The Pharmacoeconomics of Age-inappropriate Formulations (AiFs)
Research type
Research Study
Full title
A non-interventional cohort study to investigate the variety of dosage forms (DF) administered to in-patient children at a large, regional UK paediatric hospital and specialised neonatal unit in order to estimate the market size and pharmacoeconomic impact of using age-inappropriate formulations (AiF).
IRAS ID
164741
Contact name
Mark Turner
Contact email
Sponsor organisation
University of Liverpool
Clinicaltrials.gov Identifier
14/74/RE, Alder Hey R&D Reference
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Many medicines are only available in dosage forms (DF) that healthy adults can use. Children (and incapacitated adults) may lack the physical or mental ability to take the medicine as supplied by the manufacturer (e.g. small children cannot swallow large tablets). This problem arises because the medicines are not appropriate for the patient e.g. because of age. Pilot studies suggest that a significant number of medicines given to children are supplied as so-called "age-inappropriate formulations" (AiF). This leads to overdosing and under dosing of medicines and causes a lot of hassle for parents and Pharmacists.
While it is preferable to use an age-appropriate formulation (AaF) there are many reasons why age-inappropriate formulations are used. Cost is a major factor when hospitals choose medicines. The goal of the project is to inform manufacturers and purchasers of medicines about the costs and benefits of AaF and AiF.
We will study some groups of children that use a lot of medicines. Within each group, we will find out how many medicines they take and how many medicines are AaF and how many are AiF. The first step will be to develop methods to record the data accurately. Prescriptions do not always reflect what happens in reality so we will describe ways that reliably capture how children take their medicines. Then we will find out how much each medicine costs. We will use all this information to work out how much is spent on medicines with AiF.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/1437
Date of REC Opinion
8 Dec 2014
REC opinion
Further Information Favourable Opinion