ABSTRACT
The pediatric population exhibits an important age-dependent heterogeneity in pharmacokinetics and pharmacodynamics parameters, resulting in differences in drug efficacy and toxicity compared to the adult population, particularly for neonates. Toxicity and efficacy divergences have been studied for active molecules, but the impact on the pharmacological parameters of excipients remains less well known. To fill this lack of knowledge, several initiatives have been started to gather information on the specific toxicity of excipients, such as the KIDS list or the STEP database. In order to contribute to this much-needed action, in this work, a compilation of the 219 formulations of oral liquid forms prescribed in pediatrics and neonatology units was established based on the summary of product characteristics. Then, for excipients found in more than 10% of the analyzed formulations, a review of their toxicity data was carried out using the STEP database. Finally, for a selection of 10 frequently used liquid forms, the amounts of excipients administered daily were calculated based on the recommended posology in the Summary of Product Characteristics (SPC) and compared with the recommended daily limits proposed by the European Medicine Agency. Pediatrics-adapted formulations are still rare, and it is not always possible to find safe alternatives to drugs containing excipients of interest.
ABSTRACT
BACKGROUND: Public health policies in France and the USA promote health professionals' collaborative practices in accordance with World Health Organization recommendations emphasizing the need to promote interprofessional education and training. To optimize alignment of health-care policy and education, a scientific evidence-based approach is required. METHODS: A French translation (SPICE-R2F) of the Student Perceptions of Interprofessional Clinical Education-Revised instrument, version 2 (SPICE-R2) was generated. SPICE-R2F was then completed by a multicentric cohort of French health students, and confirmatory factor analysis was utilized to evaluate the validity and reliability of this instrument based on response patterns. RESULTS: Translation of SPICE-R2 was validated evaluating psychometric properties and conducting a confirmatory factor analysis (CFA). Adequate model fit was demonstrated using RMSEA (root mean square error of approximation) and CFI (comparative fit index) model fit criteria. Within each factor, however, low to moderate levels of reliability were observed between items. These observations diverge from other countries and highlight a potential French singularity. CONCLUSION: Our results suggest the need to improve interprofessional clinical practice education in France at early stages in the health-care curricula. The SPICE-R2F instrument may represent a valuable evidence-based tool to characterize perceptions of interprofessional education and training of health-care students and professionals in France.
