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Psychotropic prescriptions for toddlers increase as ADHD cases, psychiatric conditions rise
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Despite the lack of AAP guidelines for treatment and diagnosis of attention-deficit/hyperactivity disorder among toddlers, approximately 194,000 children aged 2 to 5 years have a current diagnosis, with a significant portion of these cases being treated with stimulant medication, according to the CDC.
Previously published numbers, which reference IMS Health industry data from 2013, also suggest that a surprising number of children aged younger than 3 years are being treated with other psychotropic drugs not currently indicated for use in young children, such as antianxiety and antipsychotic medications.
To determine the scope and implications of this issue, Infectious Diseases in Children spoke with several experts, including child psychiatrists and general pediatricians, about the reliability of raw statistical prescription data, the difficulties associated with diagnosing behavioral and psychiatric conditions among young children, the effectiveness of psychological therapy and the risk-benefit associated with off-label use of psychotropic drugs.
Understanding the numbers
According to Susanna N. Visser, DrPH, MS, , lead epidemiologist of the Child Development Studies Team within the Division of Human Development and Disability at the CDC’s National Center on Birth Defects and Developmental Disabilities, the realization that more children aged younger than 3 years are being medicated for ADHD than those receiving behavioral therapy was alarming.
Photo by Dustin Chambers/ New York Times.
“Initially, we were looking at 4- to 5-year-olds, and we found that three-quarters of them were receiving medication, and about half of them were receiving behavior therapy,” Visser said of her research presented at the 2015 Rosalynn Carter Georgia Mental Health Forum. “But then, when we looked even further down, I actually did not expect to see very many children who were 2 and 3 diagnosed with ADHD — but indeed we found that about 1% of 2- to 3-year-olds had at least one ADHD diagnostic code on their record ... and about half were receiving medication. It was surprising — not only to me, but also to the Georgia Interagency Directors Team.”
According to the FDA, the IMS Health database is used by the agency to measure retail dispensing of prescription medications; it also provides information on physician specialty and patient age. The raw data pulled from this database suggest that a significant number of children aged younger than 3 years are being treated with antipsychotics, stimulants and antianxiety medications. Visser cautioned, however, that these numbers alone lack scientific nuance and relevance.
“A limitation of those data is that it is difficult to get individual level data,” Visser said. “I know it to be a reliable source for what it is, which is reporting out information on claims that have been processed; but, in terms of being able to use it as an epidemiologic tool so that we can understand who is being prescribed these medications and for what reason, that is very difficult.”
For this reason, Visser and colleagues extrapolated Medicaid data to determine the characteristics of ADHD diagnosis and treatment among toddlers in Georgia. According to Visser, although national data are still forthcoming, results from the Georgia analysis suggest that approximately 10,000 children aged 3 years and younger are being treated for ADHD with medication.
“We will have more information on that, shortly, that looks at specific states,” Visser said. “But, when we ran these same analyses on these same age groups, what we found was that the [national] rates were very, very similar.”
According to Ryan S. Sultan, MD, of the department of child and adolescent psychiatry at Columbia University Medical Center, there are many factors that could confuse raw statistical data related to the use of psychotropics among toddlers.
“In this age group, the percentages of children receiving a prescription for these medications are fractions of a percent,” Sultan told Infectious Diseases in Children. “There is room for human error in the generation of these data. Further, some providers may write prescriptions for psychiatric ill – but uninsured – parents under the name of their insured children.”
Further, Paul H. Lipkin, MD, a developmental pediatrician at the Kennedy Krieger Institute in Baltimore and an Infectious Diseases in Children Editorial Board member, said in an interview that when taken out of context, the amount of psychotropic medications prescribed to toddlers does not adequately represent each individual case.
“I think it is very crude data that requires more detailed understanding before we know whether this represents too large or even too small a number,” Lipkin said. “From my professional experience, there are young children who have very severe behavior problems and are a danger to themselves or to others. And, I think they and their families do merit special help. I think nobody knows what the best treatment options are for them at this point, but I would not exclude medication as one of the possibilities.”
Medications in severe circumstances
P. Brian Smith, MD, MHS, MPH, of the division of neonatology at Duke University School of Medicine, said at least some of the data revealing the use of antipsychotics among children aged younger than 3 years can be attributed to treatment for severe conditions in neonatal and pediatric ICUs. Smith told Infectious Diseases in Children that benzodiazepines, such as Xanax (alprazolam, Pfizer) are regularly used in children who present with severe illnesses for sedation. In addition, “Children in intensive care may experience delirium from exposure to multiple medications used for sedation,” Smith said. “These are usually kids who have been very sick and needed high-levels of sedation for a period of time because they were on a ventilator, or had a number of surgeries. We’ve had some limited experience using an atypical antipsychotic this situation. However, delirium is rare in this setting and many more children are exposed to benzodiazepines in the ICU compared to antipsychotics. ”
Likewise, Lipkin said the amount of antipsychotic and behavioral medication used among toddlers is a result of children with severe conditions requiring effective treatments.
“I do not think that these are just children with normal behavior problems,” Lipkin said. “I think these are children with complex problems that this data doesn’t quite reflect. We’re talking about children that will run out into the street, who will run away, who will jump off high places, who will escape out of a window, who are on the go 24/7, who do not sleep at night. We are talking about children who have developmental problems, who don’t have an understanding of the consequences of their actions. These are not children that just have tantrums once in a while. These are children with severe problems.”
William T. Gerson, MD, clinical professor of pediatrics at the University of Vermont College of Medicine and an Infectious Diseases in Children Editorial Board member, said the increased amount of children being treated for psychiatric and neurological issues is more likely due to an increase in these conditions, rather than lax prescription practices.
“I think the numbers on medication use are likely true reflections of practice,” Gerson told Infectious Diseases in Children. “It is worrisome because I believe it reflects a response to a rise in the number of young children with significant mental illness. A true increase in prevalence and not just a manifestation of inappropriate treatment modalities.”
Diagnosing ADHD in young children
The AAP does not currently make any recommendations for prescribing ADHD medications for children aged younger than 4 years due to challenges confirming the presence of key symptoms, such as inattentiveness and hyperactivity. Furthermore, the AAP diagnostic algorithm requires a non-parent, in-classroom observer, who may be unavailable in preschool environments where staff are not certified, or nonexistent for children younger than school age.
According to Paul L. Geltman, MD, MPH, assistant professor of pediatrics at Harvard Medical School and a pediatrician at the Cambridge Health Alliance, determining that a child’s behavior is universally manifesting in multiple settings is a key component of the ADHD diagnostic process. Without this perspective, he said, a diagnosis can be difficult and unreliable.
“Often, in the case of a preschool-aged child, that dichotomy is not going to exist,” Geltman said in an interview with Infectious Diseases in Children. “Parent descriptions can be a manifestation of the parent’s perspective on parenting and expectations for their child’s behavior; however, if a parent and a child have a temperamental mismatch, coupled with unreasonable expectations of a child’s behavior, then the significance of the behavioral pattern could be magnified.”
According to research by Visser, when diagnosed at a younger age, children are less likely to be diagnosed by a psychologist (P = .05), and 74.5% of children aged 5 years and younger are initially suspected of having ADHD by a family member.
Ruth E. K. Stein, MD, of the department of pediatrics, division of developmental medicine at Children’s Hospital in Montefiore, New York, said oftentimes normal developmental behavior for a toddler can be falsely perceived as hyperactivity, which can lead to a misdiagnosis of ADHD.
“The issues are commonly issues of parents who have not been helped to understand what normal development is, how to direct children in a positive way and how to rein in their behaviors so that they become more sociably acceptable,” Stein told Infectious Diseases in Children. “If you see your child’s behavior as pathological, then it is much easier to come and try to get it fixed, than if you understand that part of a child’s development of autonomy is that they are going to test all the rules, and they are going to have their ‘terrible twos.’ ”
Vague manifestations of ADHD symptoms in toddlers are not only mistakable for normal developmental behavior, but can be confused with myriad other mental illnesses. Geltman recounted a case in which a child aged 2 years presented with ADHD-like symptoms of hyperactivity and aggression. After behavioral modifications and interventions failed, Geltman conducted a diet assessment, a sleep assessment, enrolled the child in an early preschool program and sent him to an otolaryngologist to rule out enlarged adenoids and sleep apnea. Two years later, Geltman was reluctant to diagnose mental illness, so he sent the child to a behavioral pediatrician, who diagnosed ADHD and prescribed medication. After years of ineffective treatment and waxing and waning symptoms, the child revealed he had been hearing voices for years and was ultimately diagnosed with schizophrenia at age 10.
“This case dramatically highlights how symptoms of inattention, hyperactivity, or aggressive behavior can be a manifestation of any kind of behavioral problem in young children, and can frequently lead to misdiagnosis,” Geltman said. “It gets to how complicated it is to make these diagnoses of young children — you never would have been able to make the correct diagnosis at that age.”
Although, according to Visser, the AAP diagnostic and treatment guidelines for ADHD can be effectively applied to children aged 4 years. Due to the difficulty associated with making this diagnosis, however, the AAP is reluctant to make any recommendations for children younger than age 4.
“We found that it is possible, though very difficult, to diagnose a child with ADHD as young as 4,” Visser said. “You have to adapt some of our existing diagnostic tools to do this, but, if you’re very careful, and if you have a strong background in development, you can validly diagnose a child as young as 4 with ADHD. However, given how difficult it was to diagnose just a 4-year-old, the AAP does not feel comfortable collectively about making more recommendations for children under age 4.”
Ultimately, Visser’s research found there was no evidence to support the reliability of a valid diagnosis of ADHD among toddlers.
Treating with medications
The only ADHD stimulant medications indicated for use in children aged younger than 6 years are amphetamine and dextroamphetamine, according to the CDC. The AAP guidelines, however, only recommend the use of methylphenidate in children aged 4 to 5 years, while AACAP guidelines for treatment of ADHD in children recommend titrated use of methylphenidate in patients as young as age 3 years. According to Visser, this recommendation is based on clinical trials for methylphenidate among children as young as 3.
“The biggest danger is we don’t know the impact of these medications on young children since none of these medications has been tested in children under the age of 3,” Visser said. “There has been one randomized clinical trial called the PAT study, which tested the safety and efficacy of methylphenidate in a preschool population. Those children experienced benefits from the medication, similar to older children, but the benefit was not as much as it was for older children, and they experienced more side effects than older children.”
According to Smith, the practice of extrapolating dosing information for very young children is daunting and based mostly on anecdotal evidence.
“Sort of the worst thing that we have to do is extrapolate dosing from older kids and adults,” Smith said. “A lot of the drugs we don’t have dosing studies for, and then to do the efficacy studies is even more expensive, and those trials almost nobody has done. So, we haven’t even done the first step for most of the drugs used among kids, which is to figure out the right dose. But that is what we have been trying to address in our research.”
Although the AAP and AACAP guidelines both recommend exhausting all behavioral therapies as a first-line treatment before prescribing ADHD medication, physicians sometimes feel pressure to medicate from parents due to the drugs’ easy administration and immediate results, according to Stein.
“It is very hard for parents, especially when they are working, and not always with their children, or when they have multiple children that they are taking care of, to be consistent in their limit setting and their expectations of what the child’s behavior should be,” Stein said. “The parents often don’t have the time to devote, because it’s not as easy as giving a pill.”
Sultan agrees that educating parents on the effectiveness of behavioral therapies is essential for properly treating ADHD in younger children.
“Limit-setting and other nonpharmacologic interventions are highly effective for certain children,” Sultan said “I have seen families have life-altering success with them; but, they do take time to be effective. There are occasions when families present with longstanding challenges and are now feeling overwhelmed, and they often want a rapid solution. As health care professionals, we need to provide support and education about the value of all treatments.”
According to Visser, good information about the effectiveness of behavioral therapy is important for clinicians and can allow them to disseminate that information and those options to parents effectively.
“Parents certainly can’t choose an intervention if they don’t know that it exists, and, if they don’t know that it is as effective [as medication],” Visser said. “It does take longer — certainly, taking a pill and experiencing the benefit of that medication within an hour is much more rapid than the process it takes to see impact with behavioral interventions. But, being able to share with a parent that these interventions are as effective and they don’t carry the same risks of ADHD medications is an important message.”
Looking to the future
In her report presented at the Georgia Mental Health Forum, Visser referenced research by Japla A. Doshi, PhD, and colleagues, that calculated the excess cost burden related to misdiagnosis of ADHD at $72 billion annually for Americans. Visser also laid out some of the ways in which states are responding to this information, such as requiring pre-authorization and peer review when prescribing ADHD medication for children aged younger than 6 years, preferred drug lists and mandatory psychosocial evaluation and behavioral therapies before medication.
According to Lipkin, it is important for pediatricians to consult with a network of specialists when presented with a particularly challenging case, especially when diagnosing mental and behavioral disorders in younger children.
“I think the general pediatrician needs to consult with a pediatric specialist in developmental and behavioral problems in young children,” Lipkin said. “They should also seek out assistance from local child psychologists or therapists who are familiar with ways of managing these problems in young children.”
Visser agrees that building relationships with experts in the mental health field is paramount for pediatricians dealing with ADHD in young children.
“The best advice that I can give is to try and build a relationship with a psychologist who has experience providing interventions to young children,” Visser said. “Building that relationship with a psychologist or a social worker, or someone with clinical experience, with working with these young children and families and trying to initiate these behavior interventions and having them understand what those behavior interventions look like so that they know what they are looking for.”
Gerson noted that the solution to this issue may lie in patient advocacy and forging strong relationships among the community to get children the care they need.
“As pediatricians, we are always trying to look at what is in the best interest of the child and family in front of us at the time,” Gerson said. “This problem in young children, really is begging for a more consistent, community-based approach, but affecting that change is harder. Trying to have family-based pediatric and psychiatric care for this population, matched with the social services that are required, really needs to be more available — and that just takes societal investment.”
According to Smith, when considering this issue, it is important to maintain the perspective that physicians are only prescribing medications in order to help the children they are charged with as patients.
“Doctors don’t want to go around just prescribing stuff because it makes them feel good,” Smith said. “I can’t really think of an instance where a doctor would do that. I think almost everyone looks at a child and says: ‘To the best of my ability, I feel like I should either treat or not treat this child.’ ” – by David Costill
- References:
- Doshi JA, et al. J Am Acad Child Adolesc Psychiatry. 2012;doi:10.1016/j.jaac.2012.07.008.
- Pliszka S, et al. J Am Acad Child Adolesc Psychiatry. 2007;doi:10.1097/chi.0b013e318054e724.
- Visser SN, et al. Implementing the IDT Strategic Plan & Unpacking the GA Data Among Young Children in GA. Presented at: Annual Rosalynn Carter Georgia Mental Health Forum; May 16, 2014; Atlanta.
- Visser SN, et al. The State of ADHD Care in Georgia: From Data to Action. Presented at: Annual Rosalynn Carter Georgia Mental Health Forum; May 15, 2015; Atlanta.
- Visser SN, et al. Natl Health Stat Report. 2015;81:1-8.
- Wolraich M, et al. Pediatrics. 2011;doi:10.1542/peds.2011-2654.
- For more information:
- Paul L. Geltman, MD, MPH, can be reached at Pgeltman@challiance.org.
- William T. Gerson, MD, can be reached at William.Gerson@uvm.edu.
- Paul H. Lipkin, MD, can be reached at Lipkin@kennedykrieger.org.
- P. Brian Smith, MD, MHS, MPH, can be reached at Brian.Smith@duke.edu.
- Ruth E.K. Stein, MD, can be reached at Ruth.stein@einstein.yu.edu.
- Ryan S. Sultan, MD, can be reached at Sultanr@nyspi.columbia.edu.
- Susanna N. Visser, DrPH, MS, can be reached at Svisser@cdc.gov.
Disclosures: Geltman, Gerson, Lipkin, Stein, Sultan and Visser report no relevant financial disclosures. Smith reports salary support for research from the NIH and the National Center for Advancing Translational Sciences of the NIH.