Methodology Used to Assess Acceptability of Oral Pediatric Medicines: A Systematic Literature Search and Narrative Review
- 179 Downloads
Regulatory guidelines require that any new medicine designed for a pediatric population must be demonstrated as being acceptable to that population. There is currently no guidance on how to conduct or report on acceptability testing.
Our objective was to undertake a review of the methods used to assess the acceptability of medicines within a pediatric population and use this review to propose the most appropriate methodology.
We used a defined search strategy to identify literature reports of acceptability assessments of medicines conducted within pediatric populations and extracted information about the tools used in these studies for comparison across studies.
In total, 61 articles were included in the analysis. Palatability was the most common (54/61) attribute measured when evaluating acceptability. Simple scale methods were most commonly used, with visual analog scales (VAS) and hedonic scales used both separately and in combination in 34 of the 61 studies. Hedonic scales alone were used in 14 studies and VAS alone in just five studies. Other tools included Likert scales; forced choice or preference; surveys or questionnaires; observations of facial expressions during administration, ease of swallowing, or ability to swallow the dosage; prevalence of complaints or refusal to take the medicine; and time taken for a nurse to administer the medicine.
The best scale in terms of validity, reliability, feasibility, and preference to use when assessing acceptability remains unclear. Further work is required to select the most appropriate method to justify whether a medicine is acceptable to a pediatric population.
KeywordsVisual Analog Scale Facial Expression Pediatric Population Famciclovir Hedonic Scale
Compliance with Ethical Standards
This project was supported by Innovate UK Formulated Products Collaborative R&D project (Ref: 101709). SPaeDD-UK (Accelerating Paediatric Formulation Development through Smart Design and Predictive Science), which is co-funded by Innovate UK and the contributing companies of AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Juniper Pharmaceuticals, and Pfizer.
Conflict of interest
PM and HB have no conflicts of interest.
- 4.European Medicines Agency. Guideline on pharmaceutical development of medicines for paediatric use EMA/CHMP/QWP/805880/2012. London: EMA; 2013. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/07/WC500147002.pdf. Accessed 31 April 2013.
- 5.European Medicines Agency. Guideline on the demonstration of palatability of veterinary medicinal products. EMA/CVMP/EWP/206024/2011. London: EMA; 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/07/WC500170030.pdf.
- 7.Higgins J, Green S. Cochrane handbook for systematic reviews of interventions. Version 5.1.0 (updated March 11). The Cochrane Collaboration; 2011. http://www.cochrane-handbook.org.
- 45.Peryam DR, Pilgrim FJ. Hedonic scale method of measuring food preferences. Food Technol. 1957;11:9–14.Google Scholar
- 52.Abdulla S, Amuri B, Kabanywanyi AM, Ubben D, Reynolds C, Pascoe S, et al. Early clinical development of artemether-lumefantrine dispersible tablet: palatability of three flavours and bioavailability in healthy subjects. Malar J. 2010;9:253. doi: 10.1186/1475-2875-9-253.CrossRefPubMedPubMedCentralGoogle Scholar
- 73.Meilgaard MC, Civille GV, Carr BT. Sensory evaluation techniques. 4th ed. Boca Raton: CRC Press, Taylor and Francis Group; 2007.Google Scholar
- 75.Hester NO, Foster R, Kristensen K. Measurement of pain in children: generalizability and validity of the pain ladder and the poker chip tool. In: Tyler DC, Crane EJ, editors. Advances in pain research and therapy, vol. 15. New York: Raven; 1990. p. 79–84Google Scholar
- 88.Volovitz B, Duenas-Meza E, Chmielewska-Szewczyk DA, Kosa L, Astafieva NG, Villaran C, et al. Comparison of oral montelukast and inhaled cromolyn with respect to preference, satisfaction, and adherence: a multicenter, randomized, open-label, crossover study in children with mild to moderate persistent asthma. Curr Ther Res. 2000;61(7):490–506.CrossRefGoogle Scholar
- 91.Steele RW, Thomas MP, Begue RE, Despinasse BP. Selection of pediatric antibiotic suspensions: taste and cost factors. Infect Med. 1999;16(3):197–200.Google Scholar