Psychotropic drugs and preschoolers

With little evidence for the safety and effectiveness of these drugs in the very young, doctors are in a difficult position

MJA 2000; 173: 172-173

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	Disturbingly, recent overseas reports suggest that the prescribing of stimulant, antipsychotic, antidepressant and other psychotropic drugs for very young children is increasing.1,2 Of even greater concern is that a significant number of these children may be given more than one psychotropic drug concurrently.3 While no systematic data are available to show whether the same phenomena are occurring in Australia, there are indications that prescribing of psychotropics for preschoolers is not uncommon in this country. A survey of 788 parents whose children were treated with stimulants found that 8% were aged under five years when diagnosed with attention deficit hyperactivity disorder;4 presumably, many were given medication. Preliminary data provided by the Pharmaceutical Services Branch of the New South Wales Department of Health (NSW Health) show that in the past decade stimulant treatment was initiated (an authority was given) in NSW for 5819 children younger than six years: 67 (1%) were aged two and 715 (12%) three. There was a 12-fold increase in the number of preschool children treated with stimulants between 1990 and 1999. There are no Australian data about the use of other psychotropic drugs in this age group, but our clinical experience shows that antidepressants, antipsychotics and clonidine are being used. Reports suggesting an increase in the prescribing of clonidine in preschoolers, often concurrently with stimulants, are appearing. The result is a disturbing number of clonidine poisonings in very young children.5,6
	...medication, rightly or wrongly, has become more common in managing problematic behaviour, even in the very young.
	It is worrying that psychotropics are being prescribed for preschoolers. Firstly, with few exceptions, in most countries these medications are not approved for use in the very young. Secondly, there are very few controlled data showing whether they are effective in this age group.7 Thirdly, psychiatric diagnoses in preschoolers generally lack validity and reliability. This is because preschool-age children have a limited repertoire of emotions and behaviours and a reduced ability to communicate, which leads to a reliance on parental reports. Further complications are an overlap of symptoms with temperamental characteristics, difficulties in establishing the range of age-appropriate behaviours in the context of differences in maturation, and the fact that children of this age are highly reactive to environmental stressors, family conflict and inadequate parenting. Fourthly, there is little knowledge and considerable apprehension about the long-term effect of psychotropics on the developing brain. Fifthly, there are scarce data about the pharmacokinetic and pharmacodynamic characteristics of these drugs in the very young. Finally, rather than placing the best interests of the child first, some practitioners may react to pressure from preschools, childcare services or parents. For all of these reasons, prescribing psychotropics in preschoolers is of concern. The problem is magnified if the child is reviewed infrequently, as seems the case for many of those taking stimulants.3 A review of 624 children hospitalised for any reason in five European countries showed that over two-thirds had received medications that were not licensed for use in children or "off label" (ie, used for indications or in patient groups other than those approved by the regulatory bodies).8 Thus, the prescribing of psychotropics to preschoolers is part of the world-wide pattern of prescribing drugs for children off label. This situation is the result of most drugs' not having been tested in children, let alone preschoolers. Drugs are studied in adults, and physicians assume they will be effective and safe for the young. However, such an assumption is unwarranted, as the experience with tricyclic antidepressants in the treatment of depression in children has shown.9 That experience also shows that clinicians find it difficult to wait for the evidence and, in its absence, may prescribe medications that are not only ineffective but also potentially hazardous. With society and families undergoing rapid change, physicians are confronted with growing numbers of young children with severe behavioural problems, with many parents who have limited parenting skills and with an increasingly demanding public. This is compounded by overwhelmed and inadequate social and mental health services for young people. It is not surprising that medication, rightly or wrongly, has become more common in managing problematic behaviour, even in the very young. At the same time, there are preschool children who present with severe symptoms and impairment who do not respond to appropriate psychosocial treatments.7,10,11 Depriving them of potentially effective medication (eg, stimulants, for which there is ample evidence of effectiveness in older children) may be unwarranted. Clinicians find themselves in an all-too-familiar predicament: urged to prescribe but having no evidence base for doing so. None the less, sympathy with the physician's predicament does not justify potentially unsafe practices. Education in paediatric psychopharmacology -- made more necessary by the large number of new drugs marketed recently -- and increasing awareness of the range of effective, non-pharmacological interventions available7,10,11 are probably better alternatives for minimising unproven practices than greater control of prescribing. These problems are not new. Many were identified in a 1997 report which emphasised that labelling of medications for children was poor, that liability was transferred to prescribers, that lack of research could deprive children of access (including subsidised access) to effective treatments, and that ethical concerns made it difficult to conduct treatment trials in this age group, thus creating a vicious cycle.12 We wonder whether the recommendations in this report have been implemented with the diligence this matter deserves. For example, are all relevant new drugs which are submitted for registration required to include paediatric indications? (This requirement has already been implemented in the United States.) Have disincentives for research and for registration of medications for use in children been reviewed or removed? The NHMRC needs to make funding of research on the use of drugs in children a priority, and to tackle the difficult ethical issues involved. This is not something other stakeholders, like the pharmaceutical industry, are likely to take on. It is clear that clinicians are not the only ones responsible for the current state of affairs. Joseph M Rey Professor, Department of Psychological Medicine University of Sydney and Director of Child and Adolescent Mental Health Services Northern Sydney Health Garry Walter Clinical Lecturer, Department of Psychological Medicine University of Sydney and Acting Director Central Sydney Child and Adolescent Mental Health Services Philip L Hazell Conjoint Professor of Child and Adolescent Psychiatry University of Newcastle and Director of Child and Youth Mental Health Services, Hunter Mental Health Zito JM, Safer DJ, dosReis S, et al. Trends in the prescribing of psychotropic medications to preschoolers. JAMA 2000; 283: 1025-1030. Minde K. The use of psychotropic medication in preschoolers: some recent developments. Can J Psychiatry 1998; 43: 571-575. Rappley MD, Mullan PB, Alvarez FJ, et al. Diagnosis of attention-deficit/hyperactivity disorder and use of psychotropic medication in very young children. Arch Pediatr Adolesc Med 1999; 153: 1039-1045. Hazell P, McDowell MJ, Walton JM. Management of children prescribed psychostimulant medication for attention deficit hyperactivity disorder in the Hunter region of NSW. Med J Aust 1996; 165: 477-480. Erickson SJ, Duncan A. Clonidine poisoning -- an emerging problem: epidemiology, clinical features, management and preventative strategies. J Paediatr Child Health 1998; 34: 280-282. Kappagoda C, Schell DN, Hanson RM, Hutchins P. Clonidine overdose in childhood: implications of increased prescribing. J Paediatr Child Health 1998; 34: 508-512. Hazell P. Attention deficit hyperactivity disorder in preschool children. Adelaide: The Australian Early Intervention Network for Mental Health in Young People, 2000: 15-28. Conroy S, Choonara I, Impicciatore P, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ 2000; 320: 79-82. Hazell P, O'Connell D, Heathcote D, et al. Efficacy of tricyclic drugs in treating child and adolescent depression: a meta-analysis. BMJ 1995; 310: 897-901. Barkley RA, Shelton TL, Crosswait C, et al. Preliminary findings of an early intervention program with aggressive hyperactive children. Ann N Y Acad Sci 1996; 794: 277-289. Sanders MR, Gooley S, Nicholson J. Early intervention in conduct problems in children. Adelaide: The Australian Early Intervention Network for Mental Health in Young People, 2000: 43-50. Australian Drug Evaluation Committee. Report of the working party on the registration of drugs for use in children. Canberra: Australian Drug Evaluation Committee, October 1997. ©MJA 2000 Make a comment Other articles have cited this article:   Michael G Sawyer, Joseph M Rey, Brian W Graetz, Jennifer J Clark and Peter A Baghurst. Use of medication by young people with attention-deficit/hyperactivity disorder Med J Aust 2002; 177 (1): 21-25. [Research] <http://www.mja.com.au/public/issues/177_01_010702/saw10558_fm.html> Home | Issues | eMJA shop | Terms of use | Classifieds | More... | Contact | Topics | Search The Medical Journal of Australia    eMJA   Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company. Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/> © 2000 Medical Journal of Australia. We appreciate your comments.