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J Okla State Med Assoc. 2018 Oct;111(8):776-783.

Off-Label Medication use in Children, More Common than We Think: A Systematic Review of the Literature.

Author information

Department of Pediatrics: Section of Pediatric Critical Care, University of Oklahoma College of Medicine, Oklahoma City, OK.
Department of Pediatrics: Section of General and Community Pediatrics, University of Oklahoma College of Medicine, Oklahoma City, OK.
Department of Pediatrics: Section of Neonatology, University of Oklahoma College of Medicine, Oklahoma City, OK.
University of Oklahoma College of Pharmacy, Department of Pharmacy: Clinical and Administrative Science, Oklahoma City, USA.



Clinician prescribing of off-label medications is common due to a lack of pediatric-specific data regarding the dosing, efficacy and safety of medications regularly prescribed to children.


This systematic review summarizes the published incidence of off-label medication use in children from the past 10 years. We also performed a retrospective chart review to determine the incidence of off-label prescriptions for children seen in the OU Physicians clinics.

Data Sources:

We conducted a literature search of PubMed and OVID Medline from 2007 to 2017. Search terms included off-label use of medications and all child. For the local review, the outpatient electronic medical record (EMR) was queried.

Study Selection:

Studies were eligible for inclusion if the study included children < 18 years of age, defined off-label use in the paper, and included the incidence of off-label drug use.

Data Extraction:

Each review author extracted the study data from their assigned studies. For the retrospective chart review, the EMR was queried for patients <21 years of age who had a clinic visit and received a new prescription during 2017.


We identified 31 studies, with off-label prescription rates from 3.2 % to 95%. The local retrospective chart review included 1,323 prescriptions; 504 were off-label (38.1%) and 819 were approved. The frequency of off-label prescriptions does not differ significantly between the meta-analysis from the systematic review and the local retrospective chart review (30.9% vs 38.1%).


The use of off-label medications in children remains a common practice for pediatric providers.


Conflict of interest statement

Conflicts of Interest and Disclosures The authors declare no pertinent conflict of interest and did not receive funding for this project.

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