Inappropriate Prescribing of Atypical Antipsychotic Drugs in the Elderly: Inexcusable Deaths and Medicare Dollars Wasted

In April 2011, the Office of Inspector General (OIG) of the Department of Health and Human Services released a study, “Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents,” with dismal results. The study was conducted at the request of Sen. Charles Grassley (R-Iowa) and evaluated the extent to which elderly nursing home residents receive newer, more expensive atypical antipsychotic drugs and the associated cost to the Medicare system. It also assessed the extent to which dangerous, off-label prescribing of these drugs was occurring.

The Food and Drug Administration (FDA) requires a black box warning for atypical antipsychotic drugs (see “FDA Black Box Warning” and the “Atypical Antipsychotic Drugs” table). A black box warning is the most serious type of warning the FDA can require a manufacturer to display in a drug’s professional product label. A shorter version of the antipsychotic black box warning is included in the FDA-approved Medication Guide, a document given to the person picking up a prescription in a pharmacy:

“Increased risk of death in elderly patients with dementia-related psychosis:

“Medicines like ABILIFY can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). [Name of atypical antipsychotic drug such as ABILIFY] is not approved for the treatment of patients with dementia-related psychosis.”

It is unlikely that nursing home residents with dementia are given such Medication Guides or, even if they are, that they can understand their significance. In addition, too many nursing-home health professionals appear indifferent to this important warning.

Thus, the following findings from the OIG study are horrifying but not surprising.

During this same interval:

Currently, the FDA has approved nine atypical antipsychotic drugs for sale in the U.S. (see “Atypical Antipsychotic Drugs” table). These drugs are approved only for treatment of schizophrenia and/or bipolar disorder.

Scarce Medicare dollars wasted

There are those who say that we should not want the government in our medicine cabinets. Actually, we should want good government in our medicine cabinets; it would be less expensive and safer, especially for the elderly.

The OIG report found that in the first six months of 2007 alone, the Medicare system paid out more than $200 million (more than $400 million for the year) for the dangerous, inappropriate prescribing of just one family of drugs: atypical antipsychotics. Imagine the savings to Medicare if inappropriate prescribing and utilization of medical interventions were eliminated or just reduced.

If inappropriate prescribing were reduced, the quality, including the effectiveness and safety, of drug treatment would improve, and costs to the Medicare system would decrease.

The inappropriate prescribing of drugs, particularly in the elderly, does not seem to be improving. However, Worst Pills, Best Pills News and WorstPills.org are published and maintained by Public Citizen’s Health Research Group to give consumers the information they need to avoid drug-induced harm.

What You Can Do

You need to be attentive regarding the well-being of elderly family members or friends who reside in nursing homes or live at home. They are vulnerable, and some are in no condition to make decisions on their own. The elderly often need assistance verifying that the care they receive is appropriate.

Any time you visit an elderly family member or friend in a nursing home, ask whether they are being prescribed one of the atypical antipsychotic drugs on the list above. If they are, find out if the reason for the prescription is dementia-related psychosis. If so, bring this article with you and explain why such drugs in elderly patients increase the risk of death and ask for the prescription to be stopped. If you are caring for someone elderly outside of a nursing home, get a list of all the prescription drugs the person is taking and follow the same sequence stated above, inquiring of the prescribing physician.

The complete Medication Guides for the atypical antipsychotics and other drugs can be obtained from the FDA’s website at http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm or by asking a pharmacist.

Consumers may report serious adverse events or product quality problems to the FDA’s MedWatch Adverse Event Reporting program online or by regular mail, fax or phone.

• Online: www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
• Regular mail: Use postage-paid, pre-addressed FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: (800) FDA-0178
• Phone: (800) FDA-1088

Atypical Antipsychotic Drugs