Evidence map›Paper›PMID 31527173›Full record

ArticlePediatrics2019

Trends in Off-Label Drug Use in Ambulatory Settings: 2006-2015.

Divya Hoon, Matthew T Taylor, Pooja Kapadia, Tobias Gerhard, Brian L Strom, Daniel B Horton

Abstract read
In one paragraph

Article in Pediatrics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

49 citing papers in PubMed.

  1. Article
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  7. Pediatric Pharmacy Association 2025 KIDs List of Key Potentially Inappropriate Drugs in Pediatrics.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025
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  8. Article
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  11. Review
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  14. Article
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  16. Acid-suppressive medication and incidence of chronic childhood immune-mediated diseases: A scoping review.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2023
    Article
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Divya HoonRutgers Robert Wood Johnson Medical School.
Matthew T TaylorRutgers Center for Pharmacoepidemiology and Treatment Science, Institute for Health, Health Care Policy, and Aging Research, Rutgers University, New Brunswick, New Jersey.
Pooja KapadiaRutgers Robert Wood Johnson Medical School.
Tobias GerhardRutgers Center for Pharmacoepidemiology and Treatment Science, Institute for Health, Health Care Policy, and Aging Research, Rutgers University, New Brunswick, New Jersey.
Brian L StromRutgers Center for Pharmacoepidemiology and Treatment Science, Institute for Health, Health Care Policy, and Aging Research, Rutgers University, New Brunswick, New Jersey.
Daniel B HortonRutgers Center for Pharmacoepidemiology and Treatment Science, Institute for Health, Health Care Policy, and Aging Research, Rutgers University, New Brunswick, New Jersey; daniel.horton@rutgers.edu.

Funding

Drugs, Germs, and Joints: Antibiotics, Gut Microbiota, and Juvenile Idiopathic ArthritisK23AR070286 · NIAMS · RBHS-ROBERT WOOD JOHNSON MEDICAL SCHOOL · PI HORTON, DANIEL BENJAMIN · 2016 to 2020
$909k
NIAMS NIH HHS K23 AR070286NIAMS NIH HHS L40 AR070497
6 · The paper itself

Abstract

backgroundOff-label drug use in children is common and potentially harmful. In most previous off-label use research, authors studied hospitalized children, specific drug classes, or non-US settings. We characterized frequencies, trends, and reasons for off-label systemic drug orders for children in ambulatory US settings.

methodsUsing nationally representative surveys of office-based physicians (National Ambulatory Medical Care Surveys, 2006-2015), we studied off-label orders of systemic drugs for children age <18 based on US Food and Drug Administration-approved labeling for age, weight, and indication. We characterized the top classes and diagnoses with off-label orders and analyzed factors and trends of off-label orders using logistic regression.

resultsPhysicians ordered ≥1 off-label systemic drug at 18.5% (95% confidence interval: 17.7%-19.3%) of visits, usually (74.6%) because of unapproved conditions. Off-label ordering was most common proportionally in neonates (83%) and in absolute terms among adolescents (322 orders out of 1000 visits). Off-label ordering was associated with female sex, subspecialists, polypharmacy, and chronic conditions. Rates and reasons for off-label orders varied considerably by age. Relative and absolute rates of off-label orders rose over time. Among common classes, off-label orders for antihistamines and several psychotropics increased over time, whereas off-label orders for several classes of antibiotics were stable or declined.

conclusionsUS office-based physicians have ordered systemic drugs off label for children at increasing rates, most often for unapproved conditions, despite recent efforts to increase evidence and drug approvals for children. These findings can help inform education, research, and policies around effective, safe use of medications in children.

Indexed as

AdolescentAge DistributionAmbulatory Care FacilitiesAnti-Bacterial AgentsChildChild, PreschoolConfidence IntervalsCross-Sectional StudiesFemaleHealth Care SurveysHistamine AntagonistsHumansInfantInfant, NewbornLogistic ModelsMaleAnti-Bacterial AgentsHistamine AntagonistsPsychotropic Drugs

Identifiers

PMID31527173
PMCPMC7286122

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.