Palliative care providers face a host of legal and regulatory challenges when seeking to expand patients’ access to certain controlled substances. Providing therapeutic- and medically-guided patient experiences involves a deep understanding of compliance with evolving laws and safe utilization.
Drugs that fall into the realm of federally controlled substances include cannabis, ketamine, MDMA and psychedelics such as psilocybin and LSD, among others.
Much legal, ethical and logistical consideration goes into whether these drugs can be utilized for medicinal and symptom relief purposes, according to Kelsey Hanley-Kollar, senior project manager at Allay Consulting. The consulting company provides guidance around compliance with cannabis and psychedelic product utilization rules. Quality, efficacy and accessibility are additional factors in what is often viewed as a slow-moving regulatory process, Hanley-Kollar stated.
“It’s making sure that your product is safe and that regulations are created for licensing, traceability and dosing,” Hanley-Kollar told Palliative Care News. “There needs to be some type of oversight so that even from a caregiver perspective someone without a medical background can have confidence in providing products to patients and knowing exactly what’s in it and what dosage is safe. It’s understanding that the patient is in a very vulnerable state of being.”
Current law and regulation
Palliative providers that are interested in psychedelic-assisted therapies need to be aware of the local laws within their areas, said Dr. Carlo Reyes, immediate past president at Ventura County Medical Association and a member of the Ventura County Coalition for Compassionate Care’s steering committee. Reyes is also founder and CEO of the nonprofit Health-e-Charity and an attorney at the California-based law firm Schaeffer Cota Rosen LLP.
Ensuring safe, quality patient experiences is among the leading priorities for policy makers, according to Reyes.
“During the altered state … the psychotherapist serves as ‘facilitator’ or ‘guide’ to ensure a safe, supportive space,” Reyes told Palliative Care News in an email. “It is this guided experience combined with the psychedelic experience that leads to clinically positive outcomes.”
Some states and the federal government have considered legislation that would establish a “right to try” psychedelics and other experimental interventions for certain seriously ill patients.
Most recent data available show that 41 states have adopted some type of laws permitting the use of “investigational drugs” since the passing of the Right to Try Act of 2017, as has Congress. These laws allow patients with serious or terminal illnesses to utilize drugs prior to approval by the U.S. Food & Drug Administration (FDA) and those that are “off-label” or unapproved, that have gone through clinical trial studies.
The FDA in 2022 published a final rule, Annual Summary Reporting Requirements Under the Right to Try Act, which established statutes for manufacturers and sponsors of eligible investigational drugs to submit yearly data on dosages supplied and the number of patients treated. The final rule also featured provisions for content submission including the use for which a drug was available and any known adverse events associated with it.
Navigating the differences between federal and state right-to-try laws can be challenging for palliative care providers seeking to help guide patients through these therapeutic experiences.
An important consideration for palliative care providers to understand is determining the patient eligibility requirements, according to CDER Trade Press, part of the FDA.
“The Right to Try Act is one way for eligible patients who have been diagnosed with life-threatening diseases or conditions who have exhausted approved treatment options and who are unable to participate in a clinical trial to access certain investigational drugs,” a spokesperson told Palliative Care News in an email.
Psilocybin is among the substances potentially eligible to fall within the scope of investigational drugs. Among the FDA eligibility requirements is a stipulation that a drug must undergo phase 1 clinical trial testing. To date, roughly 48 psilocybin clinical trial studies have been completed nationwide, while 57 studies are actively recruiting participants, according to the most recent data from the National Library of Medicine’s National Center for Biotechnology Information.
Rep. Earl Blumenauer (D-Oregon) last year introduced the Right to Try Clarification Act, which would have allowed some end-of-life patients to use psilocybin and other investigational treatments. The proposed bill would add Schedule I substances that have completed phase 1 clinical studies to the list of available right-to-try options. Sen. Cory Booker (D-New Jersey) introduced a similar bill in the Senate, but neither passed.
Policy makers need a wide view when trying to establish laws that balance patients’ eligibility, dosing guidelines and patients’ goals of care and safety, according to Hanley-Kollar. Determining eligibility involves assessing (and reassessing) a patient’s individualized goals and intentions for utilization of a substance such as psychedelics and cannabis, she stated.
Designing cost-setting structures also represent a significant piece of the regulatory equation, Hanley-Kollar added.
Operational expenses can include interdisciplinary care teams navigating the patient’s therapeutic experience, while production and quality oversight costs also factor in. This can result in high costs that are not covered by traditional palliative care payment avenues in the Medicaid and Medicare reimbursement system. Cost can be a barrier, with some patients having greater potential to afford psychedelic utilization compared to others with lower economic status, according Hanley-Kollar.
“It’s having oversight of what is the intent of their experience and pairing that with the patient,” she said. “Caregivers and [palliative] providers really need to dial-in on that intent, and dosage plays a huge role in measuring someone’s experience. Having that potency on paper tied to a batch of a certain product is very important. Additionally, there are so many different hands that touch a product that it adds a lot of cost. So by the time it gets to the consumer it can be expensive, and then you’re not making it accessible to everyone.”
Widening accessibility
More types of psychedelic drugs are becoming accessible through a “patchwork” of state legislative reforms, according to research published in the Journal of the American Medical Association (JAMA) Psychiatry. About 25 states have considered some form of legislation related to psychedelic utilization, the research found. The number of psychedelic reform bills introduced on a year-over-year basis has climbed steadily since 2019, with some laws also increasingly focusing on MDMA and cannabis as well.
Many of these laws focus on decriminalization, with only 35% pointing to medical oversight, training and licensure requirements, according to the findings. This trend necessitates greater consensus of standardized treatment models, education and guidance for health care providers, as well as planning for implementation and regulation, the researchers stated.
Palliative care providers can impact change when it comes to evolving current regulatory frameworks around right-to-try laws, said Gaetano (Guy) Lardieri, special executive advisor at Future Entheogenic Medicines. One way is by participating in clinical trials and adding to the mounting volume of evidence supporting how these investigational drugs can help address patients’ unmet needs.
Lardieri is also the New Jersey state director at Minorities for Medical Marijuana and serves on the advisory board of The JUSTÜS Foundation. He is a clinical researcher in cancer, autism, cannabis, psychedelics and hemp, among other areas.
“Providers can refer eligible patients to clinical trials or research studies for controlled substances like MDMA or psilocybin, which are undergoing FDA-approved research for PTSD, depression or anxiety,” Lardieri told Palliative Care News in an email “Research participation allows safe, legal access under controlled conditions. Participating in clinical trials is particularly critical when demand for controlled substances grows, and patient requests must be balanced with legal frameworks and medical ethics.”
Legal and liability concerns can complicate access to treatment, Lardieri added. Consulting with legal and regulatory experts to ensure compliance with local and federal regulations is a key component of clinical trial participation, he said.
Detailed documentation and ongoing patient monitoring are other significant pieces of compliance. Tracking patients’ symptoms, goals and outcomes allows for transparency and accountability and the opportunity to set ethical guidelines around therapeutic palliative utilization, according to Lardieri.
Palliative patients’ access to investigational drugs in large part hinges on the availability of quality products and experts that understand the broad range of potential side effects, said Christine Caldwell, founder and executive director at End of Life Psychedelic Care. The nonprofit advocacy group focuses on including death doulas on psychedelic care teams and offers educational programs for these professionals.
The organization recently launched an end-of-life professional care directory, intended to be a resource for individuals with terminal and serious illnesses seeking psychedelic therapy assistance. Rising demand and interest in these therapies drove the directory’s unveiling, which is intended to help patients find the right provider to align with their goals of care, according to Caldwell. Patients can search by location and drug type, as well as by interdisciplinary clinical and nonclinical professionals in end-of-life and serious illness care.
“We’re trying to help people explore the potential and make an informed decision,” Caldwell told Palliative Care News. “Interest is just burgeoning and people desperately want medical and interdisciplinary professionals that really know about facilitating [experiences]. For a palliative or hospice care organization, it’s learning more to expand help for their patients.”
Patients who are approved for utilization under right-to-try laws are often those with severe agitation and chronic pain, Caldwell indicated.
However, current laws do not sufficiently explore the potential benefits of these investigational drugs when it comes to existential distress – an aspect of utilization consideration in which palliative care providers can contribute, she stated.
“I think we’ll see more palliative and hospice organizations supporting things like ketamine, psychedelics and MDMA when it comes to more than pain, but for psychological and existential distress,” Caldwell said. “But they’re going to have to wait for wider federal approval and results from clinical trials showing great efficacy across the board.”
Psychedelic-assisted therapy has a unique role in the realm of palliative care delivery, Reyes stated. These guided treatments have the potential to create lasting changes lasting behavioral and psychological changes in patients, he stated.
Palliative care providers may see rising interest among patients as researchers dig deeper into the impacts, Reyes indicated.
“Psychedelic-assisted therapy has the potential to become the preferred modality to address the existential suffering individuals experience upon learning of a life-limiting diagnosis, and can be initiated as an early intervention in palliative care, as a means to clarify one’s values to help determine their goals of care moving forward,” he said.
