Off-Label Prescription of Psychopharmacological Drugs in Child and Adolescent Psychiatry

Abstract

This study aimed to describe the frequency of off-label prescriptions of psychopharmacological drugs in a child and adolescent psychiatric setting. A cross-sectional study was conducted on November 1, 2014, including all inpatients and outpatients at the Mental Health Centre for Child and Adolescent Psychiatry, Capital Region of Denmark, aged 0 to 17 years receiving medical treatment with antidepressants, antipsychotic agents, benzodiazepines, melatonin and/or attention deficit hyperactivity disorder (ADHD) medication. We included a total of 5555 prescriptions representing 2932 patients. The main findings were that 32.3% of all prescriptions were off-label, and 41.6% of subjects received at least 1 off-label prescription. The most frequent off-label category was low age, 72.2%, meaning that the drug was not approved for the age group of the patient. The off-label rates for each drug class were as follows: melatonin, 100%; antipsychotic agents, 95.6%; benzodiazepines, 72.5%; antidepressants, 51.1%; and ADHD medication, 2.7%. Prescription of 2 or more psychopharmacological drugs per patient was common (31.5%). The group of subjects with 4 or more prescriptions (n = 36) was characterized by a higher frequency of inpatients, older age, and a different distribution of diagnoses. This study found a frequent use of off-label prescriptions when treating children and adolescents with psychopharmacological drugs other than ADHD medication. In addition, prescription of more than 1 psychotropic drug is common. These findings support the need for extending the evidence base for psychopharmacologic treatment in children and adolescents.

Use of Psychotropic Drugs among Children and Adolescents with Autism Spectrum Disorders in Denmark: A Nationwide Drug Utilization Study

“…Contrary to our findings, one study showed a noticeable drug use in children with ASD and no comorbid disorder, potentially indicating that medication is used to treat ASD [ 10 ]. Although in Denmark melatonin is not approved for use in children, off-label use to treat for example sleep disturbances has been reported [ 33 , 34 , 35 ]. Melatonin has shown good effect in children with ASD [ 36 ] and the low use of melatonin in children with no reported comorbidity might therefore be explained by off-label use to treat sleep problems which often affects children with ASD [ 37 ].…”

“…However, in both children and adolescents, it is possible that aripiprazole is used off-label (but with good evidence [ 9 , 39 ]) as a substitute for risperidone in patients with ASD where risperidone is not tolerated. Accordingly, two studies conducted in 2014 among Danish children in two different psychiatric settings showed that the off-label prescribing rate of aripiprazole was high mainly due to use for unapproved indications [ 34 , 35 ] with ASD appearing as one [ 34 ].…”

Off-label prescription of psychiatric drugs by non-psychiatrist physicians in three general hospitals in Germany

“…Although the bias due to the underreporting of adverse events is difficult to estimate, the rate of spontaneous reporting seems lower for unlicensed medicines compared to licensed medicines [ 13 ], which may be due to the fear of legal consequences by physicians. Furthermore, patients are often not informed about the unlicensed status of the drug that they receive [ 15 , 16 ].…”

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 .…”