What are the legal and ethical considerations of using haloperidol (antipsychotic medication)?

From the Guidelines

Haloperidol use in patients with dementia or agitation involves significant legal and ethical considerations, and prescribers must carefully navigate these issues to minimize risks and ensure informed consent, as emphasized by the American Psychiatric Association practice guideline 1. When considering the use of haloperidol, it is crucial to weigh the potential benefits against the risks, including extrapyramidal symptoms, tardive dyskinesia, and QT prolongation. The most recent and highest quality study, which is the American Psychiatric Association practice guideline 1, suggests that antipsychotic medications, including haloperidol, can be appropriate for individuals with dementia who exhibit dangerous agitation or psychosis, but the benefits are small and the risks of adverse effects, including mortality, are significant. Key considerations include:

• Obtaining informed consent from patients or their legal representatives, ensuring they understand the medication's purpose, potential benefits, and risks.
• Typical dosing ranges from 0.5-5mg orally for elderly or non-acute cases to 5-10mg for acute psychosis, with careful titration based on response, as suggested by the BMJ study 1.
• Legal requirements vary by jurisdiction but generally mandate documentation of capacity assessment, consent processes, and justification for treatment.
• Ethical practice demands regular reassessment of the need for continued treatment, monitoring for adverse effects, and consideration of the least restrictive interventions.
• Special considerations apply to vulnerable populations, including pregnant women, children, elderly patients, and those with dementia, where benefit-risk assessment is particularly critical, as highlighted by the Annals of Oncology study 1. Healthcare providers should implement regular medication reviews, document decision-making processes thoroughly, and remain aware that off-label use carries additional legal and ethical obligations due to black box warnings about increased mortality risk in elderly patients. In terms of specific dosing, the BMJ study 1 suggests starting with 0.5-1 mg orally at night and every 2 hours when required, with a maximum daily dose of 10 mg, or 5 mg in elderly patients. The Annals of Oncology study 1 provides further guidance on pharmacological interventions for delirium symptoms, including suggested starting doses and comments on the use of haloperidol and other antipsychotics. Ultimately, the decision to use haloperidol must be made on a case-by-case basis, taking into account the individual patient's needs, preferences, and circumstances, and with careful consideration of the potential benefits and risks, as emphasized by the American Psychiatric Association practice guideline 1.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Legal and Ethical Considerations of Haloperidol

• The use of haloperidol in palliative care is common, and it is essential to be aware of its indications, benefits, and risks, especially in this context 2.
• Haloperidol is recommended for use in psychosis-induced aggression or agitation, particularly in limited-resource areas where it may be the only available antipsychotic medication 3.
• The use of haloperidol alone for rapid tranquillisation may be considered unethical if alternative treatments are available, and the addition of sedating medications like promethazine may be supported by better-grade evidence 3.
• Studies have compared the efficacy and safety of haloperidol with other treatments, such as risperidone and lorazepam, for the treatment of acute agitation in patients with schizophrenia 4, 5.
• The use of intramuscular haloperidol has been compared to intramuscular olanzapine, with olanzapine exhibiting a dose-response relationship in the reduction of agitation and a favorable safety profile 6.

Adverse Effects and Safety

• Haloperidol can cause adverse effects, such as dystonia, and its use may be associated with a higher risk of extrapyramidal symptoms compared to other treatments 3, 5.
• The addition of lorazepam to haloperidol does not have strong evidence of benefit and may carry a risk of additional harm 3.
• The use of haloperidol in palliative care may require careful consideration of the patient's individual response to medication and the potential for adverse reactions 2.

Treatment Guidelines and Recommendations

• Haloperidol may be recommended for inclusion in palliative care emergency kits, particularly in home care teams 2.
• The use of haloperidol for rapid tranquillisation may be considered in situations where no other alternative exists, but its use should be carefully evaluated and monitored 3.
• Alternative treatments, such as risperidone and olanzapine, may be considered for the treatment of acute agitation in patients with schizophrenia, particularly if they have a more favorable safety profile 4, 5, 6.