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Off-label prescribing of psychotropic drugs in a Danish child and adolescent psychiatric outpatient clinic

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Abstract

This study aimed to describe the level of off-label treatment with psychotropic drugs at a child and adolescent psychiatric outpatient clinic in Denmark. We performed a cross-sectional study assessing records on patients treated with medicine at two outpatient clinics at the child and adolescent psychiatric ward, on 1 day in 2014. Prescriptions of drugs from ATC group N05–N06 were classified according to label status. Six hundred and fifteen drug prescriptions distributed on nine different drugs were prescribed to 503 children eligible for this study. Overall results showed that 170 of the 615 prescriptions were off-label, which corresponds to 27.6 %. Attention deficit hyperkinetic disorder (ADHD) drugs were prescribed 450 times (73.2 %) of which 11 prescriptions were off-label (2.4 %). Other psychotropic drugs comprised 165 (26.8 %) prescriptions and of these 159 (96.4 %) were off-label. With 106 prescriptions, melatonin was the most prescribed of these drugs; all prescriptions were off-label. The main reasons for classifying prescriptions as off-label were age and indication of treatment. This cross-sectional study reveals that medical treatment of children with other psychotropic drugs than ADHD drugs is usually off-label. ADHD drugs were, as the only drug group, primarily prescribed on-label. Although off-label prescription may be rational and even evidence based, the responsibility in case of, e.g. adverse drug reactions is a challenge, and clinical trials in children should be incited.

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Conflict of interest

PHT has received speaker’s fee from Novartis, Medice and Eli-Lilly within the last 3 years. No other conflicts of interest.

Ethical standards

The study was approved by The Danish Data Protection Agency and Danish legislation was followed when patient charts were reviewed.

Author information

Authors and Affiliations

  1. Department of Biomedicine: Pharmacology and Clinical Pharmacology, Aarhus University Hospital and Aarhus University, Aarhus C, Denmark

    Eva Skovslund Nielsen, Maja Hellfritzsch & Torben Laursen

  2. Centre of Child and Adolescent Psychiatry, Aarhus University Hospital, Risskov, Denmark

    Merete Juul Sørensen, Helle Rasmussen & Per Hove Thomsen

Authors
  1. Eva Skovslund Nielsen
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  2. Maja Hellfritzsch
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  3. Merete Juul Sørensen
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  4. Helle Rasmussen
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  5. Per Hove Thomsen
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  6. Torben Laursen
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Corresponding author

Correspondence to Eva Skovslund Nielsen.

Appendices

Appendix 1: Indications and ICD-10 codes

Psychostimulants

Age group

Indication and ICD-10 code

Dose

Methylphenidate

N06BA04

>6 years

ADHD

DF90.X, DF98.8, DF98.8C

Max 60 mg/day

Dexamphetamine

N06BA12

>6 years

ADHD

DF90.X, DF98.8, DF98.8C

Max 70 mg/day

Atomoxetine

N06BA09

>6 years

ADHD

DF90.X, DF98.8, DF98.8C

<70 kg: max 1.8 mg/kg

>70 kg: max 100 mg/day

Sedatives

Age group

Indication and ICD-10 code

Dose

Melatonin

N05CH01

Not approved for use in children and adolescents

Not approved for use in children and adolescents

Not approved for use in children and adolescents

SSRI

Age group

Indication and ICD-10 code

Dose

Fluoxetine

N06AB03

>8 years

Moderate–severe depression

DF32.1-3, DF33.1-3

Max 20 mg/day

Sertraline

N06AB06

>6 years

OCD

DF42.X

Max 200 mg/day

Antipsychotic agents

Age group

Indication and ICD-10 code

Dose/duration

Risperidone

N05AX08

>5 years

Persistent aggressive behavioral disorder for children >5 years with limited intellectual abilities or mental retardation.

Aggressive behavior mentioned in the patient record AND a diagnosis of DF7.X or DR41.8

<50 kg 0.75 mg/dgl

>50 kg 1.5 mg/dgl

Max 6 weeks

Aripiprazole

N05AX12

>13 years

Schizophrenia >15 years

DF20

Manic episode in Bipolar Disorder type 1, >13 years

DF30.X, DF31.0-2, DF31.6

Max 30/mg

10 mg/day

Max 12 weeks

Pimozide

N05AG02

Not approved for use in children and adolescents

Not approved for use in children and adolescents

Not approved for use in children and adolescents

Appendix 2: off-label by indication: prescriptions and indications

Drug, (n,  % of off-label prescriptions)

Off-label indications (n)

Risperidone (21, 84 %)

Aggressive behavior (8)a

Hyperkinetic disorder (5)a

Autism spectrum disorder (3)a

Psychotic symptoms (3)a

Tourette’s syndrome (1)a

Adjustment disorder(1)a

Aripiprazole (8, 72.7 %)

Tourette’s syndrome (4)

Psychotic symptoms (2)

Autism spectrum disorder (1)

Schizotypal disorder (1)

Sertraline (12, 100 %)

Moderate–severe depression (6)

Anxiety disorder (6)

Fluoxetine (3, 100 %)

Mild depression (2)

Obsessive compulsive disorder (1)

  1. aWith comorbid diseases

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Nielsen, E.S., Hellfritzsch, M., Sørensen, M.J. et al. Off-label prescribing of psychotropic drugs in a Danish child and adolescent psychiatric outpatient clinic. Eur Child Adolesc Psychiatry 25, 25–31 (2016). https://doi.org/10.1007/s00787-015-0699-z

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  • DOI: https://doi.org/10.1007/s00787-015-0699-z

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