美国食品药品监督管理局（FDA）发布含唑吡坦药物的药品安全通讯后，处方及医疗资源利用情况的变化

Changes in prescribing and healthcare resource utilization after FDA Drug Safety Communications involving zolpidem-containing medications.

作者信息

Kesselheim Aaron S, Donneyong Macarius, Dal Pan Gerald J, Zhou Esther H, Avorn Jerry, Schneeweiss Sebastian, Seeger John D

机构信息

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE), Boston, MA, USA.

出版信息

Pharmacoepidemiol Drug Saf. 2017 Jun;26(6):712-721. doi: 10.1002/pds.4215. Epub 2017 Apr 27.

DOI:10.1002/pds.4215

PMID:28449404

Abstract

PURPOSE

Products containing the sedative/hypnotic zolpidem were subject to Drug Safety Communications (DSCs) in January and May 2013 describing the risk of next-morning impairment and recommending lower starting doses particularly for women. This study aimed to assess whether zolpidem DSCs were associated with prescribing-pattern changes between January 2011 and December 2013.

METHODS

We assessed overall dispensings of zolpidem-containing products between January 2011 and December 2013 by conducting a time-series analysis. Analyses were stratified by gender because the DSC contained gender-specific information. Participants were patients drawn from the Optum Clinformatics data source of commercially insured people in the USA. We evaluated changes in mean prescribed dose of the two drugs and health care utilization metrics.

RESULTS

Each month of the study, more than 80 000 patients received a zolpidem-containing product and approximately one-tenth as many received eszopiclone. The two DSCs did not affect the downward trajectory of new zolpidem prescriptions. However, there was an increase in use of lower-dose forms of zolpidem (30% increase, p < 0.001), coupled with a reduction in higher-dose forms (13% decrease, p = 0.03), so that the average dose decreased after the DSCs (from 9.7 mg to 9.4 mg, p < 0.001), a change that was not seen with eszopiclone (from 2.74 mg to 2.74 mg, p = 0.45).

CONCLUSION

摘要

目的

含镇静催眠药唑吡坦的产品在2013年1月和5月受到了药品安全通报（DSC），通报描述了次晨功能损害风险，并建议特别是对女性使用更低的起始剂量。本研究旨在评估唑吡坦药品安全通报是否与2011年1月至2013年12月期间的处方模式变化相关。

方法

我们通过进行时间序列分析，评估了2011年1月至2013年12月期间含唑吡坦产品的总体配药量。由于药品安全通报包含特定性别的信息，分析按性别进行分层。参与者是从美国商业保险人群的Optum临床信息数据源中抽取的患者。我们评估了这两种药物的平均处方剂量和医疗保健利用指标的变化。

结果

在研究的每个月，超过80000名患者接受了含唑吡坦的产品，接受艾司佐匹克隆的患者约为前者的十分之一。两份药品安全通报并未影响唑吡坦新处方的下降趋势。然而，唑吡坦低剂量剂型的使用有所增加（增加了30%，p<0.001），同时高剂量剂型的使用有所减少（减少了13%，p=0.03），因此在药品安全通报发布后平均剂量下降了（从9.7毫克降至9.4毫克，p<0.001），而艾司佐匹克隆未出现这种变化（从2.74毫克降至2.74毫克，p=0.45）。