Michala Walker, a team leader for the Office of Evaluation and Inspections in Kansas City, is interviewed by Brian Whitley, Regional Inspector General for the Office of Evaluation and Inspections.
[Brian Whitley] I'm Brian Whitley, Regional Inspector General for the Office of Evaluation and Inspections in Kansas City. I'm speaking with Michala Walker, a team leader in our office about a new report on the use of powerful antipsychotic drugs prescribed for children enrolled in the Medicaid program. The report uncovered a number of quality-of-care concerns. Michala, can you tell us about the report's findings?
[Michala Walker] Certainly. Our study found that for 67 percent of the children whose medical records we reviewed, there was at least one quality-of-care concern related to the prescription of antipsychotic drugs. And more than half of the children's medical records indicated multiple quality-of-care concerns related to those drugs.
[Brian Whitley] Could you describe how you identified quality-of-care concerns?
[Michala Walker] We selected a sample of Medicaid claims for antipsychotic drugs for children in five States and pulled the medical records for those children. We hired board-certified child and adolescent psychiatrists to review those records. Those psychiatrists looked for quality-of-care concerns related to seven criteria: dosage, duration, indications for use, monitoring, polypharmacy (or using multiple drugs at the same time), patient age, and side effects.
[Brian Whitley] What types of quality-of-care concerns did you find?
[Michala Walker] One of the most common issues we encountered was a lack of monitoring. We found lack of monitoring in more than half the cases we reviewed. Poor monitoring can have serious implications, especially for young patients.
[Brian Whitley] Michala, why did the OIG look at the use of antipsychotic drugs in children?
[Michala Walker] Well Brian, there has been growing concern about the increasing use of these drugs in the treatment of children for a number of years. This class of medications, referred to as "second-generation antipsychotics," can be effective treatments for children with mental health conditions. However, these drugs can have serious side effects and little clinical research has been conducted on the safety of treating children with these drugs.
[Brian Whitley] So are you saying antipsychotic drugs are too dangerous to use in children?
[Michala Walker] No. I'm not saying that antipsychotic drugs should never be used in children. But they should only be used for a medically appropriate reason and, when they're used, they must be very carefully managed to ensure safety and quality care.
[Brian Whitley] What are some of the problems these drugs can cause?
[Michala Walker] One child in our sample developed a condition called akasthisia, a serious disorder which causes involuntary movements and restlessness. Another child experienced hallucinations, paranoia, and suicidal thoughts while being treated with a regimen of six psychotropic drugs including three second-generation antipsychotic drugs. When all her medications were stopped, those symptoms resolved. This child also experienced significant side effects while being treated with her medications, including weight gain, insomnia, and swelling of her hands and feet, but those side effects were not properly monitored. So Brian, you can see just how serious a concern this is.
[Brian Whitley] What other quality-of-care concerns did you frequently identify?
[Michala Walker] As I mentioned earlier, these are powerful drugs that should only be used for a medically appropriate reason. For 41 percent of the children in our sample, the medical records did not state a reason why the antipsychotic drugs were prescribed or stated an indication for which this type of pharmacotherapy is not appropriate.
[Brian Whitley] Can you give us some examples?
[Michala Walker] Sure. One child whose treatment we reviewed was only four years old. The medical reviewer reported that the antipsychotic he was taking wasn't indicated for such a young patient, and that doctors should have tried to treat him with nonpharmacologic therapy, before treating him with drugs.
[Brian Whitley] Do you have another example?
[Michala Walker] In the case of the child with hallucinations that I mentioned earlier, we found that child was taking six psychotropic drugs, with little documentation for why the drugs were prescribed. The only explanation in this child's medical record for her regimen of multiple drugs was a vague reference to her hallucinations. In 37 percent of the claims, our reviewers found quality-of-care concerns with children being prescribed multiple drugs simultaneously.
[Brian Whitley] What else did the study find?
[Michala Walker] In the five States, only 8 percent of antipsychotic drugs were prescribed for the limited number of medically accepted pediatric indications. Ninety-two percent of the antipsychotic prescriptions for these children were for indications that were not medically accepted.
[Brian Whitley] What do you mean by "medically accepted indications"?
[Michala Walker] A medically accepted indication is a use of a drug that is approved by the Food and Drug Administration as safe and effective or that is supported by certain approved compendia of drug information.
[Brian Whitley] Must physicians only prescribe drugs for medically accepted indications?
[Michala Walker] No, not necessarily. Prescribing antipsychotic drugs to children for indications that are not medically accepted is entirely legal and some Medicaid programs pay for such prescriptions. It is also very common because, as I said before, there are very few medically accepted pediatric indications for antipsychotic drugs.
[Brian Whitley] What other issues did the report examine?
[Michala Walker] Three of the antipsychotic drugs in this evaluation carry FDA's boxed warning of increased chances of suicidal thinking and behavior in children. We found that over a third of antipsychotic drugs were prescribed in the presence of conditions described in the FDA boxed warning.
[Brian Whitley] What steps should be taken to ensure better quality-of-care for children receiving antipsychotic drugs?
[Michala Walker] We recommended that the Centers for Medicare & Medicaid Services, or CMS, work with State Medicaid programs to perform utilization reviews of antipsychotic drugs prescribed to children. We also urged CMS to conduct periodic reviews of medical records related to treatment of children prescribed antipsychotic drugs. We also recommended that CMS work with States to find other ways to improve oversight of these antipsychotic drugs prescribed to children, like peer review programs.
[Brian Whitley] Did CMS agree with OIG's recommendations?
[Michala Walker] Yes, CMS agreed with all three recommendations.
[Brian Whitley] Thank you, Michala, for sharing this important work.
[Michala Walker] Thank you.