According to a recent report by The Department of Health and Human Services (HHS) Office of the Inspector General (OIG), many nursing home residents suffering from dementia are being prescribed atypical antipsychotic drugs (AAP) despite potentially life-threatening consequences.
Atypical (or second-generation) antipsychotic drugs are used to treat various psychiatric conditions, such as schizophrenia and bipolar disorder. Many of these drugs, which include Astra Zeneca’s Seroquel, Johnson & Johnson’s Risperdal and Ely Lilly’s Zyprexa, have black box labels that warn of an increased risk of death when given to elderly patients with dementia.
In 2007, Sen. Charles Grassley (R-Iowa) asked OIG to examine the prescriptions given to nursing home residents with off-label conditions, including dementia. He was moved to do so after FDA epidemiologist David Graham testified before Congress that approximately 15,000 nursing home residents die per year due to off-label use of these kinds of medication.
The FDA (Food and Drug Administration) permits doctors to prescribe drugs for off-label usage based on their expertise and discretion, however pharmaceutical companies may only promote their drugs for the uses that appear on the drug’s label, which are the uses approved by the FDA.
Off-label prescribing occurs when a drug is used in a way for which it was not intended or as a therapy, cure, or treatment for one or more conditions for which it has not been approved. While this type of use can lead to a more expansive application of a successful drug, it can also cause a higher incidence of known side effects as well as unforeseen adverse reactions that can be quite serious − even deadly.
The off-label prescribing of drugs beyond the scope of their FDA approval has become a serious concern in recent years. Dosage levels, medical conditions, and treatment durations for which drugs were never intended or tested make the entire area of off-label use problematic at best. There is also the problem of off-label prescribing to age groups (infants, adolescents, and seniors) for which no, or insufficient, clinical data exists. At its worst, the practice can be downright deadly.
According to a 2011 article, Off-label indications (those not approved by the FDA) doubled from 1995 to 2008.
The incredibly strange thing about off-label use, however, is that doctors may prescribe drugs to treat conditions for which the Food and Drug Administration has even denied approval. Therefore, while a manufacturer cannot market a drug for an unapproved off-label use, a doctor may prescribe the drug for that use.
The aforementioned study, conducted over a six month period, showed that 88% of reimbursement claims given to Medicare for AAP prescriptions in nursing homes were for people with dementia.
Additionally, the study revealed that 83% of claims were for off-label use and 76% were for off-label use and dementia.
HHS Inspector General Daniel Levison thinks that pharmaceutical companies are ultimately to blame, as they continue to violate the federal government’s False Claims Act (FCA) by advertising their drugs for uses not approved by the FDA.
After the study was concluded, Levison found it troubling “that so many nursing home residents are prescribed these drugs in the first place.” He urged “government, taxpayers, nursing home residents, as well as their families” to be “outraged and seek solutions.”
Steven Levin, a Chicago attorney familiar with these types of cases, agreed. He said that “anecdotal evidence suggests that when the resident is placed on these drugs, something bad happens.”
In Levin’s opinion, the use of AAPs is so widespread in nursing homes, “because it’s easier to control the patient and requires fewer staff.” He concluded by saying that “nursing homes should never use antipsychotic drugs for the purpose of convenience.”
Levin has represented two patients that have suffered acute kidney failure resulting from dehydration while on Seroquel. In one instance the patient died, the other was diagnosed with brain damage.
According to Mr. Levin, attorneys that represent plaintiffs in similar situations need to be more aware of “the roles that these types of drugs might play in cases involving nursing home neglect.” He emphasized the importance of monitoring whether patients’ needs are being properly assessed, behavioral changes while on the drug and whether or not the drug is stopped if harmful side effects arise.
Off-label usage has become an ongoing issue. While this practice can be beneficial to an individual patient on a case-by-case basis, it can have very serious consequences when used generally and at no point should doctors prescribe drugs for off-label use as a “quick fix.”