Innovations-Magazine-February-2023 - 4

POLICY PERSPECTIVES
As States Begin to Legalize 'Magic' Mushroom Use, Boards of
Pharmacy and Pharmacists Should Stay Alert and Informed
Starting January 2, 2023, the Oregon
Carly Helman, JD
Faegre Drinker Biddle
& Reath LLP
Jonathan A. Keller,
PharmD, JD, RPh, Faegre
Drinker Biddle & Reath LLP
Psilocybin, a hallucinogenic substance
derived from a variety of different naturally
occurring mushrooms, has been a part
of shamanic medicine and spirituality
for Aztec and Mazatec communities in
Mexico for centuries. However, psilocybin,
more commonly known as " magic "
mushrooms, only came to public awareness
in the United States during the 1950s,
growing to particular notoriety during the
counterculture movement of the 1960s. In
recent years, research, discussion, and use
of psilocybin as a legitimate therapeutic
treatment tool has been on the rise in the
US. From new federally funded psychedelic
drug studies to state legalization of
psilocybin, and potential Food and Drug
Administration (FDA)-approved psilocybinand
MDMA-based drugs on the horizon,
now is the time for pharmacists and the
boards of pharmacy to take note of the
increasing body of research on the topic of
psychedelic drugs.
The Patchwork of State
(and Municipal) Laws
Prior to May 2019, there were no US cities
or states that allowed the use of psilocybin.
Just under four years later in January 2023,
the use of psilocybin was decriminalized or
deprioritized in 14 cities, two states (Colorado
and Oregon), and the District of Columbia.
In addition, cities and counties in California,
Massachusetts, Michigan, and Washington
have decriminalized some combination of
possession, distribution, manufacturing, and
use of psilocybin. In addition to decriminalizing
2 | FEBRUARY 2023
psilocybin, both Colorado and Oregon are
in the process of legalizing its use under
tightly controlled circumstances. Unlike
decriminalization, legalization would provide a
regulatory framework for Colorado and Oregon
residents to openly manufacture, transport,
sell, purchase, and use psilocybin products and
services.
Although legalization in Colorado is not
expected to become effective until at least
2024, Oregon's legalization statute went into
effect on January 2, 2023, after more than
two years spent building out the necessary
regulatory framework.
The Oregon Model
As neither Oregon, nor any other state,
has fully implemented a law legalizing and
regulating psilocybin use, it is difficult
to predict what issues may arise and how
effective state regulation will be in curbing
potential risks to individual users. However,
both pharmacists and state boards of
pharmacy should familiarize themselves with
Oregon's blueprint for regulation, seek to
understand the positive and negative effects of
psilocybin therapies, and consider how they
may get caught up in the legalization process
as more Oregonians gain access to psilocybin.
In an effort to understand how Oregon's
legalization of psilocybin may unfold, there
is a temptation to draw comparisons to the
recent wave of state recreational marijuana
laws. However, Oregon's legalization
model (and early indications of Colorado's
planned model) looks very different than the
legalization of recreational, or even medicinal,
marijuana. Unlike Oregon's 2015 rollout
of recreational marijuana, residents will not
be allowed to purchase psilocybin from a
dispensary and use the product at their leisure.
Instead, both the sale and use of psilocybin
will be circumscribed to state-licensed service
centers, staffed by state-licensed facilitators
who are responsible for supervising all
on-premises uses of psilocybin. Any use of
psilocybin outside a service center will remain
illegal, though decriminalized.
Psilocybin Services, a division within the
Oregon Health Authority, began accepting
licenses for service centers (and service center
employees) planning to sell psilocybin and
supervise its use. The psilocybin service
center is the most critical part of Oregon's
legalization model. In order to obtain a
license, the Oregon Psilocybin Services
requires all service centers to be run by a
state-licensed operator and staffed by statelicensed
facilitators.
The Oregon Psilocybin Services
mandates that service centers provide a
" preparation session " before administering
psilocybin, a supervised " administration
session " at the service center where the
client uses the psilocybin and experiences
a guided therapeutic process, and, finally,
an optional " integration session " following
the administration session. Each of these
sessions are overseen by a licensed and
trained facilitator, who must satisfy certain
minimum education requirements related to
patient safety, use and misuse of psilocybin,
psilocybin dosing, and other relevant topics.
Prior to using psilocybin, prospective
clients will engage in a preparation session
and complete and sign a client information
form. The preparation session will determine
whether the prospective client is a good
candidate for psilocybin use, including
identifying any known risk factors,
contraindicated medication, and psychological
instability. The client information form
will record a client's medical conditions and
medications, as well as provide the prospective
client with a disclosure of known health risks
associated with psilocybin use.
During psilocybin use, the client is
supervised by a facilitator trained to guide the
client through a psilocybin " trip, " identify
any complications during the trip, and use
appropriate methods to mitigate risk as it may
arise. The facilitator will also be responsible
for determining when the client is no longer
under the influence of the drug and is safe to
return home, either assisted or unassisted.
Innovations-Magazine-February-2023

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