What parents say about medicines that are not designed for children
Research type
Research Study
Full title
Qualitative Study of parental perceptions of Age in-appropriate Formulations (AiF); barriers to administration and the effect on patients and /or families when a suitable formulation is not available on the pharmaceutical market for use in children. (AiF QUAL)
IRAS ID
201550
Contact name
Mark Turner
Contact email
Duration of Study in the UK
0 years, 3 months, 28 days
Research summary
Paediatric medicines should be fit for purpose and suitably formulated to meet the needs of children. Unfortunately, not all medicines available on the pharmaceutical market today have been designed specifically with children in mind. In 2007, the introduction of the paediatric regulation aimed to provide more information on the use of new medicines in children with regard to quality, safety and efficacy by ensuring products were tailored made for paediatric use. However, poor incentives for manufacturers to develop better medicines for children, means this regulation has had little impact so far. The Regulation does not apply to existing medicines.
Children tend to require smaller doses than adults. This means that the available tablet or capsule (generally a dosage form) might have to be manipulated / altered from its original form in order to obtain the required paediatric dose. These medicines can cause problems with inaccurate or inconsistent dosing and are typically difficult to administer.
Age-appropriate formulations (AaF) are “medicines which are suitable for use in all target populations, whether that be for an adult or small child, without it having to be altered first prior to administration” (e.g. a tablet which does not need to be split or crushed first, before it is taken). In general, AaFs should always be used were possible. However, the current lack of suitable drug formulations and strengths on the pharmaceutical market for use in children which are “ready to administer” means age-inappropriate formulations (AiFs) are often used.
The aim of this study is to inform regulators, the pharmaceutical industry, and health care professionals about the “real-life” problems associated with supplying AiFs to children from a parental perspective. We will do this by conducting qualitative interviews with parents/ carers who have received an AiF as part of routine clinical care for their child. We hope to identify what impact, if any, this has on family life and add to the case for improved paediatric medicine development by identifying the value parents/ carers ascribe to AaFs and the health care losses attributable to AiFs in order to contribute to future health economic evaluations. Since we are not aware of any published information on this topic we have selected a qualitative approach in order to generate a preliminary understanding of the issues.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
16/NW/0231
Date of REC Opinion
20 Apr 2016
REC opinion
Further Information Favourable Opinion