Effective January 1, 2024, AB 48 codifies existing regulations that state residents have the right to be free of psychotherapeutic drugs when used for the purpose of resident discipline or staff convenience and to be free from psychotherapeutic drugs used as a chemical restraint. CDPH has the authority to implement, clarify and make specific this law by means of an AFL.

Definitions

“Chemical restraint" is a drug used to control behavior and used in a manner not required to treat the resident's medical symptoms.

“Psychotherapeutic drug" is a drug to control behavior or to treat thought disorder processes, excluding antidepressants.

Informed Consent Existing Requirements

Facilities are subject to AB 48's requirements, summarized below, effective January 1, 2024. As summarized below, AB 48's amendments to Health and Safety Code section 1599.15 requires the continuation of certain existing requirements and establishes new requirements when prescribing a resident, a psychotherapeutic drug:

• The prescriber must conduct a personal examination of the resident and obtain written consent from the resident or the resident's representative.
• The prescriber must share the material information a reasonable person in the resident's condition and circumstances would consider necessary for the resident or representative to make a decision about the treatment.
• ​Material information that the provider shall provide includes but is not limited to:
• ​​​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 United States Food and Drug Administration (FDA).
• ​Whether the proposed drug is being prescribed for a purpose that has or has not been approved by the United States 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.
• ​​​All communications and forms should be in a language the resident understands and in an accessible format for those with hearing or vision impairments. 
  
• The facility must document the informed consent and have policies and procedures on how to obtain and document proper informed consent, including for psychotherapeutic drugs. (Cal. Code Regs. tit. 22, §§ 72527, 72528, 73523, 73524.)
• The facility must check the medical record for proper informed consent prior to an initial administration. (Cal. Code Regs. tit. 22, §§ 72528, 73524.)
• The facility must review the resident’s medications on a regular basis. For SNFs, a pharmacist shall review the resident’s drug regimen at least monthly. For ICFs, a registered nurse or a pharmacist shall review each resident's medications monthly, and as needed by the physician. (Cal. Code Regs. tit. 22, §§ 73313, 72375.) 
  
• Residents may revoke consent at any time for any reason. ​
  

Standardized Written Informed Consent Form Development

CDPH in consultation with stakeholders will begin developing a standardized informed consent form specifically for psychotherapeutic drugs. CDPH must distribute the form on or before December 31, 2025.

Once CDPH publishes the final written consent form, facility staff shall verify that the resident's health record contains the standardized form and all of the required signatures before initiating treatment with psychotherapeutic drugs.

The resident or the resident's representative, and a health care professional who declares the resident or resident representative has been provided with the material information, must sign the form. If the signature of the resident or resident's representative cannot be obtained, a licensed nurse must sign the consent. The nurse must verify that they confirmed proper informed consent and record the name of the person who provided the consent and the date. The facility must provide copies of the signed consent form to both the resident and their representative. Electronic signatures are acceptable.

Every six months from the initial consent date, the facility must give the resident or their representative a written notice including any dosage changes and remind residents or their representative that they have the right to revoke consent for the psychotherapeutic drug at any time, for any reason. The notice must offer the resident or their representative the option of gradual dose reductions and behavioral interventions.

CDPH survey teams will confirm that all facilities are using the standardized form, obtaining the required signatures, recording the form in the resident's medical record, and notifying the resident every six months about dosages and possible behavioral interventions as alternatives to psychotherapeutic drugs. ​

Updates to Federal Regulations for SNFs, ICFs, and Hospice Facilities

AB 48 updated references to federal regulations found in HSC section 1599.1(i). The updated references align with the 2017 version of Title 42 of the Code of Federal Regulations (CFR).

Additionally, all residents of SNFs, ICFs, and hospice facilities have the right to 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.

Facilities are responsible for following all applicable laws. CDPH's failure to expressly notify facilities of statutory or regulatory requirements does not relieve facilities of their responsibility for following all laws and regulations. Facilities should refer to the full text of all applicable sections of the HSC and Title 22 of the CCR.

If you have any questions about this AFL, please contact your local district office.

If you have questions about the development of the standardized form, please contact the CHCQ Regulation Development Section at CHCQRegulations@cdph.ca.gov. 

Resources:

• AFL 09-12 Informed Consent for Antipsychotic Medication
• AFL 11-08 Informed Consent
• AFL 11-31 Questions and Answers about Informed Consent
• AFL 12-56 California Forging Major Campaign to Improve Dementia Care and Reduce Unnecessary Antipsychotic Drug Use in Nursing Homes
• AFL 14-11 Informed Consent – Physician Assistants