Off-label prescribing of SGAs in children varies by diagnosis

 

TORONTO – On-label prescribing of second-generation antipsychotics in hospitalized pediatric patients with bipolar disorder and schizophrenia was greater than off-label prescribing, but not for patients with autism spectrum disorder, results from a single-center study showed.

“There is an increasing trend for using second-generation antipsychotics (SGAs) in children,” lead study author Debra V. McQuade, MD, PhD, said in an interview in advance of the Pediatric Academic Societies meeting. “This trend has already been widely acknowledged as concerning, due to the relatively high adverse event burden associated with them. Also, and perhaps more concerning, the great majority of these prescriptions are prescribed as ‘off-label’ (without Food and Drug Administration approval or indication). This is true in all settings, whether outpatient or inpatient. And, this off-label use is really high – usually reported as 60%-95% of all SGA prescriptions to children. We wanted to understand more about this practice of off-label prescribing of SGAs to children – to understand what drives it, to see if there were any organizing principles that might help to better explain it.”

©drpnncpp/thinkstockphotos.com

Dr. McQuade, of the division of pediatric psychiatry and behavioral health at the University of Utah, Salt Lake City, and her associates retrospectively reviewed data for 86 inpatients hospitalized at Primary Children’s Hospital Wasatch Canyons Behavioral Health Campus, also in Salt Lake City, in 2015 with a diagnosis of autism spectrum disorder, bipolar disorder, or schizophrenia, and who were prescribed an SGA. The medications were identified as on-label (full psychiatric indication for children and adolescents) or off-label (no full psychiatric indication for children and adolescents) based upon the patients’ diagnoses and age. Next, the researchers calculated the frequency and percentage of on-label and off-label prescriptions overall and for the three diagnostic groups.

Dr. McQuade and her associates found that for the three diagnostic groups overall, on-label prescribing of SGAs was greater than off-label prescribing (65% vs. 35%, respectively; P less than .001). Prescriptions for patients with bipolar disorder and schizophrenia followed this pattern, with on-label and off-label prescribing rates of 73% vs. 27%, for bipolar disorder, and 85% vs. 14% for schizophrenia. However, this prescription pattern was reversed for patients with autism spectrum disorder (35% vs. 64%; P less than .001), a finding that the researchers did not expect.

“Although we entertained several hypotheses about why this might be so, the reasons for this remain unclear,” Dr. McQuade said. “Our study was not designed to explain this question directly, and our post hoc review of available data did not reveal any meaningful patterns. This is left as an open question for further research.”

She said that while off-label prescribing of SGAs to pediatric patients remains widespread and is a concerning trend, the study findings suggested that prescribers “do select and prescribe SGAs in ways that are directly or indirectly influenced by FDA guidelines, mitigating risk to their pediatric patients.” Dr. McQuade acknowledged certain weaknesses of the study, including the fact that it was limited to one hospital setting and by the small number of prescribers who contributed to the overall pool of data.

She reported having no relevant financial disclosures.

[email protected]

 

TORONTO – On-label prescribing of second-generation antipsychotics in hospitalized pediatric patients with bipolar disorder and schizophrenia was greater than off-label prescribing, but not for patients with autism spectrum disorder, results from a single-center study showed.

“There is an increasing trend for using second-generation antipsychotics (SGAs) in children,” lead study author Debra V. McQuade, MD, PhD, said in an interview in advance of the Pediatric Academic Societies meeting. “This trend has already been widely acknowledged as concerning, due to the relatively high adverse event burden associated with them. Also, and perhaps more concerning, the great majority of these prescriptions are prescribed as ‘off-label’ (without Food and Drug Administration approval or indication). This is true in all settings, whether outpatient or inpatient. And, this off-label use is really high – usually reported as 60%-95% of all SGA prescriptions to children. We wanted to understand more about this practice of off-label prescribing of SGAs to children – to understand what drives it, to see if there were any organizing principles that might help to better explain it.”

©drpnncpp/thinkstockphotos.com

Dr. McQuade, of the division of pediatric psychiatry and behavioral health at the University of Utah, Salt Lake City, and her associates retrospectively reviewed data for 86 inpatients hospitalized at Primary Children’s Hospital Wasatch Canyons Behavioral Health Campus, also in Salt Lake City, in 2015 with a diagnosis of autism spectrum disorder, bipolar disorder, or schizophrenia, and who were prescribed an SGA. The medications were identified as on-label (full psychiatric indication for children and adolescents) or off-label (no full psychiatric indication for children and adolescents) based upon the patients’ diagnoses and age. Next, the researchers calculated the frequency and percentage of on-label and off-label prescriptions overall and for the three diagnostic groups.

Dr. McQuade and her associates found that for the three diagnostic groups overall, on-label prescribing of SGAs was greater than off-label prescribing (65% vs. 35%, respectively; P less than .001). Prescriptions for patients with bipolar disorder and schizophrenia followed this pattern, with on-label and off-label prescribing rates of 73% vs. 27%, for bipolar disorder, and 85% vs. 14% for schizophrenia. However, this prescription pattern was reversed for patients with autism spectrum disorder (35% vs. 64%; P less than .001), a finding that the researchers did not expect.

“Although we entertained several hypotheses about why this might be so, the reasons for this remain unclear,” Dr. McQuade said. “Our study was not designed to explain this question directly, and our post hoc review of available data did not reveal any meaningful patterns. This is left as an open question for further research.”

She said that while off-label prescribing of SGAs to pediatric patients remains widespread and is a concerning trend, the study findings suggested that prescribers “do select and prescribe SGAs in ways that are directly or indirectly influenced by FDA guidelines, mitigating risk to their pediatric patients.” Dr. McQuade acknowledged certain weaknesses of the study, including the fact that it was limited to one hospital setting and by the small number of prescribers who contributed to the overall pool of data.

She reported having no relevant financial disclosures.

[email protected]

 

TORONTO – On-label prescribing of second-generation antipsychotics in hospitalized pediatric patients with bipolar disorder and schizophrenia was greater than off-label prescribing, but not for patients with autism spectrum disorder, results from a single-center study showed.

“There is an increasing trend for using second-generation antipsychotics (SGAs) in children,” lead study author Debra V. McQuade, MD, PhD, said in an interview in advance of the Pediatric Academic Societies meeting. “This trend has already been widely acknowledged as concerning, due to the relatively high adverse event burden associated with them. Also, and perhaps more concerning, the great majority of these prescriptions are prescribed as ‘off-label’ (without Food and Drug Administration approval or indication). This is true in all settings, whether outpatient or inpatient. And, this off-label use is really high – usually reported as 60%-95% of all SGA prescriptions to children. We wanted to understand more about this practice of off-label prescribing of SGAs to children – to understand what drives it, to see if there were any organizing principles that might help to better explain it.”

©drpnncpp/thinkstockphotos.com

Dr. McQuade, of the division of pediatric psychiatry and behavioral health at the University of Utah, Salt Lake City, and her associates retrospectively reviewed data for 86 inpatients hospitalized at Primary Children’s Hospital Wasatch Canyons Behavioral Health Campus, also in Salt Lake City, in 2015 with a diagnosis of autism spectrum disorder, bipolar disorder, or schizophrenia, and who were prescribed an SGA. The medications were identified as on-label (full psychiatric indication for children and adolescents) or off-label (no full psychiatric indication for children and adolescents) based upon the patients’ diagnoses and age. Next, the researchers calculated the frequency and percentage of on-label and off-label prescriptions overall and for the three diagnostic groups.

Dr. McQuade and her associates found that for the three diagnostic groups overall, on-label prescribing of SGAs was greater than off-label prescribing (65% vs. 35%, respectively; P less than .001). Prescriptions for patients with bipolar disorder and schizophrenia followed this pattern, with on-label and off-label prescribing rates of 73% vs. 27%, for bipolar disorder, and 85% vs. 14% for schizophrenia. However, this prescription pattern was reversed for patients with autism spectrum disorder (35% vs. 64%; P less than .001), a finding that the researchers did not expect.

“Although we entertained several hypotheses about why this might be so, the reasons for this remain unclear,” Dr. McQuade said. “Our study was not designed to explain this question directly, and our post hoc review of available data did not reveal any meaningful patterns. This is left as an open question for further research.”

She said that while off-label prescribing of SGAs to pediatric patients remains widespread and is a concerning trend, the study findings suggested that prescribers “do select and prescribe SGAs in ways that are directly or indirectly influenced by FDA guidelines, mitigating risk to their pediatric patients.” Dr. McQuade acknowledged certain weaknesses of the study, including the fact that it was limited to one hospital setting and by the small number of prescribers who contributed to the overall pool of data.

She reported having no relevant financial disclosures.

[email protected]