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加巴喷丁治疗双相障碍的兴衰:一个关于标签外药物扩散的案例研究。

The rise and fall of gabapentin for bipolar disorder: a case study on off-label pharmaceutical diffusion.

机构信息

Department of Health Care Policy, Harvard Medical School, 180 Longwood Avenue, Boston, MA 02478, USA.

出版信息

Med Care. 2010 Apr;48(4):372-9. doi: 10.1097/MLR.0b013e3181ca404e.

DOI:10.1097/MLR.0b013e3181ca404e
PMID:20195173
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4879613/
Abstract

CONTEXT

Rising drug costs have increased focus on how new pharmaceuticals diffuse into the marketplace. The case of gabapentin use in bipolar disorder provides an opportunity to study the roles of marketing, clinical evidence, and prior authorization (PA) policy on off-label medication use.

DESIGN

Observational study using Medicaid administrative and Verispan marketing data. We examined the association between marketing, clinical trials, and prior authorization on gabapentin use.

SETTING AND PATIENTS

Florida Medicaid, bipolar disorder-diagnosed enrollees ages 18 to 64 for fiscal years 1994 to 2004.

RESULTS

Gabapentin prescriptions increased from 8/1000 enrollees per quarter in 1994 to a peak of 387/1000 enrollees in 2002. Its uptake tracked marketing efforts towards psychiatrists. The publication of 2 negative clinical trials in 2000 and the discontinuation of marketing expenditures towards psychiatrists were associated with an end to the steep rise in gabapentin prescriptions. After these events gabapentin use remained between 319/1000 and 387/1000 enrollees per quarter until the PA policy, which was associated with a 45% decrease in prescriptions filled. After 1 year, scientific evidence and marketing discontinuation were associated with a 5.4 percentage point decrease in the predicted probability of filling a gabapentin prescription and the PA policy, a 7.1 percentage point decrease.

CONCLUSIONS

Pharmaceutical marketing can influence off-label medication prescribing, particularly when pharmacologic options are limited. Evidence of inefficacy and/or the cessation of pharmaceutical marketing, and a restrictive formulary policy can alter prescriber behavior away from targeted pharmacologic treatments. These results suggest that both information and policy are important means in altering physician prescribing behavior.

摘要

背景

药品成本的上升使得人们更加关注新药品如何进入市场。加巴喷丁在双相情感障碍中的使用情况为研究市场营销、临床证据和事先授权(PA)政策对非标签药物使用的作用提供了机会。

设计

使用医疗补助管理和 Verispan 营销数据的观察性研究。我们研究了市场营销、临床试验和事先授权对加巴喷丁使用的影响。

设置和患者

1994 年至 2004 年,佛罗里达州医疗补助,年龄在 18 至 64 岁的双相情感障碍诊断患者。

结果

加巴喷丁的处方从 1994 年每季度每千名参保人 8 例增加到 2002 年的每千名参保人 387 例。其采用与向精神科医生进行营销努力有关。2000 年发表的 2 项负面临床试验和停止向精神科医生进行营销支出与加巴喷丁处方的急剧增加结束有关。这些事件发生后,加巴喷丁的使用量仍保持在每千名参保人 319 至 387 例之间,直到 PA 政策生效,这与处方数量减少 45%有关。1 年后,科学证据和营销停止与填写加巴喷丁处方的预测概率降低 5.4 个百分点以及 PA 政策降低 7.1 个百分点有关。

结论

制药营销可以影响非标签药物的处方,尤其是当药理学选择有限时。无效证据和/或制药营销的停止以及限制的配方政策可以改变医生远离目标药物治疗的处方行为。这些结果表明,信息和政策都是改变医生处方行为的重要手段。

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Longitudinal racial/ethnic disparities in antimanic medication use in bipolar-I disorder.双相I型障碍中抗躁狂药物使用的纵向种族/族裔差异。
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