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Who cares about a label? The effect of pediatric labeling changes on prescription drug utilization

Christopher Ody1, Matt Schmitt2

  • 1Northwestern University, Evanston, USA.

International Journal of Health Economics and Management
|March 20, 2019
PubMed

Insights

Pediatric drug labeling changes significantly impact drug use. Establishing safety and efficacy increases market share by 2.8%, while failure to do so has a minor, insignificant impact.

Area of Science:

  • Pharmacoeconomics
  • Pediatric Pharmacology
  • Health Policy

Background:

  • Off-label drug use is prevalent in pediatric populations.
  • Legislation mandates or incentivizes pediatric clinical trials for drug manufacturers.
  • Changes in drug labeling can affect prescribing patterns.

Purpose of the Study:

  • To assess the impact of pediatric drug labeling changes on drug utilization.
  • To quantify the effect of establishing safety and efficacy versus failing to do so on market share.
  • To understand the influence of regulatory and market incentives on pediatric drug trials.

Main Methods:

  • Utilized New Hampshire's all-payer claims database.
  • Employed difference-in-differences models to compare pediatric and adult drug utilization trends.
  • Controlled for temporal factors to isolate labeling change effects.

Main Results:

  • Establishing drug safety and efficacy in pediatric populations significantly increased market share by 2.8%.
  • Failure to establish safety and efficacy resulted in a statistically insignificant decrease in market share of 0.9%.
  • The findings highlight the differential impact of labeling outcomes on drug utilization.

Conclusions:

  • Regulatory efforts to improve pediatric drug labeling have a measurable positive effect on utilization.
  • Market and public incentives effectively drive the establishment of pediatric drug safety and efficacy.
  • Further research can explore long-term impacts and specific drug classes.

Keywords:
Pediatric exclusivityPediatric labelingPrescription drug utilization

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