The impact of pediatric labeling changes on prescribing patterns of cough and cold medications

J Pediatr. 2014 Nov;165(5):1024-8.e1. doi: 10.1016/j.jpeds.2014.07.047. Epub 2014 Sep 5.


Objective: To evaluate the impact of initiatives created by the pharmaceutical industry and the Food and Drug Administration to limit the use of over-the-counter (OTC) cough and cold medications (CCMs) in young children in emergency departments (EDs) and ambulatory clinics.

Study design: Analysis of the National Hospital Ambulatory Medical Care Survey and National Ambulatory Medical Care Survey was performed comparing 2005-2006 and 2009-2010 in children aged ≤ 12 years with a reason for visit consistent with cough or cold-related symptoms. Data were stratified by age (<2 years, 2-6 years, and 6-12 years). Descriptive frequencies and survey-weighted χ(2) tests were used to assess OTC and prescription CCM prescription rates in ED and ambulatory clinic settings.

Results: Comparing 2005-2006 and 2009-2010 revealed no changes in ED use of OTC CCMs; however, the use of prescription CCMs decreased, from 6.7% to 2.9% (P = .001). In ambulatory clinics, the overall rate of OTC CCM use increased from 6.3% to 11.1% (P = .001); however, use by children aged <2 years was unchanged. Prescription CCM use in EDs declined in all age groups, but in ambulatory clinics, decreases were significant only in patients aged <2 years.

Conclusion: Implementation of pharmaceutical industry and Food and Drug Administration initiatives did not decrease the use of OTC CCMs in children aged <2 years in EDs or ambulatory clinics. The use of prescription CCMs was decreased in both settings, however.

MeSH terms

  • Adolescent
  • Child
  • Child, Preschool
  • Common Cold / drug therapy*
  • Cough / drug therapy*
  • Drug Labeling*
  • Drug Prescriptions / statistics & numerical data*
  • Emergency Service, Hospital / statistics & numerical data
  • Female
  • Health Care Surveys
  • Humans
  • Infant
  • Male
  • Nonprescription Drugs / administration & dosage*
  • Outpatient Clinics, Hospital / statistics & numerical data
  • Practice Patterns, Physicians' / statistics & numerical data*
  • Retrospective Studies
  • United States
  • United States Food and Drug Administration


  • Nonprescription Drugs