MedicalResearch: What is the background for this study?
Dr. Zito: Atypical antipsychotic (AAP) use in children and adolescents has grown substantially in the past decade, largely for behavioral (non-psychotic) conditions. Poor and foster care children with Medicaid-insurance are particularly affected. This ‘off-label’ usage has insufficient evidence of benefits regarding improved functioning (i.e. appropriate behavior and performance, socially and academically) while the little evidence that accrues tends to emphasize ‘symptoms’, i.e. less acting out. Recent evidence shows that youth treated with atypical antipsychotics are at risk of serious cardiometabolic adverse events including diabetes emerging after atypical antipsychotics are ‘on board’.
Method and Findings:
Dr. Zito: The continued expansion in atypical antipsychotics use for behavioral conditions, particularly in poor and foster care youth prompted several government reports asking states to implement oversight programs. In our survey of state Medicaid agencies, we identified programs implementing a new and promising approach to increase the likelihood that these medications are used appropriately. These ‘peer review’ programs have been launched in 15 of the 31 prior authorization state Medicaid programs. There is a distinct advantage in having a qualified peer review, on a case-by-case basis, of the rationale for use of an atypical antipsychotic in a condition or age group that is ‘off-label’ according to the FDA product information label.
MedicalResearch: What should patients and clinicians take away from this report?
Dr. Zito: After a medication is marketed, additional information (post-marketing surveillance) is warranted but generally not widely undertaken. Families should be encouraged and trained to help clinicians evaluate the benefits and monitor the potential risks of these potent but problematic medications. Treating ‘behavior’ is a complicated matter and multiple perspectives (including teachers) along with research evaluations are needed for comprehensive short and long-term benefit to risk assessments.
MedicalResearch.com: What recommendations for future research do you have as a result of this work?
Dr. Zito: Promulgating this study information widely, our goal is to inform pediatric researchers and funding agencies of the need to conduct robust, well designed impact studies to learn about the effectiveness of peer review in advancing quality psychopharmacologic treatment of behavioral conditions.
In addition, policy makers can ensure compliance with laboratory monitoring at baseline and with repeated antipsychotic use in youth, so that youth for whom an atypical is warranted, will avoid unnecessary cardiometabolic risk.
Finally, we call for a broad national conversation on the current underlying model of behavioral and emotional treatments of youth (known as ‘biological psychiatry’) which should be widely discussed among stakeholders in terms of its limitations in the management of pediatric behavioral and mental health conditions. Returning to a ‘biopsychosocial’ model would encourage non-pharmacologic as well as psychopharmacologic interventions to support community-based effectiveness and safety studies in a post-marketing surveillance approach to biomedical science.
MedicalResearch.com Interview with:Dr. Julie Magno Zito, PhD (2015). Some Medicaid Programs Offer Peer-Review For Pediatric Atypical Antipsychotic Medications