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Defined daily doses in pediatric dosing- a theoretical example

Elin Dahlén1,2, Jenny Marianne Kindblom3, Elin Eyfells Kimland1

  • 1Swedish Medical Products Agency, Uppsala, Sweden.

Pharmacology Research & Perspectives
|February 22, 2023
PubMed

Insights

A new defined daily dose for children (cDDD) may not be optimal for measuring pediatric drug utilization, especially for younger children. Validation with real-world data is needed to assess its effectiveness in pediatric drug studies.

Area of Science:

  • Pediatric Pharmacology
  • Drug Utilization Research
  • Pharmacometrics

Background:

  • Standardized measures for pediatric drug utilization are lacking.
  • The World Health Organization's Defined Daily Dose (DDD) may not be suitable for children.
  • A defined daily dose for children (cDDD) has been proposed as a potentially better metric.

Purpose of the Study:

  • To evaluate the suitability of the proposed cDDD for pediatric drug utilization studies.
  • To assess the impact of body weight on cDDD calculations in children.
  • To identify challenges and needs for accurate pediatric drug utilization research.

Main Methods:

  • Calculated theoretical cDDD for three common pediatric medications in a Swedish setting.
  • Utilized authorized medical product information for dosage data.
  • Incorporated national pediatric growth curves for body weight data.

Main Results:

  • The cDDD concept demonstrated potential limitations for pediatric drug utilization.
  • These limitations were particularly evident in younger children and weight-based dosing scenarios.
  • The study highlighted the need for accessible individual-level data (age, weight, dosage).

Conclusions:

  • The proposed cDDD may not be an optimal measure for pediatric drug utilization studies.
  • Further validation of cDDD using real-world data is essential.
  • Accurate pediatric drug utilization research requires comprehensive individual-level patient data.

Keywords:
body weightchilddefined daily dosedrug utilizationpediatric prescription

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