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2013 至 2016 年德克萨斯州医疗补助计划儿童和青少年抗精神病药物的标签外使用趋势。

Trends in off-label use of antipsychotic medications among Texas Medicaid children and adolescents from 2013 to 2016.

机构信息

College of Pharmacy, The University of Texas at Austin.

Sookmyung Women's University, Korea.

出版信息

J Manag Care Spec Pharm. 2021 Aug;27(8):1035-1045. doi: 10.18553/jmcp.2021.27.8.1035.

Abstract

Antipsychotics are frequently prescribed for off-label indications in the pediatric population. However, little is known regarding this issue in Texas Medicaid. To (1) describe off-label antipsychotic use among Texas Medicaid children and adolescents and (2) examine factors associated with off-label use. Texas Medicaid prescription and medical claims from January 2013 to August 2016 were analyzed retrospectively among subjects aged 2-17 years with an antipsychotic prescription. Three diagnostic status groups (on-label, off-label, no diagnosis) were categorized based on FDA-approved indications. Descriptive and chi-square tests were conducted to determine if diagnostic status differed by age group (2-4, 5-9, 10-14, and 15-17 years), sex, and antipsychotic type. A logistic regression analysis was used to identify factors associated with off-label use. In this study, 43,792, 44,335, 37,221, and 24,879 (January-August) children with at least 1 antipsychotic prescription were identified from 2013 to 2016, respectively. The proportions with off-label use declined from 66.9% (2013) to 59.8% (2016). Among off-label users, more than one-half (51.3%-55.8%) had a diagnosis of attention-deficit/hyperactivity disorder. Less than 8% (6.0%-7.7%) of subjects had no mental health disorder diagnosis. Chisquare analyses (2015 data) revealed that the proportion of off-label and no diagnosis users combined were significantly ( < 0.01) higher among users aged 5-9 years (82.5%) than adolescents 10-14 years (61.9%) and 15-17 years (56.5%); males (67.7%) than females (65.3%); and first-generation antipsychotics (FGAs; 79.3%) than second-generation antipsychotics (66.7%) users. Logistic regression analyses revealed younger age and FGA users had higher odds of off-label/no diagnosis use. The proportion of off-label/no diagnosis antipsychotic use declined from 2013 to 2016. Younger children and those receiving FGAs were more likely to be off-label antipsychotic users, with attention-deficit/hyperactivity disorder being the most prevalent off-label diagnosis. No outside funding supported this study. The authors have nothing to disclose. This study was presented as an abstract at the American Academy of Child and Adolescent Psychiatry's 67th Annual Meeting (Virtual), October 2020.

摘要

抗精神病药经常被开给儿科患者的标签外适应证。然而,在德克萨斯州医疗补助计划中,关于这个问题的了解甚少。(1)描述德克萨斯州医疗补助计划中儿童和青少年的标签外抗精神病药使用情况,(2)检查与标签外使用相关的因素。对 2013 年 1 月至 2016 年 8 月有抗精神病药处方的 2-17 岁患者的德克萨斯州医疗补助计划处方和医疗索赔进行了回顾性分析。根据 FDA 批准的适应证,将三种诊断状态组(标签内、标签外、无诊断)进行分类。描述性和卡方检验用于确定诊断状态是否因年龄组(2-4、5-9、10-14 和 15-17 岁)、性别和抗精神病药类型而不同。使用逻辑回归分析来确定与标签外使用相关的因素。在这项研究中,分别从 2013 年至 2016 年确定了至少有 1 种抗精神病药处方的 43792、44335、37221 和 24879 名(2013 年至 2016 年 1 月至 8 月)儿童。标签外使用的比例从 2013 年的 66.9%下降到 2016 年的 59.8%。在标签外使用者中,超过一半(51.3%-55.8%)有注意力缺陷/多动障碍的诊断。不到 8%(6.0%-7.7%)的患者没有精神健康障碍的诊断。卡方分析(2015 年数据)显示,5-9 岁年龄组的标签外和无诊断使用者的比例明显(<0.01)高于 10-14 岁(61.9%)和 15-17 岁(56.5%)青少年;男性(67.7%)高于女性(65.3%);第一代抗精神病药(FGAs;79.3%)高于第二代抗精神病药(66.7%)使用者。逻辑回归分析显示,年龄较小和使用 FGAs 的患者标签外/无诊断使用的可能性更高。从 2013 年到 2016 年,标签外/无诊断抗精神病药的使用比例有所下降。年龄较小的儿童和使用 FGAs 的儿童更有可能成为标签外抗精神病药使用者,注意力缺陷/多动障碍是最常见的标签外诊断。本研究无外部资金支持。作者没有要披露的信息。这项研究作为摘要在美国儿科学会第 67 届年会(虚拟)上提出,2020 年 10 月。

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