The rise and fall of gabapentin for bipolar disorder: a case study on off-label pharmaceutical diffusion.
The rise and fall of gabapentin for bipolar disorder: a case study on off-label pharmaceutical diffusion.
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DOI：
10.1097/mlr.0b013e3181ca404e
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发表时间：
2010-04
期刊：
影响因子：
3
通讯作者：
Frank RG
中科院分区：
文献类型：
--
作者：
Fullerton CA;Busch AB;Frank RG
不断上涨的药品成本使人们更加关注新药如何进入市场。加巴喷丁用于双相情感障碍（BPD）的情况下，提供了一个机会，研究的作用，市场营销，临床证据，和事先批准（PA）的政策，标签外用药。使用Medicaid管理和Verispan营销数据的观察性研究。我们研究了加巴喷丁使用的市场营销、临床试验和事先授权之间的关系。1994-2004财政年度，佛罗里达医疗补助计划，BPD诊断的18-64岁注册者。加巴喷丁处方从1994年的每季度8/1000登记者增加到2002年的峰值387/1000登记者。它的吸收追踪了针对精神科医生的营销努力。2000年发表的两项阴性临床试验和停止对精神科医生的营销支出与加巴喷丁处方急剧增加的结束有关。在这些事件发生后，加巴喷丁的使用保持在每季度319/1000和387/1000之间，直到PA政策，这与处方减少45%有关。一年后，科学证据和市场中断与加巴喷丁处方和PA政策的预测概率下降5.4个百分点相关，下降7.1个百分点。药品营销可以影响标签外药物处方，特别是当药理学选择有限时。无效的证据和/或药品销售的停止，以及限制性处方集政策可以改变处方者的行为，远离靶向药物治疗。这些结果表明，信息和政策是改变医生处方行为的重要手段。
Rising drug costs have increased focus on how new pharmaceuticals diffuse into the marketplace. The case of gabapentin use in bipolar disorder (BPD) provides an opportunity to study the roles of marketing, clinical evidence, and prior authorization (PA) policy on off-label medication use. Observational study using Medicaid administrative and Verispan marketing data. We examined the association between marketing, clinical trials, and prior authorization on gabapentin use. Florida Medicaid, BPD-diagnosed enrollees ages 18–64 for fiscal years 1994–2004. 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 two 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 one 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. 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.