Prescription of psychotropic drugs off label

Petrova N.N.

Saint-Petersburg State University

ORCID: 0000-0003-4096-6208

Semenova N.V.

Bekhterev National Medical Research Center for Psychiatry and Neurology

ORCID: 0000-0002-2798-8800

Prescription of psychotropic drugs off label

Authors:

Petrova N.N., Semenova N.V.

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Journal: S.S. Korsakov Journal of Neurology and Psychiatry. 2023;123(7): 130‑135

DOI: 10.17116/jnevro2023123071130

Downloaded: 34

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To cite this article:

Petrova NN, Semenova NV. Prescription of psychotropic drugs off label. S.S. Korsakov Journal of Neurology and Psychiatry. 2023;123(7):130‑135. (In Russ.)
https://doi.org/10.17116/jnevro2023123071130

Подписка 2025-2 (S.S. Korsakov Journal of Neurology and Psychiatry)

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The review was written based on the analysis of available publications (Pubmed, other Internet resources) on the problem of off-label use of drugs. It reveals the concept of off-label prescribing and discusses modern approaches to the use of off-label drugs in domestic psychiatric and addiction practice. The problems of normative substantiation of prescribing off-label drugs are discussed. It has been established that, despite some progress in this matter, for patients in adult psychiatric practice, the use of off-label therapy is carried out only by decision of the medical commission. The issue of substantiating the prescription of off-label drugs on the basis of scientific and clinical studies and experience in the use of drugs at the legislative level remains relevant.

Keywords:

Off-label prescribing

Drug treatment

Psychopharmacology

Authors:

Petrova N.N.

Saint-Petersburg State University

ORCID: 0000-0003-4096-6208

Semenova N.V.

Bekhterev National Medical Research Center for Psychiatry and Neurology

ORCID: 0000-0002-2798-8800

Received:

07.10.2022

Accepted:

18.11.2022

List of references:

Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med. 2006;166:1021-1026.
Duffy S. Off-Label Prescribing Common With Certain Psychiatric Medications. MPR. July 26, 2018.
Report from the commission to the European Parliament and the Council, Better Medicines for Children — From Concept to Reality; General Report on experience acquired as a result of the application of Regulation (EC) N 1901/2006 on medicinal products for paediatric use, 2013.
Devulapalli KK, Nasrallah HA. An analysis of the high psychotropic off-label use in psychiatric disorders the majority of psychiatric diagnoses have no approved drug. Asian J Psychiatr. 2009;2:29-36.
Haw C, Stubbs J. A survey of off-label prescribing for inpatients with mild intellectual disability and mental illness. J Intellect Disabil Res. 2005;49:858-864. https://doi.org/10.1111/j.1365-2788.2005.00723.x
Stafford RS. Regulating off-label drug use — Rethinking the role of the FDA. N Engl J Med. 2008;358(14):1427-1429. https://doi.org/10.1056/NEJMp0802107
Jacob MK, Ammu A, Eapen BA, et al. Evaluation of off label drug use in the outpatient department of a psychiatry hospital. Int J Pharm Sci Rev Res. 2016;40:206-210.
Sridharan K, Arora K, Chaudhary S. Off-label drug use in psychiatry: A retrospective audit in a tertiary care hospital. Asian J Psychiatr. 2016;24:124.
Evidence of harm from off-label or unlicensed medicines in children. European Medicines Agency. Pre-authorisation Evaluation of Medicines for Human Use. October 2004. EMEA/126327/2004.
EU needs guidelines on off-label use of medicines. Piernicola Pedicini. The Parliament. Politics, policy and people magazine. On June 16, 2017.
Study on off-labl use of medicinal products in the European Union. https://ec.europa.eu/
Kozlovskiy VL, Kosterin DN, Popov MYu. The role of agonistic/antagonistic activity in the development of psychotropic effects of antipsychotics. Obozrenie Psihiatrii i Medicinskoj Psihologii im. V.M. Bekhtereva. 2019;1:3-7. (In Russ.). https://doi.org/10.31363/2313-7053-2019-1-3-7
Off-label use of medicines: consensus recommendations for evaluating appropriateness. Med J Aust. 2006;185(10):544-548.
Declaration on Good Off-Label Use Practice. https://www.braincouncil.eu/projects/wp-content/uploads/2015/05/GOLUP-declaration.pdf
Khanra S, Das B. Off-label Psychotropics Use: Isn’t it Now an Inevitable and a «Norm» in Psychiatry? Indian J Psychol Med. 2018;40(4):390-391. https://doi.org/10.4103/IJPSYM.IJPSYM_563_17
Vijay A, Becker JE, Ross JS. Patterns and predictors of off-label prescription of psychiatric drugs. PLoS One. 2018;13(7):e0198363. 2018. https://doi.org/10.1371/journal.pone.0198363
O’Brien PL, Cummings N, Mark TL. Off-Label Prescribing of Psychotropic Medication, 2005-2013: An Examination of Potential Influences. Psychiatr Serv. 2017;68(6):549-558. https://doi.org/10.1176/appi.ps.201500482
Mandell BF. Off-label and oft-prescribed. Cleve Clin J Med. 2019;86(12):766-767. https://doi.org/10.3949/ccjm.86b.12019
Taylor D. Prescribing according to diagnosis: how psychiatry is different World Psychiatry. 2016;15(3):224-225. https://doi.org/10.1002/wps.20343
Wong J, Motulsky A, Abrahamowicz M, et al. Off-label indications for antidepressants in primary care: descriptive study of prescriptions from an indication based electronic prescribing system. BMJ. 2017;356:j603.
Cyganova OA. Analysis of the legal regulation of «off-label» therapy in the Russian Federation and abroad. Analiz normativno-pravovogo regulirovaniya «off-label»-terapii v Rossijskoj Federacii i za rubezhom. Medicinskoe Pravo. 2018;4:9-13. (In Russ.).

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