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Children's views on unlicensed/off-label paediatric prescribing and paediatric clinical trials

Tareq Mukattash1, Karen Trew, Ahmed F Hawwa

  • 1Clinical and Practice Research Group, School of Pharmacy, Medical Biology Centre, Queen's University Belfast, 97 Lisburn Road, BT9 7BL, Belfast, UK.

European Journal of Clinical Pharmacology
|August 18, 2011
PubMed

Insights

Children perceive unlicensed medicine use as unsafe and unethical, advocating for more pediatric medicine testing and licensing. They believe older children and parents should be informed about off-label drug use.

Area of Science:

  • Pediatric pharmacology and ethics
  • Child psychology and healthcare decision-making

Background:

  • Unlicensed/off-label medicine use in children is prevalent, raising ethical and safety concerns.
  • Limited research exists on children's perspectives regarding their own medication use and clinical trial participation.

Purpose of the Study:

  • To investigate children's views on the unlicensed/off-label use of medicines in pediatric populations.
  • To explore children's perspectives on their involvement in clinical trials for medication development.

Main Methods:

  • Focus-group discussions were conducted with 123 school children aged 10-16 years in Northern Ireland.
  • A purposeful sampling strategy ensured representation across various socioeconomic groups.
  • Discussions covered perceptions of medicine safety, ethics, and informed consent in pediatric drug use.

Main Results:

  • Children generally considered unlicensed/off-label medicine use in pediatric patients to be unsafe and unethical.
  • A majority of participants believed that medicines should be tested in children to increase the availability of licensed products.
  • Most children felt that older children and their parents should be informed about off-label medicine use, acknowledging potential impacts on adherence.

Conclusions:

  • This study highlights that children can articulate informed opinions on the risks of unlicensed medicines.
  • Children recognize the necessity of testing and licensing more medicines specifically for pediatric use.
  • Healthcare professionals should integrate children's perspectives into healthcare decisions affecting them.
Abstract

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