Pediatric Content in Drug Labeling Has Increased

But only 46 percent of drugs listed in the Physicians' Desk Reference have pediatric information

WEDNESDAY, May 9 (HealthDay News) -- Pediatric content in the labeling of drugs has improved from 1975 to 1999, but still only 46 percent of drug labeling in the electronic Physicians' Desk Reference (ePDR) includes pediatric information, according to research published in the May 9 issue of the Journal of the American Medical Association.

Aaron N. Sachs, from the U.S. Food and Drug Administration in Silver Spring, Md., and colleagues applied methods established by John T. Wilson, M.D., in his 1973 analysis of the print PDR to evaluate labeling in the June 2009 ePDR. Labeling was "adequate" if it stated that the drug was approved for pediatric use; had been studied; or had safety, efficacy, or dosing information for all appropriate pediatric populations. Labeling was "inadequate" if it lacked data on dosing, safety, or efficacy in at least one pediatric subpopulation. "Partially labeled" was defined as adequate labeling for at least one but not all pediatric subpopulations.

The researchers analyzed 560 products in the ePDR. Of those, 231 (41 percent) were adequately labeled and 29 (5 percent) were partially labeled for pediatric use. If products deemed not relevant to pediatric use were excluded from the analysis, 231 of 461 (50 percent) were adequately labeled for pediatric use and 29 (6 percent) were partially labeled.

"Labeling with pediatric information in only 46 percent of products is still insufficient," the authors conclude. "Legislation to increase pediatric clinical trials and require the resulting information be added to labeling is necessary."

Full Text (subscription or payment may be required)

Copyright © 2012 HealthDay. All rights reserved.

Powered by

jQuery UI Accordion - Default functionality

For life-long learning and continuing professional development, come to Lippincott's NursingCenter.

Nursing Jobs Plus
Featured Jobs
Recommended CE Articles

Blunt Chest Trauma
Journal of Trauma Nursing, November/December 2014
Expires: 12/31/2016 CE:2 $21.95

The School Age Child with Congenital Heart Disease
MCN, The American Journal of Maternal/Child Nursing, January/February 2015
Expires: 2/28/2017 CE:2.5 $24.95

Understanding multiple myeloma
Nursing Made Incredibly Easy!, January/February 2015
Expires: 2/28/2017 CE:2 $21.95

More CE Articles

Subscribe to Recommended CE

Recommended Nursing Articles

Comprehensive Care: Looking Beyond the Presenting Problem
Journal of Christian Nursing, January/March 2015
Free access will expire on March 2, 2015.

Pain and Alzheimer dementia: A largely unrecognized problem
Nursing Made Incredibly Easy!, January/February 2015
Free access will expire on February 16, 2015.

Glycemic control in hospitalized patients
Nursing2015 Critical Care, January 2015
Free access will expire on February 16, 2015.

More Recommended Articles

Subscribe to Recommended Articles

Evidence Based Practice Skin Care Network NursingCenter Quick Links What’s Trending Events