Thursday, September 4, 2008

Anti-psychotic drugs for kids get state look

Arkansas Democrat
Anti-psychotic drugs for kids get state look
August 31, 2008

Millions of kids nationwide are prescribed atypical antipsychotic drugs for a variety of mental-health diagnoses, including attention-deficit hyperactivity disorder, bipolar disorder, autism and schizophrenia.
In Arkansas, 11, 404 children and teenagers under 18 on the state Medicaid program took antipsychotics between July 2007 and June 2008, according to the state Department of Human Services.

But only two atypical anti-psychotics are approved by the U. S. Food and Drug Administration to treat adolescents, and there is little published research to support their use in children, said Dr. William Golden, medical director for health policy with the state Medicaid program.

"The literature to support it is almost nonexistent," Golden said.

Arkansas is one of many states studying how the drugs are prescribed to children and teenagers and is one of about 15 states in a consortium formed to compile data and analyze prescribing trends nationwide.

The consortium plans to produce a report of initial findings by the end of January, said Dr. Jeffrey Thompson, the chief medical officer of the Washington state Medicaid program, who is leading the effort.

Arkansas spent $ 23. 5 million on atypical anti-psychotics for Medicaid recipients under age 18 in fiscal 2007. National expenditures for the drugs for all ages were estimated at about $ 13. 3 billion, according to a Rutgers University report.

Atypical anti-psychotics, which is a name applied to second-generation anti-psychotics, first came on the market in the 1990 s. They affect the neurotransmitters serotonin and dopamine, chemicals that allow communication between nerve cells in the brain.

Side effects of the drugs can include weight gain, breast milk production in both sexes, facial tics, muscle tremors and a potentially fatal neurological disorder that causes fever and stiffness, said Dr. Steven Domon, section chief of adolescent services at the State Hospital.

The 2006 death of a 4-yearold Massachusetts girl has helped raise the issue of anti-psychotic drug use in children nationally, Domon said.

Rebecca Riley was diagnosed with bipolar disorder and attention-deficit hyperactivity disorder at age 2 and was prescribed powerful medications by age 4, including the atypical anti-psychotic Seroquel. She was also taking Depakote, used to treat bipolar disorder and epilepsy, and Clonidine, used to treat high blood pressure.

Rebecca was found dead on the floor beside her parents' bed Dec. 13, 2006.

Her parents - who are awaiting trial on second-degree murder charges filed after authorities concluded an overdose killed her - filed a malpractice lawsuit against Rebecca's psychiatrist in April.

While many doctors prescribe medications for purposes other than indicated on their label - known as "off-label" prescribing - Domon said such prescribing should be done with caution. Atypical anti-psychotics are powerful medications, and their effects on young, developing brains are unknown.

Domon said he was alarmed by the case of a 3-year-old Arkansas boy diagnosed with autism and intermittent explosive disorder, associated with tantrums in which people throw or break things.

Despite his age, the boy was prescribed four medications for depression, anxiety and high blood pressure. One of his medications, Olanzapine, is used to treat patients with schizophrenia and bipolar disorder and is not FDA-approved for children.

Domon, a child psychiatrist, said many clinicians would be uncomfortable making a diagnosis as serious as bipolar disorder in a child so young.

In looking at initial data from Arkansas, Golden, the state Medicaid official, said concerns are whether drugs are being appropriately prescribed for children ages 5 and under. Also, the dosing for children between ages 6 and 12 varies greatly, with many children taking high doses of anti-psychotics or multiple medications.

"Some of the 6- to 12 -year-olds are on some pretty strange concoctions," he said.

Of the 11, 404 Arkansas Medicaid recipients under 18 who were prescribed anti-psychotics in fiscal 2008, 893 were under 6. Those ages 6-12 numbered 5, 602, and 4, 909 were ages 13-18 ...

Risperdal, the brand name for risperidone, is one of the two atypical anti-psychotics that's FDA-approved for treatment of some patients under age 18, FDA spokesman Sandy Walsh said. It was approved last year for treatment of schizophrenia in ages 13-17 and short-term treatment of bipolar disorder in ages 10-17. It is also approved for treatment of children with autism between age 5-16.

This year, the FDA also approved the use of the anti-psychotic Abilify to treat schizophrenia in ages 13-17 and bipolar disorder for those age 10 and older.

Walsh said physicians may choose to use non-FDA-approved drugs off label on the basis of their own clinical knowledge and their patient's condition.

"The FDA does not regulate the practice of medicine," Walsh said.

FINDING SOLUTIONS Arkansas is one of several states that have filed lawsuits against pharmaceutical manufacturers AstraZeneca, Janssen Pharmaceutica of Johnson & Johnson Inc., and Eli Lilly & Co. claiming they encouraged doctors to prescribe anti-psychotics to children and the elderly beyond what is approved by the FDA and thereby harmed patients and cost the state Medicaid plan millions of dollars.

"We want to send a message that these pharmaceutical companies need to walk a straight line when they're dealing with Arkansas and other states because the health and safety of consumers across this country depend on that," Justin Allen, chief deputy attorney general, said when the last suit, against AstraZeneca, was filed in late May.

Golden, with the state Medicaid program, said the Department of Human Services' study of antipsychotic drug use by children isn't related to the lawsuits.

"The goal is to have a better understanding of what's going on and to sensitize our mental-health community to these issues," Golden said.

According to initial data, it appears that Arkansas children are being prescribed anti-psychotics at a higher rate than other states, Domon said.

For example, 12 per every 1, 000 children up to age 18 on Florida Medicaid were prescribed antipsychotics in 2005, compared with 27. 8 per every 1, 000 children up to age 18 on Arkansas Medicaid in 2007, Domon said.

"We're two to three times more likely to prescribe anti-psychotics to young children than Florida, and Florida thinks they have a problem," Domon said.

Most of the prescribing of antipsychotics to children is in central Arkansas, but Domon said that doesn't surprise him. There are only about 30 child psychiatrists in the state, and most of them practice in and around Pulaski County.

Golden said Arkansas' first focus is on foster-care children. Last fiscal year, 982 of the 6, 957 children in foster care were prescribed anti-psychotics.

Golden said state officials are considering developing guidelines on how and when anti-psychotics should be prescribed. But there are no plans to regulate prescribing.

"We need flexibility with these kids," Golden said. "You can't have a cookie-cutter formula for these kids. Very often these are very difficult cases." Several other states, including Texas, Washington and Florida, are taking similar steps.

In the aftermath of Rebecca Riley's death, Massachusetts set up an early-warning system to identify preschoolers who might be getting excessive medication and now reviews Medicaid records of children under 5 who are on an anti-psychotic or at least three psychiatric medications.

Thompson, with the Washington Medicaid program, said the consortium will help states compare data and learn what other states are doing to help curb inappropriate prescribing of anti-psychotics.

Participating states will submit their data in September and hold a national meeting in Washington, D. C., in October. Preliminary findings will be presented to the National Association of State Medicaid Medical Directors in November. Rutgers University is helping to analyze the data.

"This isn't just about drugs. It's really about appropriate mental health care for kids and adults," Thompson said. "Drugs are only a component of that care."

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