Study of the acceptability of antibiotic syrups, suspensions, and oral solutions prescribed to pediatric outpatients

Abstract

This observational study was designed to evaluate the acceptability of oral antibiotics (including generics) commonly prescribed to children by community practitioners in France. Between February and July 2006, the parents of 953 children enrolled by 46 pediatricians completed a questionnaire, including a taste assessment based on representations of five facial expressions. The proportions of "satisfactory" taste judgments showed a significant difference between amoxicillin-clavulanate reference product and its generics (77.9% vs. 65%, p = 0.01). The amoxicillin-clavulanate generics were more likely than the reference product to be spat out at least once (28.7% vs. 19%, p = 0.05). The full treatment course was taken by 91.7% and 82.3% of children prescribed the amoxicillin-clavulanate reference product and its generics, respectively (p = 0.02). The proportions of "satisfactory" taste judgments showed no significant difference between amoxicillin reference product and generics (64.3% vs. 72.5%, p = 0.3). The amoxicillin generics were not different from the reference product to be spat out at least once (8.6% vs. 14.3%, p = 0.2). The full treatment course was taken by 90.7% and 94.6% of children prescribed the amoxicillin reference product and its generics, respectively (p = 0.3). This study suggests the role of the active substance in the taste, and calls for the evaluation of palatability of future drugs (generics and references) before granting of the marketing authorization, particularly for active substances of poor taste; this palatability plays a significant role in the compliance of the treatment, notably in children. Poor compliance increases the risk of therapeutic failures and the emergence of resistance.

Prescribing for children – taste and palatability affect adherence to antibiotics: a review

“…Palatability is so significant in ensuring successful administration of a course of treatment that a recent call has been made for the evaluation of palatability and taste before European marketing authorisation is granted 11. Current European Parliament legislation12 also emphasises the importance of making new drugs more acceptable.…”

“…The use of universal, standardised visual analog scales to quantify a child's response to the taste of a medicine (eg, the facial hedonic method) are widely described throughout the literature 6 8 10 11 21. One study has shown that the hedonic method is worse than own spontaneous verbal judgements at discriminating between taste differences in children under 6 years of age, although both methods are equally effective for older children 21.…”

“…Randomised control trials are the gold standard in comparing treatment outcomes8 9 11 19 20 23–25 and have been shown to be an effective method of demonstrating antibiotic superiority in terms of both treatment outcomes and taste.…”

Determination of formulation factors that affect oral medicines acceptability in a domiciliary paediatric population

“…Further studies compare the acceptance and flavour preferences of a spectrum of drugs from one class (e.g. antibiotics) using a "one-off" taste test method, commonly with the aid of a visual analogue scale (VAS) most often in healthy children or adults (Bagger-Sjöbäck and Bondesson, 1989;Chan et al, 1997;Cohen et al, 2009;El-Chaar et al, 1996;Samulak et al, 1996;Toscani et al, 2000).…”

Taste acceptance of Captopril and Furosemide Extemporaneous Oral Pediatric Formulations among Hospitalized Children

“…Sensory analysis is a stage of product development that analyzes and interprets the reactions produced by its features. Ideally should be performed whenever a new formulation is introduced in a given context [28][29][30].…”