Concern is on the rise about psychotropic medications—especially atypical antipsychotics—given to foster children covered under Medicaid. Two state Medicaid officials and a representative of the American Academy of Pediatrics (AAP) spoke at hearings of the House Ways and Means Subcommittee on Income Security and Family Support on May 8. Rep Jim McDermott, MD (D, Washington), the only psychiatrist in Congress, has introduced legislation that requires states to improve care coordination for foster children.
Section 421 of McDermott’s Invest in KIDS Act (HR 5466) requires the state agency responsible for foster children to put together a coordinat-ed health care plan for each child
that would identify and respond to, among other things, mental health needs and would include oversight of any prescription medicine use.
“Some children in foster care may need and benefit from psychotropic medication,” said McDermott. “But these drugs should not be used as a shortcut to treat foster children when more effective treatments, including counseling, might provide long-term benefits. We need to carefully oversee the prescription of these medicines, especially when it comes to giving foster children multiple drugs or prescribing medication for off-label use.”
Among the drugs frequently prescribed for foster children are atypical antipsychotics such as olanzapine (Zyprexa), aripiprazole (Abilify), ziprasidone (Geodon), risperidone (Risperdal), quetiapine (Seroquel), clozapine (Clozaril), and paliperidone (Invega). Only risperidone and aripiprazole have been approved for children, and only for the short term.
Laurel K. Leslie, MD, MPH, associate professor of medicine and pediatrics at Tufts Medical Center and a member of the AAP Task Force on Foster Care, expressed the AAP’s support for section 421 of McDermott’s bill. “We hope it can be passed expeditiously,” she said. She added that the AAP is “profoundly concerned that the recent Centers for Medicare and Medicaid Services interim final rule on case management services represents a step away from care coordination.”
Case management services are viewed as particularly important to foster children, who are sometimes shuffled from home to home, and suffer from a lack of parental medical oversight. As a result, and because of other factors, foster children apparently receive more psychotropic medications than other children covered by Medicaid.
Julie M. Zito, PhD, professor of pharmacy and psychiatry, Pharmaceutical Health Services Research, University of Maryland, Baltimore, ran through some of the studies she has done on prevalence of psychotropic medications given to children in foster care. Her latest study was done at the request of Carole K. Strayhorn, Texas state comptroller, who in 2006 requested an independent analysis of psychotropic medication patterns for foster care children in her state.
Based on the Texas data, Zito found that in 2004, 38% of the more than 32,000 foster care youth in Texas younger than 19 years received a psychotropic drug. When 2005 data were disaggregated by age group, the 2005 annual prevalence of psychotropic medication was 12.4% in 0- to 5-year-olds, 55% in 6- to 12-year-olds, and 66.5% in 13- to 17-year-olds. “When two-thirds of foster care adolescents receive treatment for emotional and behavioral problems, far in excess of the proportion in the nonÐ foster care population, we should have assurances that the youth are benefiting from such treatment,” Zito told the subcommittee. She named other states with similar patterns.
FDA to Improve Postmarketing Surveillance
It was just happenstance that the latest evidence of adverse psychiatric events caused by an approved pharmaceutical was published the day before the FDA announced the initial shape of the new Sentinel Network it will be deploying in the near future. This network, which is required by the FDA Amendments Act (FDAAA) that Congress passed last October, is designed to vastly improve the intelligence the FDA receives about drug effects once a medication goes on the market. Unforeseen psychiatric effects have cast a pall over a number of drugs, most recently Pfizer’s Chantix (varenicline) and Merck’s Singulair (montelukast).
Currently, the FDA gets anecdotal information on possible side effects of approved drugs from voluntary reports from health care professionals. Those data flow into the agency’s MedWatch system, whose shortcomings are many. Failures in the reporting system led Congress to require this new postmarketing data retrieval system to be based on the computerized patient data held by public and private insurers. The FDA announcement on May 22 mentioned only the Medicare Part D database and did not name any other components of this sentinel system.
The FDAAA gives the agency 2 years to develop the data sources. By July 1, 2010, there must be at least 25 million patients in the database; the number must increase to 100 million 2 years after that. There are at least 25 million Medicare beneficiaries in the Part D drug program.
The report from the Institute of Safe Medication Practices (ISMP) issued on May 20 concerned Chantix, the smoking cessation drug. In November 2007, the FDA had raised questions about possible psychiatric side effects associated with Chantix. The ISMP report discussed an unusually large number of adverse event reports to the FDA for problems that included psychiatric events.
Reputed psychiatric side effects have been reported frequently in the recent past, as in March, when the FDA announced it was investigating a possible association between the asthma medicine Singulair and behavior and mood changes, suicidal ideation, and completed suicides.
Questions raised—but not authoritatively answered—about a possible link between SSRI antidepressants and suicidal ideation in adolescents led to the FDA requesting a “black box” warning on those drug labels. That warning, added in 2003, has resulted in fewer diagnoses of depression among children and fewer SSRI prescriptions for children with this diagnosis, according to a University of Colorado Health Sciences Center study published in 2007.