Off-label and unlicensed drug use in a Spanish Neonatal Intensive Care Unit.

Unlabelled: Objetive: To describe off-label and unlicensed drugs in clinical practice in a Neonatal Intensive Care Unit (NICU).

Method: The design of the study was a descriptive and retrospective three months research in a NICU of a Spanish University Hospital. All prescriptions were classified as approved, off-label and unlicensed drug used, according to the information available on the Summary of Product Characteristics.