Harvard Medical School and Harvard Pilgrim Healthcare Institute, Department of Population Medicine, 133 Brookline Ave, 6th Floor, Boston, MA 02215, USA.
Pediatrics. 2010 Mar;125(3):475-82. doi: 10.1542/peds.2009-1288. Epub 2010 Feb 8.
The uptake of new antipsychotic medications among children has not been studied adequately. Although ziprasidone received Food and Drug Administration approval for the treatment of psychotic disorders among children in June 2009, it first became available for off-label use by children in 2001 and presented an excellent case study for off-label market entry. The objective of this study was to determine the pattern of initiation and switching for off-label use of ziprasidone among Michigan children who were insured by Medicaid in the first year that ziprasidone was available.
We conducted a retrospective study by using Michigan Medicaid data for patients who were aged <21 years and had 2 years of continuous enrollment and at least 1 prescription for ziprasidone in the first year the medication was available. The main outcome measures were proportion of children prescribed ziprasidone as their first antipsychotic, with evidence of treatment resistance, and by a psychiatrist.
In the first year, 292 individuals who met criteria were prescribed ziprasidone. Approximately 53% had a diagnosis of psychosis. Explosive personality disorder and oppositional defiant disorder were the next most common diagnoses. For 33% of individuals, this was the first antipsychotic medication. Only 12% of individuals showed evidence of treatment resistance to other antipsychotic medications before switching to ziprasidone.
During the period when ziprasidone had no approved pediatric usages, a small percentage of patients who were prescribed ziprasidone showed evidence of treatment resistance, the primary expected indication. Some prescribing for ziprasidone in the first year in this population could be considered inappropriate considering what was known about the safety and efficacy of ziprasidone in children and adolescents at the time. "Fail first" and prior authorization policies may be appropriate in the first year a medication is available so as to protect children from potential serious harm.
儿童新抗精神病药物的使用情况尚未得到充分研究。尽管齐拉西酮于 2009 年 6 月获得美国食品和药物管理局批准用于治疗儿童精神障碍，但该药于 2001 年首次获准用于儿童的标签外使用，为标签外市场准入提供了一个极好的案例研究。本研究的目的是确定在齐拉西酮获准使用的第一年，密歇根州接受医疗补助的儿童中，标签外使用齐拉西酮的起始和转换模式。
我们通过使用密歇根州医疗补助数据对年龄<21 岁且连续 2 年参保且在药物可用的第一年至少有 1 份齐拉西酮处方的患者进行了回顾性研究。主要结局指标为被处方齐拉西酮作为其第一种抗精神病药物的儿童比例，这些儿童有治疗抵抗的证据，且由精神病医生处方。
在第一年，符合标准的 292 名患者被处方齐拉西酮。约 53%的患者有精神分裂症的诊断。暴发性人格障碍和对立违抗性障碍是下一个最常见的诊断。对于 33%的患者来说，这是他们的第一种抗精神病药物。在转换为齐拉西酮之前，只有 12%的个体显示出对其他抗精神病药物治疗有抵抗的证据。
在齐拉西酮没有批准儿科用途的时期，一小部分被处方齐拉西酮的患者表现出治疗抵抗的证据，这是主要的预期指征。考虑到当时已知的齐拉西酮在儿童和青少年中的安全性和疗效，在该人群中，该药在第一年的某些处方可能被认为是不合适的。在药物可用的第一年，“先失败后授权”和事先授权政策可能是合适的，以保护儿童免受潜在的严重伤害。
