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Off-label antipsychotics prescription to adolescents with acute psychotic episodes does not cause adverse drug reactions

https://doi.org/10.14412/2074-2711-2021-3-19-26

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Abstract

Antipsychotics are often used to treat children and adolescents. Because of their age, there are a lot of off-label prescribed antipsychotics in that population. However, the off-label use of medications is considered to be potentially unsafe.

Objective: to evaluate whether the off-label prescription of antipsychotics outside of the approved age group increased the risk of adverse drug reactions in adolescents experiencing an acute psychotic episode.

Patients and methods. We analyzed 450 charts of adolescents hospitalized due to an acute psychotic episode (only completed cases). In addition, we evaluated adverse drug reactions adjusted by off-label antipsychotics prescription outside the approved age group using the Global Trigger Tool (GTT). We also registered prescriptions with duplicates drug classes and potentially dangerous drug interactions.

Results and discussion. Off-label antipsychotics prescription outside the approved age group was less frequently associated with adverse drug reactions (3.2% vs. 10.5%; p=0.013). The logistic regression analysis did not show any significant associations between the off-label antipsychotic use and increased risk of adverse drug reactions (Odds ratio=0.994 (95% confidence interval 0.572-1.726), p=0.982). Although, patients with off-label use of antipsychotics were more likely to have potentially dangerous drug interactions (35.2% vs. 16.15%; p=0.0001) and prescriptions with duplicates drug classes (39.6% vs. 15.43%; p=0.0001).

Conclusion. Off-label antipsychotic prescription outside the approved age group in adolescents with acute psychotic episode does not increase the risk of adverse drug reactions. However, an increase in potentially dangerous drug interactions and prescriptions with duplicates drug classes frequency could be considered red flags. Therefore, we have concluded that the concerns about off-label antipsychotics prescription outside of approved age groups in adolescents with acute psychotic episodes were overrated.

About the Authors

D. V. Ivashchenko
Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia; Institute for Further Training of Physicians – Penza Branch, Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia
Russian Federation

Dmitriy Vladimirovich Ivashchenko

Barrikadnaya St., Build. 1, Moscow 125993

8A, Stasova St., Penza 440060



N. I. Buromskaya
G.E. Sukhareva Scientific and Practical Center for Mental Health of Children and Adolescents, Moscow Healthcare Department
Russian Federation

21A, 5th Donskoy Dr., Moscow 119334



A. D. Malakhova
I.M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia
Russian Federation

8, Trubetskaya St., Build. 2, Moscow 119991



N. A. Tsarkova
National Research University Higher School of Economics, Ministry of Education and Science of Russia
Russian Federation

20, Myasnitskaya St., Moscow 101000



L. M. Savchenko
Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia
Russian Federation

Barrikadnaya St., Build. 1, Moscow 125993



Yu. S. Shevchenko
Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia
Russian Federation

Barrikadnaya St., Build. 1, Moscow 125993



D. A. Sychev
Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia
Russian Federation

Barrikadnaya St., Build. 1, Moscow 125993



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For citation:


Ivashchenko D.V., Buromskaya N.I., Malakhova A.D., Tsarkova N.A., Savchenko L.M., Shevchenko Yu.S., Sychev D.A. Off-label antipsychotics prescription to adolescents with acute psychotic episodes does not cause adverse drug reactions. Neurology, Neuropsychiatry, Psychosomatics. 2021;13(3):19-26. https://doi.org/10.14412/2074-2711-2021-3-19-26

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ISSN 2074-2711 (Print)
ISSN 2310-1342 (Online)