New York 2025-2026 Regular Session

New York Senate Bill S04380

Introduced
2/4/25  
Refer
2/4/25  

Caption

Limits the off label use of antipsychotic drugs with black box warnings on elderly patients with dementia; provides for professional misconduct for any health care professional who uses such drug on such patient.

Summary

This bill would add a new section to the Public Health Law restricting the off-label use of antipsychotic drugs that carry FDA black box warnings when prescribed to elderly patients with dementia. It defines key terms such as off-label use, black box warning, chemical restraint, antipsychotic drug, and the covered patient population, which includes elderly individuals with dementia in residential health care facilities, adult care facilities, hospitals, and other health care facilities. Under the bill, antipsychotic drugs with black box warnings could not be used off label on a patient known to have dementia, and could not be used as a chemical restraint. The only exception would be an emergency situation, when the patient is agitated and the drug is reasonably necessary to protect the life, health, or safety of the patient or another person. In that case, the medication could only be ordered by a health care professional who specializes in dementia or has specific dementia training, and the provider would have to document the use, reason, dosage, and required notifications in the medical record. The bill also amends the Education Law to make noncompliance with the new Public Health Law section a form of professional misconduct. That means a health care professional who violates the restrictions could face discipline under the state’s professional misconduct rules. The bill expressly states that it does not expand the lawful scope of practice of any health care professional or change existing consent requirements. The overall sentiment reflected by the bill text is protective and patient-safety oriented, focusing on reducing potentially harmful or coercive medication practices for vulnerable older adults with dementia. No committee transcript or vote history was provided, so there is no recorded public debate, support, or opposition in the supplied materials. The main point of contention likely would be the balance between protecting dementia patients from inappropriate sedation and preserving clinical discretion in emergencies. The bill narrows when these medications may be used and ties violations to professional discipline, which could raise concerns among providers about regulatory burden, emergency decision-making, and the availability of trained specialists in urgent settings.

Impact

The bill would create a new statutory restriction in the Public Health Law on the off-label use of black box-warning antipsychotic drugs for elderly patients with dementia, while also adding a corresponding professional misconduct violation to the Education Law. It would affect physicians and other health care professionals treating dementia patients in hospitals, residential health care facilities, adult care facilities, and similar settings, and would require documentation and notification procedures whenever an emergency exception is used.

Sentiment

The bill’s tone is strongly protective of elderly dementia patients and appears aimed at preventing misuse of antipsychotic drugs as chemical restraints. Because no committee discussion or votes were provided, there is no recorded legislative sentiment beyond the bill’s text itself, but the measure reads as a patient-safety and elder-protection proposal rather than a controversial expansion of treatment authority.

Contention

The likely area of contention is whether the bill goes too far in limiting clinicians’ ability to respond quickly to agitation or dangerous behavior in dementia patients. Providers may be concerned about the narrow emergency exception, the requirement that the ordering professional be specially trained in dementia care, and the possibility of professional misconduct charges for noncompliance. Supporters would likely emphasize preventing chemical restraint and inappropriate sedation of vulnerable seniors, while opponents may argue the bill could constrain necessary clinical judgment in acute situations.

Companion Bills

NY A04296

Same As Limits the off label use of antipsychotic drugs with black box warnings on elderly patients with dementia; provides for professional misconduct for any health care professional who uses such drug on such patient.

Previously Filed As

NY A03374

Limits the off label use of antipsychotic drugs with black box warnings on elderly patients with dementia; provides for professional misconduct for any health care professional who uses such drug on such patient.

NY A04296

Limits the off label use of antipsychotic drugs with black box warnings on elderly patients with dementia; provides for professional misconduct for any health care professional who uses such drug on such patient.

RI H7278

Permits healthcare professionals to diagnose and treat patients remotely with store-and-forward technology when provision of services in such manner is consistent with the standard of care.

AZ SB1672

AHCCCS; antipsychotic drugs; authorization

TX HB2264

Relating to information provided by friends and family for inclusion into certain patients' medical records and to health care professionals' duties when discharging certain patients from inpatient care.

NY A08081

Strengthens protections for patients regarding sexual misconduct by medical providers; requires medical expert consultants involved in investigations disclose conflicts of interest and to not be under investigation, on warning, or on probation; requires a zero-tolerance policy to be adopted and training to be provided on sexual misconduct by the board for professional misconduct; includes provisions related to the right to have a chaperone; includes sexual misconduct in the definition of professional misconduct.

AZ HB2335

health professionals; patients; vaccination status

TX SB90

Relating to patient access to prescription drugs for off-label use.

MO HB1928

Creates provisions relating to immunity from liability for health care professionals who inquire about potential dangers in patients' homes

NJ S1979

Requires parents and guardians be provided access to medical records of minor patients; provides immunity to health care facilities and professionals that provide access to records.

Similar Bills

RI S0786

Prohibits prior authorization or a step therapy protocol for the prescription of a nonpreferred medication on their drug formulary used to assess or treat an enrollee's bipolar disorder, schizophrenia or schizotypal.

WI SB83

Utilization management controls for antipsychotic prescription drugs under the Medical Assistance program. (FE)

WI AB54

Utilization management controls for antipsychotic prescription drugs under the Medical Assistance program. (FE)

AZ SB1672

AHCCCS; antipsychotic drugs; authorization

MI HR0082

A resolution to declare May 5-9, 2025, as Tardive Dyskinesia Awareness Week in the state of Michigan.

NJ A2120

Requires NJ FamilyCare to reimburse inpatient providers for long-acting injectable antipsychotic drugs at outpatient reimbursement rate.

NJ S3165

Requires NJ FamilyCare to reimburse inpatient providers for long-acting injectable antipsychotic drugs at outpatient reimbursement rate.

DE SCR66

Designating The First Full Week Of May As "tardive Dyskinesia Awareness Week" In Delaware.