With the rapid increase in the elder population nationwide, the problem of excessive dependence on risky antipsychotic drug treatment for dementia-related behavioral problems in nursing facilities must be addressed. At the federal level, the over-prescription of antipsychotics to the elderly in nursing homes is addressed first by regulation specific to nursing facilities, such as the Federal Nursing Home Reform Amendments (FNHRA), a part of the Ombudsman Budget Reconciliation Act of 1987 (OBRA ’87) as well as through the Centers for Medicare and Medicaid Services (CMS) guidelines. Secondarily, the Food and Drug Administration (FDA) has authority to issue black box warnings and regulation pertaining to off-label drug use for antipsychotics used to treat behavioral problems associated with dementia, a use that has not been approved by the FDA. Additionally, under state common law, these problems are addressed under the informed consent and right to refuse treatment doctrines. Despite the extensive multi-tiered body of law addressing this issue, no coherent and effective system has yet been devised to effectively protect patient rights. This paper suggests solutions to system failures via multi-faceted changes at federal and state levels in order to make the available framework more coherent and facilitate a shift to a nonpharmacologic treatment emphasis in the future
