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The impact of more restrictive hydrocodone rescheduling on unintentional pediatric opioid exposures.
Mallama, Celeste; Karami, Sara; Zhang, Di; Zhao, Yueqin; Yang, Yuze; Woods, Corinne; Ding, Yulan; Meyer, Tamra; McAninch, Jana.
Afiliação
  • Mallama C; 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.
  • Karami S; 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.
  • Zhang D; 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.
  • Zhao Y; 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.
  • Yang Y; 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.
  • Woods C; 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.
  • Ding Y; 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.
  • Meyer T; 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.
  • McAninch J; 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.
Pharmacoepidemiol Drug Saf ; 33(6): e5793, 2024 Jun.
Article em En | MEDLINE | ID: mdl-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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Oxicodona / Centros de Controle de Intoxicações / Codeína / Controle de Medicamentos e Entorpecentes / Serviço Hospitalar de Emergência / Hidrocodona / Analgésicos Opioides Limite: Child / Child, preschool / Humans / Infant País/Região como assunto: America do norte Idioma: En Revista: Pharmacoepidemiol Drug Saf Assunto da revista: EPIDEMIOLOGIA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Oxicodona / Centros de Controle de Intoxicações / Codeína / Controle de Medicamentos e Entorpecentes / Serviço Hospitalar de Emergência / Hidrocodona / Analgésicos Opioides Limite: Child / Child, preschool / Humans / Infant País/Região como assunto: America do norte Idioma: En Revista: Pharmacoepidemiol Drug Saf Assunto da revista: EPIDEMIOLOGIA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Estados Unidos