Safety Issues of Psychotropic Medications

The Honorable Kathleen Sebelius
Secretary
U.S. Department of Health & Human Services
200 Independence Avenue, SW
Washington, D.C. 20201

Dear Secretary Sebelius:

As you are aware, expenditures for mental and behavioral treatments
continue to rise while the quality of patient care suffers. The vast
majority of behavioral health treatments are publicly funded. In 2009,
the total expenditure for mental health care, substance abuse treatment
excluded, amounted to approximately 4\% of health care expenditures,or
about $100 billion. This increase in expenditures is directly attributed
to the expanded use psychotropic medications and the shift of behavioral
and mental health care to primary care settings.The result of this shift
has resulted in poor health outcomes and increased health care costs.

Many patients who present with symptoms of depression are being provided
expensive medications as the first line treatment for their condition
when many of these drugs have not been proven more effective than a
placebo and where psychotherapy should be the first line treatment.

Numerous dangerous side effects have been identified with prescribed
antipsychotic medications, which are the number one selling class of
prescription drugs in the United States. A recent study found that
widening use of antipsychotic medications is even linked to shrinkage in
the brain.

In regards to children the research findings are equally alarming.
Children appear to be at higher risk than adults for a number of adverse effects,
such as extrapyramidal symptoms and metabolic and endocrine abnormalities ie diabetes,osteoporosis, and reproductive problems.
As treatment is administered at a time of rapid brain development,
there is a need to evaluate the possible impact, either favorable or detrimental, of antipsychotic medications
on cognition and other aspects of brain maturation. Also, almost one third (32.4\%) of the psychotropic prescriptions for children
were associated with visits to nonmental health providers.

We believe modest changes to reimbursement rules for Medicare/Medicade and other federally funded mental health care programs
will promote better patient care while reducing overall taxpayer costs associated with ineffective medications.

We propose the following for your consideration:

Medicare/Medicade and other federally-funded mental health programs should not reimburse for any psychotropic medication unless the patient first has
been appropriately evaluated and diagnosed by a doctoral level mental
health specialist and where it has been determined that psychtherapeutic intervention would not benefit the patient's condition. Appropriate
diagnosis is critical when considering the most effective treatment
options for the patient. Moreover, the costs associated with an
inappropriate prescription can be significant. In 2007, the estimated
cost associated with adverse drug events was $172 billion; additional
hospitalizations add approximately $6000 to a hospital stay. The fact
that patients are not receiving an appropriate evaluation and diagnoses
is alarming and must change.

The practice of reimbursing for off-label prescribing of prescription
drugs should cease. Off-label prescribing for conditions that are not
approved by the FDA is inconsistent with the manifest function of why
such a system exists. A 2009 study reports that among the nearly 300,000
veterans who received a prescription for an antipsychotic medication,
more than 60\% had no record of a diagnosis for which the drug was
approved. Off-label prescribing of drugs that have not been tested for
the specific condition for which they were approved is inappropriate and
may be unsafe for the patient.

There should be no reimbursement for any psychotropic medications that
have not been validated by an unbiased peer review. Newly introduced
medications should reach a standard before being prescribed to patients.
Unbiased peer review will establish the effectiveness and safety of a
drug. Patients should not be prescribed medications without a
determination of the true risks and potential side effects.