Drug treatments in a neonatal setting: focus on the off-label use in the first month of life.
OBJECTIVE
The purpose of this work was to analyse drugs prescribed in the first month of life among a group of newborns admitted to the Neonatal Intensive Care Unit and Neonatal Pathology of Cagliari University Hospital.


METHODS
This pilot study was prospectively conducted during a 1-month period and involved all newborns admitted to our hospital that received a pharmacotherapy. After obtaining written parental consent, data collected from each newborn included date of birth, sex, gestational age and weight. Also, diagnosis and information about each drug administered during the first month of life: dose, frequency, route of administration, and indication for use was collected.


RESULTS
Among the 79 newborn infants admitted to our hospital during the study period, 38 received a pharmacotherapy and were enrolled in our study. A total of 88 treatments were given: 41 (47%) followed the terms of the product license, 47 (53%) were used in an unlicensed or off-label manner.


CONCLUSIONS
Our results confirm this trend of drug use in the neonatological field and suggest the need to update information contained in the data sheets of medicines.
Dessì
Angelica
A
Chief Neonatal Intensive Care Unit, Puericultura Institute and Neonatal Section, University of Cagliari, Cagliari, Italy.
Salemi
Claudia
C
Fanos
Vassilios
V
Cuzzolin
Laura
L
D000367:Age Factors; D001835:Body Weight; D005260:Female; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D007558:Italy; D008297:Male; D056687:Off-Label Use / Q000706:statistics & numerical data*; D010865:Pilot Projects; D011446:Prospective Studies; D012737:Sex Factors