Editorial: Off-Label Paediatric Prescriptions

Abstract

Off-label prescribing refers to use of drugs for an unapproved indication in an unapproved age group or unapproved dose regimen. The terms off-label and off-licence are used interchangeably. Off-label prescribing carries a negative connotation but it is not illegal. It is estimated that one out of five outpatient prescriptions written in the USA is off-label. It is assumed that practitioners always use their best professional judgement, based on available information or experience, in prescribing off-label drugs. It is more prevalent in paediatrics because less than 20 % of medicines are approved by national regulatory bodies for use in children because they lack evidence of safety and efficacy in this age group.