Age-specific safety of pharmacotherapy for behavioral disorders in children and adolescents: a retrospective study

Ivaschenko D.V., Aysin F.R., Byalkovskaya P.A., Gragyants B.R., Shevchenko Yu.S., Sychev D.A.

1) Russian Medical Academy of Continuous Professional Education, Moscow, Russia; 2) G.E. Sukhareva Scientific and Practical Center for Mental Health of Children and Adolescents, Moscow, Russia; 3) Pirogov Russian National Research Medical University, Moscow, Russia

Background: Behavioral disorders occur in 1–11% of children and adolescents. Antipsychotics, which are unsafe medications, are often used for behavioral disorders. There are studies that demonstrate different rates of adverse drug reactions (ADRs) among children under 13 years of age or older. This emphasizes the need for separate analysis of children and adolescents when assessing risk factors for ADRs to pharmacotherapy.
Objective: Determination of clinical and demographic risk factors for ADRs to pharmacotherapy for behavioral disorders with separate analysis for children and adolescents.
Materials and methods: The study included 300 case histories of children and adolescents hospitalized in an acute psychiatric hospital for behavioral disorders. The sample was divided into 150 patients aged 12 years or younger (subgroup «Children») and 150 aged 13 years and older (subgroup «Adolescents»). All patients received an antipsychotic as their primary therapy. Using the global trigger method, each case history was searched for ADRs. Data on the pharmacotherapy taken were extracted, potentially dangerous drug interactions were recorded, and the Medical appropriateness index and Anticholinergic scale score were calculated. Risk factors for the development of ADRs were assessed using nonparametric statistics and logistic regression analysis.
Results: 57 ADRs were detected among patients (28 in the Children subgroup, 29 in the Adolescents subgroup). Most often, ADRs were detected in patients aged 11 to 15 years. The subgroups of children and adolescents differed significantly in the maximum dose of the second prescribed antipsychotic (higher in adolescents: 60 [37.5; 108] versus 45 [25; 72] mg/day, p=0.019), the number of hospitalizations over the past 12 months (children – 1 [1; 2], adolescents – 1 [1; 1]; p=0.005). Logistic regression identified significant risk factors for the development of ADRs: 1) for the entire sample «Duplicate antipsychotics» (OR=2.505; 95% CI: 1.308–4.798; p = 0.006), high body mass index (OR=0.915; 95% CI: 0.845–0.991; p = 0.029); 2) for the subgroup «Adolescents» – «Duplicate antipsychotics» (OR=2.461; 95% CI: 1.072–5.65; p = 0.034); 3) for the subgroup «Children» no significant risk factors for the development of ADRs were identified.
Conclusion: ADRs to antipsychotics in children and adolescents with behavioral disorders depend on the rationality of pharmacotherapy. Duplicate antipsychotics is a significant risk factor for the development of ADRs. The risk of developing ADRs in patients under 13 years of age is less dependent on the parameters of pharmacotherapy (antipsychotic dosage, duplication of antipsychotics). This study indicates the need for a detailed study of risk factors for ADRs depending on the child’s age.

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About the Authors

D.V. Ivaschenko, Dr. Sci. (Med.), Associate Professor, Head of the Department of Child Psychiatry and Psychotherapy, Russian Medical Academy of Continuous Professional Education, Moscow, Russia; ORCID: https://orcid.org/0000-0002-2295-7167
F.R. Aysin, Clinical Pharmacologist, G.E. Sukhareva Scientific and Practical Center for Mental Health of Children and Adolescents of the Moscow Healthcare Department, Moscow, Russia;; aysinf@yandex.ru; ORCID: https://orcid.org/0000-0003-1145-1600; eLibrary SPIN: 3573-6558 (corresponding author)
P.A. Byalkovskaya, Senior Laboratory Assistant, Department of Child Psychiatry and Psychotherapy, Russian Medical Academy of Continuous Professional Education, Moscow, Russia; ORCID: https://orcid.org/0009-0003-0664-6953
B.R. Gragyants, Student, Pirogov Russian National Research Medical University, Moscow, Russia; ORCID: https://orcid.org/0009-0007-4074-3983
Yu.S. Shevchenko, Dr. Sci. (Med.), Russian Medical Academy of Continuous Professional Education, Moscow, Russia; ORCID: https://orcid.org/0000-0001-9871-8704
D.A. Sychev, Dr. Sci. (Med.), Professor, Professor of the Russian Academy of Sciences, Academician of the Russian Academy of Sciences, Head of the Department of Clinical Pharmacology and Therapy named after B.E. Votchal, Russian Medical Academy of Continuous Professional Education; Scientific Director of the Center for World-Class Genomic Research «Center for Predictive Genetics, Pharmacogenetics and Personalized Therapy», Petrovsky National Research Centre of Surgery, Moscow, Russia; ORCID: https://orcid.org/0000-0002-4496-3680

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