Off-Label Medication in Children: Responsibilities of Pediatrician and Neonatologist

Use of drug in pediatrics and neonatology should be rational. There are clinical situations when the use of unlicensed medicines or use of medicines outside the terms of license (i.e., 'off-label') may be judged by prescriber in the best interest of the patient. Off-label prescribing is clinically appropriate when the benefits outweigh the potential risks. Such practice is particularly common in pediatrics and neonatology where development of age-appropriate formulations is difficult. Before going to prescribe a drug on off-label basis, the clinician should be satisfied that an alternative medicine would not meet the patient's needs. The clinician should be satisfied that there is sufficient evidence base safety and efficacy on off-label drug use. Communication with legal guardian with sufficient information about proposed treatment is needed. The clinician has a responsibility to monitor the off-label use of drug. He should submit a report on suspected adverse drug reactions if he observes to the authorized body.