Background Many medications have not been extensively studied in children. Medications may be prescribed for indications for which their use has not been approved (unlicensed use); or may be given for an approved indication, but to an age group or at a dose or frequency or by a route that has not been approved (off-label use). We wished to determine the extent of unlicensed and off-label prescription in our NICU.

Methods We prospectively studied infants admitted to our tertiary level NICU over 2 months. We recorded demographic data and all medications prescribed for all infants. We compared the use of each medication to their licensed indications as contained in the Summary of Product Characteristics.

Results 110 infants were admitted. All infants received a prescribed medication. 79 different medications were prescribed to these 110 infants, a median (IQR) of 4 (3, 12) each. 41% of prescribed medications were given in an unlicensed manner and 15% in an off-label manner. 12 (11%) infants received an unlicensed medication, 5 (4%) infants received an off-label medication and 38 (35%) infants received both an unlicensed and off-label medication. Of infants < 32 weeks, 91% received unlicensed and 85% off-label medications. 100% of infants < 28 weeks received an unlicensed and an off-label medication. There were 2 adverse events related to medications.

Conclusions Most medications prescribed to newborn are unlicensed or given for off-label indications. Many infants, and the majority of preterm infants, admitted to NICU receive unlicensed and off-label prescriptions. Adverse events appear uncommon.