Effect of FDA Investigation on Opioid Prescribing to Children After Tonsillectomy/Adenoidectomy
Effect of FDA Investigation on Opioid Prescribing to Children After Tonsillectomy/Adenoidectomy
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DOI：
10.1542/peds.2017-1765
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发表时间：
2017-12-01
期刊：
影响因子：
8
通讯作者：
Conti, Rena M.
中科院分区：
文献类型：
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作者：
Chua, Kao-Ping;Shrime, Mark G.;Conti, Rena M.
背景：2012年8月，美国食品和药物管理局调查了扁桃体切除术和/或腺样体切除术后儿童使用可待因的安全性，并于2013年2月发布了黑框警告。本研究的目的是评估调查与阿片类药物处方给接受这些手术的儿童之间的关系。方法：我们在2010-2015年Truven MarketScan商业索赔和遭遇数据库中确定了362 992名接受扁桃体切除术和/或腺样体切除术的私人保险儿童。采用中断时间序列设计，我们估计了手术后7天内使用>= 1处方可待因填充剂和>= 1替代阿片类药物（如氢可酮）填充剂的儿童比例的水平和斜率变化。结果：该调查与扁桃体切除术和/或腺样体切除术后使用>= 1处方填充可待因的儿童比例显著变化13.3（95%置信区间：-14.5至-12.1）个百分点相关。尽管有所下降，但在2015年12月，仍有5.1%的儿童服用了bb0 = 1份可待因处方。尽管由于其他因素，在研究期间接受替代阿片类药物的儿童比例有所增加，但该调查与替代阿片类药物处方的显着水平变化无关。结论：美国食品和药物管理局的调查大大减少了扁桃体切除术和/或腺样体切除术后儿童的可待因处方。然而，2015年12月，每20名接受这些手术的儿童中仍有1人服用可待因，尽管其安全性和有效性问题已得到充分证明。
BACKGROUND: In August 2012, the Food and Drug Administration investigated the safety of codeine use by children after tonsillectomy and/or adenoidectomy, culminating in a black box warning in February 2013. The objective of this study was to evaluate the association between the investigation and opioid prescribing to children undergoing these surgeries.METHODS: We identified 362 992 privately insured children in the 2010-2015 Truven MarketScan Commercial Claims and Encounters database who underwent tonsillectomy and/or adenoidectomy. Using an interrupted time series design, we estimated level and slope changes in the proportion of children with >= 1 prescription fills for codeine and >= 1 fills for an alternative opioid, such as hydrocodone, within 7 days of surgery.RESULTS: The investigation was associated with a significant -13.3 (95% confidence interval: -14.5 to -12.1) percentage point level change in the proportion of children with >= 1 prescription fills for codeine after tonsillectomy and/or adenoidectomy. Despite this drop, 5.1% of children had >= 1 prescription fills for codeine in December 2015. The investigation was not associated with significant level changes in alternative opioid prescribing, although the proportion of children receiving alternative opioids increased during the study period because of other factors.CONCLUSIONS: The Food and Drug Administration investigation substantially decreased codeine prescribing to children after tonsillectomy and/or adenoidectomy. However, 1 in 20 children undergoing these surgeries were still prescribed codeine in December 2015 despite its well-documented safety and efficacy issues.