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

Tareq Mukattash, Karen Trew, Ahmed F. Hawwa, James C. McElnay

Research output: Contribution to journalArticle

Abstract

Objectives - To explore the views and perspectives of children on the unlicensed/off-label use of medicines in children and on the participation of children in clinical trials.
Methods - Focus-group discussions, involving school children, were carried out in a range of primary and secondary schools in Northern Ireland. A purposeful sample was chosen to facilitate representation of various socioeconomic groupings.
Results - A total of 123 pupils, aged from 10 to 16 years, from six schools, participated in 16 focus groups. In general, pupils viewed the unlicensed/off-label use of medicines in children as unsafe and unethical and felt it is necessary to test medicines in children to improve the availability of licensed products. The majority felt that older children should be told, and that parents should be told, about the unlicensed/off-label use of medicines in children, yet they recognised some implications of this, such as potential medication non-adherence.
Conclusions - This is the first study to explore the views of healthy children on unlicensed medicine use in children. Children were able to recognise potential risks associated with the unlicensed use of medicines and felt it is necessary to test and license more medicines in children.
Practice implications - Health care professionals should consider the views of children in decisions that affect their health.
Original languageEnglish
Pages (from-to)141-148
Number of pages8
JournalEuropean Journal of Clinical Pharmacology
Volume68
Issue number2
Early online date17 Aug 2011
DOIs
Publication statusPublished - Feb 2012

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Off-Label Use
Clinical Trials
Pediatrics
Pupil
Focus Groups
Northern Ireland
Medication Adherence
Licensure

Keywords

  • unlicensed medicines
  • off-label medicines
  • clinical trials
  • children

Cite this

Mukattash, Tareq ; Trew, Karen ; Hawwa, Ahmed F. ; McElnay, James C. / Children's views on unlicensed/off-label paediatric prescribing and paediatric clinical trials. In: European Journal of Clinical Pharmacology. 2012 ; Vol. 68, No. 2. pp. 141-148.
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abstract = "Objectives - To explore the views and perspectives of children on the unlicensed/off-label use of medicines in children and on the participation of children in clinical trials.Methods - Focus-group discussions, involving school children, were carried out in a range of primary and secondary schools in Northern Ireland. A purposeful sample was chosen to facilitate representation of various socioeconomic groupings.Results - A total of 123 pupils, aged from 10 to 16 years, from six schools, participated in 16 focus groups. In general, pupils viewed the unlicensed/off-label use of medicines in children as unsafe and unethical and felt it is necessary to test medicines in children to improve the availability of licensed products. The majority felt that older children should be told, and that parents should be told, about the unlicensed/off-label use of medicines in children, yet they recognised some implications of this, such as potential medication non-adherence.Conclusions - This is the first study to explore the views of healthy children on unlicensed medicine use in children. Children were able to recognise potential risks associated with the unlicensed use of medicines and felt it is necessary to test and license more medicines in children.Practice implications - Health care professionals should consider the views of children in decisions that affect their health.",
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Children's views on unlicensed/off-label paediatric prescribing and paediatric clinical trials. / Mukattash, Tareq; Trew, Karen; Hawwa, Ahmed F.; McElnay, James C.

In: European Journal of Clinical Pharmacology, Vol. 68, No. 2, 02.2012, p. 141-148.

Research output: Contribution to journalArticle

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