Very few new regulations in nursing homes have anything to do with physicians or medical directors.  The new written informed consent regulation for California facilities is an exception.  On January 1, 2024, AB 48 became law at Health & Safety Code (HSC) §1599.1 and 1599.15 and raises the requirements prior to clinicians prescribing and facilities administering psychoactive medications. 

Under the new regulation, psychotherapeutic drugs are defined as “a drug to control behavior or to treat thought disorder processes, excluding antidepressants.” Informed consent must be documented on a standardized form that includes all required elements and must be signed by the clinician and the person consenting. But there have been questions about what drugs and indications are covered by the new law and how their consent should be handled if not on the CDPH form. 

CALTCM hosted an educational forum on the new law on January 28, 2026.  The session was attended by 167 participants, one of the most popular sessions hosted by CALTCM since the pandemic. The session was hosted by an expert panel and joined by three Directors of Nursing who shared their experience and expertise on this topic. In that webinar, we highlighted terminologies on “off-label” medication use, FDA approval, and use of intramuscular psychotherapeutic medications. We have heard from our members that many questions remain about what medications are covered by the regulations and new form, and about the requirement set in CDPH in AFL 25.38.1 for obtaining a new form every six months.   

We recognize the potential burden on clinicians and nursing staff posed by the new regulation.  Nursing home clinicians’ and staff time is a valuable resource.  CALTCM is committed to helping facilities not just be compliant but also provide person-centered care.  

To provide expert consensus and guidance on how to interpret this new law, we are holding another webinar on the topic on Wednesday, March 25, 2026.  This Webinar will review expert consensus on “what goes on the form” by reviewing definitions of "thought disorder” and “control behavior.”  As a preview: Thought disorders consist of “psychotic disorders” that are manifested by a “loss of touch with reality”, most commonly sensory or perceptual disturbances such as hallucinations, and fixed false beliefs such as delusions.  However, disorganized speech patterns as behaviors are also considered part of thought disorders (especially in schizophrenia).  Commonly accepted thought disorders included schizophrenia, schizoaffective disorder, bipolar disorders with psychotic features, major depressive disorders with psychotic features, and unspecified psychosis. Psychotic disorders can also occur as part of Major Neurocognitive Disorders (Dementias), but the majority of those with dementia do not have a thought disorder. What the law means by "controlling" behavior will also be discussed and how this relates to the legal definitions of chemical restraints.  Practical strategies for implementing this new regulation, including the requirement to re-do all applicable old consents by April 1, 2026 will also be discussed.

Please join us for the next CALTCM webinar on Wednesday, March 25, 2026 at 12:00 - 1:00pm Pacific, details below.  We will hear from content experts on which medications, diagnoses, and syndromes are covered by the regulation. They will review what might be a common-sense, efficient, person-centered practice that meets the new regulations in HSC §1599.1 and 1599.15. 

CALTCM believes the best way for us to meet the purpose of the law and the needs of those we serve is for us, the providers, to set the standards and agree on best practices.  To date, we have not been made aware of any facility receiving a deficiency related to these new informed consent requirements. A group of CALTCM clinicians and pharmacists have created a consensus statement to address questions arising from the new law from a clinical and practical perspective. 

If anyone in your facility has asked, “What orders have to go on the new consent form?” then you need to attend this meeting. With your involvement, we will make this complex, challenging process as clear and simple as possible for our overworked staff. If you have ever felt helpless and overwhelmed by all the changes in our industry, now is a great time to get involved. We welcome your contribution to this initiative.  This is an opportunity to participate and voice your insights to drive “standard-of-care” conversations and maintain compliance with the new law.

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