Prescribing Antipsychotic Medications to Patients With Dementia: Boxed Warnings and Mitigation of Legal Liability

Rachel V. Rose, JD, MBA; Joseph S. Kass, MD, JD, FAAN Dementia p. 254-259 February 2019, Vol.25, No.1 doi: 10.1212/CON.0000000000000701
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Clinicians caring for patients with dementia are often at a loss when trying to manage dementia-related behavioral disturbances pharmacologically because no drugs have been proven effective for this indication. Antipsychotics are commonly prescribed for these patients despite a US Food and Drug Administration (FDA)–mandated boxed warning about the heightened risk of death in patients with dementia treated with antipsychotic drugs. This boxed warning does not prevent clinicians from prescribing antipsychotics to patients with dementia. However, it serves as a heightened warning to prescribers to include the specific risks mentioned in the boxed warning in their discussion of risks and benefits of the proposed therapy with their patients or their patients’ health care proxy and to document this informed consent conversation in the medical record. By documenting that the risks of the treatment, including those the FDA has deemed serious enough to include in a boxed warning, were discussed and accepted by the medical decision maker, the prescriber also reduces the risk of liability should an adverse event ensue.

Address correspondence to Dr Joseph S. Kass, Baylor College of Medicine, One Baylor Plaza M-210, Houston, TX 77030, kass@bcm.edu.

RELATIONSHIP DISCLOSURE: Ms Rose serves on the editorial board of BC Advantage and receives book royalties from the American Bar Association. Dr Kass serves as associate editor of medicolegal issues for Continuum, as an associate editor for Continuum Audio, as a neurology section editor of Ferri’s Clinical Advisor for Elsevier, and as co-editor of Neurology Secrets, Sixth Edition. Dr Kass has received personal compensation for CME lectures from Pri-Med Medical Group and has received personal compensation as a medicolegal consultant in legal cases involving criminal proceedings, malpractice, and personal injury.

UNLABELED USE OF PRODUCTS/INVESTIGATIONAL USE DISCLOSURE: Ms Rose and Dr Kass report no disclosure.

© 2019 American Academy of Neurology.