BACKGROUND: Despite major improvements in neonatal care, information on the medication use remain poor and a great percentage of drugs are still not labeled for pediatric use. OBJECTIVE: To present a picture of medication use in a large Italian NICU and to determine the extent use of off and on-label drugs on neonates, using a computer based clinical chart. DESIGN/METHODS: A retrospective analysis of all drugs administered in our NICU during the year 2009 has been conducted. The drug treatment process was electronically assisted and recorded in the computer based clinical chart. Clinical data and information on therapeutic process were analyzed. Medicines with no information for pediatric use in the marketing authorization or used with no regard to authorized age/dose/route of administration were off-label. RESULTS: 641 patients were admitted to our NICU. 439 patients (68.4%) were preterm: 8.2% ≤ 26 wga (week of gestational age), 10.9% 27-30 wga, 42.5% 31-33 wga, 38.4% 34-36 wga. 202 (31.6%) were term infants. 8.9% had a birth weight ≤ 1000 g, 13.8% 1001-1500g, 15.9% 1501-2000 g, 17.5% 2001-2500g, 43.9% > 2500 g. Medications at our disposal were 191: 47.6% were for parenteral route, 24% for oral route, 2.6% for inhalation, 1% for endotracheal instillation, the other through several routes. 24% of medicines were on-label, 75.5% off-label and 0.5% unlicenced. The total amount of drug doses was 121686: 44.3% off-label, 55% on-label and 0.7% unlicenced. 16309 doses (13.4%) were given to term (54.5% off-label) and 105377 doses (86.6%) to preterm (42.7% off-label) infants. The percentage of off-label doses was greater for lower gestational ages. According to the ATC Classification System, group J (Antiinfectives for systemic use) (31 drugs; off-label 61.3%), C (Cardiovascular system) (20 drugs; off-label 80%) and A (Alimentary tract and metabolism) (16 drugs; off-label 68.8) drugs were the majority of the medications we used, corresponding to 22325 (18.5%; off-label 55.7%), 13148 (10.8%; off-label 97.2%) and 55108 (45.5%; off-label 23%) administrations, respectively. CONCLUSIONS: Our study confirms a persistent extremely high percentage of off-label medicines for neonates. Even if an off-label use of drugs does not imply an improper use, labeling is important to reduce medication errors. Initiatives aiming to promote research in newborn population have to be promoted
Medication Use in Neonates : Data from a Computer Based Clinical Chart of an Italian NICU / G. Cristofori, G. Cavallaro, S. Pisoni, M. Fumagalli, M. Colnaghi, F. Ciralli, G. Weissmann, F. Mosca. ((Intervento presentato al convegno pediatric academic societies tenutosi a Denver nel 2011.
|Titolo:||Medication Use in Neonates : Data from a Computer Based Clinical Chart of an Italian NICU|
|Data di pubblicazione:||2011|
|Settore Scientifico Disciplinare:||Settore MED/38 - Pediatria Generale e Specialistica|
|Citazione:||Medication Use in Neonates : Data from a Computer Based Clinical Chart of an Italian NICU / G. Cristofori, G. Cavallaro, S. Pisoni, M. Fumagalli, M. Colnaghi, F. Ciralli, G. Weissmann, F. Mosca. ((Intervento presentato al convegno pediatric academic societies tenutosi a Denver nel 2011.|
|Appare nelle tipologie:||14 - Intervento a convegno non pubblicato|