Children and young people are often administered medicines which are not tested or approved for use in this population. It is acknowledged that this use of off-label and unlicensed medicines to treat children can lead to over- or under-dosing, adverse drug reactions, and low treatment success (EMA, 2012). A key challenge to developing age-appropriate and acceptable medicines is that limited information is available for the development of paediatric medicines. Patient acceptability of medicines is thought to have a significant impact on treatment adherence and ultimately safety and efficacy. However, a lack of knowledge about what is considered acceptable to children and best practice methods to assess acceptability is limited and fragmented.
Aim and objectives
The aim of this study was to explore the experiences of children in relation to medicines, to incorporate their views to develop a better understanding of the acceptability of medicine, and to relate this to the tools that are used to assess the acceptability of medicines.
Three objectives were proposed to ensure that the overall aim of the study was achieved. These were to:
1. Explore children’s experiences of medicines to gain a better understanding about what is acceptable to children in formulations.
2. Evaluate with children methods used to assess the acceptability of medicine.
3. Use this new information to propose ways that existing tools used to assess acceptability of formulations in a paediatric population can be re-designed to better reflect children’s perspectives on the acceptability of medicine.
This study used a generic qualitative methodology and employed child-centred qualitative methods including activity booklets, drawing and ranking activities, interviews and participant observation to generate data with children aged 5-12 years in group workshops and one-to-one. Children were recruited through convenience sampling via schools, clubs, a museum and a hospital.
One hundred and eleven children participated in the study. The findings are organised into six superordinate themes presented in two separate chapters clearly reflecting the children’s perspectives. The first findings chapter, Exploring Children’s Perspectives to Improve the Understanding of the Acceptability of Medicines, encompasses three major themes: 1) What children can tell us about the acceptability of medicines, 2) What helps improve the acceptability of medicines to children, and 3) What reduces the acceptability of medicines to children. The second findings chapter, Improving the Methods Used to Assess the Acceptability of Medicines, also has three key themes: 4) Children’s experience and understanding of scales, 5) Children’s perceptions on and preferences for scales, and lastly, 6) Improving acceptability assessment.
The findings from the study present original contributions to knowledge of the acceptability of medicine in a child population, demonstrating that involving children in acceptability research provides a much-needed perspective on the acceptability of medicine and the factors thought to impact acceptability. A new definition of the acceptability of medicine is presented, grounded in data provided by the children. The “Framework of Children’s Medicine Acceptability”, provides a novel theoretical framework for the acceptability of medicine. Key recommendations address the factors that should be measured when assessing acceptability, improvements for acceptability assessment measures, and future directions for research.
|Date of Award||29 Mar 2021|
|Supervisor||BERNIE CARTER (Director of Studies) & LUCY BLAKE (Supervisor)|
- medicine acceptability
- acceptability assessment
- assessment measures
- paediatric acceptability
- age-appropriate formulations