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

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.

Healthcare professional experiences and attitudes on unlicensed/off-label paediatric prescribing and paediatric clinical trials.

OBJECTIVES: To investigate the knowledge and views of a range of healthcare professionals (consultant paediatricians, general practitioners (GPs), community pharmacists and paediatric nurses) regarding the use of unlicensed/off-label medicines in children and the participation of children in clinical trials. METHODS: A regional study in which a survey instrument with 39 items was issued to 500 randomly selected GPs, all community pharmacists (n = 512), 50 hospital consultants and 150 paediatric nurses in Northern Ireland. RESULTS: Approximately half (46.5%) of the 1,212 healthcare professionals approached responded to the questionnaire. The majority of respondents indicated their familiarity with the term unlicensed (82.9%) or off-label (58.6%) prescribing with the most frequently quoted reason for such prescribing being younger age (33.6%). Apart from community pharmacists, most respondents reported having gained their knowledge through personal experience. Even though a large percentage of respondents expressed concerns about the safety (77.8%) or efficacy (87.9%) of unlicensed/off-label prescribing in children, only 30.7% reported informing parents/guardians of these concerns on the use of such medicines in children. In addition, only 56% of respondents believed that unlicensed/off-label medicines should undergo clinical trials in children. Overall, 28.4% of respondents (20.1% of GPs, 41.4% of community pharmacists, 27.7% of paediatric nurses and 94% of consultant paediatricians) indicated their willingness to be actively involved in, and recruit their patients for paediatric clinical research. CONCLUSION: The use of unlicensed and off-label medicines remains a major issue in paediatric medicine. Until such times as more licensed medicines are available for children, clear guidance should be developed to allow consistency in practice across the spectrum of healthcare professionals who are involved with such medicines in their routine practice.

Adolescents' views of food and eating: identifying barriers to healthy eating.

Contemporary Western society has encouraged an obesogenic culture of eating amongst youth. Multiple factors may influence an adolescent's susceptibility to this eating culture, and thus act as a barrier to healthy eating. Given the increasing prevalence of obesity amongst adolescents, the need to reduce these barriers has become a necessity. Twelve focus group discussions of single-sex groups of boys or girls ranging from early to-mid adolescence (N=73) were employed to identify key perceptions of, and influences upon, healthy eating behaviour. Thematic analysis identified four key factors as barriers to healthy eating. These factors were: physical and psychological reinforcement of eating behaviour; perceptions of food and eating behaviour; perceptions of contradictory food-related social pressures; and perceptions of the concept of healthy eating itself. Overall, healthy eating as a goal in its own right is notably absent from the data and would appear to be elided by competing pressures to eat unhealthily and to lose weight. This insight should inform the development of future food-related communications to adolescents.