PANDA: Paediatrics and Dose Accuracy
Research type
Research Study
Full title
Hydrocortisone tablets: Human factors in manipulation and their impact on dosing accuracy in paediatric populations
IRAS ID
217947
Contact name
Emma Webb
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Children are frequently given adult pharmaceutical products and their parents/carers are asked to manipulate these for the patient to take the required dose. In the case of hydrocortisone, a child may be given a prescription that requires a dose of 2mg for example yet the product supplied is 10mg tablets and the caregiver is asked to crush and disperse the tablet into 10mL liquid and then administer 2mL of this dispersion to the child to provide the required 2mg dose. Although 2mg is used as an example dose here there are doses from 0.5mg and upwards in 0.5mg increments that also need to be prepared.
The manipulation of tablets (or other formulated products) to provide an appropriate dose to administer to children is likely to be associated with variability and has previously been reported. The accuracy of hydrocortisone tablet manipulation has yet to be explored even though it was reported to be the most common drug associated with manipulations for children.
There is currently much emphasis on the development of age-appropriate medicines. The need for an age-appropriate hydrocortisone formulation had been previously identified based on the need of accurate dosing and poor palatability of crushed tablets.
This study will:
(i) Identify common instructions provided to parents/carers on how to prepare the relevant hydrocortisone dose for their child from a 10 mg tablet
(ii) Analyse the hydrocortisone content of manipulated tablet preparations by a range of naïve and experienced individuals to measure the accuracy of the dose.The results will be used to provide advice on appropriate manipulation and potentially to justify the use of an alternative age-appropriate dosage form for children to ensure children get the medication they need.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
17/SC/0048
Date of REC Opinion
22 Feb 2017
REC opinion
Further Information Favourable Opinion