Background Many of the prescribed medications to hospitalised children are off-label and/or unlicensed. To determine the extent of unlicensed and off-label medi-cation use in the NICU and PICU at one medical centre and to compare it to a study performed in the same units thirteen years ago.

Methods All drugs prescribed to patients admitted to the NICU/PICU, during 2 months of observation, were prospectively recorded and classified as licensed, un-licensed or off-label, according to their license status, indication, age, prescribed dose, frequency and way of administration specified in each specific marketing au-thorization.

Results NICU: 134 patients were included. 1069 prescrip-tions for 49 medications were prescribed: 312 (29.2%)-li-censed. 63 (5.9%)-unlicensed and 693 (64.8%)-off-label. 23.9% of the patients received at least one unlicensed medication and 96.3% received at least one off-label medication. thirteen years ago, 16% of the prescription were unlicensed, 63% off-label and 93% of the patients received at least one unlicensed/off-label medication.

PICU: 56 patients were included. 388 prescriptions for 75 medications were prescribed. 205 (52%)-licensed, 13 (3.4%)-unlicensed, 170 (43.8%)-off-label. 86.8% of patients received at least one off-label medication, and 88.7% received at least one unlicensed/off-label medi-cation. 13 years ago, none of the medication prescribed were unlicensed, 41% were off-label and 90.5% of the pa-tients received at least one off-label medication.

Conclusion There is high prevalence of unlicensed and off-label drug use in a PICU and NICU. After thirteen years, despite regulatory efforts, the prevalence of unapproved medications is still high.