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The impact of more restrictive hydrocodone rescheduling on unintentional pediatric opioid exposures
Celeste Mallama1, Sara Karami1, Di Zhang2
1Office 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.
Insights
Rescheduling hydrocodone combination products (HCPs) to schedule II significantly decreased pediatric emergency department visits and poison center cases. This regulatory change impacted unintentional exposure trends for hydrocodone and related medications.
Area of Science:
- Pharmacology
- Public Health
- Drug Policy
Background:
- Hydrocodone combination products (HCPs) were rescheduled from Schedule III to Schedule II of the Controlled Substances Act in October 2014.
- This rescheduling aimed to increase control over these medications due to their potential for abuse and dependence.
- Understanding the impact on pediatric unintentional exposures is crucial for public health and medication safety initiatives.
Purpose of the Study:
- To evaluate the impact of rescheduling hydrocodone combination products (HCPs) to Schedule II on unintentional pediatric exposures (children aged ≤5 years).
- To compare trends in pediatric exposures of hydrocodone with those of oxycodone (Schedule II) and codeine (Schedule III combination products).
Main Methods:
- Utilized U.S. outpatient retail pharmacy dispensing data, emergency department (ED) visits, and poison center (PC) exposure cases.
- Conducted descriptive and interrupted time-series (ITS) analyses.
- Assessed trends in dispensing and pediatric exposure cases during the 16 quarters before and after the October 2014 rescheduling.
Main Results:
- Dispensing of hydrocodone products declined more steeply post-rescheduling.
- Interrupted time-series analyses revealed significant decreases in PC case rates for hydrocodone and oxycodone post-rescheduling, with a larger decrease for hydrocodone.
- Pediatric hydrocodone ED visits decreased by 50.3% (4202 to 2090 visits) post-rescheduling; oxycodone exposures showed no significant change.
Conclusions:
- The rescheduling of HCPs led to a greater-than-expected decrease in pediatric hydrocodone unintentional exposure ED visits and PC cases.
- Changes in dispensing patterns following rescheduling likely contributed to the observed trend changes.
- Despite decreases, unintentional pediatric medication exposures remain a significant public health concern requiring continued mitigation efforts.
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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