Journal of Pharmacovigilance

PEDIAVEN® AP-HP NOUVEAU NE 2 perfusion related extravasations in a neonatal intensive care unit

4^th International Conference and Exhibition on Pharmacovigilance & Clinical Trials

August 10-12, 2015 London, UK

Clement Delage

Posters-Accepted Abstracts: J Pharmacovigilance

Abstract:

PEDIAVEN� AP-HP NOUVEAU NE 2 (PNN2) is a newborns parenteral nutrition solution. In neonatology, the main interest of PNN2 is its possibility of peripheral venous administration (PVA). During PNN2 administration in the neonatal intensive care unit, several cases of extravasation have been reported, two with severe oedema and necrosis. We investigated the role PNN2 played in these extravasations, by three different ways: a pharmacovigilance (PV) report; a questionnaire to the main neonatal intensive care units in the Paris region; and the osmolarity and pH measurements. Five other reports have been compiled by the Pharmacovigilance Regional Center in Angers the last three years. After our report, the French Drug Agency ordered an investigation about PNN2. The questionnaire showed that the rate of extravasations has been trending up in most of the other units. If the responsibility of PNN2 is not clearly established, the cases are more severe with PNN2 than with other solutions. The manufacturer indicates an osmolarity ?around 790 mOsm/L? (712 to 870 mOsm/L). Tested osmolarity varied from 778 to 782 mOsm/L and pH was 5.04. There are no guidelines for the osmolarity limits in preterm VPA. The limit used in our unit is 800 mOsm/L. Besides, the pH value for the best tolerance would be within 6.5 and 9. The extremely inaccurate osmolarity value led our unit to ban PNN2 use in PVA. The results of the French Drug Agency investigation and the High Health Authority guidelines on osmolarity limits will help us to improve our practices.