Off-label therapy in neonatology

Abstract

The article examines the modern legal basis for the use of medicines "out of the instructions" (off-label therapy), foreign experience in regulating off-label prescriptions, as well as the necessary conditions for its appointment in the Russian Federation.

Keywords:safety of medical activity, off-label, therapy "outside the instructions", neonatology, medicines, instructions for use

Funding. The study had no sponsor support.

Conflict of interests. The author declare no conflict of interests.

For citation: Mustafina-Bredikhina D.M. Off-label therapy in neonatology. Neonatologiya: novosti, mneniya, obuchenie [Neonatology: News, Opinions, Training]. 2021; 9 (1): 60-3. DOI: https://doi.org/10.33029/2308-2402-2021-9-1-60-63 (in Russian)

References

1. Silva J., Flor-de-Lima F., Soares H., Guimaraes H. Off-label and unlicensed drug use in neonatology: reality in a Portuguese University Hospital. Acta Med Port. 2015; 28 (3): 297-306.

2. Gongalves A.C.S., Reis A.M.M., Margal A.C.G., Bouzada M.C.F. Use of unlicensed and off-label drugs in neonates in a Brazilian university hospital. Braz J Pharm Sci. 2018; 53 (2): e00252. DOI : https://doi.org/10.1590/s2175-97902017000300252

3. Gazarian M., Kelly M., McPhee J.R., Graudins L.V., Ward R.L., Campbell T.J. Off-label use of medicines: consensus recommendations for evaluating appropriateness. Med J Aust. 2006; 185 (10): 544-8. DOI: https://doi.org/10.5694/j.1326-5377.2006.tb00689.x PMID: 17115966.

4. Titova A.R., Asetskaya I.L., Polivanov V.A., Zyryanov S.K., Glagolev S.V. Off-label structure of drug prescriptions in children: analysis of the Russian database of spontaneous messages. Pediartiya [Pediatrics]. 2016; 95 (6): 75-84. (in Russian)

5. Koszma E.I.A., Bispo A.J.B., Santana I.A.O., Santos C.N.O. Use of off-label medications in a neonatal intensive care unit. Rev Paul Pediatr. 2021; 39: e2020063. DOI: https://doi.org/10.1590/1984-0462/2021/39/2020063 PMID: 33440406; PMCID: PMC7802993.

6. Pereverzev A.P., Lepakhin V.K. Modern view on the problem of using drugs in violation of the instructions. Meditsinskiy sovet [Medical Council]. 2013; ( 4): 110-1. (in Russian)

7. Mello M., Studdert D.M., Brennan T.A. Shifting terrain in the regulation of off-label promotion of pharmaceuticals. N Engl J Med. 2009; 360 (15): 1557-66. DOI: https://doi.org/10.1056/NEJMhle0807695

8. Schrier L., Hadjipanayis A., Stiris T., Ross-Russell R.I., Valiulis A., Turner M.A., et al. Off-label use of medicines in neonates, infants, children, and adolescents: a joint policy statement by the European Academy of Paediatrics and the European society for Developmental Perinatal and Pediatric Pharmacology. Eur J Pediatr. 2020; 179 (5): 839-47. DOI: https://doi.org/10.1007/s00431-019-03556-9 PMID: 31897842.

9. Declaration on Good Off-Label Use Practice. URL: //https://www.bram-council.eu/golup/wp-content/uploads/2017/11/GOLUP_Declaration.pdf

10. Aronson J.K., Ferner R.E. Unlicensed and off-label uses of medicines: definitions and clarification of terminology. Br J Clin Pharmacol. 2017; 83 (12): 2615-25. DOI: https://doi.org/10.1111/bcp.13394 Epub 2017 Sep 26. PMID: 28779556; PMCID: PMC5698582.

11. Gilyarevsky S.R. Prescribing medicines for indications not specified in the instructions («off-label»): a complex problem of modern clinical practice. Ratsional’naya farmakoterapiya v kardiologii [Rational Pharmacotherapy in Cardiology]. 2020; 16 (2): 324-34. DOI: https://doi.org/10.20996/1819-6446-2020-04-14 (in Russian)

12. Mustafina-Bredikhina D.M. The use of off-label medicines: International experience and prospects in Russia. Neonatologiya: novosti, mneniya, obuchenie [Neonatology: News, Opinions, Training]. 2015; (1): 77-9. (in Russian)

13. Karpova A.L., Mustafina-Bredikhina D.M., Priluchnaya I.A., et al. Conducting medical documentation in neonatology departments. In: A Guide for Neonatologists, Anesthesiologists, Resuscitators and Pediatricians: an educational and methodological manual. Moscow: RUDN, 2020: 192 p. (in Russian)

All articles in our journal are distributed under the Creative Commons Attribution 4.0 International License (CC BY 4.0 license)

CHIEF EDITOR
CHIEF EDITOR
Degtyarev Dmitriy Nikolaevich
Doctor of Medical Sciences, Professor, Deputy Director for Scientific Research of the V.I. Kulakov Obstetrics, Gynecology and Perinatology National Medical Research Center of Ministry of Healthсаre of the Russian Federation, Head of the Chair of Neonatology at the Clinical Institute of Children's Health named after N.F. Filatov, I.M. Sechenov First Moscow State Medical University, Chairman of the Ethics Committee of the Russian Society of Neonatologists, Moscow, Russian Federation

ORCID iD 0000-0001-8975-2425

Journals of «GEOTAR-Media»