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.

Off-label prescription of drugs at hospital.

Objectives: To develop a procedure for management of off-label medications, and to analyze the treatments, indications, and hospital units which will request them more frequently, as well as which variables will have an impact on the authorization decision, and its economic impact.

Methods: A procedure was designed where clinicians would complete request forms and the Hospital Unit would prepare reports assessing their efficacy, safety, convenience, and cost. The request forms for the past five years were analyzed.