ABSTRACT
The aim of this study is to determine the extent of use of medications that have not
been specifically licensed for use in children (unlicensed), or medications whose
use is not in accordance with the conditions of their license (off-label), in neonates
in a neonatal intensive care unit (NICU). Medications given to 105 neonates were prospectively
reviewed every 2 weeks during a 4-month period. The assessment as to whether every
medication prescribed was unlicensed or off-label for use in children was based on
a number of reference sources. Five hundred and twenty-five series of medications
were used, of which 310 (59%) were off-label and 87 (16%) were unlicensed. Ninety-eight
neonates (93%) received at least one off-label medication. The major reason for prescribing
off-label medications was a deviation from the recommended dosage or age of the patient.
The reason for giving unlicensed medications was changes in the formulation of the
medication. The use of off-label and unlicensed medications is common in neonates.
In view of the gravity and problematic nature of the issue, international consensus
is evolving to conduct clinical trials in neonates and infants, with regard to medications
already on the market, and new medications.
KEYWORD
Off-label medications - unlicensed medications - neonate - orphan drugs
