Office of Pharmacovigilance and Epidemiology (OPE), Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
Office of Biostatistics (OB), Office of Translational Science (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
Pharmacoepidemiol Drug Saf. 2024 Jun;33(6):e5793. doi: 10.1002/pds.5793.
To evaluate the impact of rescheduling hydrocodone combination products (HCPs) from schedule III of the Controlled Substances Act to the more restrictive schedule II on unintentional pediatric exposures (≤5 years old).
Using U.S. data on outpatient retail pharmacy dispensing, emergency department (ED) visits, and poison center (PC) exposure cases, we assessed trends in prescriptions dispensed and unintentional pediatric exposure cases involving hydrocodone (rescheduled from III to II) compared to oxycodone (schedule II) and codeine (schedule III for combination products) using descriptive and interrupted time-series (ITS) analyses during the 16 quarters before and after the October 2014 rescheduling of HCPs.
Dispensing of hydrocodone products was declining before rescheduling but declined more steeply post-rescheduling. In ITS analyses, both hydrocodone and oxycodone had significant slope decreases in PC case rates in the post versus pre-period that was larger for hydrocodone, while codeine had a small but significant slope increase in PC case rates. An estimated 4202 ED visits for pediatric hydrocodone exposures occurred in the pre-period and 2090 visits occurred in the post-period, a significant decrease of 50.3%. Oxycodone exposures showed no significant decrease.
Pediatric hydrocodone unintentional exposure ED visits and PC cases decreased after HCP rescheduling more than would be expected had the pre-rescheduling trend continued; the acceleration in the decrease in hydrocodone PC cases was partially offset by a slowing in the decrease in codeine-involved cases. The trend changes were likely due to multiple factors, including changes in dispensing that followed the rescheduling. Unintentional pediatric medication exposures and poisonings remain a public health concern requiring ongoing, multifaceted mitigation efforts.
评估将氢可酮复方制剂（HCPs）从《管制物质法》附表 III 重新安排到更具限制性的附表 II 对意外儿科暴露（≤5 岁）的影响。
利用美国关于门诊零售药房配药、急诊部（ED）就诊和中毒控制中心（PC）暴露病例的数据，我们使用描述性和中断时间序列（ITS）分析，评估了氢可酮（从 III 重新安排到 II）与羟考酮（II 类）和可待因（复方产品 III 类）处方配药和意外儿科暴露病例的趋势在 HCPs 于 2014 年 10 月重新安排前后的 16 个季度。
重新安排前氢可酮产品的配药量呈下降趋势，但重新安排后下降更为陡峭。在 ITS 分析中，氢可酮和羟考酮在 PC 病例率方面都出现了斜率显著下降，而在重新安排后时期下降幅度更大，而可待因在 PC 病例率方面斜率略有但显著增加。在重新安排前时期，估计有 4202 例儿科氢可酮暴露的 ED 就诊，而在重新安排后时期有 2090 例就诊，显著减少了 50.3%。羟考酮暴露没有显著减少。
在 HCP 重新安排后，儿科氢可酮意外暴露 ED 就诊和 PC 病例数量下降幅度超过了预期，如果继续保持重新安排前的趋势；氢可酮 PC 病例下降速度的加快部分被涉及可待因病例下降速度放缓所抵消。这种趋势变化可能是多种因素造成的，包括重新安排后配药的变化。意外的儿科药物暴露和中毒仍然是一个公共卫生问题，需要持续采取多方面的缓解措施。
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