The impact of more restrictive hydrocodone rescheduling on unintentional pediatric opioid exposures.

Pharmacoepidemiol Drug Saf

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.

Published: June 2024

AI Article Synopsis

  • The study aimed to evaluate the effects of rescheduling hydrocodone combination products (HCPs) from a less restrictive schedule III to a more restrictive schedule II on unintentional pediatric exposures in children aged 5 and under.
  • Analysis of U.S. data showed that after the rescheduling in October 2014, there was a significant drop in pediatric emergency department visits and poison center cases related to hydrocodone, decreasing by over 50%, while oxycodone cases remained stable and codeine cases slightly increased.
  • The results suggest that the rescheduling contributed to a notable reduction in unintentional hydrocodone exposures among children, highlighting the need for continued efforts to reduce pediatric medication poisonings as a

Article 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.

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Source
http://dx.doi.org/10.1002/pds.5793DOI Listing

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