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Published on: December 7, 2018
Off-label Prescribing Trends for ADHD Medications in Very Young Children
Shannon G Panther1, Alice M Knotts1, Tamara Odom-Maryon1
1College of Pharmacy (SGP, AMK), Washington State University, Spokane, Washington, College of Nursing (KD, TAK, TO), Washington State University, Vancouver and Spokane, Washington, and School of Nursing (TW), Pacific Lutheran University, Tacoma, Washington.
Insights
Most Attention-Deficit/Hyperactivity Disorder (ADHD) medications prescribed for children under 6 years old are off-label. This is concerning due to limited safety and efficacy data in this young population.
Area of Science:
- Pediatric pharmacology
- Medication safety
- Public health
Background:
- Attention-Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder in children.
- Medication is a primary treatment for ADHD, but prescribing patterns vary by age.
- Off-label prescribing is common in pediatrics, particularly for younger age groups.
Purpose of the Study:
- To examine off-label medication prescribing for Attention-Deficit/Hyperactivity Disorder (ADHD) in children covered by Medicaid.
- To analyze prescribing trends with a specific focus on very young children (under 6 years).
Main Methods:
- Observational cohort study utilizing retrospective analysis of Oregon Medicaid prescription data from 2012.
- Inclusion criteria: Children aged 3-18 years with ADHD and continuous Medicaid enrollment for at least 10 months.
- Off-label status determined by manufacturer prescribing information.
Main Results:
- A high percentage (91.4%) of ADHD medication prescriptions for children aged 3-5 years were off-label.
- Off-label prescribing significantly decreased to 21% for children over 5 years old.
- Concerns in the 3-5 year group included frequent alpha-agonist use, untested formulations (clonidine patches), atomoxetine, and high-dose stimulants.
Conclusions:
- The majority of Attention-Deficit/Hyperactivity Disorder (ADHD) medications used in very young children are prescribed off-label.
- This practice is concerning due to the lack of established safety and efficacy data for this vulnerable population.
- Further research is needed to ensure safe and effective ADHD treatment in young children.
Objective:
This study examines off-label medication prescribing use and trends in children on Medicaid with ADHD with particular focus on the very young (under age 6 years).
Methods:
This was an observational cohort study and retrospective analysis of ADHD medication prescriptions from Oregon Medicaid records (N = 83,190) in 2012. Manufacturer prescribing information was used to determine off-label designation. Children ages 3 to 18 years at the time of prescription who had continuous Medicaid enrollment of at least 10 months during the index year of 2012 were included in the sample frame.
Results:
Children with ADHD were prescribed off-label medications primarily at the ages of 5 years and younger. Among children ages 3 to 5 years, 91.4% of prescriptions were off-label. After the age of 5 years, the percentage of off-label prescriptions dropped notably to 21%, reflecting the increase in availability of approved medications for the treatment of ADHD starting at age 6 years. In the 3- to 5-year-old age group, specific off-label and concerning medication-related observations included a high frequency of alpha agonist (e.g., guanfacine, clonidine) prescribing; the prescribing of untested formulations such as clonidine patches; prescribing of atomoxetine; and prescribing of large doses of stimulant medications.
Conclusions:
Most ADHD drugs prescribed for very young children are off-label, which is concerning owing to lack of safety and efficacy data in this vulnerable population.
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