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

ABSTRACT

CONTENT 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. OBJECTIVE: 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. RESULTS: 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%). CONCLUSIONS: The use of off-label medications in children remains a common practice for pediatric providers.