Trends and off-label utilization of antipsychotics in children and adolescents from 2016 to 2021 in China: a real-world study.

IF 3.4 3区医学 Q1 PEDIATRICS Child and Adolescent Psychiatry and Mental Health Pub Date : 2024-06-21 DOI:10.1186/s13034-024-00766-4

Wang Zhaojian, Jiang Meizhu, Hong Jun, Guo Shanshan, Huo Jiping, Zhao Zhigang, Gong Ying, Li Cao

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Abstract

Background: Global antipsychotic usage, including off-label prescriptions, has increased in recent decades. However, trends in China, particularly for children and adolescents, remain unclear. This study explored these trends from 2016 to 2021 and identified factors associated with off-label prescriptions.

Methods: In this retrospective study, we analyzed on-label and off-label prescriptions based on drug information approved by the China National Medical Products Administration. To identify factors associated with off-label prescriptions, we conducted multivariate logistic regression analysis.

Results: Our study included 48,258 antipsychotic prescriptions, 52.4% (25,295) of which were prescriptions for males. Of these, 61.7% (29,813) were off-label. Over time, the number of antipsychotics and the percentage of off-label prescriptions for children and adolescents overall increased from 2016 to 2021. The use of atypical antipsychotics increased, whereas that of typical antipsychotics decreased. For off-label usage, all of the factors in our study were associated with off-label usage, including age, sex, year, region, department, reimbursement, antipsychotic type, drug expense, number of polypharmacy and diagnoses. Additionally, tiapride (15.8%) and aripiprazole (18.6%) were the most common typical and atypical antipsychotics, respectively. For pediatric diseases, common diagnoses included mood or affective disorders (31.7%) and behavioral and emotional disorders, with onset usually occurring in childhood and adolescence (29.1%). Furthermore, a depressive state was the most common diagnosis for which antipsychotic polypharmacy was used for treatment.

Conclusion: In this retrospective study, off-label antipsychotic prescriptions were common, with trends generally increasing among children and adolescents from 2016 to 2021. However, there is a lack of evidence supporting off-label usage, thus emphasizing the need for studies on the efficacy and safety of these treatments.

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2016年至2021年中国儿童和青少年抗精神病药物的趋势和标示外使用情况：一项真实世界研究。

背景：近几十年来，全球抗精神病药物（包括标签外处方）的使用量有所增加。然而，中国的趋势，尤其是儿童和青少年的趋势仍不明确。本研究探讨了 2016 年至 2021 年的趋势，并确定了与标示外处方相关的因素：在这项回顾性研究中，我们根据中国医药产品管理局批准的药品信息分析了标签内和标签外处方。为了确定与标示外处方相关的因素，我们进行了多变量逻辑回归分析：我们的研究包括 48,258 份抗精神病药物处方，其中 52.4%（25,295 份）为男性处方。其中 61.7%（29813 张）为标签外处方。随着时间的推移，从2016年到2021年，儿童和青少年的抗精神病药物处方数量和标签外处方的比例总体上都有所增加。非典型抗精神病药物的使用有所增加，而典型抗精神病药物的使用则有所减少。在标示外使用方面，我们研究中的所有因素都与标示外使用有关，包括年龄、性别、年份、地区、科室、报销、抗精神病药物类型、药物费用、多重用药次数和诊断。此外，噻必利（15.8%）和阿立哌唑（18.6%）分别是最常见的典型和非典型抗精神病药物。就儿科疾病而言，常见的诊断包括情绪或情感障碍（31.7%）以及行为和情感障碍，通常在儿童和青少年时期发病（29.1%）。此外，抑郁状态是使用抗精神病药物进行治疗的最常见诊断：在这项回顾性研究中，标签外抗精神病药物处方很常见，从2016年到2021年，儿童和青少年的处方量普遍呈上升趋势。然而，缺乏支持标示外使用的证据，因此强调有必要对这些治疗方法的有效性和安全性进行研究。

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来源期刊

Child and Adolescent Psychiatry and Mental Health PEDIATRICSPSYCHIATRY-PSYCHIATRY

CiteScore

7.00

自引率

3.60%

发文量

审稿时长

16 weeks

期刊介绍： Child and Adolescent Psychiatry and Mental Health, the official journal of the International Association for Child and Adolescent Psychiatry and Allied Professions, is an open access, online journal that provides an international platform for rapid and comprehensive scientific communication on child and adolescent mental health across different cultural backgrounds. CAPMH serves as a scientifically rigorous and broadly open forum for both interdisciplinary and cross-cultural exchange of research information, involving psychiatrists, paediatricians, psychologists, neuroscientists, and allied disciplines. The journal focusses on improving the knowledge base for the diagnosis, prognosis and treatment of mental health conditions in children and adolescents, and aims to integrate basic science, clinical research and the practical implementation of research findings. In addition, aspects which are still underrepresented in the traditional journals such as neurobiology and neuropsychology of psychiatric disorders in childhood and adolescence are considered.