In the last 15 years of my career, I worked as a physician and medical director exclusively in the SNF setting. When the National Partnership to Improve Dementia Care went live in 2012, as a CALTCM board member, I joined the California Partnership to Improve Dementia Care, where I have continued to serve even after retiring from full time practice at the end of 2020. That partnership developed a model informed consent form in 2015 for use in older adults with dementia and psychosis living in SNFs (attached).  With the approval of brexipiprazole (Rexulti) in 2023, this form is out of date.  A new form is expected in 2025 when CDPH completes its informed consent tool kit for psychotropic medications in SNFs.  

This year, I assumed an Interim Position for a local PACE (Program for All Inclusive Care of the Elderly) program while their medical director is on childbirth leave. Our participants live in home and community-based settings where state and federal regulations for the use of antipsychotics do not require informed consent. Serious mental illness and or dementia with BPSD (Behavioral and Psychological Symptoms-Manifestations of Dementia) are common in our participants. Recently, I saw a patient who has bipolar disorder with hypomania who has persistently refused medications for her hypomania and consultation with our geropsychiatrist. Over time, our PACE program has helped her through several crises and has gained her trust. In a recent visit, I recommended a low dose of an antipsychotic that she had not previously taken. She asked me if I would prescribe it for my mother (deceased years ago) and on reflection, I said I would. In retrospect, I should have obtained informed consent, but felt so strongly this was the right medication at this time for her, that I did not do so. 

I subsequently completed mandatory risk reduction training from my liability carrier and discovered that they believe the SOC (Standard of Care) requires obtaining informed consent when prescribing antipsychotics in all settings of care. On reflection, this makes good sense, as I see so many of my participants in the outpatient setting now on multiple psychotropic meds. In fact, some participants who we have tapered off these medications have had dramatic improvement in function, quality of life, and probably life expectancy. I credit our supportive interdisciplinary team and activity center to which we provide transportation and valuable exercise, activities, hygiene, med management, and social programs. 

I wonder if the black box warning for all first- and second-generation antipsychotics is too narrow. It focuses on the increased risk of dying in older adults with dementia and psychosis, but only attributes this risk to cardiovascular events and infections (pneumonia). 

In the February 20, 2024, BMJ (British Medical Journal), investigators compared the outcomes for adults > 50 y/o with a diagnosis of dementia and new antipsychotic use, who were matched with up to 15 non-users using incident density mapping. The years of the British Health system surveyed were January 1998 through May 2018. Of the 35,339 new users within the first 90 days, they noted a significant increased risk for pneumonia, acute kidney injury, venous thromboembolism, stroke, fracture, myocardial infarction, and heart failure. Pneumonia had a twofold higher risk with an NNT (Number Needed to Treat) of 9.  This sobering article is open source at: https://www.bmj.com/content/385/bmj-2023-076268

Going forward, I plan to provide informed consent for older adults with dementia and their decision-makers in the home and community settings, and for those with approved antipsychotic indications. The risks are too high for me to assume that I know what is best for potential candidates for this class of medications. 

Referenced Example Informed Consent Form