Polypharmacy and Children: The Use of Too Many Drugs

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The blog site DANGERS OF POLYPHARMACY defines polypharmacy as:

Polypharmacy refers to the use of a patient. The term can be used when too many forms of medication are used by a patient, more drugs are prescribed than clinically warranted, or even when all prescribed medications are clinically indicated but there are too many pills to take (pill burden). The common result of polypharmacy is increased adverse drug reactions and higher costs. This often results when people go to multiple physicians or pharmacies for their medical/medication needs, but can happen when someome only sees one doctor, as well. Severe adverse drug effects can result in serious life-threatening situations. Polypharmacy is most common among the elderly, but can potentially affect anyone taking more than one medication.

We can witness polypharmacy being applied to children who are diagnosed with psychiatric disorders over the past several years. I started to see a widerspread use of polypharmacy in children about ten years ago when I was working in residential treatment. Children were being admitted into the facility after multiple placements in foster care, group homes and other residential treatment facilities. They also came with histories of visiting multiple psychiatrists, clinical psychologists and medical doctors who had prescribed many medications. As one doctor prescribed medication the next one either deleted it or added on to the prescription creating an ever expanding menu of medications over time. The more medications that were added to treat a child’s elusive and ongoing symptoms and challenging behaviors the more difficult it became to remove a medication from the menu for fear of what might happen to the child and the danger it might pose to others.

Children and adolescents entered the facility with Schizophrenia, Psychosis, various forms of Autism, other severe developmental and neurological disabilities, Bipolar, Conduct and Antisocial disorders, PTSD, and anxiety related diagnoses. Their histories were filled with extreme problematic and violent behaviors. A number of the children had anywhere from four to eight medications that needed to be administered every day of the week, sometimes three or four times a day. A child would take antipsychotic, antidepressant, antianxiety, antiseizure, sleep aide, medications and inhalers for breathing problems, making for a potent mix.

In a post titled “IMFAR 2009: Polypharmacy Common Among Children With Autism” from Medscape states:

An analysis of medication use in children with autism reveals polypharmacy is common, with up to 20% of children between the ages of 3 and 12 years being prescribed 4 or more medications.

and:

The most commonly used drugs were stimulants and antidepressants, followed by antipsychotics and other psychotropics. The research team found antidepressants were initiated in children as young as 3 years old and antipsychotics in children as young as 4 years old.

“I didn’t expect to see so much polypharmacy,” lead investigator Annette Estes, PhD, from the University of Washington, in Seattle, told Medscape Psychiatry. “In addition, I was surprised that the average age of initiation was quite similar for all classes of medications except anticonvulsants. I would have expected the antipsychotics to be [initiated] later than the stimulants, for example.”

Psychiatrists treating the children were concerned about how or if to unwind the number of medications a child was on. They spent a great deal of time trying to figure out how, when and why medications were prescribed and what to do about it. In 2005 EurekAlert posted an article titled “Polypharmacy in children on the rise in the US.” It states:

“This is a critical issue – it’s not uncommon to find a child on an anti-depressant, 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” says co-author Joseph Penn, MD a child psychiatrist with the Bradley Hasbro Children’s Research Center (BHCRC) in Providence, RI and Brown Medical School.

The authors reviewed 10 years of scholarly articles pertaining to polypharmacy in pediatric settings, and found that all the studies comparing these rates across time showed an increase in the practice.

However, the authors warn there are almost no studies or published research on which to justify prescribing multiple medications for psychiatric disorders in children.

According to the study, the most frequent combination were stimulants such as methylphenidate (Ritalin) or dextroamphetamine (Dexedrine, Adderall) commonly used to treat ADHD, with another psychotropic medication.

Another contributing factor to the increased risks of prescribing multiple drugs is the prevalence of off-label prescriptions � the practice of prescribing a medication to children when there is not a FDA approved indication for that disorder in children.

“For example, aytpicals 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 co-author Henrietta Leonard, MD, 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 there are limits to the data available on the efficacy of a single medication in the pediatric age group, the authors express deep concern over the rise in polypharmacy because it could multiply the risk of adverse events.

Sadly, not much has changed in the years since this article was posted. Children are still being given inordinate amounts of medications without any definitive indication in a number of cases that what they are being given actually helps. As I have stated in several posts on this blog I am not advocating that children should not take psychiatric medications when their symptoms and behaviors pose a serious danger to themselves and others. But, the science of necessity and safety should play the central role when prescribing these types of drugs. The fact that many of these medications continue to not have FDA approval for treating certain disorders in children should be as alarming now, if not more so, than it was when these articles were first posted.

Furious Seasons has a post from June 11, 2009 titled “Perspective On Antipsychotics For Kids FDA Panel Recommendation.” It helps demonstrate how little distance we have traveled in terms of prescribing major psychiatric medications to children, especially going so long without FDA approval while psychiatric drugs are being prescribed. Because this post is so important I am copying it here in full:

Many of you know that an FDA advisory panel yesterday recommended that the agency approve Zyprexa, Seroquel and Geodon–atypical antipsychotics all–for use in teens 13 to 17 with schizophrenia and kids 10 to 17 with alleged pediatric bipolar disorder. I heard from a bunch of readers about how distressed they are over the committee’s finding and while there is something disgusting about the idea of these drugs being given to youths, the committee’s recommendation, which I expect the FDA to follow, may not actually mean too much in a real world way. That said, there are a couple of things that blow my mind about what’s gone on here.

I doubt that we’re going to see a massive consumer advertising campaign for any of these drugs–schizophrenia is rare and rarer in teens so there’s not much of audience to advertise to, and the doctors who would be targets of any direct to physician campaign (ie, psychiatrists) already likely know of the three drugs and have already prescribed them off-label for several years. On the pediatric bipolar front, in recent years the FDA has approved Risperdal and Abilify for this disorder and that hasn’t led to a DTC campaign that I’m aware of, so I’d be surprised if Lilly, AZ and Pfizer mounted a teens with bipolar ad campaign, especially since the drugs are already widely used off-label in teens and younger kids.

But the companies did go out of their way to run clinical trials for the drugs and those don’t come cheaply, so they’d likely want to see some kind of return on their investment, especially since Seroquel and Zyprexa go off-patent in 2011 and Geodon in 2012. Who knows, maybe we will get TV and magazine ads targeting “troubled” teens and angry adolescents?

What does blown my mind is that the members of the committee voted to approve drugs for a disorder–pediatric bipolar disorder–that doesn’t exist in the DSM and has such a shaky evidence base that it remains a controversial diagnosis within psychiatry. What’s more, pediatric bipolar disorder is a diagnosis largely ginned up and slapped together by researchers at Harvard (and elsewhere) who’ve literally been on the payroll of pharma for years, by the pharma companies themselves and then by the FDA itself. And now the committee’s recommendation is going to be decided upon by the FDA’s director of psychiatry products, Thomas Laughren, who several years ago helped researchers and pharma companies design the very clinical trials for the alleged disorder. Yes, my mind is blown.

What also shakes me up is that for this committee hearing a whole collection of mental health advocacy groups submitted a joint statement of support for the drugs (I’ve not been able to locate an online copy, but I can assure you it made the email rounds). That’s an unusual move, as I cannot think of the last time NAMI, Mental Health America (the old NMHA), the APA, the American Society for Suicide Prevention and so on issued such a statement for a drug’s potential approval (all of these groups get millions a year from pharma companies). I wonder what prompted them to do so this time out.

Obviously, there are a lot of other things to consider here (diabetes, brain shrinkage, etc.), but I’m going to leave it at that for now.

Posted by Philip Dawdy at June 11, 2009 12:03 AM

The FDA is only now coming to the point of making recommendations as important as this after years of giving these medications without approval. As far as I can tell the committee is only targeting children as young as ten years of age and we know that children much younger then this are being prescribed these types of medications as well. How have we come to a place where we are medicating children on this level before we know the facts? Add to this dilemma the highly suspect and problematic associations between “Big Pharma” and the professionals who make decisions about these types of medication and then prescribe them to our children. It still seems as if we are a long way from getting this question answered. Until then, the drugs will keep flowing………..

See also a post from this blog “Branding Mental Illness: Big Pharma and the Business of Disorders

4 thoughts on “Polypharmacy and Children: The Use of Too Many Drugs

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