New Users of Antipsychotics Among Children and Adolescents in 2008–2017: A Nationwide Register Study

Varimo, Eveliina; Saastamoinen, Leena; Rättö, Hanna; Mogk, Hannu; Aronen, Eeva T.

doi:10.3389/fpsyt.2020.00316

Cited by 16 publications

(19 citation statements)

References 39 publications

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“…The early presentation of psychiatric symptoms can have a profound physiological, psychological, and social impact that diminishes quality of life and leads to a poor prognosis 2,3 . Recent epidemiological studies have suggested that the increased prevalence of bipolar I disorder and schizophrenia in pediatric patients has led to an overall increase in drug utilization of atypical antipsychotics 1,4 . To date, there are a limited number of second‐generation agents approved to treat schizophrenia and manic and mixed episodes associated with bipolar I disorder (6 and 5 atypical antipsychotics approved for schizophrenia and bipolar I disorder, respectively).…”

Section: Pediatric Drug Development In Psychiatrymentioning

confidence: 99%

Extrapolation of Efficacy and Dose Selection in Pediatrics: A Case Example of Atypical Antipsychotics in Adolescents With Schizophrenia and Bipolar I Disorder

Kalaria

Farchione

Uppoor

et al. 2021

The Journal of Clinical Pharma

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Pediatric labeling information for novel atypical antipsychotics can be significantly delayed as the result of time lag between initial drug approval in adults and the completion of pediatric clinical trials. This delay can lead health care providers to rely on limited evidence‐based literature to make critical therapeutic decisions for pediatric patients. Effective and scientifically justified dosing recommendations are needed to improve treatment outcomes in pediatric patients with schizophrenia and bipolar I disorder. Extrapolation‐based drug development strategies rely on leveraging prior data to reduce evidentiary requirements for newer data in establishing drug efficacy. On January 13, 2020, the US Food and Drug Administration (FDA) released a general advice letter to sponsors highlighting the acceptance of extrapolating efficacy of atypical antipsychotics to pediatric patients. This review provides insight into the FDA's justification for extrapolating efficacy from adult to pediatric patients and provides a rationale for dose selection in pediatric patients with schizophrenia and bipolar I disorder.

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Section: Pediatric Drug Development In Psychiatrymentioning

confidence: 99%

Extrapolation of Efficacy and Dose Selection in Pediatrics: A Case Example of Atypical Antipsychotics in Adolescents With Schizophrenia and Bipolar I Disorder

Kalaria

Farchione

Uppoor

et al. 2021

The Journal of Clinical Pharma

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“…Другая особенность пациентов с применением антипсихотиков «вне показаний»признаки нерациональной фармакотерапии. Нерациональное использование лекарств в данном случае выражается в наличии потенциально опасных МВКМ и дублировании препара- [8,10,14]. Все пациенты в нашем исследовании имели показания к назначению антипсихотика, и только возраст мог быть критерием отнесения к использованию «вне показаний».…”

Section: Baseline Characteristics Of the Study Participants Considering Off-label Antipsychotics Prescriptionunclassified

“…Похожей чертой нашего и ранее проведенных исследований является то, что «вне показаний» детям чаще назначают АВГ. В то же время наше исследование включает анализ применения АПГ, что почти отсутствует в других исследованиях [8,10,14]. Использование АПГ актуально для России и некоторых других стран Европы.…”

Section: Baseline Characteristics Of the Study Participants Considering Off-label Antipsychotics Prescriptionunclassified

“…По данным Е. Varimo и соавт. [10], с 2008 по 2017 г. число случаев назначения антипсихотиков возросло в 1,5 раза среди детей 7-12 лет и в 2,2 раза у подростков 13-17 лет. В США использование АПГ довольно ограниченно, в то время как в странах Европы они сохраняют свою значимость [9,11].…”

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“…В России нет единого регистра пациентов, которым назначаются психотропные препараты. Это затрудняет проведение крупных исследований, подобных проводимым в других странах [9,10,13,15,18]. Таким образом, единст-…”

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

Ivashchenko

Buromskaya

Malakhova

et al. 2021

RJTAO

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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.

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Antipsychotic prescribing patterns in children and adolescents attending Australian general practice in 2011 and 2017

Klau,

Gonzalez‐Chica,

Raven

et al. 2023

JCPP Advances

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BackgroundAntipsychotics are increasingly prescribed to children and adolescents worldwide, but little is known about reasons for prescribing. We aimed to examine patterns of paediatric antipsychotic prescribing in Australian primary care services in 2011 and 2017, including diagnoses, sociodemographic characteristics, off‐label prescribing, and psychotropic co‐prescribing.MethodsRetrospective analysis of electronic health records (EHRs) using a large Australian general practice database (MedicineInsight). Diagnoses of mental disorders were extracted from EHRs and associated with antipsychotic prescriptions within the same calendar year for three age‐groups: 0–9, 10–14, and 15–18‐year‐olds.ResultsIn 2017, children/adolescents with mental health diagnoses were more likely to be prescribed antipsychotics (2.9% of 27,412 patients) than in 2011 (2.0% of 8418 patients; absolute difference +0.9, 95% CI + 0.5, +1.4). The likelihood was greater for patients with bipolar disorders (21.6% vs. 41.5%), eating disorders (1.1% vs. 7.2%), and autism without behavioural problems (3.7% vs. 6.1%). Depression/anxiety (adjusted 26.8% of patients 2011; 30.8% 2017) was the most common diagnosis associated with antipsychotics in both years. Most antipsychotics were prescribed off‐label (69.8% 2011; 79.7% 2017; absolute difference +9.8, 95% CI + 1.54, +18.4). Off‐label prescribing increased most among those aged 15–18‐years, females, and patients living in outer regional/remote/very remote communities and the most disadvantaged areas. The three most frequently prescribed antipsychotics in both years were risperidone, quetiapine, and olanzapine. Psychotropic co‐prescribing among patients receiving antipsychotic prescriptions was approximately 69% in both years.ConclusionsPrescribing antipsychotics for mental health diagnoses to children/adolescents attending Australian general practices was more frequent in 2017 than 2011, and most commonly associated with depression/anxiety diagnoses. In both years, most prescribing was off‐label. The majority of patients were co‐prescribed other classes of psychotropics along with antipsychotics.

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New Users of Antipsychotics Among Children and Adolescents in 2008–2017: A Nationwide Register Study

Cited by 16 publications

References 39 publications

Extrapolation of Efficacy and Dose Selection in Pediatrics: A Case Example of Atypical Antipsychotics in Adolescents With Schizophrenia and Bipolar I Disorder

Extrapolation of Efficacy and Dose Selection in Pediatrics: A Case Example of Atypical Antipsychotics in Adolescents With Schizophrenia and Bipolar I Disorder

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

Antipsychotic prescribing patterns in children and adolescents attending Australian general practice in 2011 and 2017

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