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Utilization of Child-Appropriate Medicines: Use of Pediatric Use Marketing Authorisation (PUMA) Products in Croatia

Andrej Belančić1, Marta Kučan Štiglić1, Arnes Rešić2,3

  • 1Department of Basic and Clinical Pharmacology and Toxicology, Faculty of Medicine, University of Rijeka, 51000 Rijeka, Croatia.

Journal of Clinical Medicine
|September 13, 2025
PubMed

Insights

Pediatric Use Marketing Authorisation (PUMA) medicines saw increased use and expenditure in Croatia. However, clinical adoption remains limited, highlighting the need to address barriers to PUMA medicine utilization for children.

Area of Science:

  • Pediatric pharmacology
  • Pharmacoepidemiology
  • Drug utilization research

Background:

  • Children are underserved in pharmaceutical development, leading to prevalent off-label prescribing.
  • Lack of age-appropriate formulations contributes to the need for specialized pediatric medicines.

Purpose of the Study:

  • To evaluate the national uptake of Pediatric Use Marketing Authorisation (PUMA)-labelled medicines in Croatia.
  • To analyze the utilization trends and expenditure of PUMA products from 2017 to 2024.

Main Methods:

  • Retrospective, descriptive pharmacoepidemiological study.
  • Utilized IMS and IQVIA datasets for tracking PUMA product utilization and expenditure.
  • Assessed utilization via defined daily doses per 1000 inhabitants per day (DDDs/1000/day) and product dispensation counts.

Main Results:

  • Five PUMA medicines entered the Croatian market between 2017 and 2024.
  • PUMA medicine usage increased significantly, with package numbers rising from 853 to 9232.
  • Defined daily doses per 1000 inhabitants per day (DDDs/1000/day) increased 33.8-fold, and expenditure rose nearly 5.8-fold.

Conclusions:

  • Regulatory availability of PUMA products has improved in Croatia.
  • Clinical adoption and utilization of PUMA medicines remain limited despite increased availability.
  • Barriers related to economics, education, and policy require addressing to enhance PUMA medicine utilization for pediatric needs.

Keywords:
drug utilizationoff-label usepediatric use marketing authorisationpediatricspharmacoepidemiology

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