Related Experiment Video
Updated: Jul 10, 2026

A Novel Approach for the Administration of Medications and Fluids in Emergency Scenarios and Settings
Published on: November 9, 2016
Paediatric clinical pharmacology: at the beginning of a new era
1Poison Information Centre, Helsinki University Central Hospital, Helsinki, Finland. kalle.hoppu@hus.fi
Insights
The global problem of insufficient pediatric medicines persists, with over half of children receiving unapproved drugs. Recent initiatives offer hope for improved pediatric drug research and authorization.
Area of Science:
- Pediatric Pharmacology
- Global Health
- Drug Regulation
Background:
- The widespread unavailability of medicines for children is a significant global health issue.
- Many pediatric patients, even in developed nations, are treated with off-label or unlicensed medications.
- This practice highlights a critical gap in pediatric drug development and regulatory oversight.
Observation:
- Historically, physicians have accepted the suboptimal use of medicines in children.
- Recent years have seen increased focus on pediatric drug initiatives in the US, Europe, and by the World Health Organization (WHO).
- Intensive developments in the last two years suggest a potential paradigm shift.
Findings:
- Ethical, high-quality research and appropriate authorization are essential for pediatric medicines.
- Pioneering initiatives and recent developments indicate progress towards addressing the pediatric medicine gap.
- A new era of opportunities and challenges is emerging for pediatric clinical pharmacology.
Implications:
- Improved access to safe and effective medicines for children worldwide is a critical goal.
- This evolving landscape presents both opportunities and challenges for pediatric clinical pharmacologists and stakeholders.
- Addressing the pediatric medicine deficit requires continued collaboration and regulatory advancement.
Abstract:
The lack of availability of medicines for children is a large problem. This problem is global. It concerns all children of the world, those in the developing world but also those in the developed world, even in the richest countries. Many generations of paediatricians and other physicians have learned to live with the situation, where more than half of the children are prescribed off-label or unlicensed medicines. However, there is no doubt that medicinal products used to treat the paediatric population should be subjected to ethical research of high quality and be appropriately authorised for use in the paediatric population. Within the last 10 years, the pioneering paediatric initiative in the United States and recent encouraging developments in Europe and at the WHO indicate that change may finally be possible. The developments of the last 2 years have been particularly intensive. It seems that a new era is beginning which will provide unprecedented opportunities but also great challenges for paediatric clinical pharmacologists and other stakeholders working to provide children with the medicines they need.
Related Concept Videos
Pharmacokinetics in Pediatric Patients: Drug Metabolism
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
Pharmacokinetics in Pediatric Patients: Drug Excretion
Pharmacokinetics in Pediatric Patients: Drug Distribution
Drug Dosing: Infants and Children
Preclinical Development: Overview
