Off-label Drug Prescribing: Deciphering the Ambiguity

ABSTRACT

The term off label prescribing refers to use of a drug in amanner not approved by the regulatory authorities. Theterm also applies to the use of a marketed medication in apatient population, dosage, or dosage form that does not haveregulatory approval. The practice of off label prescribing iswidespread and is seen in almost all branches of medicine.The usage may be supported by strong scientific evidence andresearch but it does not guarantee the safety of the drug ina large population. Therefore this review focusses on usageof off label medications in different fields of medicine, thepossible reason for the use and possible benefits and harms ofoff label prescribing.