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February 22, 2000

The amount of prescriptions being written for preschoolers for stimulants and
antidepressants is on the rise, suggesting increased unapproved use of these
medications, according to an article in the February 23 issue of The Journal of the
American Medical Association.

Julie Magno Zito, PhD, from the University of Maryland, Baltimore, and colleagues
studied the prescription records of children aged 2 to 4 years enrolled in 2
Medicaid programs (Midwestern state Medicaid program and Mid-Atlantic state
Medicaid program) and 1 health maintenance organization (HMO, in the Northwest
United States) to determine the prevalence of psychotropic medication use in
preschoolers. Psychotropic medications are drugs such as stimulants,
antidepressants, sedatives, and antipsychotic drugs that have an effect on the mind.
The researchers analyzed data from 1991, 1993, and 1995 from more than
200,000 patients.

“Several prominent trends characterized the use of psychotropic medications in
preschoolers during the early to mid 1990s,” the authors explain. “Overall, there
were large increases for all study medications (except neuroleptics) and
considerable variation according to gender, age, geographic region, and health care
system. These findings are remarkable in light of the limited knowledge base that
underlies psychotropic medication use in very young children.”

In 1995, the prevalence rates per 1,000 2- through 4-year-old children in the
Midwestern state Medicaid program were 12.3 for stimulants, 3.2 for
antidepressants, and 2.3 for clonidine; in the mid-Atlantic state Medicaid program
prevalence rates were 8.9 for stimulants, 1.6 for antidepressants, and 1.4 for
clonidine; and in the HMO program prevalence rates were 5.1 for stimulants, 0.7
for antidepressants, and 1.9 for clonidine.

Increases in prevalences were noted between 1991 and 1995 across the 3 sites for
stimulants, antidepressants, and clonidine. From 1991 to 1995, Methylphenidate (a
nervous system stimulant) prevalence in 2- through 4-year-olds increased at each
site: Midwestern state Medicaid program, a 3-fold increase; mid-Atlantic state
Medicaid program, a 1.7 fold increase; and the HMO had a 3.1-fold increase.
Decreases occurred in the relative proportions of previously dominant
psychotherapeutic agents in the stimulant and antidepressant classes, while increases
occurred for newer, less established agents.

According to background information cited in the article, approved and unapproved
indications for psychotropic medications in young children are not extensive. The
reasons for prescribing include: pain relief (analgesics and sedatives/hypnotics);
situational anxiety associated with medical, presurgery, and dental procedures
(hydroxyzine); bed wetting in children 6 years or older (tricyclic antidepressants);
and attention-deficit/hyperactivity disorder in those 3 years and older

The authors express concern about psychotropic medication treatment for children
younger than 5 years with off-label prescriptions that have little or no proven
efficacy and lack product package insert labeling information approved by the US
Food and Drug Administration. They add that the vast majority of psychotropic
medications prescribed for preschoolers are being used off-label.

“Unresolved questions involve the long-term safety of psychotropic medications,
particularly in light of earlier ages of initiation and longer durations of treatment,”
caution the researchers. “While it is reassuring that anecdotal reports have rarely
documented these problems, the possibility of adverse effects on the developing
brain cannot be ruled out. Active surveillance mechanisms for ascertaining subtle
changes that the developing personality may undergo as a result of a psychotropic
drug’s impact on brain neurotransmitters should be developed.”

In an accompanying editorial, Joseph T. Coyle, MD, from Harvard Medical
School, Boston, offers additional concerns regarding the increase in the prescription
of psychotropic medications to preschoolers. “Given that there is no empirical
evidence to support psychotropic drug treatment in very young children and that
there are valid concerns that such treatment could have deleterious effects on the
developing brain, the reasons for these troubling changes in practice need to be
identified,” Dr. Coyle writes. “Unfortunately the study by Zito et al does not provide
the diagnoses of the children or the professional identities or specialties of the
prescribers, which could shed some light on the reason for these prescribing
patterns. One possible contributing factor is the way mental health services are
provided to children. For example, many state Medicaid programs now provide
quite limited reimbursement for the evaluation of behavioral disorders in children and
preclude more than one type of clinical evaluator per day. Thus, the multidisciplinary
clinics of the past that brought together pediatric, psychiatric, behavioral, and family
dynamic expertise for difficult cases have largely ceased to exist. As a consequence,
it appears that behaviorally disturbed children are now increasingly subjected to
quick and inexpensive pharmacologic fixes as opposed to informed, multimodal
associated with optimal outcomes. These disturbing prescription practices
suggest a growing crisis in mental health services to children and demand more
thorough investigation.”

JAMA. 2000;283:1025-1030,1059-1060

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