Off-Label Antipsychotic Prescribing Common in Very Young Kids

Nancy A. Melville

December 12, 2016

Off-label prescribing of antipsychotics for very young children is common, with younger physicians more likely than older ones to write such prescriptions, new research shows.

"Using all-payer, physician-level prescription data on psychiatrists and family medicine physicians who prescribed antipsychotic medications over the period 2009 to 2011, we found that over 40% of prescribers had written at least one antipsychotic prescription for a child between the ages of zero and nine," the authors, led by Haiden Huskamp, PhD, Department of Health Care Policy, Harvard Medical School, in Boston, Massachusetts, write.

The study was published in the December issue of Psychiatric Services.

Prescriber Characteristics

The study included data on prescribing patterns of US psychiatrists from 2009 to 2011 that were derived through IMS Health's Xponent database and from the American Medical Association Masterfile. The data included a random 5% sample of family medicine physicians who wrote at least 10 prescriptions for antipsychotics per year.

Of 31,713 clinicians who had prescribed antipsychotics, 42.2% had written at least one antipsychotic prescription for a young child (age 0 to 9 years). Fewer antipsychotics were prescribed to young children (median, 2) compared to adults (median, 7).

Among prescriptions to young children, 75% were for indications approved by the US Food and Drug Administration (FDA) for the patient's age, compared to 35.7% of antipsychotic prescriptions for adults.

"Compared with prescribing practices for adults, when treating young children, physicians were more likely to prescribe an antipsychotic with an FDA-approved indication for that age group," the authors note.

They add that among those who had written at least one antipsychotic prescription for a young child (age 0 to 9 years), 64% had written at least one prescription for a medication with no FDA-approved indication for a child of that age.

Physicians who were aged 39 years or younger were more likely than those aged 60 years or older to prescribe antipsychotics to young children (odds ratio [OR] = 1.70).

Other characteristics of physicians more likely to prescribe to young children were those in rural vs nonrural areas (OR = 1.11). Prescriptions to youths were less likely to be written by men (OR = .93) and graduates of a top-25 US medical school vs a lower-ranked US medical school (OR = .87).

In addition, physicians who were not in group practices (OR = .86) and those with a high share of antipsychotic prescriptions paid for with cash (OR = .54) were less likely to write prescriptions to youths.

Of those writing prescriptions for children, 31% were child and adolescent psychiatrists, 65.6% were other psychiatrists, and 2.7% were in family medicine.

Only two second-generation antipsychotics, risperidone (Risperdal, Janssen) and aripiprazole (Abilfy, Otsuka) currently have an FDA-approved indication for use in children aged zero to nine years; that indication is treatment of irritability associated with autism.

Although the American Psychiatric Association and the Academy of Child and Adolescent Psychiatry both urge caution in the use of the medications in young children, antipsychotics are increasingly used off label for conditions in young children, including attention-deficit/hyperactivity disorder (ADHD), conduct disorder, and psychosis.

Among key concerns regarding such prescribing is that little is known about the risks associated with the use of antipsychotics in young children. Increasing evidence links second-generation antipsychotics to potentially serious cardiometabolic side effects, including excessive weight gain, hypertension, and abnormalities in lipid and glucose levels in children.

"The importance of this association is amplified by evidence that cardiometabolic disturbances in childhood predict adult cardiometabolic outcomes," the authors write.

Previous research showing such effects include a 2014 study published in the Journal of the American Academy of Child and Adolescent Psychiatry. In that study, investigators found that the antipsychotics olanzapine (multiple brands), quetiapine (Seroquel, AstraZeneca), and risperidone were associated with significant increases in body weight in the first 6 months of initiating treatment. After 6 months of treatment of children with olanzapine, increases were reported in nearly all lipid parameters.

In addition, patients younger than 12 years who were treated with risperidone were found to be at higher risk for glucose intolerance than older patients.

The authors of the new study speculate that some physicians may turn to antipsychotics for young children when access to evidence-based nonpharmacologic treatments is limited, particularly for the treatment of children with ADHD who engage in disruptive behaviors.

"This possibility points to the need for broader interventions focused on the competencies and geographic distribution of the mental health workforce and financing of mental health services," they write.

Common strategies for influencing physician prescribing behavior include requiring prior authorization, step therapy, tiered formularies, monitoring, and feedback, such as through computerized alerts and reminders. These have been shown to be effective in influencing physician prescribing behavior in general, and the authors recommend such strategies with respect to the use of antipsychotics to young children.

"Payers and health plans could consider applying these approaches to antipsychotic prescribing for young children in an effort to remind prescribers of the risk-benefit tradeoffs associated with antipsychotic use among children," they note.

Indicator of Child Psychiatrist Shortage

Commenting on the study for Medscape Medical News, Mary Margaret Gleason, MD, assistant professor of psychiatry and neurology and of pediatrics, Department of Psychiatry, and director for Tulane Infant Mental Health Services at Tulane University, in New Orleans, Louisiana, said the findings, particularly those regarding higher prescribing rates in rural areas, reflect the need for more child and adolescent specialists.

"Given the extreme workforce shortage related to child and adolescent psychiatry around the country, but particularly in the rural areas, it is not surprising that general psychiatrists find themselves in the position of treating children under 9, for whom they have less training. Pediatricians often find themselves in this situation as well," said Dr Gleason.

Limitations of the study include the fact that the clinical context of the indications is not known, she added.

"Although some of the factors associated with prescribing may suggest quality ― for instance, reported rank of medical school training or living in a lower resource area ― this study doesn't give information about the appropriateness or lack thereof of the prescriptions for any individual child."

Dr Gleason noted that the study nevertheless offers important insights into the characteristics of potentially risky prescribing practices.

"It is critical that we think about not just what children are receiving with specific treatment approaches but also what about the provider and about the clinical context might be influencing the treatment decisions in order to identify the factors that could be modified to ensure children can access the best possible treatment," she said.

The study received funding from the National Institute of Mental Health. The authors and Dr Gleason have disclosed no relevant financial relationships.

Psychiatr Serv. 2016;67:1307-1314. Abstract


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