Assembly Bill 48 (Chapter 794, Statutes of 2023) requires the California Department of Public Health (CDPH) to create, with input from stakeholders, a standardized consent form for obtaining informed consent for the use of a psychotherapeutic drug. CDPH held stakeholder sessions and considered all feedback and comments when developing the form. This AFL announces the release of the CDPH Psychotherapeutic Drug Informed Consent Form (PDF).
Use of the Informed Consent Form
Facilities may use the CDPH Psychotherapeutic Drug Informed Consent Form (PDF) or use their own in-house form as long as the in-house form contains all the data elements on the CDPH form. Surveyors will assess and evaluate the use of in-house forms to ensure accuracy and completeness and include the same information that is collected on the CDPH form. The form must be in use by January 1, 2026.
Renewals of Informed Consent
Facilities must renew the Informed Consent form every six months during which the resident receives a psychotherapeutic drug. Within six months after the Consent Form is signed, and every six months thereafter during which the resident receives a psychotherapeutic drug, the facility shall, using the Informed Consent form, inform the resident and, if applicable, the resident's representative, of any recommended dosage adjustments and the resident's right to revoke consent and to receive gradual dose reductions and behavioral interventions in an effort to discontinue the psychotherapeutic drug.
Applicable Facility Types
The Informed Consent form must be used in Skilled Nursing Facilities (SNFs) and Intermediate Care Facilities (ICFs).
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.
Sincerely,
Original signed by Mandi Posner
Mandi Posner
Deputy Director
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