warning signFlorida Medicaid is in the news again as a new investigation into the over prescription of atypical antipsychotic drugs for treating symptoms in very young children was just launched at the Federal level by the Inspector General’s Office at the Department of Health and Human Services.

Florida Medicaid defines “young children” as Birth through age 5 and older children as 6 through age 17. The new study will look at both age brackets and concentrate on California, Florida, Illinois, New York and Texas from January to June 2011 when 84,654 children received atypical antipsychotics.

Atypical antipsychotics were developed and marketed in the 1990’s and early 2000’s as “safer” replacements for the original 1950’s antipsychotic drugs, Haldol and Thorazine, since the side effects of those two drugs had earned them the name “chemical lobotomies.”

Florida like other states with large Medicaid roles soon began doling out atypicals at an alarming rate.

The drugs in question include Abilify from Otsuka America Pharmaceutical, Inc. said to be the number one selling prescription drug in America. Others atypicals being investigated are Risperdal, Seorquel and Zyprexa – all big money makers.

Medicaid now spends more on atypical antipsychotics than any other drug class. In 1999 it was $1.65 billion and in 2008 it had climbed to $3.6 billion as shown by Mathematica Policy Research in Washington D.C. who monitors these statistics for the Dept. of Health and Human Services. Prescriptions given to children tripled during these years.

Some of these drugs have Food and Drug Administration approval for treatment of children labeled as bipolar or just having  irritability associated with autism. But the concern about possible side effects on young people and growing off-label use by doctors to treat various forms of violent or aggressive behavior has sparked debate about whether they are being dispensed too freely to troubled children.

Doctors have legal leeway to go beyond FDA approved uses and these drugs are being used off-label to quiet kids thought to be too aggressive or violent or perhaps just too alive, active and noisy for adults to deal with.

Dr. Fernando Siles, a pediatric psychiatrist in the Dallas area, gave a typical justification for giving these drugs to foster children who only have behavior problems. “A child that continues to be aggressive will be kicked out from his foster home,” he says. “The antipsychotic is to stabilize the behavior of the child, to keep him from being moved and moved again.”

On the manufacturer’s own website page describing Ablify it gives these warnings which show that the drug goes far beyond “stabilizing the behavior of the child”.

  • Children, adolescents, and young adults taking antidepressants for major

depressive disorder (MDD) and other psychiatric disorders are at increased

risk of suicidal thinking and behavior.

  • Increased risk of suicidality in children, adolescents, and young adults with major depressive disorder

 

  • Tardive dyskinesia – involuntary movements of the tongue, lips, face, trunk, and extremities . Tardive means “delayed” and dyskinesia means “abnormal movement.” (This was one of the problems with Haldol and Thorazine)

 

  • Hyperglycemia – Having an abnormally high blood glucose (blood sugar) level.

 

  • Diabetes Mellitus – Diabetes is usually a lifelong (chronic) disease in which there are high levels of sugar in the blood.

 

  • Dyslipidemia  – an abnormal amount of cholesterol and/or fat in the blood. It can lead to cardiovascular problems, like cardiac arrest and stroke.

 

  • Weight gain has been observed with atypical antipsychotic use

 

  • Lowered immune system conditions  have been reported with antipsychotics including Abilify

 

  • Seizures/Convulsions – Use cautiously in patients with a history of seizures or

with conditions that lower the seizure threshold

 

  • Potential for Cognitive and Motor Impairment – Use caution when operating

machinery

 

If parents clearly understood the risk of these side effects they would never permit a young child or infant to take such a prescription drug. Yet, in 2008, Medicaid doctors gave these drugs to 19,045 children under age 5. In the states being investigated there were hundreds under age 3, over one hundred children under 2, and a handful under 1 including one baby listed as one month old.

A document called “Florida Best Practice Medication Child and Adolescent Guidelines” includes Florida Medicaid instructions to doctors called “Principles of Practice Regarding the Use of Psychotropic Medication Under Age 6”.

Here we learn how psychiatrists decide which infants, toddlers and pre-school kids get to try out atypical antipsychotics.

Level 0 consists of questionnaires and assessments filled in by parents or teachers.

Ages 12-36 months have the Strengths and Difficulties Questionnaire (SDQ) where the adult gets to decide Not True, Somewhat True or Certainly True to questions which would apply to any toddler or don’t seem to apply to a toddler at all.

Considerate of other people’s feelings, Restless, Overactive, Cannot stay still for long, Generally well behaved, Usually does what adults request, Many worries or often seems worried, Has at least one good friend, Generally liked by other children, Picked on or bullied by other children, Can stop and think things out before acting, etc.

Ages 12 to 36 month could also get a Brief Infant-Toddler Social Emotional Assessment (BITSEA) which in 7 to 10 minutes can point them toward a life with psychiatric drugs.. It checks into such things as how active, impulsive or defiant an infant is and whether it experiences distress when separated from someone (presumably a parent) – nothing unexpected to find in a 1 to 3 year old.

Ages 3-6 years receive the Early Childhood Inventory (ECI) which is a behavior rating scale that screens for DSM-IV emotional and behavioral disorders in children of that age bracket.

It claims to detect in little children many of the so-called disorders voted into existence by the psychiatrists on the DSM board including ADHD, Oppositional Defiant Disorder,   Conduct Disorder, Separation Anxiety Disorder  Obsessive-Compulsive Disorder  and Posttraumatic Stress Disorder.

Next the child gets “An assessment of family psychiatric history which includes past and current history of parental psychiatric illnesses, substance abuse and treatment history of parents, parent figures (e.g., step parent) siblings, and other relatives”. Apparently if the family has already bought into the need for psychiatric drugs, it will be easier to get children into the same treatment.

Level 1 then says to always start with “psychosocial treatment” which means “talk therapy” and “social and vocational training” – pretty hard to do with an infant 1 to 3 years old.

Level 2 then calls for medication accompanied by the psychosocial treatments.

Acknowledging that studies have not been conducted in preschoolers, infant dosages are then given for Risperdal or Abilify. Risperdal is specifically recommended for “Disruptive behavior disorder” under age 6.  Being of the male sex is a “risk factor” and being active, impulsive and inattentive are target symptoms.

Florida Medicaid under public pressure in 2008 made at least a token effort to rein in the use of atypical antipsychotic drugs in the birth to age 6 bracket by requiring that doctors get approval before giving these drugs to kids.

However, refills were automatically granted when requested and, in some new cases, psychiatrists not wanting to bother with the paperwork, just went back to prescribing the older typical antipsychotics from the 1950’s!

Child psychiatrist Dr. Mark Cavitt from All Children’s Hospital in St. Petersburg, Florida has been involved in industry-funded atypical research and has spoken on behalf of Abilify.

He’s not surprised or bothered by industry funding and says,

“In a perfect world, it would be much better if research were funded by independent agencies, but most of the research dollars in child psychiatry comes from the pharmaceutical companies.”Now that drug companies are required to reveal negative as well as positive studies, I’m not overly concerned.”

He also was quoted about the new Medicaid paperwork. “It’s probably an important step in terms of establishing some regulation of medication that can be very helpful but have potential negative consequences and are expensive.”

When the Medicaid’s review process denies a request of his for an atypical prescription, he has “reluctantly” put those patients on first-generation antipsychotics.

The attitude is clearly that any drug is better than no drug and no loss in profits will be tolerated.

Despite a sizeable reduction in the number of atypical antipsychotic prescriptions given to kids under the new approval process in Florida, the total Medicaid money spent on these drugs for all kids 18 and under rose in the state from $30.8 million (in 2007) to $34.2 million (in 2008)

Florida Medicaid law has a legal loophole a mile wide as seen in its stated Rule 59G-4.250:

“To be reimbursed by Medicaid, a drug must be medically necessary and either

1. For an FDA approved indication;

2. For an indication not approved by the FDA, but in which the prescribing practice is recognized in the official drug compendia such as American Hospital Formulary Service (AHFS™) or DrugDex®5; or

3. For an indication not approved by the FDA, and where the prescribing practice is not recognized in the official drug compendia.”

Thus, prescribing certain atypical antipsychotic medications for a young child would be consistent with item 3 above.

Hopefully the latest Federal inquiry by the Dept. of Health and Human Services will find these all such loopholes nationwide and rule that no atypical or typical antipsychotics, the most powerful psychiatric drugs created to date, will ever be given to infants, kids or teenagers in the Medicaid system.

http://www.anh-usa.org/medicaid-psychiatric-drugs/

http://pharmagossip.blogspot.com/2013/08/at-last-us-probes-use-of-antipsychotic.html

http://centerforchildwelfare2.fmhi.usf.edu/kb/psychmed/FlMedicaid-OversightOff-LabelMeds2009.pdf

http://www.tampabay.com/news/health/approval-process-lowers-the-number-of-kids-on-atypical-prescriptions/987612