Abstract
The term ‘off label use’ was first mentioned by Higgins et al. in 1988.1 Off-label (unlabelled or unapproved) drug use (OLDU) refers to prescribing a registered medicine for a use that is not included or is disclaimed in the product information.2 The term off-label drug use (OLDU) is used extensively in the medical literature, continuing medical education (CME) exercises and the media. It is a polarizing term because it can be associated with great benefit or harm to patients. 3 Examples include use of a drug for a different indication, patient age group, dose and route other than which is approved by regulatory authorities. Both prescription drugs and over the counter (OTC) drugs can be used in off label ways. An unlicensed or unregistered medicine is a medicine or dosage form of a medicine that has not been evaluated nor approved for a particular clinical condition by the regulatory authorities.
Keywords: off-label drug use, continuing medical education, Investigational New Drugs, expanded access programs