д. Н., Тютюнник В. Л. Преждевременное излитие вод. Клиническое руководство «Преждевременный разрыв плодных оболочек». Москва. 2013. С. 20–1.
4. Valdes E., Salinas H., Toledo V., Lattes K., Cuellar E., Perucca E., Diaz R., Montecinos F., Reyes A. Nifedipine versus fenoterol in the management of preterm labor: A randomized, multicenter clinical study. Gynecol Obstet Invest. 2012 Jul 10; 74 (2): 109–15.
5. Nikbakht R., Taheri Moghadam M., Ghane’ee H. Nifedipine compared to magnesium sulfate for treating preterm labor: A randomized clinical trial. Iran J Reprod Med. 2014; Feb; 12 (2): 145–50.
6. Definition of Unlicensed Medicine. URL: http://medicaldictionary.thefreedictionary.com/Unlicensed+Medicine
7. Зырянов С. К., Белоусов Ю. Б. Использование лекарств в педиатрии: есть ли проблемы? Медицинские технологии. Оценка и выбор. 2011; 2: 37–41.
8. Грацианская А. Н., Бологов А. А., Костылева М. Н., Постников С. С. Применение лекарственных средств off label в педиатрической практике. Опыт многопрофильного педиатрического стационара. Заместитель главного врача. 2012; 8: 46–52.
9. Кутехова Г. В., Лепахин В. К., Романов Б. К. Выявление назначения лекарственных средств с нарушениями предписаний инструкции (off-label) в педиатрической практике. Ведомости НЦЭСМП. 2012; 3: 23–7.
10. Тополянская С. В. Общие методологические проблемы проведения клинических исследований у детей. Педиатрическая фармакология. 2010; 5 (7): 6–10.
11. Riley J. B., Basilius P. A. Physicians liability for off-label prescriptions. Hematol Oncol News Issues. 2007 May/June. Р. 24–7.
12. Good practice in prescribing and managing medicines and devices. 2013. URL: http://www.gmc-uk.org/Good_practice_in_prescribing.pdf_58834768.pdf
13. Завидова С. С., Намазова-Баранова Л. С., Тополянская С. В. Клинические исследования лекарственных препаратов в педиатрии: проблемы и достижения. Педиатрическая фармакология. 2010; 1 (7): 6–14.
14. Bang V., Mallad A., Kannan S., Bavdekar S. B., Gogtay N. J., Thatte U. M. Awareness about and views of parents on the off-label drug use in children. Int J Risk Saf Med. 2014; Jan 1; 26 (2): 61–70.
15. 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): 51–4.
16. Shah S. S., Hall M., Goodman D. M., Feuer P., Sharma V., Fargason C. Jr., Hyman D., Jenkins K., White M. L., Levy F. H., Levin J. E., Bertoch D., Slonim A. D. Off-label drug use in hospitalized children. Arch Pediatr Adolesc Med. 2007 Mar; 161 (3): 282–90.
17. Knopf H., Wolf I-K., Sarganas G., Zhuang W., Rascher W., Neubert A. Off-label medicine use in children and adolescents: results of a population-based study in Germany. BMC Public Health. 2013; 13: 631.
18. Lindell-Osuagwu L., Hakkarainen M., Sepponen K., Vainio K., Naaranlahti T., Kokki H. Prescribing for off-label use and unauthorized medicines in three paediatric wards in Finland, the status before and after the European Union Paediatric Regulation. J Clin Pharm Ther. 2014 Apr; 39 (2): 144–53.
19. Langerova P., Vrtal J., Urbanek K. Incidence of unlicensed and off-label prescription in children. Ital J Pediatr. 2014; 40: 12.
20. Maltz L. A., Klugman D., Spaeder M. C., Wessel D. L. Off-label drug use in a single-center pediatric cardiac intensive care unit. World J Pediatr Congenit Heart Surg. 2013 Jul; 4 (3): 262–6.
21. Lee J. L., Redzuan A. M., Shah N. M. Unlicensed and off-label use of medicines in children admitted to the intensive care units of a hospital in Malaysia. Int J Clin Pharm. 2013 Dec; 35 (6): 1025–9.
22. Костылёва М. Н. Оценка безопасности лекарственных средств, применяемых в многопрофильном педиатрическом стационаре. Автореф. дис. … канд. мед. наук. Москва. 2013. 30 с.
23. Колбин А. С., Шабалов Н. П., Любименко В. А. Частота использования нелицензированных лекарств в неонатологии: данные фармакоэпидемиологического исследования. Педиатрическая фармакология. 2007; 4 (4): 35–40.
24. Якимова Ю. Н. Современные проблемы функционирования формулярной системы в педиатрической практике. Бюллетень медицинских Интернет-конференций. 2013; 12 (3): 1357–61.
25. Neubert A., Dormann H., Weiss J., Egger T., Criegee-Rieck M., Ras cher 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): 1059–67.
26. 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
27. of inpatients in a pediatric hospital. BMC Med. 2013 Nov; 11: 238.
28. Mukattash T., Trew K., Hawwa A. F. et al. Children’s views on unlicensed/off-label paediatric prescribing and paediatric clinical trials. Eur J Clin Pharmacol. 2012 Feb; 68 (2): 141–8.
Review
For citations:
Titova A.R., Asetskaya I.L., Zyryanov S.K., Polivanov V.A. Off-Label Drug Use in Pediatric Practice: Unsolved Problems. Pediatric pharmacology. 2015;12(3):304-308. https://doi.org/10.15690/pf.v12i3.1355
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