Off-label drug use in Neonatal Intensive Care Units in China: a
descriptive, multicenter study
Abstract Aim: Off-label drug use in neonates remains a global problem.
The retrospective, multicenter study was to study the rates and reasons
of off-label drug use among representative NICUs in Henan, China.
Methods: Prescriptions were randomized sampled from eight NICUs. Patient
characteristics and diseases were collected. Classifications of
off-label drug use including age, frequency, dose, indication and route
of administration were analyzed. Results: 1770 neonates sampled from
eight NICUs were evaluable in the study, with a mean body weight 2.98 kg
(SD = 0.80, range 0.78-6.0), 92.03% of whom were exposed to ≥ 1
off-label prescription. 5813 prescriptions with 113 drugs were
registered, 84.62% of which were off label. 63.03% of the off-label
use was in relation to age. Conclusion: Off-label drug use among
neonates remains fairly prevalent in Henan, China. Initiative and
effective implementation is urgently required to improve this situation.