French National Approach - The history of the 12 standards

Following tragic events affecting newborns in 2013, a national evaluation mission on professional practices was conducted by the French General Inspectorate of Social Affairs (IGAS) on the topic of parenteral nutrition in neonatology and pediatrics.
This mission resulted in the development of 41 recommendations for improvement. Two of these recommendations specifically concerned standardized nutritional mixtures.
At the request of the Ministry of Social Affairs and Health, a first working group, led by the French Society of Neonatology, focused on rationalizing the use of standardized parenteral nutrition solutions. Following the group’s work, a list of 12 standardized formulations for neonatal parenteral nutrition was proposed.
In parallel, a second group, led by the French National Authority for Health (Haute Autorité de Santé), drafted good practice recommendations for parenteral nutrition in neonatology, incorporating the 12 previously developed formulas.
Under the auspices of the French National Agency for Medicines and Health Products Safety (ANSM), a third group studied the stability of the 12 standardized formulations to validate their preparation and control procedures, leading to the drafting of monographs for inclusion in the French Pharmacopoeia and the National Formulary.
Now ready to be published and used, it has become necessary to promote awareness of these monographs, fruit of a collective institutional work, and in particular to communicate about their development and validation processes.
The presentation focuses mainly on the work of the "Neonatology" group in designing standardized formulas, and on the study of the "Stability" group.