Passage of AB 48, effective 1/1/2024, codifies current regulations related to a resident’s right to be free from psychotherapeutic drugs (used to control behavior or to treat thought disorder process, excluding antidepressants) when used for the purpose of resident discipline or staff convenience and to be free from psychotherapeutic drugs when used as a chemical restraint (used to control behavior and used in a manner not required to treat the resident’s medical symptoms) and, to provide informed consent before treatment with psychotherapeutic drugs and clarifies applicable federal regulations.

This updates HSC §1599.1(i)(2):

The SNF is required to obtain written informed consent and specifies that the disclosure of material information for proper informed consent for a prescription for psychotherapeutic drugs must include:

Possible nonpharmacologic approaches that could address the resident's needs.

Whether the drug has a current boxed warning label along with a summary of, and information about how to find, the contraindications, warnings, and precautions required by the FDA.

Whether the proposed drug is being prescribed for a purpose that has or has not been approved by the FDA.

Possible interactions with other drugs the resident is receiving.

How the facility and prescriber will monitor and respond to any adverse side effects and inform the resident of side effects.

SNFs must renew the written informed consent every six months and provide the resident with any recommended dosage adjustments and the option of revoking consent. If the resident decides to discontinue using the drug, the prescriber is responsible for planning any necessary, gradual dose reduction, as well as possible behavioral interventions.

The prescriber must personally examine (can be done using remote technology) the resident and obtained inform consent along with the signature of the health care professional declaring that the required material information has been provided (in a language they understand and in an accessible format the resident can understand).

SNF Policies and Procedures must be reviewed and revised to ensure compliance with the new law and specifically consider and plan for how the facility will verify that the resident provided informed consent or refused treatment or a procedure pertaining to the administration of psychotherapeutic drugs.

SNFs must also follow the appeal process provided in Title 42 CFR section 483.204 in the event of an appeal for an involuntary transfer or discharge, regardless of a resident's payment source or the Medi-Cal or Medicare certification status.

AFLs from 2009, 2011, 2012 and 2014 on informed consent remain in effect, AFL 09-12; 11-08; 11-31; 12-56; and 14-11.

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