Pharmaceutical

Large number of off-label antipsychotics prescribed to children on Medicaid

risperdal Large number of off label antipsychotics prescribed to children on MedicaidSecond-generation antipsychotics are widely prescribed to treat children enrolled in Medicaid who have mental conditions; however, these drugs can have serious side effects and there is little research to gauge the safety of these medications on children, according to a Health & Human Services study.

Second-generation antipsychotics, which include the brand-name medication Risperdal, are used to treat psychiatric disorders such as schizophrenia, bipolar disorder and psychotic depression. Some, like Risperdal, are also approved to treat irritability with autism. And many are prescribed for off-label conditions such as attention deficit hyperactivity disorder (ADHD) and anxiety. Not all antipsychotics are approved for use in children, but doctors have the authority to prescribe medications for unapproved uses.

Children being treated with second-generation antipsychotics need careful management and monitoring because the drugs have been associated with serious side effects for which children can be even more sensitive. For example, Risperdal, known generically as risperidone, can cause an increase in the hormone prolactin, which can result in gynecomastia, a condition which causes breast growth in boys and young men. The condition can be emotionally devastating and physically painful. In many cases, treatment involves surgeries such as liposuction and mastectomy.

Health & Human Services conducted the evaluation to examine the quality of care provided to children who were prescribed second-generation antipsychotics that were paid for by Medicaid. The analysis involved a sampling of 687 claims for the drugs prescribed to children in California, Florida, Illinois, New York and Texas, representing about 39 percent of total Medicaid payments for the drugs in 2011. The medical records were reviewed by board-certified child and adolescent psychiatrists.

Researchers found that in the five states involved in the study, 8 percent of second-generation antipsychotics were prescribed for the five medically accepted pediatric indications. Many of the children were being treated for conditions that are not considered “medically accepted,” meaning doctors were taking the liberty of prescribing the drugs for off-label uses.

The agency recommended that State Medicaid programs perform utilization reviews of children taking these drugs and conduct periodic reviews of medical records associated with claims for antipsychotics prescribed to children.

Source: Office of Inspector General