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Journal Article

Citation

Mallama C, Karami S, Zhang D, Zhao Y, Yang Y, Woods C, Ding Y, Meyer T, McAninch J. Pharmacoepidemiol. Drug Saf. 2024; 33(6): e5793.

Copyright

(Copyright © 2024, John Wiley and Sons)

DOI

10.1002/pds.5793

PMID

38783553

Abstract

PURPOSE: 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).

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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.


Language: en

Keywords

*Analgesics, Opioid/adverse effects; *Codeine; *Drug and Narcotic Control/legislation & jurisprudence; *Emergency Service, Hospital/statistics & numerical data; *Hydrocodone; *Oxycodone/adverse effects; *Poison Control Centers/statistics & numerical data; child; Child; Child, Preschool; codeine; Drug Combinations; Humans; hydrocodone; Infant; Interrupted Time Series Analysis; opioid epidemic/trends; oxycodone; pediatric; poisoning; United States/epidemiology

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