Off Label Drug Use In Children
Off Label Drug Use In Children
Write a 1 to 2 page narrative in APA format that addresses the following:
- Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
- Describe strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Include descriptions and names of off-label drugs that require extra care and attention when used in pediatrics. Off Label Drug Use In Children
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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: Off Label Drug Use In Children
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.
Introduction
In comparison to adults, there is limited data pertaining to the dosing, efficacy, and safety of medications in children. This relative lack of data can be attributed to many causes, including unfamiliarity with age-related developmental pharmacology in pediatric patients, ethical considerations with conducting pediatric research, and a lack of financial incentive for the pharmaceutical industry. As a result, over the years there have been many significant therapeutic misadventures with off-label use of medications involving children with thalidomide and chloramphenicol being prominent examples. This lack of knowledge regarding pediatric specific drug use is an on-going area of concern in need of significant research. To address these concerns, Congress approved several pieces of legislation over the last 30 years. provides an overview of the actions created by each bill,[which were designed to stimulate research related to drug pharmacology in pediatric populations. Following introduction of these bills in the United States over the last 15 years, 1200 studies have been submitted to the Food and Drug Administration (FDA), resulting in changes to over 700 medication labels. Other countries have also adopted similar legislation. The European Medicines Agency created the European Pediatric regulation in 2007 in an effort to facilitate the development and availability of medicines for children while Canada created the Pediatric Expert Advisory Committee in 2009 in order to promote the development and licensing of drugs for children Off Label Drug Use In Children.
