Changes to Prescription Drug Pediatric Labeling: Awareness by Practicing Pediatricians

Ther Innov Regul Sci. 2013 Mar;47(2):214-218. doi: 10.1177/2168479012459854.

Abstract

The US Congress and the US Food and Drug Administration encouraged studies in children so that the labeling information about pediatric use could be updated for pharmaceutical products. Pediatricians receive this updated labeling information through many different sources. A pilot survey was conducted to determine what source pediatricians use to learn about this updated information and whether and when they learned of specific changes. It appears that most pediatricians did not know that there had been recent changes in pediatric drug labels, although changes to drugs that were used more commonly in practice were more likely to be known.

Keywords: labeling; pediatric; pediatrician; prescribing information.