Prescribing Off-label Antipsychotic Drugs Can Be Damaging to Nursing Home Patients

The job of prescribing medications requires balance. The goal must be to improve the health of the patient as much as possible while minimizing risks, taking into account any negative side-effects or quality of life issues. Such considerations are especially important for elder care in nursing homes, as the residents generally have more delicate systems. The US Food and Drug Administration (FDA) puts out guidelines for best practice prescribing based on scientific studies about efficacy and side-effects. And yet a poor prescribing policy can be found in most nursing homes. A study published in The American Journal of Geriatric Pharmacotherapy looked at this problem specifically through the lens of antipsychotic medications.

Antipsychotic medications are developed to treat patients with psychotic episodes, such as can been seen in bipolar disorder and schizophrenia. These medications include haloperidol and clozapine and generally act as sedatives. In nursing homes, use is usually off-label, frequently to subdue patients with dementia-related agitation. Off-label use is not supported by the FDA. Up to 80% of all antipsychotic use in nursing homes is off-label, for behavioral management. But with off-label use there are no FDA guidelines regulating prescription. Less testing for efficacy and side-effects is carried out for off-label usage. Such prescribing can be risky, even with the “black box” labels that the FDA puts on to warn nursing home staff of the drugs’ dangers.

Hundreds of thousands of nursing home residents are currently being prescribed antipsychotic medications. Most of this use is non-recommended. The issue of nursing home overuse of antipsychotics is important as the clinical studies conducted for off-label use of these medications report that there are little to no medical benefits, while there are many side-effects including strokes and increased morbidity and mortality. Such use is generally just for the purpose of subduing or restraining patients, to make caring for them an easier task. But the use of any type of restraint, physical or chemical, that is not for the direct medical benefit of the patient is prohibited by federal and state law.

Off-label use of antipsychotic drugs for non-medical purposes is commonly found in conjunction with understaffing in nursing homes. The belief is that more subdued and compliant patients mean that fewer nurses can perform the same care tasks in less time. But this assumption is not fact based, and is a violation of patient rights. Studies have shown that nursing homes that do not use any type of restraint with such patients do not actually need more staff to complete daily assistance and care activities. Nursing homes seem to act without much regard for scientific evidence in their use of antipsychotic drugs. Even with federal regulation of antipsychotic medication use, with sanctions for improper prescription, many facilities still refuse to change their policies. There is a financial motivation for such drug use, as Medicaid pays out billions each year for such prescriptions. And unfortunately, nursing homes placing finances ahead of patient welfare and health is not an unknown phenomenon.

Such actions are not only immoral, they are illegal. Both state and federal legislation speak to the quality of care and treatment that nursing homes must provide. This includes a fully staffed home with a hygienic and safe environment. But if a nursing home fails to meet these legally proscribed standards, under California Health and Safety Code 1430(b), you are allowed to sue for damages to health and wellbeing.


So if your loved one has been injured while in a nursing home, due to the use of off-label antipsychotic medications or any other reason, please contact us today. Discuss your case with us in a free consultation and find out how we can help you get just compensation for your loved one’s suffering.