Jennifer C Duncan1, Louise E Bracken2, Anthony J Nunn2,3, Matthew Peak2,3, Mark A Turner2,3,4. 1. Paediatric Medicines Research Unit, Institute in the Park, Alder Hey Children's NHS Foundation Trust, Liverpool, UK. Jennifer.Duncan@alderhey.nhs.uk. 2. Paediatric Medicines Research Unit, Institute in the Park, Alder Hey Children's NHS Foundation Trust, Liverpool, UK. 3. Department of Women's and Children's Health, Institute of Translational Medicine, University of Liverpool, Liverpool Health Partners, Liverpool, UK. 4. Liverpool Women's NHS Foundation Trust, Liverpool, UK.
Abstract
BACKGROUND: Medicines designed for adults may be inappropriate for use in children in terms of strength, dosage form and/or excipient content. There is currently no standardised method of assessing the age-appropriateness of a medicine for paediatric use. AIM: To develop and test a tool to assess whether a dosage form (formulation) is appropriate for children and estimate the proportion of formulations considered 'inappropriate' in a cohort of hospitalised paediatric patients with a chronic illness. METHOD: A multi-phase study: patient data collection, tool development, case assessments and tool validation. Inpatients aged 0-17 years at two UK paediatric/neonatal hospitals during data collection periods between January 2015 and March 2016. Written informed consent/assent was obtained. Medicines assessed were new or regularly prescribed to inpatients as part of their routine clinical care. All medicine administration episodes recorded were assessed using the Age-appropriate Formulation tool. The tool was developed by a consensus approach, as a one-page flowchart. Independent case assessments were evaluated in 2019. RESULTS: In 427 eligible children; 2,199 medicine administration episodes were recorded. Two assessors reviewed 220 episodes in parallel: percentage exact agreement was found to be 91.7% (99/108) and 93.1% (95/102). In total, 259/2,199 (11.8%) medicine administration episodes involved a dosage form categorised as 'age-inappropriate'. CONCLUSION: A novel tool has been developed and internally validated. The tool can identify which medicines would benefit from development of an improved paediatric formulation. It has shown high inter-rater reliability between users. External validation is needed to further assess the tool's utility in different settings.
BACKGROUND: Medicines designed for adults may be inappropriate for use in children in terms of strength, dosage form and/or excipient content. There is currently no standardised method of assessing the age-appropriateness of a medicine for paediatric use. AIM: To develop and test a tool to assess whether a dosage form (formulation) is appropriate for children and estimate the proportion of formulations considered 'inappropriate' in a cohort of hospitalised paediatric patients with a chronic illness. METHOD: A multi-phase study: patient data collection, tool development, case assessments and tool validation. Inpatients aged 0-17 years at two UK paediatric/neonatal hospitals during data collection periods between January 2015 and March 2016. Written informed consent/assent was obtained. Medicines assessed were new or regularly prescribed to inpatients as part of their routine clinical care. All medicine administration episodes recorded were assessed using the Age-appropriate Formulation tool. The tool was developed by a consensus approach, as a one-page flowchart. Independent case assessments were evaluated in 2019. RESULTS: In 427 eligible children; 2,199 medicine administration episodes were recorded. Two assessors reviewed 220 episodes in parallel: percentage exact agreement was found to be 91.7% (99/108) and 93.1% (95/102). In total, 259/2,199 (11.8%) medicine administration episodes involved a dosage form categorised as 'age-inappropriate'. CONCLUSION: A novel tool has been developed and internally validated. The tool can identify which medicines would benefit from development of an improved paediatric formulation. It has shown high inter-rater reliability between users. External validation is needed to further assess the tool's utility in different settings.
Authors: Terry B Ernest; Jo Craig; Anthony Nunn; Smita Salunke; Catherine Tuleu; Joerg Breitkreutz; Rainer Alex; John Hempenstall Journal: Int J Pharm Date: 2012-06-05 Impact factor: 5.875
Authors: Jennifer R Bellis; Jamie J Kirkham; Signe Thiesen; Elizabeth J Conroy; Louise E Bracken; Helena L Mannix; Kim A Bird; Jennifer C Duncan; Matthew Peak; Mark A Turner; Rosalind L Smyth; Anthony J Nunn; Munir Pirmohamed Journal: BMC Med Date: 2013-11-07 Impact factor: 8.775