Potentially harmful excipients in neonatal medicines: a pan-European observational study. Issue 7 (8th April 2015)

• Record Type: Journal Article
• Authors: Nellis, Georgi; Metsvaht, Tuuli; Varendi, Heili; Toompere, Karolin; Lass, Jana; Mesek, Inge; Nunn, Anthony J; Turner, Mark A; Lutsar, Irja
• Other Names: author non-byline.; Graham Susan author non-byline.; Duncan Jennifer author non-byline.; Shah Utpal author non-byline.; Mulla Hussain author non-byline.; Pandya Hitesh author non-byline.; McElnay James author non-byline.; Millership Jeff author non-byline.; Yakkundi Shirish author non-byline.; Rieutord Andre author non-byline.; Storme Thomas author non-byline.; Vaconsin Pascal author non-byline.; Resch Bernhard author non-byline.; De Cock Pieter author non-byline.; Jekova Nelly author non-byline.; Iyore Elisabeth author non-byline.; Sarafidis Kosmas author non-byline.; Vegso Aranka author non-byline.; O'Callaghan Noreen author non-byline.; Agostino Rocco author non-byline.; Kviluna Daiga author non-byline.; Tameliene Rasa author non-byline.; Kornelisse Rene F. author non-byline.; Bratlid Dag author non-byline.; Pereira Almerinda author non-byline.; Ognean Maria Livia author non-byline.; Bajcetic Milica author non-byline.; Paro Darja author non-byline.; Valls Elizabeth author non-byline.; Nydert Per author non-byline.; Bucher Hans Ulrich author non-byline.; Cordina Maria author non-byline.;
• Is Part Of: Archives of disease in childhood. Volume 100:Issue 7(2015)
• Page Start: 694
• Page End: 699
• Publication Date: 2015-04-08
• Subjects: Neonatology -- Pharmacology; Children -- Diseases -- Periodicals; Infants -- Diseases -- Periodicals; 618.920005
• DOI: 10.1136/archdischild-2014-307793
• Languages: English
• ISSNs: 0003-9888

Abstract

Abstract : Objectives: We aimed to describe administration of eight potentially harmful excipients of interest (EOI)—parabens, polysorbate 80, propylene glycol, benzoates, saccharin sodium, sorbitol, ethanol and benzalkonium chloride—to hospitalised neonates in Europe and to identify risk factors for exposure. Methods: All medicines administered to neonates during 1 day with individual prescription and demographic data were registered in a web-based point prevalence study. Excipients were identified from the Summaries of Product Characteristics. Determinants of EOI administration (geographical region, gestational age (GA), active pharmaceutical ingredient, unit level and hospital teaching status) were identified using multivariable logistical regression analysis. Results: Overall 89 neonatal units from 21 countries participated. Altogether 2095 prescriptions for 530 products administered to 726 neonates were recorded. EOI were found in 638 (31%) prescriptions and were administered to 456 (63%) neonates through a relatively small number of products (n=142; 27%). Parabens, found in 71 (13%) products administered to 313 (43%) neonates, were used most frequently. EOI administration varied by geographical region, GA and route of administration. Geographical region remained a significant determinant of the use of parabens, polysorbate 80, propylene glycol and saccharin sodium after adjustment for the potential covariates including anatomical therapeutic chemical class of the active ingredient. Conclusions: European neonates receive a number of potentially harmful pharmaceutical excipients. Regional differences in EOI administration suggest that EOI-free products are available and provide the potential for substitution to avoid side effects of some excipients.