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Comparing prescribing patterns for topical corticosteroids based on their FDA indication by age
Megan E Freeze1, Esther A Balogh1, Abigail Cline1
1Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC, USA.
Insights
Topical corticosteroids (TCS) are frequently prescribed off-label for pediatric atopic dermatitis (AD), indicating a gap between clinical practice and FDA guidelines. Further research is needed to ensure safe and effective use in younger patients.
Area of Science:
- Dermatology
- Pediatrics
- Pharmacology
Background:
- Atopic dermatitis (AD) affects up to 20% of children, with increasing prevalence.
- Topical corticosteroids (TCS) are a common first-line treatment for AD, used in 59% of visits.
- Concerns exist regarding the prescription of TCS outside of their FDA-approved age indications.
Purpose of the Study:
- To investigate the frequency of off-label topical corticosteroid prescribing for atopic dermatitis based on age.
- To identify specific TCS and age groups with higher rates of off-label use.
Main Methods:
- Prescribing data for AD were analyzed from the National Ambulatory Medical Care Survey (NAMCS).
- Off-label use was assessed by comparing prescriptions to FDA-approved age indications across four age groups (0-1, 2-7, 8-18, and 19+ years).
Main Results:
- While all identified TCS had indications for dermatoses, some were prescribed off-label.
- Off-label prescription rates varied significantly, with desoximetasone at 52% and halobetasol/alclometasone at 0% or undetectable rates.
Conclusions:
- Off-label use of TCS for pediatric AD is prevalent, highlighting a discrepancy with regulatory guidelines.
- Further pediatric studies are recommended to gather evidence for maintaining or expanding TCS label indications in younger populations.
Background/Objectives:
Atopic dermatitis (AD) affects up to 20% of the pediatric population, with a growing prevalence over the past 30 years. Topical corticosteroids (TCS) are commonly used as a first-line topical therapy for AD and are prescribed in 59% of all AD visits. However, some topical corticosteroids are prescribed outside of their age range indications. This paper aims to explore the frequency with which topical corticosteroids are prescribed for AD outside of their FDA-approved age range.
Methods:
Data on prescribing patterns for AD were obtained from the National Ambulatory Medical Care Survey (NAMCS). We assessed the frequency of off-label use of topical corticosteroids with respect to age indications in four specific age-groups, as delineated in the data (0-1, 2-7, 8-18, and 19+ years).
Results:
All prescribed topical corticosteroids found in the NAMCS database have an indication for AD or other inflammatory dermatoses or pruritic dermatoses. However, some medications were prescribed outside of their FDA-approved age indications. These off-label prescription rates ranged from 52% for desoximetasone to 0% for halobetasol and alclometasone, or rates lower than could be detected by our study.
Conclusions:
Much like other medications for AD treatment, TCS are sometimes used off-label. The off-label use of topical corticosteroids to treat pediatric AD highlights a gap between clinical practice and regulating guidelines. Additional pediatric studies would offer a greater body of evidence to maintain or expand label indications for the use of TCS in younger patients.
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