A significant number of @entity1 receive either an unlicensed or an off-label drug during their stay in hospital. Studies throughout Europe have shown that at least one-third of @entity1 in hospital and up to 90% of neonates in a neonatal intensive care unit receive such drug prescriptions. The medicines that are most frequently used off-label include analgesics, antibiotics and bronchodilators. The purpose of licensing a drug is to ensure safety, efficacy and quality. If a drug is used in a different manner, one would expect a greater risk of @entity137 . Only three studies have commented on the risk of @entity137 in relation to unlicensed or off-label drug use. Only one of these three studies prospectively tried to evaluate the risk associated with off-label and unlicensed drug prescription. This study suggested that the percentage of unlicensed and off-label drug use was significantly associated with the risk of an @entity137 . Two studies looking at @entity137 suggest that there is a greater risk of a severe @entity137 occurring in association with the off-label or unlicensed use of drugs. One study found that five out of eight severe @entity137 were associated with the off-label use of a medicine. The other study found that 14 of 19 drug prescriptions associated with 17 severe @entity137 were either unlicensed or off-label. The risk of prescribing off-label and unlicensed drugs in @entity1 is not clear from the limited data available.

Unlicensed and off-label drug use in XXXX : implications for safety.

@entity1 :: ('9606', 'Species') :: ['children'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'adverse drug reaction', 'adverse drug reactions']
@entity1 :: (9606,Species) :: ['children']
