With continued support from the Endowment for Health, PPC carries on its work to research and explore best practices related to the use of certain antipsychotic drugs in children.

Given the FDA’s recent approval of a few of these drugs for use in children, PPC’s work could not be more timely. Prescribing of antipsychotic medications to children in the US has increased dramatically. In less than a decade, the use of potent psychotropic medication (mostly prescribed “off-label”) in children and adolescents grew by five-fold, raising policy challenges for patients, clinicians, and payers. In fact, some children as young as just one year old are being prescribed these medications at increasing rates. Behaviors once considered “normal”—a baby not sleeping through the night or a toddler going through the “terrible twos”—are being diagnosed as sleep-resistant or oppositional-defiant with mood swings.

Youth in foster care covered by Medicaid insurance receive psychotropic medication at a rate greater than three times more than other Medicaid-insured youth, even though such treatment lacks substantive evidence as to its effectiveness and safety. Medicaid expenditures for atypical antipsychotics grew 21 percent between 2000 and 2007.

The growth in prescribing rates previously described occurred prior to new FDA approval of three atypical antipsychotic drugs associated with serious health risks, including significant weight gain and high blood sugar (diabetes) and cardiovascular disorders. Seroquel, Geodon, and Zyprexa were approved last year for use in the treatment of schizophrenia and bipolar mania or mixed episodes associated with bipolar disorder.

The prescribing of these powerful drugs to kids needs to be of concern to policy makers and caregivers. A preliminary study of several states supported by the Agency for Health Research and Quality found widespread use of the drugs in certain children, including foster care children, even though evidence justifying such use was limited. There is wide variation in the use of these drugs across clinics and geographical areas, and concerns have been raised about the adequacy of initial assessment(s) leading to the prescribing of the drugs, as well as ongoing monitoring and follow-up. While the final report has not been released, initial presentations of information gained from the study suggest that too many kids are being prescribed these drugs.

With the approval of some of these drugs (in spite of weak recommendations from the FDA advisory panel), state health programs and private insurers will now be under tremendous pressure by the drug industry to provide instant coverage for the drugs. Certainly children with severe mental health diagnoses who may benefit from the drugs should have access. The question is, who actually needs the drugs and who actually benefits from taking them?

Negative health risks should be weighed as part of the decision about whether or not to prescribe the drugs, and careful thought and diligence in monitoring children who use the drugs should be considered. Caregivers should also be informed of negative health consequences, some of which will last a lifetime, as well as the evidence (or lack thereof) as to the effectiveness of using these medications. State drug utilization review (DUR) committees
that decide which drugs are covered and which require prior authorization are being barraged by drug manufacturers in an effort to get their drugs on approved list(s) for public health programs. At the same time, drug reps are headed to physician’s offices to promote use of these drugs for kids.

Fortunately, many states are taking steps to ensure access while safeguarding kids. Those steps and other policy options to best help and protect children will be described in the next issue of the newsletter.