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.
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Abbreviations
- ACA:
-
Amoxicillin–clavulanate
- ACTIV:
-
Association Clinique et Thérapeutique Infantile du Val de Marne
- Afssaps:
-
Agence Française de Sécurité Sanitaire des Produits de Santé
- Amox:
-
Amoxicillin
- CPAM:
-
Caisse Primaire d’Assurance Maladie
- CPD P:
-
Cefpodoxime proxetil
- EMEA:
-
European Medicines Evaluation Agency
- G:
-
Generic
- AOM:
-
Acute otitis media
- ENT:
-
Ear, nose, and throat
- P:
-
Princeps
- RDT:
-
Rapid diagnostic test
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Acknowledgments
We thank all the pediatricians who participated in the study:
Doctors A’kou ou Marie-Hélène, Amzallag Micheline, Bakhache Pierre, Baudino Nathalie, Beley Gérard, Benani Mohamed, Bodin Marie-José, Boucherat Michel, Bouillot Fabrice, Brami Allegra, Cohen Robert, Corrard François, De Brito Brigitte, Deberdt Patrice, Delatour Anne, Delourme Anne, Derkx Véronique, Desvignes Véronique, Donikian Pujol Isabelle, Dubosc Mireille, Dumont Catherine, Elbez Annie, Elkhoury Atieh Nadim, Guy Martine, Hayat André, Hunin Michel, Kemeny Georgina, Koskas Marc, Lastmann-Lahmi Chantal, Migault Pascaline, Navel Michel, Nicolas Jean-François, Noblins Michèle, Romain Catherine, Romain Olivier, Rondeau Marie-Charlotte, Schlemmer Catherine, Somerville David, Taieb Gabriel, Temam-Basse Nathalie, Thollot Franck, Thouzery Patrick, Vuillemin Jean Luc, Wisnewsky Rose, Wollner Alain, and Wollner Claudie.
ACTIV
Michel Boucherat, for the database
Corinne Levy
Sadia Tortorelli, Manuela Pereira, Pascale Latil
We also thank David Young for editorial assistance.
Financial support
Afssaps and ACTIV
All authors
No conflicts
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Cohen, R., de La Rocque, F., Lécuyer, A. et al. Study of the acceptability of antibiotic syrups, suspensions, and oral solutions prescribed to pediatric outpatients. Eur J Pediatr 168, 851–857 (2009). https://doi.org/10.1007/s00431-008-0857-0
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DOI: https://doi.org/10.1007/s00431-008-0857-0