The prescribing of psychotropic medications for children can be an emotive subject, much discussed and debated amongst professionals1 as well as in the community. A vocal minority decry the perceived widespread prescribing for children, in spite of the scientific evidence supporting the substantial benefits to children and families from the appropriate use of stimulant medications in children.
We have now entered a new era, where the prescribing of psychotropic medications has expanded beyond the use of stimulants. A series of publications from the USA in recent years have described a number of trends including:
- 1An expanding ‘menu’ of psychotropic medications being prescribed to children2−5. Drugs such as clonidine, selective serotonin reuptake inhibitors (SSRI), antipsychotics and mood stabilizers are now part of the pharmacologic armamentarium being used by practitioners to help children regulate their mood states and behaviours.
- 2Polypharmacy, with many children receiving two or more psychotropic medications simultaneously, and up to five or six sequentially5.
- 3The prescribing for very young children, some as young as 2 or 3 years of age3,5.
What is known about current patterns of prescribing in Australia? There are some good data on the stimulants, at least in some states. The number of children commenced on stimulant medication increased dramatically in the first half of the 1990s, but seems to have levelled off since6. In 2000, 11.3 per thousand children and adolescents in New South Wales were being treated with stimulant medication6. Significant variation between states in the rate of prescribing of stimulants has recently been reported7. The recent registration of the first proprietary extended-release stimulant preparation on the Australian market (methylphenidate biphasic capsules − Ritalin LA; Novartis Pharmaceuticals Australia Pty Ltd, North Ryde, NSW, Australia) confers a significant advantage for many children by obviating the need for a dose at school. Hopefully, this will be followed by other preparations currently available overseas using novel delivery systems which employ new technologies.
There are few data available regarding the prescribing of non-stimulant psychotropic medications for Australian children. In late 2000, a survey was undertaken of all general paediatricians and child and adolescent psychiatrists in Australia (n = 870, response rate 72%)8. The findings broadly demonstrated similar trends to those reported in the USA. Australian paediatricians and child psychiatrists are now prescribing a variety of medications, some relatively frequently (e.g. stimulants, clonidine), others less frequently (e.g. SSRI, typical neuroleptics, atypical neuroleptics, and mood stabilizers). For each medication/medication group, a substantial proportion of practitioners reported not prescribing at all. The use of combinations of psychotropic medications was reported by 72% of respondents, the most common combination reported being a stimulant and clonidine (60%), followed by a stimulant and an SSRI (31%). A minority of practitioners reported that they had prescribed various medications for a child aged less than 3 years (e.g. 10% for clonidine, 8% for stimulants, 6% for typical neuroleptics).
Much of this prescribing is ‘off-label’, as studies of these medications for children with these indications have not been conducted. In fact, this applies to 80% of all drugs used for children, a situation unchanged since 1968 when Shirkey coined the term ‘therapeutic orphan’ to describe the therapeutically disadvantaged position of children9. It is important to note that off-label prescribing is not illegal or even indicative of improper or poor quality practice, if based on rational scientific theory, expert opinion or controlled clinical trials10. The package insert is only a guide, not a mandate. The atypical antipsychotic risperidone is an example of a medication that has been off-label for children, although the label was recently altered to include the indication ‘Treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with subaverage intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent’ (MIMS, May 2003).
The paper by King et al. in this issue of the journal reports a retrospective series of 51 patients treated with risperidone at the Department of Psychological Medicine, The Children's Hospital, Westmead, between 1995 and 199811. The patients ranged in age from 2 to 21 years (mean 13), and suffered from a variety of disorders; two-thirds had an intellectual disability, 61% attention deficit−hyperactivity disorder (ADHD), 29% epilepsy, 27% autistic spectrum disorders (ASD), and 25% psychosis. All subjects exhibited severe behaviour disturbance with aggression that was threatening the safety of staff, themselves and/or property. Doses of risperidone ranged from 1 to 5 mg/day (0.1−0.8 mg/kg/day). While many benefits were reported, the reported incidence of sedation (28%), anticholinergic (10%) and especially extrapyramidal effects (8%) were concerning. This paper provides some real-life clinical experiential data (a diverse variety of conditions, with two-thirds of the subjects concurrently taking another psychotropic medication) to complement the recently reported promising results of a multicentre 8-week RCT comparing risperidone with placebo in 101 children with ASD and severe behaviour disturbance12.
How should paediatricians practice in a field where the evidence base has major gaps? Families present children with complex problems, and paediatricians do the best they can with the skills and tools at their disposal. They often face pressures from desperate families with limited supports, as well as schools with limited resources to assist children with special needs. Mental health services are often difficult to access in a timely manner. Paediatricians are thus presented with challenging management decisions on a daily basis.
Paediatricians seeing children with emotional−behavioural problems will and should continue to practice in such a way as to maximize the chances of symptomatic improvement and better outcomes for children, with low exposure to risk of harm from the intervention. This should be evidence-based where evidence exists. Medication is clearly one of the most effective interventions; however, often the trials in groups with the particular problem mix presented by these children have not been undertaken, so the prescribing options are off-label.
Sensible principles of assessment and prescribing, while self-evident, will offer the best chance of good outcomes while minimizing the risk of harm. Children need to be assessed properly, with detailed information obtained from multiple sources, generally the parents and teachers. There are multiple modalities of therapy that can be helpful for children with emotional−behaviour disturbance − many children with diagnosable ‘psychiatric disorders’ do not require psychotropic medication. However, as the MTA study has demonstrated in ADHD, medication is often the most powerful intervention to improve children's functioning13. Successful medication therapy may additionally make children more ‘available’ for other interventions. If medication is prescribed, families must be informed about important potential side-effects, and the paediatrician be accessible for telephone contact. Children taking medication should be monitored regularly. Finally, the importance of informal peer support in this difficult work cannot be overstated.
It is likely that the number of children with emotional-behavioural problems seen by paediatricians will continue to grow in the years to come. Treating these children with psychotropic medications will continue to be an option. Paediatricians face considerable challenges in becoming confident and competent clinicians in an area where a strong evidence base has not yet been established.