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

Maryann Mazer-Amirshahi1, Irit Rasooly2, Gill Brooks3

  • 1Department of Clinical Pharmacology, Children's National Medical Center, Washington, DC; Department of Emergency Medicine, MedStar Washington Hospital Center, Washington, DC.

The Journal of Pediatrics
|September 8, 2014
PubMed

Insights

Pharmaceutical industry and FDA initiatives did not reduce over-the-counter cough and cold medication use in young children. Prescription medication use decreased in emergency departments and clinics.

Area of Science:

  • Pediatrics
  • Pharmacology
  • Public Health

Background:

  • Over-the-counter (OTC) cough and cold medications (CCMs) are widely used in children.
  • Concerns exist regarding the safety and efficacy of CCMs in young children.
  • Regulatory bodies and the pharmaceutical industry have implemented initiatives to limit CCM use in this population.

Purpose of the Study:

  • To evaluate the impact of pharmaceutical industry and Food and Drug Administration (FDA) initiatives on CCM use in children.
  • To assess changes in the utilization of OTC and prescription CCMs in emergency departments (EDs) and ambulatory clinics.

Main Methods:

  • Analysis of national survey data (National Hospital Ambulatory Medical Care Survey and National Ambulatory Medical Care Survey) from 2005-2006 and 2009-2010.
  • Comparison of CCM prescription rates in children aged 12 years or younger presenting with cough or cold symptoms.
  • Stratification of data by age groups: <2 years, 2-6 years, and 6-12 years.

Main Results:

  • No significant change in the use of OTC CCMs in children under 2 years old in EDs or clinics.
  • A significant increase in OTC CCM use was observed in ambulatory clinics overall (6.3% to 11.1%).
  • Prescription CCM use decreased in EDs across all age groups and in ambulatory clinics for children under 2 years old.

Conclusions:

  • FDA and pharmaceutical industry initiatives were ineffective in reducing OTC CCM use in young children.
  • Prescription CCM use showed a decline in both emergency and ambulatory care settings.
  • Further strategies may be needed to effectively limit OTC CCM use in pediatric populations.
Abstract

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