Off-label and unlicensed drug use among neonatal intensive care units in Southern Italy.
BACKGROUND
Many drugs used for neonates are unlicensed or off-label. An increased risk of medication errors and unexpected adverse drug reactions is associated with their use. This risk is even higher in preterm newborns, because of their physiological immaturity and the exposure to many different medicines. The objective of this study was to evaluate the use of unlicensed or off-label drugs in eight tertiary-level neonatal intensive care units (NICU) from two different southern Italian regions.


METHODS
All drugs prescribed to newborns admitted to each NICU, during 1 month of observation, were recorded and classified as licensed, unlicensed or off-label, according, respectively, first, to their license status and, then, their indications, dose, treatment route, and duration of treatment specified in each specific marketing authorization.


RESULTS
A total of 126 newborns were treated with at least one drug during the observation period. A total of 483 prescriptions referred to 87 different drugs, classified as licensed, unlicensed or off-label. Each newborn was exposed to three (median) different drugs; 88.6% were licensed and 11.4% unlicensed (range, according to different NICU, 1.9-26.7%). Among licensed drugs, 37.4% were used as off-label (range, 27.3-53.4%).


CONCLUSIONS
The use of unlicensed or off-label drugs use is common practice in NICU, with wide variation in local policies and newborn characteristics. Well-designed and -conducted pharmaceutical studies in newborns are needed to increase the number of licensed drugs, thereby reducing any risk for patients due to over- or under-treatment, and also legal issues for clinicians.
Department of Gynecology, Obstetrics and Neonatology, Section of Neonatology and NICU, University Hospital Policlinico, Bari, Italy.
Nicola
N
Laforgia
Melissa Maria
MM
Nuccio
Federico
F
Schettini
Marisa
M
Dell'Aera
Anna Rita
AR
Gasbarro
Alessandro
A
Dell'Erba
Biagio
B
Solarino
D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D011307:Drug Prescriptions; D004363:Drug Utilization / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal / Q000706:statistics & numerical data*; D007558:Italy; D008297:Male; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D011446:Prospective Studies; D012189:Retrospective Studies
neonatal intensive care unit; off-label drug; southern Italy; unlicensed medicine