Massachusetts To Track Meds Given Kids
34 CommentsBy Ed Silverman // October 7th, 2007 // 8:48 am
Following the death of a 4-year-old girl from an overdose of psychiatric drugs last December, Massachusetts officials have created an early-warning system to spot preschoolers who may be getting excessive meds for mental illness. In just the first three months, the system has flagged the cases of at least 35 children for further investigation, and the number is expected to rise, The Boston Globe reports.
The state Medicaid program is analyzing records of 82,900 children under age 5, looking for those taking at least three psychiatric drugs or a single prescription of a powerful antipsychotic drug, according to the Globe. Mental health professionals will review the care of these children and, if necessary, contact the prescribing doctor for an explanation, say officials of the state insurance program for lower-income families, known as MassHealth.
Although cases like the overdose of Rebecca Riley are rare, the prescription of psychiatric drugs to young children is not. Doctors last year prescribed Clonidine - a drug sometimes used to treat hyperactivity that was found in lethal quantities in the girl’s bloodstream - to 955 children under age 7 in MassHealth. Doctors also prescribed antipsychotic drugs, which raise the risk of diabetes and obesity, to 536 children under age 7, according to MassHealth records. MassHealth could not say how many of these cases involve children under age 5 and might be subject to review, the paper writes.
Some psychiatrists have been concerned for years about the rise of psychiatric drug treatment of young children, largely because few preschoolers are old enough to show clear signs of mental illness and there are almost no studies on how the chemicals affect their developing brains. And until recently, so-called atypical antipsychotics weren’t approved by the FDA for children. But until Riley’s death from three drugs she was taking to treat bipolar disorder and hyperactivity, the state provided little oversight of doctors’ prescribing practices.
MassHealth managers want to make sure that doctors have good reason for prescribing psychiatric drugs to such young patients and that they are not relying solely on the parents or guardians for information about each child’s condition. Riley’s parents have been charged with deliberately giving her a fatal overdose.
“If the behavior is extreme enough to require this level of medication, we ought to make sure that the behavior exists,” says John Straus, vice president for medical affairs at the Massachusetts Behavioral Health Partnership, one of the organizations that manage mental health care for children in MassHealth. Riley’s death, he adds, “was a wake up call.”
Until the 1990s, children under age 5 were rarely treated with psychiatric drugs for mental illness, in part because the conditions are hard to diagnose in children too young to discuss their feelings or control their impulses. But by 2000, Dr. Joseph T. Coyle of McLean Hospital in Belmont was warning of a “growing crisis in mental health services to children” amid reports that the number of preschoolers taking drugs for attention deficit/hyperactivity disorder had doubled in four years. Writing about a major study of preschool psychiatric drug prescriptions in the Journal of the American Medical Association, Coyle argued that disturbed children were getting drugs as a “quick fix” instead of more time-consuming therapy and other family services
Despite unease over the amount of psychiatric drugs being prescribed to preschoolers, few states have tried to rein in prescriptions beyond drug educational programs for doctors or other forms of doctor assistance, such as Massachusetts’ popular network of psychiatrists who are available for instant phone consultations concerning young patients.
The oversight system is too new to say how many cases will merit contacting the prescribing doctor, officials said, but the largest provider of mental health services for MassHealth - Massachusetts Behavioral Health - identified 35 preschoolers in the first three months of the system who were taking three psychiatric medications or one antipsychotic drug. Four other managed-care organizations have also begun reviewing children’s MassHealth prescription records, but their findings have not been released
Deputy Mental Health Commissioner Robert J. Keane, who led the effort to create the tracking system, stressed that it isn’t meant to punish doctors or second-guess their judgment. He noted that some children, such as those who are extremely self-destructive, may need multiple medications. However, he said MassHealth’s outreach could help some doctors make more informed decisions when they prescribe drugs for very young children.
“Clinical decision making often happens in isolation. It’s a problem in healthcare,” said Keane, suggesting that some doctors may not realize they are overprescribing psychiatric drugs to preschoolers.
Riley’s death focused attention on the growing use of drugs among preschoolers for another condition, bipolar disorder, which is characterized by wide mood swings and was once thought to begin in late adolescence. Her doctor, Kayoko Kifuji, diagnosed the girl with the condition when she was 2 1/2 years old. Kifuji has voluntarily given up her license to practice medicine while regulators investigate her treatment of Riley, and the girl’s mother, Carolyn Riley, said on “60 Minutes” last Sunday that she no longer believes her daughter was bipolar. The parents blame Kifuji for their daughter’s death, though she denies wrongdoing.
However, one state’s experience is instructive: Texas officials adopted an early-warning system last year for mental health care of children in state foster care, and they saw an immediate drop in prescriptions of psychiatric drugs for children under 18 once they started contacting doctors who prescribe large amounts of psychiatric medication. Since 2004, the percentage of foster children receiving at least one psychiatric drug prescription has fallen from 29.9 to 24.4 today.
“Just the fact that doctors are being asked to get involved in this discussion, they are going to be a little more reflective about what they are doing,” explained Ted Hughes, spokesman for the Texas Health and Human Services Commission. He added that foster children tend to have a higher rate of medication than others because they often face complex emotional problems.
MassHealth officials said it’s unclear whether Massachusetts needs to reduce the rate of drug prescriptions to young children: their records show that the number of young children receiving antipsychotic drugs began declining in 2005.
Keane said that most psychiatric drug prescriptions for preschoolers are written by child psychiatrists rather than pediatricians or family doctors, meaning that trained specialists are making the drug decisions. Riley’s doctor was a child psychiatrist at a Boston teaching hospital, Tufts-New England Medical Center.
Under the early-warning system, managed care organizations are reviewing prescription records for all children under age 5 who are receiving mental health treatment paid for by MassHealth. They are expected to keep a closer eye on those who are taking drugs and to conduct a case review of children receiving an unusual quantity or an antipsychotic.
The reviewers will be looking to make sure that the high rate of prescriptions is not an error caused by more than one doctor writing them, and checking to make sure the drugs don’t have dangerous side effects when taken together, Straus said. They will also look at the child’s history for signs of abuse, evidence of emotional problems, and other issues aside from mental illness that could explain behavior problems. The point is to make sure doctors try other forms of treatment or social services before turning to drugs, Straus said.
Straus said he is encouraged by results of the early-warning system. He said the behavioral health partnership has only contacted a handful of doctors so far to discuss prescriptions for at-risk children, but they had reasonable explanations for the children’s treatment plans. “They were being thoughtful about it,” he said.
Keane said the new system is an experiment since apparently no other state has done something quite like it before. But, if the tracking system works, he said, it could be expanded to many of the 300,000 Massachusetts children under age 5 who are not in the MassHealth program.
“This is really the start of this process,” he said.
Source: The Boston Globe
Benedict
Surely the diagnosis would be “Munchausen’s by Proxy”. However, is that the parent, the prescribing doctor or the pHARMaceutical inductry?
Benedict
Lisa Van S
Benedict,
In this case..Its the Doctor!..
Its time to hold Physicians accountable….
Hank
I’d like to raise a wider question for the consideration of the Pharmalot readers.
As has been discussed here, the surge of bipolar dx’ing in kids is a phenomena that is significantly based on the work of a group at Harvard, spearheaded by Dr. Joseph Biederman (interviewed by 60 minutes last week, as many of you no doubt saw). As has been reported elsewhere (but not on 60 minutes), Dr. B. is or has been a speaker, consultant, etc. for virtually all the companies who manufacture the relevant meds.
That may or may not be relevant. My core question is this: Given that the science here is new and controversial, and that the dx’ing is for off-label uses, does Harvard itself carry any responsibility? Clearly, his association with the Harvard “logo” is part of what makes what Dr. B. says and writes “noteworthy.”
He may turn out to be right. He may not. And I’m certainly not suggesting the work should not go on. But I’m trying to think through the role of a university like Harvard in a case like this, when - de facto - its name is part of the promotion engine of these meds off-label.
Thank you for your thoughts.
Lisa Van S
Hank,
You right,an investigation of Harvard,may bring about some interesting revolutions.
Hopefully NJ will be next in overseeing the abuse of overprescribing powerful psychotropics to infants and toddlers at Taxpayers expense.
Hank
Thanks, Lisa. I’m trying to think this through from a policy perspective re: a university’s responsibilities in such circumstances, particularly when they have a uniquely influential “logo.”
Lisa Van S
Ed,
NJ’s got Massuachusettes beat,according to NJ Medicaid data. There were 647 prescriptions for age 4 and under,and that was just for one month.
19 psychotropic drugs for infants under 12 months,three were given antipsychotics on top of their antidepressant.
174 prescriptions for Risperdal alone!!! We cane assume that J&J sure was in a hurry to get that drug approved.
Lori
Interesting question. I don’t know legally if they have any responsibility, but from a consumer perspective, the fact that there is a well-known institution involved is significant and persuasive. In a recent instance, a researcher used his affiliation with a university to imply the research was done at the university, when in fact it was sponsored by pharma and had no relation.
Institutional sponsorships of CME programs featuring off-label uses (i.e. simply providing a Safe Harbor) without any affiliations with the authors I also find troublesome for the same reason: the logo implies endorsement. I would find more comfort from an explicit institutional disclaimer on such programs that the views are those of the author(s) and not the institution.
Laurie
Makes you wonder how Beiderman and Glenmullen could be from the same institution.
Stephany
I appreciate this dialogue.
Lisa Van S
Stephany,
Im glad,are you a family member?
Doug Bremner
President Bush has promoted drug treatment of psychiatric conditions from the time he was Governor of Texas using his Texas Medication Algorithm Project (TMAP) in which he advocated all children being screened for mental illness and receiving ‘appropriate treatments’ (i.e. medications).
This was payback for the support he received in his re-election campaign from Big Pharma.
In Pennsylvania and Illinois there were ‘extensions’ of the TMAP model. This led to several deaths of incarcerated children given antipsychotics. When a psychiatrist working for the state of Pennsylvania talked to bmj.com about this he was fired. I have posted about related topics at
http://www.beforeyoutakethatpill.com/blog.html
Stephany
Lisa Van S–
I’m a mother of a 19 year old woman who was misdiagnosed at age 11 w/Bipolar Disorder. I am due in court this week to prevent her from being sent to the state mental institution for “long term care”. I am a relentless advocate for my youngest of 3 daughters. My blog should be linked to my name. Thanks for asking.
Lisa Van S
Stephany,
Did your daughter’s diagnosis of Bipolar come after she had been prescribed an antidepressant or an ADD or ADHD Medication.
My E mail is lvansyckel61@yahoo.com if you choose to answer privately.
Stephany
Oh and Lisa, I’m Bipolar, just to divert the “are you a family member” diversion from the real topic at hand, I am a one woman advocate, I take Lamictal, my daughter was screwed by misdignoses in 1999. I do not belong to NAMI, nor do I promote anything or anyone who does not represent open-ended non-biased diaglogue.
Rebecca Riley didnt have to die, and I am one woman who will make sure we all know why.
Stephany
800 pages of reading at my blog.
Stephany
Click on the 1999-2007 Evolution series, then get back to me. This should take about 8 years.
Jane
The dr is at fault for this child being lost. It is high time the psychiatrist’s are held for the deaths and damages for these drugs. Once drs start losing their license pressure will be placed on the Biederman’s and their respective institutions. These drugs are causing serious injuries and deathes in adults, you would think the leading thought leaders would step up and protect these children, hell infants for crying out loud. We need pulic service ads advising everyone of the dangers of these drugs and to report adverse events with these drugs.
Lisa Van S
Stephany,
Please correct me if I am wrong,but isnt Lamictal an anti seizure mediaction,and if so has it been FDA approved for the treatment of Bipolar?…
Hank
Referring back up the line to Lori’s message, thanks for taking the time and for your thoughtful reflection.
I think the issue of university/researcher/company connections is a subtle one. I know Harvard sets limits on how much a researcher can own financial shares in a company connected with their research. But I am fairly sure there are no limits to paid consultancies, speakerships, and other wayz a company might want to “celebrate” a particular researcher. (I’m not saying there ought to be, just reflecting). I do think the sums involved need to be reported at Harvard. In any case, the distinction between having a direct financial investment in a company, and an enriching relationship of another kind with said company, is not a crystal clear one. As far as potential COIs, I’m not sure there is much practical difference.
In the meantime, the “logo question” remains.
Reality
Lisa,
It is approved for bipolar.
For you and others, the FDA has a very good resource with label and approval information for drugs: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
Lisa Van S
Reality,
Thank you,I appreciate your forwarding the information to me.
todd
Wow, I figured you would know about mood stabilizers. It is in the guidelines. I hate to say it, but when you have people who are not health care professionals advocating how medicine should be practiced, this is what you get. Misinformation, misunderstandings, general confusion. Thanks for reinforcing the thought.
Lisa Van S
Reality,
GSK’s Patient information leaflet on Lamictal is great,easy to read and understand.It was wonderful to see that they included the importance of monitoring mood changes.
Todd,
Lamictal is not FDA approved for the treatment of mood disorders in children and adolescents under 18.
Question:Were clinical trials conducted in Patients under 18? If so, are they available for review.
Stephany
Hank brings up good points not many people understand, regarding conflict of interest via psychiatrists, who are often the same researchers, and paid speakers for CME classes for doctors representing certain pharmaceuticals. The question re: if Lamictal is an antiseizure medication is irrelevant to the discussion, being this is about adult medications being used in toddlers and re: Rebecca’s death that was a preventable tragedy. Depakote is an antiseizure medication as well, and that is what Rebecca was being rx’d along with Seroquel, an antipsychotic. Depakote has a blackbox warning for pancreatitus, and polycystic ovary syndrome in use in women under age 20. Adding dexthromethophan to the mix re: Rebecca–cough medicine–created a dangerous mix of chemicals even for an adult to take with caution. Rebecca’s mother like most people listen to the doctor, and in Rebecca’s case I am alarmed a child so young could have been dx Bipolar and given medications that are difficult for some adults to manage per the side effects. I think it is important to question the use of psych meds in children under at least age 13. It’s important to understand that Lilly withheld data that compromised patient health re: diabetes. The Zyprexa documents that the public was not supposed to see can be found at Furious Seasons, the link is on my side bar. It does not take a professional of any kind to see how the pharma industry is corrupt, and its a trickle down effect that usually takes people back to where the research began, in this case Harvard. [and Emory]. I’m glad to see people asking questions and raising concern, once again this was a tragic and preventable death of a 4 yr.old.
Stephany
Furious Seasons is on the sidebar blog roll on this site as well. The bottom line is most medications were not approved for use in kids under age 18, and dx were based on adult criteria. As far as being tested in kids–some were. I’ve linked quite a few abstracts for reading re: this topic in my 1999-2007 evolution of a dx series. Or, Google scholar Beiderman or Nemeroff and start reading their published work. Then read the fine print most were funded by the same Pharma company that the drug trial was being tested—and then take it further for instance w/ Nemeroff and see how he is a paid speaker for CME classes, paid by Pharma company…there’s much to the complex puzzle that came down to an innocent child dying on psych meds approved for adult use, and who had a bipolar dx at age 2-3 based on adult criteria. It’s unbelievable.
Reality
Lisa (and others), there are resources out there to check on these things:
If you search clinicaltrials.gov, you’ll see there are trials currently recruiting for pediatric bipolar disorder. You may also want to search clinicalstudyresults.org to see if there are unpublished results.
Lisa Van S
Reality,
Im always more interested in the ones that arent published,
For obvious reasons of course.
Reality
Lisa,
Also, a quick, top-level search of pubmed (pubmed.gov) shows at least 1 trial (albeit open-label) of lamotrigine in adolescents with bipolar.
Note, I am not commenting on the trial itself, the design, its weaknesses, the results, conflicts of interests, etc. This is simply to let users know that there are a lot of resources out there, so use them!
todd
LVS,
How many meds are written off-label in peds? Well over 50%. And when they do put the time and energy into research, as the post on acid suppression in peds shows, then people blame pharma for marketing to kids by providing data.
Ask any pediatrician, there is a lack of information for peds. They have to use their professional judgement and experience. If you wait for the manufacturer to get it approved through the FDA it may never happen. It is now a large financial committment to get increased labeling. So if the data is out there, and financially it doesn’t make sense, most companies chose not to pursue formal indications.
todd
Also, Stephany commented that she took Lamictal, I am assuming she is over 18
Lisa Van S
Todd,
(PREA)!!!
Reality
Lisa,
When you say you are most interested in unpublished studies, I think what you are implying is that pharma is trying to hide negative results. While this may be the case in some instances, I’d like to take the opportunity to say that journals and their editors are at least as culpable in the publication bias (of unpublished negative studies).
Generally speaking, unless they’re dealing with a huge, major, paradigm-shifting study, journals are not interested in publishing negative results, and those that will publish those results are not exactly NEJM or JAMA. The sanctimonious editors at those and other top-tier journals who criticize pharma for allegedly not publishing negative results are the same who reject negative trials on first-pass. By the time authors find a journal for those results, 2 years may have passed since the study ended.
Lisa Van S
Reality,
I agree with you 100%.
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