Prescribing,dispensing and administration of oral prednisolone
Research type
Research Study
Full title
The Prescribing, Dispensing and Administration of Oral Prednisolone in Children with Asthma or Wheeze.
IRAS ID
155102
Contact name
Rebecca H Venables
Contact email
Sponsor organisation
Keele University
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
Corticosteroids are commonly used in children for a variety of illnesses. They are available in different dosage forms such as inhalers, tablets, liquids and creams. More than 10 million new corticosteroid prescriptions are filled each year with 7% of hospitalised patients receiving oral corticosteroid therapy at some point during their admission (Lucas-Bouwman, Roorda et al. 2001).
Despite this, there is very little information available about the pharmacokinetics of prednisolone in children. There is no gold standard for prescribing, dispensing and administering prednisolone in young children resulting in wide variation in dosages and formulations which are prescribed. There is also very little information on the appropriateness of prescribing solid tablets versus soluble formulations for children although the European Medicines Association acknowledges that tablet size needs to be considered when formulating medicines for children (EMA 2006).
Short courses of oral prednisolone are vital when treating acute asthma in children. It is available in the UK as tablets, enteric coated tablets and soluble tablets. Anecdotal evidence suggests most are prescribed as soluble tablets. Prescribers assume children prefer soluble to non-soluble dosage forms. The taste, texture and volume of soluble prednisolone tablets, however, are barriers to adherence in up to 81% of children (Venables, Marriott et al. 2012). Adherence issues with oral prednisolone are common in children with asthma due to parental influence (Mansour, Lanphear et al. 2000) and parental fear about their side effects (Kieckhefer, Ratcliffe 2000, Peterson-Sweeney, McMullen et al. 2003). Poor adherence results in poor disease control, clinical deterioration and increase in hospital attendances.
Patient involvement is at the centre of our research. Young people have been involved in the development of the project to date and their involvement continues regularly. We work closely with the NIHR CRN:Children and Young Persons’ Group in the West Midlands. This project brings together researchers from Keele University and The Royal Stoke University Hospital within a larger clinical study network within the WM. It will increase patient recruitment into clinical trials and raise awareness about clinical research. It has potential cost-benefit by reducing medical wastage, asthma exacerbations and hospital attendances. The study will focus on prednisolone prescribing at The Royal Stoke University Hospital.REC name
North West - Preston Research Ethics Committee
REC reference
15/NW/0455
Date of REC Opinion
28 May 2015
REC opinion
Further Information Favourable Opinion