Kids & Pills
- What you don't know about the meds your children are taking could harm them
March 3, 2006—Bend, Oregon
By Markian Hawryluk / The Bulletin
Published: March 02.
No drug is completely safe. Whether it's a matter of known side effects or unforeseen consequences, every prescription drug carries risks as well as benefits. And as patients take more than one drug, the risks are multiplied.
Yet, a recent analysis found an increasing number of children, some as young as 2 or 3 years old, are taking multiple prescription medications. And that has many child health experts concerned.
"This is a critical issue," says Dr. Joseph Penn, a child psychiatrist with the Bradley Hasbro Children's Research Center in Providence, R.I. "It's not uncommon to find a child on an antidepressant, a mood stabilizer and a sleep agent all at the same time, but there's no research to see how these drugs interact with each other."
Penn and his colleague Dr. Henrietta Leonard recently reviewed 10 years of research about pediatric polypharmacy, publishing their findings in the journal Psychiatry. Every study they came across documented an increase in kids taking more than one drug.
Data from two national surveys found that the percentage of children taking multiple prescription drugs increased from 0.03 in 1987 to 0.23 by 1996, an eight-fold increase. Among patients taking any medication, the rate of adding a second medication increased 25 times over that decade.
The most common combination was pairing medications for depression and attention-deficit/hyperactivity disorder. In 1996, more than a third of children using antidepressants also used another class of medications, most often stimulants prescribed for ADHD. Similarly, a fifth of children taking stimulants also took another class of drugs, most often antidepressants.
Yet both classes of drugs may now include so-called black box warnings from the Food and Drug Administration. In 2004, the FDA issued a public health advisory suggesting the possibility of a link between the use of antidepressants in children and suicide. And in February, an FDA advisory committee recommended that ADHD drugs carry a warning of an increased risk of injury or death. The agency is now considering whether to adopt the committee's recommendation.
"If there is so much concern over the effects of a single drug, how much riskier is it to prescribe multiple drugs?" Penn says.
Clinicians are concerned that the risk of side effects is exponentially higher when taking multiple drugs because those drugs can interact in unforeseen ways. While there have been isolated documented cases of sudden death of children taking multiple medications, the researchers said adverse-events data for single medications are limited. Trying to track the effects of multiple medications is even tougher.
Taking multiple behavioral medications may carry a higher risk because many target serotonin levels. That can subject kids to serotonin syndrome, a serious and potentially fatal illness that can result from excessive serotonin levels.
Many parents may be surprised to know that most of the behavioral medications on the market have not been tested or approved for use in children. Physicians use medications that have been approved for adults and are therefore on the market. But nothing precludes physicians from prescribing these drugs for children.
"Atypicals like risperidone are sometimes used to symptomatically treat psychosis or aggression in children, but most of these medications don't have FDA approval for use on psychiatric symptoms in the pediatric age group," says Dr. Henrietta Leonard, a child psychiatrist with the Bradley Hasbro Children's Research Center and Brown Medical School. "We just don't have the efficacy or safety data to back up what is common clinical practice."
Because many of these medications cause fewer or better tolerated side-effects in adults than some of the older medications, clinicians have been turning to them at a higher rate.
Because many of these medications cause fewer or better tolerated side effects in adults than some of the older medications, clinicians have been turning to them at a higher rate.
But there is evidence that children react to drugs differently than adults. Dr. Ronald Hines, professor of pediatrics and of pharmacology and toxicity at the Medical College of Wisconsin, found that as children develop, the types and levels of enzymes that react with chemical compounds in their bodies change. These enzymes can activate or deactivate the medications, changing their impact.
Unless drugs are specifically tested in children, there's no way to know whether they will be effective or even safe, Hines says.
"It's recognized as a fairly major problem," he says. "Up until the FDA Modernization Act of 1997, there were hardly any drugs tested in kids. It was considered unethical by many to do so. I think that whole attitude now has changed."
Still, only five psychiatric drugs are approved for use in children. The rest are being used "off-label." While progress has been made in increasing testing of pharmaceuticals in children, costs and other obstacles continue to limit research in this area.
Children often end up on multiple medications when a single medication therapy has failed, or when they are diagnosed with multiple disorders or higher levels of social dysfunction. But some of the studies suggest that of late, prescribing multiple medications is becoming a lot more routine.
The National Ambulatory Medical Care Survey found that in pediatric office visits in 1993-1994 in which a stimulant was prescribed, less than 5 percent also included a prescription for a psychotropic drug. By 1997-1998, that rate had increased to nearly 25 percent.
A study of office-based practices in Michigan examined the records of 223 children, 3 years old or younger, diagnosed with ADHD. Some 57 percent were on a psychotropic medication, and of those, 35 percent were being treated with multiple medications.
And those studies didn't even consider whether those children were also on medications for such conditions as allergies or asthma. There is even less data available on potential interactions between those drugs and behavioral medications.
Drugs and drug interactions can sometimes lead to additional prescriptions as new symptoms emerge, something physicians refer to as "chasing symptoms."
A child may have problems focusing or paying attention and is prescribed a stimulant, such as Ritalin or Adderall, which in turn prevents him from sleeping, so a sleeping pill is added, which may cause him to become irritable or moody, so he's put on an antidepressant.
"Before you know it, the kid's on three or four psych meds," Penn says. "If all you're treating is the symptom, you can become a dog chasing its tail very easily."
But Penn says doctors, particularly pediatricians, are under the gun from schools and parents to prescribe behavioral drugs.
"This is a more complicated issue than just what doctors want to prescribe. There's increasing pressure on doctors to medicate," Penn says. "Bottom line, we're a quick-fix society."
Those pressures are accentuated by the economics of health care. Insurance companies may pay for antidepressant or ADHD medications, but often have strict limits on mental health care services such as counseling or therapy.
"Many times more intensive behavioral interventions, such as counseling and therapy, and work with family aren't immediately available," Penn says. "Or you have to really pull teeth to get those kinds of services approved by insurance companies."
While difficult cases in the past could be admitted to hospitals for a complete evaluation, the realities of managed care now limit hospitals to crisis stabilization. What was once a two- or three-month stay is now limited to a week.
"It's more like, get the kid under control, until they're safe, and then discharge them," Penn says.
A polypharmacy work group organized by the American Academy of Child and Adolescent Psychiatrists in 2003, concluded that the piecemeal approach to treating mental health issues exacerbates the problem.
"Within child mental health service delivery, fragmentation is a way of life, resulting in service duplication and gaps in service coordination," Dr. David Pruitt wrote in a summary of the group's findings. "Children are treated in multiple settings and placed on medications by different providers with little coordination."
The group said even when physicians know children are taking multiple medications, they often are reluctant to discontinue a drug they didn't prescribe themselves.
"With polypharmacy, there's little or no research on the benefits and there's no research on the interaction effects in pediatric population," says Dr. Michael Conner, a clinical psychologist in Bend. "We're literally experimenting with children."
Conner says he talks to parents whose kids take more than one medication and their moods and behaviors are still out of control.
"They have tried multiple trials of medications and multiple combinations, and behaviorally, nothing seems to be working," he says. "And the long-term side effects are completely unknown."
According to a report on psychiatric polypharmacy by the National Association of State Mental Health Program Directors in 2001, a shortage of child psychiatrists has increased pressure to treat psychiatric conditions in children with medications. Managed care plans, the report said, would rather deploy scarce resources towards medication treatment than consultation, which requires a greater amount of physician time and overall expense.
Despite research showing that the combination of medication and therapy is more effective at treating depression than either treatment alone, many children have access only to the meds, effectively sealing their fate.
"The problem is many people have medical benefits and not mental health benefits," Conner says. "And physicians are constrained in the amount of time they can diagnose and prescribe. With the proper information, physicians make excellent decisions. The challenge is that they have difficulty getting the information they need in the time they have available."
Conner has developed an online screening tool that parents can use to gather information about their child and give the physician a head start. Nancy Webb, a parent and foster parent from Gresham, used the tool recently when she brought a foster child in to see a psychiatrist for a medication check.
Based on a school report documenting explosive outbursts and other incidents that happened at school, the psychiatrist started writing out another prescription. Then Webb showed him the information she had collected.
"When he was finished looking at that evaluation, he chose a very different course. He did not prescribe the medication for explosive outbursts. And he started decreasing and taking away some of the medications that he'd previously been on," Webb says. "The evaluation showed high levels of depression, anxiety and suicidal tendencies, and he felt those medications that the young man was taking were contributing to that. So we actually took him off several different medications and didn't add that new one."
Conner says parents need to advocate for their children and help ensure that they don't wind up on multiple medications without good cause.
"I'm not saying that kids don't need these medications. Some kids can't function (without them.) It ends up being a life jacket for some kids," he says. "But the solution is not just to medicate these kids. That's the option you get when you only have a small piece of the picture."
Meanwhile, child psychiatrists are working on ways to help sort out when kids legitimately need multiple prescriptions and when more medication doesn't truly help. The child psychiatrists work group borrowed the economic concept of decreasing marginal returns. They proposed that certain medications might provide the vast majority of the benefit, and adding other medications provides only marginal benefits, while substantially increasing short and long risk, and using up valuable resources.
Based on that notion, the group has developed a review tool to help clinicians review a child's medication history and determine what drugs can or should be eliminated. The review tool is still being evaluated. For now, Penn says parents need to be extra vigilant about what drugs their kids are prescribed.
"They really need to be educated consumers. The family really needs to know what the risks are and what the other alternatives are," Penn says. "We're not talking about M&Ms. These are real risks."
Markian Hawryluk can be
reached at 541-617-7814 or firstname.lastname@example.org.
Contact Kevin Rea: 541 390-9848
# # #