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

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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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Acknowledgment

We gratefully thank all children who took part in the focus-group discussions and all teachers who facilitated the research.

Competing interests

None declared.

Author information

Author notes

  1. Tareq Mukattash

    Present address: Department of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, 22110, Jordan

Authors and Affiliations

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

    Tareq Mukattash, Ahmed F. Hawwa & James C. McElnay

  2. School of Psychology, Queen’s University, BT7 1NN, Belfast, UK

    Karen Trew

Authors
  1. Tareq Mukattash
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  2. Karen Trew
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  3. Ahmed F. Hawwa
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  4. James C. McElnay
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Corresponding author

Correspondence to James C. McElnay.

Additional information

An abstract on this research work was presented at the British Pharmaceutical Conference, 2008.

Appendix 1

Appendix 1

All slides simply contained a title and pictures (Table 3). The researcher, using terminology appropriate to age, explained the process of drug discovery, animal testing and testing in man before medicinal products are licensed and released on to the market. He then explained that some medicines are not tested and licensed for use in children and raised the question of dosage selection for medicines which were not licensed.

Table 3 Slides used in slide show to explain the discovery and licensing of medicines and the fact that not all medicines are licensed for use in children
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Mukattash, T., Trew, K., Hawwa, A.F. et al. Children’s views on unlicensed/off-label paediatric prescribing and paediatric clinical trials. Eur J Clin Pharmacol 68, 141–148 (2012). https://doi.org/10.1007/s00228-011-1110-8

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  • DOI: https://doi.org/10.1007/s00228-011-1110-8

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