Rose Rachel V, Kass Joseph S
Continuum (Minneap Minn). 2019 Feb;25(1):254-259. doi: 10.1212/CON.0000000000000701.
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.
在试图通过药物治疗来管理与痴呆症相关的行为障碍时，照顾痴呆症患者的临床医生常常感到束手无策，因为尚无药物被证实对这一适应症有效。尽管美国食品药品监督管理局（FDA）强制要求在使用抗精神病药物治疗的痴呆症患者中存在死亡风险增加的黑框警告，但抗精神病药物仍常用于这些患者。此黑框警告并不能阻止临床医生为痴呆症患者开具抗精神病药物。然而，它向开处方者发出了更强的警告，要求他们在与患者或患者的医疗保健代理人讨论拟议治疗的风险和益处时，将黑框警告中提到的具体风险包括在内，并在病历中记录这一知情同意谈话。通过记录治疗风险，包括FDA认为严重到足以列入黑框警告的风险，已被医疗决策者讨论并接受，开处方者在发生不良事件时也降低了承担责任的风险。
