Understanding the Shifting Regulations on Psychedelics for the Terminally Ill

Hospice and palliative care providers can benefit from understanding federal and state laws around the use of psychedelics by serious and terminally ill patients.

Current regulations govern not only access to these substances, but the research into how patients could be affected. But any rules should include clear federal standards for this research as far as what is and is not allowed, according to Jennifer Moore Ballentine, CEO of the Coalition for Compassionate Care of California.

“There’s a lot of promise and very interesting opportunities in different controlled substances to address physical pain and symptoms, and in particular existential and spiritual suffering as well,” Ballentine told Hospice News. “But we don’t know enough yet exactly about how they work, what effective dosing or side effects are going to be. We badly need good, rigorous, approved and ethical research to guide that.”

Laws evolve around psychedelics

Some states and local governments now permit the use of some psychedelics among hospice and palliative care patients, as well as cannabis, or have decriminalized these substances.

Case in point, the town of Ferndale, Michigan, earlier this year decriminalized the recreational use of psychedelic plants and fungi such as psilocybin mushrooms, ayahuasca and the hallucinogenic Dimenthyltryptamine (DMT). This is the fourth Michigan community to enact such a policy.

Laws like these can increase access by addressing legal risks that providers face and removing financial barriers for patients, according to Dr. Michael D. Fratkin, palliative care specialist for Humboldt Center for New Growth, and founding partner and principal palliative care consultant at Fire & Water Consulting. He was previously the founder and former CEO of ResolutionCare, a palliative care company.

“There are these rules and regulations that are emerging on local, regional and state levels seeking to decriminalize structures and liberalize access to a set of plant medicine and other things for people facing the end of their life within a hospice structure,” Fratkin said. “We are in this sort of psychedelic Renaissance era of therapeutics.What’s happening now has been a long haul of education and evolving basics and fundamentals around assisted therapies. Some are very effective, others less so. But it’s ultimately giving people the choice to address the serious health aspects as they struggle in the face of mortality.”

Fratkin is a chair on American Academy of Hospice and Palliative Medicine’s “Safe Use of Psychedelic Assisted Therapy” forum and also sits on the Compassion & Choices’ health care advisory council. He is a facilitator for Drugs Over Dinner, a nonprofit education initiative around psychedelic therapies in end-of-life care and bereavement services.

We are in this sort of psychedelic Renaissance era of therapeutics. What’s happening now has been a long haul of education and evolving basics and fundamentals around assisted therapies.

—Dr. Michael D. Fratkin, palliative care specialist, Humboldt Center for New Growth and founding partner, Fire & Water Consulting

States like Oregon and Colorado have been at the forefront of changing psychedelic and cannabis policies. In 2020, Oregon essentially decriminalized the personal use of a number of drugs that remain illegal at the federal level. A law in the state also authorized the development of psilocybin service centers where adults older than 21 can consume the mushroom-derived substance under the supervision of a state-certified facilitator.

A range of plant-derived psychedelics have been decriminalized in Colorado as well, including DMT, psilocybin, ibogaine and mescaline (excluding peyote). The state will also allow psychedelic-assisted therapy for a number of conditions.

Drawing parallels with regulation and research

Regulation and research are meeting somewhere in the middle in what Fratkin dubbed a “parallel phenomenon.”

Legislators in Illinois and New Mexico are also considering bills that would permit the use of psychedelics for medical research purposes.

New Mexico approved the creation of an advisory health group that will study the feasibility of using psilocybin-derived products to treat patients with mental health conditions in a clinical setting. A similar bill in Illinois proposes to decriminalize psychedelic and hallucinogenic drug administration to treat severe or serious mental illnesses (SMIs).

Several other states are considering similar legislation, including California, New York and Washington. Some municipalities have also decriminalized certain psychedelics, such as Seattle, Washington D.C., and San Francisco.

At the federal level, Senators Cory Booker (D-N.J.) and Rand Paul (R-KY) recently introduced an updated version of the Breakthrough Therapies Act, which if enacted would expand opportunities for research and therapies using 3,4-Methyl​enedioxy​methamphetamine (MDMA) and psilocybin. A companion bill was introduced in the House by Reps. Nancy Mace (R-S.C.) and Madeleine Dean (D-Penn.).

Additionally, a new bill introduced in March by Rep. Earl Blumenauer (D-Ore.) would allow some terminally ill patients to use psilocybin and other investigational treatments.

The Right to Try Clarification Act would revise a current law that was designed to allow access to experimental treatments for dying patients who have exhausted other options. The proposed bill would add Schedule I substances that have completed phase 1 clinical studies to the list of available options.

Wider availability and a greater wealth of knowledge around these substances could go a long way in understanding their application and effectiveness in end-of-life care, according to Dr. Karl Steinberg, medical director for Hospice by the Sea.

Steinberg is also CEO of California-based Stone Mountain Medical Associates, Inc. and serves on the national advisory board for the California State University Shiley Institute for Palliative Care.

“A concern is that if they were made readily available then they could do some harm in a patient,” Steinberg told Hospice News. “What’s really important is that if a patient is being administered these substances, then there’s a medical professional there who can serve as a guide to help them monitor use. Increased availability of these could do a lot of potential good in some patients, but the concern is mainly misuse.”