Â鶹´«Ã½ — Psychotropic medications, which act on the central nervous system to alter emotion or behavior temporarily, are frequently used to treat youth in foster care, but there is a lack of "substantive evidence of their effectiveness and safety," says a University of Maryland, Baltimore (UMB) researcher.

In a study of Texas children with Medicaid coverage, the latest in a series of analyses of state Medicaid records, foster care youth received at least three times more psychotropic drugs than comparable children in poor families. But there is no clear treatment advantage to the foster children, according to Julie Zito PhD, professor of pharmacy and psychiatry at the UMB School of Pharmacy.

Of 32,135 Texas foster care children enrolled in Medicaid from September 2003 to August 2004, 12,189 (38 percent) were dispensed one or more psychotropic medications. Among those receiving psychotropic medications, 41.3 percent of a random sample of 472 youths received three or more psychotropic drugs daily.

The medicated children were most likely to be Caucasian males, and 10 to 14 years of age. This sizable proportion of youth receiving drug combinations poses questions about appropriateness, benefits and risks, says Zito.

The Texas study also indicated that decisions to give some children three or more psychotropic drugs may be largely based on behavioral and emotional symptoms rather than conclusive diagnosis of a specific mental condition. "These data do not provide sufficient information to address questions of severity and impairment that might explain such complex drug regimens," Zito suggests.

Emphasizing symptoms can lead to the diagnosis of more than one mental disorder in a patient, leading to greater use of combinations of drugs, said the study, which was published earlier this year in the journal Pediatrics.

Zito says, "There are serious behavioral and emotional problems with many foster children and we want to make sure they are medicated appropriately. These are our troubled children." Many foster children experience multiple family placements and such disruption poses real challenges for the developing child, caregivers, and treating clinicians.

She says the extensive use of such drugs in foster care youth is an indication of a trend of expanding use "in U.S. youth across the country. This [increase in psychotropic drug use] represents a sea change in the practice of child mental health treatment since 1990. Such trends in community treatment deserve further investigation. Let's learn more about the medications being taken by children, the reasons for use, who benefits and who doesn't."

More than 75 percent of the psychotropic medication use for children is off-label, a practice of prescribing drugs for a purpose other than the approved use on its label. "So we are generalizing our [knowledge] from adults to children without knowing enough about pharmacokinetics, dosing, or long-term safety in the pediatric population," said Zito.

Zito has been leading studies of children's use of medication in the Medicaid population for more than a decade, with funding for the past five years from the National Institutes of Health's National Institute of Child Health and Human Development.

To enhance the work, the Maryland School of Pharmacy's Pharmaceutical Research Computing (PRC) center has established state-of-the-science computing resources to analyze very large data sets.

As one of a new breed researchers called pharmacoepidemiologists, Zito studies community populations for the use and safety of medications already on the market. She says her work may be thought of as phase IV drug analysis, a logical continuation of the common three-phase clinical trials that a drug maker needs to complete before seeking federal approval to market the drug.

"This is a 'post-marketing' view of how a drug is doing," she says.

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