Duncan, Jennifer C 
ORCID: 0000-0001-9713-888X, Bracken, Louise E, Nunn, Anthony J, Peak, Matthew ORCID: 0000-0003-1909-3211 and Turner, Mark A ORCID: 0000-0002-5299-8656
(2022)
Development and evaluation of an assessment of the age-appropriateness/inappropriateness of formulations used in children.
INTERNATIONAL JOURNAL OF CLINICAL PHARMACY, 44 (6).
pp. 1394-1405.
Abstract
<h4>Background</h4>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.<h4>Aim</h4>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.<h4>Method</h4>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.<h4>Results</h4>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'.<h4>Conclusion</h4>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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Age-appropriate formulations, Children, Off-label prescribing, Unlicensed medicines |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences Faculty of Health and Life Sciences > Clinical Directorate |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 02 Feb 2023 09:36 |
| Last Modified: | 23 Mar 2023 05:46 |
| DOI: | 10.1007/s11096-022-01478-5 |
| Open Access URL: | https://doi.org/10.1007/s11096-022-01478-5 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3168089 |
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