TABLE 2.

The 10 Most Frequently Used Unlicensed or Off-Label Drugs

DrugNo. (%) of Total PrescriptionsReason(s) for Unlicensed/ Off-Label Status
Morphine119 (8.3)Off-label: “safety and effect in neonates have not been established”
Theophylline81 (5.6)Off-label: not indicated for prevention or treatment of apnea of prematurity
Aminophylline79 (5.5)Off-label: not indicated for prevention or treatment of apnea of prematurity
6% Sodium chloride41 (2.8)Unlicensed: “homemade” product
Phosphate41 (2.8)Off-label: not indicted for prevention or treatment of osteopenia of prematurity
Dobutamine34 (2.4)Off-label: not indicated for treatment of hypotension in neonates
Paracetamol30 (2.1)Off-label: “administration to infants under 1 mo is not recommended”
Spirononlactone21 (1.5)Unlicensed: modified licensed product
Dopamine21 (1.5)Off-label: not indicated for treatment of hypotension in neonates
Phenobarbitone21 (1.5)Off-label: “use of this preparation … is not recommended in neonates”