BAP Position Statement: Off-label prescribing of psychotropic medication to children and adolescents

Abstract

The off-label use of medicines for children and adolescents remains a common and important issue for prescribing practice across child and adolescent psychiatry, paediatrics and primary care. This editorial focusses on psychotropic drug treatment, which plays an essential part in the comprehensive management of a range of child and adolescent psychiatric disorders. Despite a growing evidence base for drug treatment in child and adolescent psychiatric disorders, much psychotropic medication continues to be prescribed off-label (i.e. outside the limits of the marketing authorisation or product license). The reasons for and implications of off-label prescribing, including the potential clinical benefits/risks and medico-legal implications, are often poorly understood by both patients and prescribers. An important unintended consequence of the uncertainties and confusion surrounding the status of off-label prescribing for children and adolescents may be that effective drug treatments are being withheld or underused. This BAP Position Statement aims to clarify these issues, challenge some of the myths surrounding off-label prescribing for children and adolescents and offer practical guidance for prescribers.

Safety of 80 antidepressants, antipsychotics, anti‐attention‐deficit/hyperactivity medications and mood stabilizers in children and adolescents with psychiatric disorders: a large scale systematic meta‐review of 78 adverse effects

“…Several antidepressants, antipsychotics, anti‐attention‐deficit/hyperactivity disorder (ADHD) medications and mood stabilizers indicated in adults have received regulatory approval for use in children and/or adolescents 5 , and many are used off‐label 6‐10 . However, despite evidence for the efficacy of a number of psychotropic medications in youth, the duration of untreated illness in depressive disorder 11 , bipolar disorder 12,13 , schizophre­nia 14 , obsessive‐compulsive disorder 15 , anxiety disorders 16 , and other mental disorders 17 is often long 18,19 , which adversely affects long‐term outcomes 14,20‐24 .…”

Off-label Psychotropics Use: Isn't it Now an Inevitable and a “Norm” in Psychiatry?

“…[ 1 2 ] In principle, though it may not be compliant to the ethics in clinical practice, reports of off-label use of psychotropics have been widespread across clinical diagnoses and age groups. [ 1 3 4 5 6 7 8 9 10 11 ] Among all medications, psychotropics are one of the most commonly prescribed for off-label purpose. [ 5 12 ] A few studies from the Indian subcontinent had found that off-label use of psychotropics was seen in a significant proportion of prescriptions (up to 42%) and off-label uses were most common for indications (48.9%) followed by for dose (37.2%).…”

Safety and efficacy of lithium in children and adolescents: A systematic review in bipolar illness

“…More than one third of children with BD receive two or more medications belonging to different classes (i.e. mood stabilizers, antipsychotics, antidepressants or stimulants) feeding the problem of off-label prescriptions [63].…”