Children with autism spectrum disorder (ASD) are still commonly prescribed psychotropic medications alone and in combinations despite “minimal evidence” of their effectiveness, new research suggests.
A retrospective study of more than 33,000 children with ASD showed that 64% had been prescribed at least 1 psychotropic. In addition, 35% had been prescribed 2 or more classes of psychotropics concurrently, and 15% had been prescribed 3 or more classes.
“Our results indicate the need to develop standards of care around the prescription of psychotropic medications to children with ASD,” write Donna Spencer, PhD, from OptimumInsight, Life Sciences, in Eden Prairie, Minnesota, and colleagues.
They note that the study participants who had comorbidities such as bipolar disorder or attention-deficit disorders, who were older, or who had visited a psychiatrist were significantly more likely to use psychotropics.
New standards of care should be based on “a coordinated, multidisciplinary approach to improving the health and quality of life of children with ASD and their families,” write the investigators.
The study was published online October 21 in Pediatrics.
Few Treatment Options
As reported at the time by Medscape Medical News, a systematic review of 33 randomized controlled trials, which was published in 2011, showed that only 3 psychotropics (all of which were antipsychotics) “have established evidence” in treating symptoms of ASD.
These included aripiprazole and risperidone for irritability and hyperactivity, aripiprazole for stereotypy, and haloperidol for negative behavioral symptoms. Promising evidence of benefit was shown for methylphenidate, and preliminary evidence was shown for 5 other agents, including naltrexone and atomoxetine.
However, “the humbling or sobering news is that we still have no medicines that treat the core features of autism — social/interaction and language impairments and repetitive behaviors,” said Matthew Siegel, MD, medical director of the developmental disorders program at Spring Harbor Hospital, Maine Medical Center, in Westbrook, at the time.
Yet other studies have shown “increasing rates of psychotropic use and [polypharmacy] among children overall” as well as in children with ASD, note the current investigators.
Because there is a wide variance in use estimates of psychotropic medications and because many reports are based on a period of 1 year or less, are based on parent reports, and include small sample sizes, the researches sought to conduct a study that answered these concerns.
They assessed data from medical and pharmacy claims for 33,565 insured children and adolescents younger than 21 years with ASD (82% boys; 60% between the ages of 6 and 10 years, 22% between the ages of 11 and 17 years, 17% between the ages of 0 and 1 year).
Claims for all participants had been made at least 6 months prior to baseline, and all had at least 6 months of continuous care between January 2001 and December 2009.
For this study, the psychotropic medication classes included antidepressants, both stimulants and nonstimulants for treating attention-deficit disorder (ADD), antipsychotics, anxiolytics, lithium, anticholinergics, and anticonvulsants/antiepileptics.
“Polypharmacy was defined as at least 1 episode of multiclass polypharmacy,” explain the investigators, noting that “an episode of multiclass polypharmacy” denoted prescriptions that overlapped 2 or more classes for at least 30 days.
Results showed that 63.56% of the participants had any psychotropic use, whereas 34.36% showed evidence of multiclass polypharmacy.
Psychotropic or polypharmacy use increased with the age of the children. A total of 34% of the 0- to 1-year age group had use of any psychotropic, and 10% had polypharmacy use.
These numbers jumped dramatically to 64% and 32%, respectively, for those in the 2- to 10-year age group; to 84% and 57% for those in the 11- to 17-year age group; and to 87% and 62% for those in the 18- to 20-year age group.
Of those in the polypharmacy subgroup, total episodes of multiclass polypharmacy averaged 5.63 per child. The average maximum number of medications per episode was 2.6, and the average maximum number of classes per episode was 3.3.
In addition, 10.4% of the entire study group had 3-class polypharmacy, and 4.5 had polypharmacy with 4 or more classes.
“Common class combinations were antidepressants and ADD medications (38% of subjects), antipsychotics and ADD medications (28%), antipsychotics and antidepressants (20%), and antipsychotic, antidepressant, and ADD medications (18%),” report the investigators.
The average total days of all episodes of polypharmacy was 525. The median was 346 days.
Interestingly, use of either psychotropics or polypharmacy was lower in the participants from the northeast and western regions of the United States and highest in the southern regions.
This raises questions “about the availability of nonpharmacologic, behaviorally based services and treatments in the south, where other health outcomes and health care services have been found to be poorer than in other parts of the country,” note the researchers.
The strongest predictor of psychotropic and polypharmacy use was having a comorbid condition, especially seizures, bipolar disorder, and ADD. Household income was not found be a significant factor.
Overall, the findings emphasize the need for more research of psychotropics in kids with ASD “to assess the value of these medications when weighed against their potential for harm,” conclude the investigators.