UNLABELLED: The aim was to describe the exposure to excipients among neonates hospitalised in the neonatal intensive care unit (NICU) of a public hospital in Brasilia, Brazil. This was a retrospective study based on medicines that were prescribed electronically to neonates (≤28 days) who were admitted to the NICU of a hospital in Brasilia between January 1 and March 31, 2012. Excipients were identified from the medicine package leaflets and were classified according to toxicity. Seventy-nine infants received a total of 1,303 prescriptions comprising 77 formulations and 70 active drugs. Eighty-six excipients were identified, of which, 9 were harmful excipients (HE) and 48 were potentially harmful excipients (PHE). Almost all the neonates (98.7 %) were exposed to at least one HE and PHE. Preterm neonates (n = 64; 1,502 neonate days) presented high risk of exposure to polysorbate 80 (3.26/100 neonate days), sodium hydroxide (3.39), PG (3.19) and propylparaben (3.06). Full-term neonates (n = 15; 289 neonate days) presented risks in relation to phenol (4.84), ethanol (3.8) and sodium citrate (3.46). CONCLUSION: Neonates in NICUs in Brazil are exposed to a wide variety of HE and PHE with unpredictable results. Safer alternatives are needed, as well as further studies on the subject.
UNLABELLED: The aim was to describe the exposure to excipients among neonates hospitalised in the neonatal intensive care unit (NICU) of a public hospital in Brasilia, Brazil. This was a retrospective study based on medicines that were prescribed electronically to neonates (≤28 days) who were admitted to the NICU of a hospital in Brasilia between January 1 and March 31, 2012. Excipients were identified from the medicine package leaflets and were classified according to toxicity. Seventy-nine infants received a total of 1,303 prescriptions comprising 77 formulations and 70 active drugs. Eighty-six excipients were identified, of which, 9 were harmful excipients (HE) and 48 were potentially harmful excipients (PHE). Almost all the neonates (98.7 %) were exposed to at least one HE and PHE. Preterm neonates (n = 64; 1,502 neonate days) presented high risk of exposure to polysorbate 80 (3.26/100 neonate days), sodium hydroxide (3.39), PG (3.19) and propylparaben (3.06). Full-term neonates (n = 15; 289 neonate days) presented risks in relation to phenol (4.84), ethanol (3.8) and sodium citrate (3.46). CONCLUSION: Neonates in NICUs in Brazil are exposed to a wide variety of HE and PHE with unpredictable results. Safer alternatives are needed, as well as further studies on the subject.
Authors: M A Turner; J C Duncan; U Shah; T Metsvaht; H Varendi; G Nellis; I Lutsar; S Yakkundi; J C McElnay; H Pandya; H Mulla; P Vaconsin; T Storme; A Rieutord; A J Nunn Journal: Adv Drug Deliv Rev Date: 2013-11-13 Impact factor: 15.470
Authors: Antonia M Calafat; Jennifer Weuve; Xiaoyun Ye; Lily T Jia; Howard Hu; Steven Ringer; Ken Huttner; Russ Hauser Journal: Environ Health Perspect Date: 2008-12-10 Impact factor: 9.031
Authors: Kate O'Hara; Ian M R Wright; Jennifer J Schneider; Alison L Jones; Jennifer H Martin Journal: Br J Clin Pharmacol Date: 2015-10-26 Impact factor: 4.335
Authors: Georgi Nellis; Tuuli Metsvaht; Heili Varendi; Jana Lass; Jennifer Duncan; Anthony J Nunn; Mark A Turner; Irja Lutsar Journal: Paediatr Drugs Date: 2016-06 Impact factor: 3.022
Authors: H Mulla; S Yakkundi; J McElnay; I Lutsar; T Metsvaht; H Varendi; G Nellis; A Nunn; J Duncan; H Pandya; M Turner Journal: Pharm Res Date: 2014-09-19 Impact factor: 4.200
Authors: Alcidésio Sales de Souza; Djanilson Barbosa Dos Santos; Luís Carlos Rey; Marina Garruti Medeiros; Marta Gonçalves Vieira; Helena Lutéscia Luna Coelho Journal: BMC Pediatr Date: 2016-01-21 Impact factor: 2.125