Libby Anne M, Orton Heather D, Valuck Robert J
School of Public Health, University of Colorado Denver, 13055 E 17th Ave, Nighthorse Campbell Native Health Building, Campus Box F800, Aurora, CO 80045, USA.
Arch Gen Psychiatry. 2009 Jun;66(6):633-9. doi: 10.1001/archgenpsychiatry.2009.46.
In October 2003 the Food and Drug Administration (FDA) issued a Public Health Advisory about the risk of suicidality for pediatric patients taking antidepressants; a boxed warning, package insert, and medication guide were implemented in February 2005. The warning was extended to young adults aged 18 to 24 years in May 2007. Immediately following the 2003 advisory, unintended declines in case finding and non-selective serotonin reuptake inhibitor substitute treatment were shown for pediatric patients, and spillover effects were seen in adult patients, who were not targeted by the warnings.
To determine whether the unintended declines in depression care persisted for pediatric, young adult, and adult patients.
Time series analyses.
Ambulatory care settings nationally. Patients Pediatric, young adult, and adult cohorts of patients with new episodes of depression (n = 91 748, 70 311, and 630 748 episodes, respectively).
Post-FDA advisory trends were compared with expected trends based on preadvisory patterns using a national integrated managed care claims database from July 1999 through June 2007.
Depression diagnosis; antidepressant, antipsychotic, and anxiolytic prescriptions; and psychotherapy visits.
Changes in pediatric depression care were similar to changes for adults. National diagnosis rates of depression returned to 1999 levels for pediatric patients and below 2004 levels for adults. Primary care providers continued significant reductions in new diagnoses of depression (44% lower for pediatric, 37% lower for young adults, 29% for adults); diagnoses by mental health providers who were not psychiatrists increased. Numbers of prescriptions of anxiolytic and atypical antipsychotic medications did not significantly change from preadvisory trends. Psychotherapy increased significantly for adult, though not pediatric, cases. Selective serotonin reuptake inhibitor use decreased in all cohorts; serotonin-norepinephrine reuptake inhibitor increased for adults.
Diagnosing decreases persist. Substitute care did not compensate in pediatric and young adult groups, and spillover to adults continued, suggesting that unintended effects are nontransitory, substantial, and diffuse in a large national population. Policy actions are required to counter the unintended consequences of reduced depression treatment.
2003年10月,美国食品药品监督管理局(FDA)发布了一份关于服用抗抑郁药的儿科患者自杀风险的公共卫生咨询;2005年2月实施了黑框警告、药品说明书和用药指南。2007年5月,该警告范围扩大至18至24岁的青年成人。在2003年的咨询发布后,立即出现了儿科患者病例发现的意外下降以及非选择性5-羟色胺再摄取抑制剂替代治疗的情况,并且在未被警告针对的成年患者中也出现了溢出效应。
确定抑郁症治疗的意外下降在儿科、青年成人和成年患者中是否持续存在。
时间序列分析。
全国范围内的门诊医疗机构。患者 新发生抑郁症发作的儿科、青年成人和成年患者队列(分别有91748、70311和630748例发作)。
利用1999年7月至2007年6月的全国综合管理医疗索赔数据库,将FDA咨询发布后的趋势与基于咨询发布前模式的预期趋势进行比较。
抑郁症诊断;抗抑郁药、抗精神病药和抗焦虑药处方;以及心理治疗就诊次数。
儿科抑郁症治疗的变化与成人相似。儿科患者的全国抑郁症诊断率恢复到1999年的水平,而成人则低于2004年的水平。初级保健提供者对抑郁症新诊断的减少仍很显著(儿科降低44%,青年成人降低37%,成人降低29%);非精神科医生的心理健康提供者做出的诊断有所增加。抗焦虑药和非典型抗精神病药的处方数量与咨询发布前的趋势相比没有显著变化。成人病例的心理治疗显著增加,但儿科病例没有。所有队列中选择性5-羟色胺再摄取抑制剂的使用均减少;成人中5-羟色胺-去甲肾上腺素再摄取抑制剂的使用增加。
诊断减少的情况持续存在。替代治疗在儿科和青年成人组中没有起到补偿作用,并且对成人的溢出效应仍在继续,这表明意外影响在全国大量人群中是持久的、实质性的和广泛存在的。需要采取政策行动来应对抑郁症治疗减少带来的意外后果。