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Optimisation de la prise en charge médicamenteuse en pédiatrie : de la forme galénique à l'efficacité clinique

Audrey Lajoinie 1 
1 Evaluation et modélisation des effets thérapeutiques
Département biostatistiques et modélisation pour la santé et l'environnement [LBBE]
Abstract : The acceptability of a medicine oral dosage form is fundamental in paediatrics as it determines the success of the administration and treatment adherence. Despite regulations implemented to stimulate the development of appropriate medicine for the paediatric population, the lack of high level proof data concerning advantages and limits of the different oral dosage forms makes difficult the choice of a suitable paediatric dosage form. The objectives of this thesis were (i) to assess advantages and limits of the different available oral dosage forms in children, and (ii) to propose a method to evaluate the influence of the oral dosage form on both clinical and overall (i.e. including economic, practical and logistical aspects) risk/benefit balance in paediatrics. First, we assessed and discussed advantages and limits of oral dosage forms used in children based on a literature review of expert’s opinion and available studies, and conducting observational studies in our paediatric hospital. We finally designed a Cochrane meta-analysis protocol. In addition, the analysis of oral dosage forms currently administered in our paediatric hospital allowed to identify those not suitable for children. Secondly, we studied the feasibility of a pharmacokinetic pharmacodynamic model to assess the influence of the oral dosage form on the valproate (VPA) risk/benefit balance. Routine data (serum trough concentrations) did not allow to simulate the influence of the oral dosage form on the VPA serum level profile. Thus, we designed a protocol of a randomised controlled trial aiming to assess the acceptability and adherence of the different VPA oral dosage forms, and to collect VPA pharmacodynamic and pharmacokinetic data needed for the building of the model to evaluate the influence of the oral dosage form on the risk/benefit balance. The difficulties related to medicine acceptability measurement in children and limits we encountered were decisive for the design of such protocol
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Audrey Lajoinie. Optimisation de la prise en charge médicamenteuse en pédiatrie : de la forme galénique à l'efficacité clinique. Pharmacie galénique. Université de Lyon, 2017. Français. ⟨NNT : 2017LYSE1080⟩. ⟨tel-01643692⟩

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