Additionally, ASKP3 suspects patients seek treatment through
online companies partially due to a lack of insurance coverage.
HOUSTON, June 27,
2024 /PRNewswire-PRWeb/ -- Amidst increased
public interest and controversy around at-home ketamine, including
recent reports that some telehealth companies offer
self-administered subcutaneous treatment, the American Society of
Ketamine Physicians, Psychotherapists & Practitioners (ASKP3),
the largest society and think tank for ketamine practitioners, is
releasing a summary of guidelines for at-home use. The aim is to
underscore the importance of responsible treatment and emphasize
the significance of safety and proper patient selection.
ASKP3 maintains its long-standing position
that ketamine is most appropriate in medically-supervised
settings.
AT-HOME KETAMINE VIA UNSAFE DELIVERY METHODS
When administered correctly and with supervision, ketamine is
often one of the only solutions for patients suffering from chronic
suicidality, treatment resistant depression, PTSD and chronic pain.
ASKP3 maintains its long-standing position that ketamine is most
appropriate in medically-supervised settings, though we acknowledge
that there are some situations in which it may be appropriate for a
clinician to prescribe compounded oral or sublingual ketamine for
use at-home between face-to-face appointments.
However, ASKP3 has become aware of at least one telehealth
company offering liquid injectable ketamine with syringes intended
for subcutaneous delivery in unsupervised, at-home settings on an
ongoing basis. For a number of reasons, we do not feel there is
adequate evidence or research to support this practice as safe and
appropriate as at-home administration. While we do believe
subcutaneous delivery shows promise, subcutaneous injection of
ketamine can be harmful to patients, and poses substantial risk for
misuse, abuse and diversion.
Regarding potential for direct harm, current liquid ketamine
formulations have a pH that is more acidic than orange juice, and a
high osmolality that is approximately 60% of the salt content of
ocean water. Off-label injection into delicate subcutaneous tissues
can cause a sterile abscess that is painful and can last for weeks.
The lesion can even resemble a burn, with reports in the research
community that post-infusion lesions have required surgical
intervention. A consistently safe subcutaneous ketamine formulation
would need to address these issues, which is arguably one of the
reasons ketamine was never FDA approved for this route of
administration.
In addition, for long-term viability, injectable ketamine for
use at home should be delivered via a tamper resistant device that
is difficult to misuse, abuse, share or divert. Sending syringes
and liquid ketamine to patients for home use is substantially
outside of community standards and is highly risky at both the
individual and community level. This practice will undoubtedly put
patients, the community, and this important mental health movement
at risk. In addition, it presents substantial medical-legal risk
for prescribers and the companies encouraging such treatment
recommendations.
ASKP3 RECOMMENDATIONS FOR ORAL AT-HOME KETAMINE
PRESCRIPTIONS
Practice standards and ethics were produced by ASKP3 in 2020
with iterative input from more than 500 members, including some of
the world's top doctors, clinicians and therapists administering
ketamine for psychiatric and pain indications.
The following is meant to provide additional context and
recommendations based on current events and concerns. These include
best practices for: dosing, environment, delivery mechanism,
contraindications, and patient-physician communication.
TREATMENT GUIDELINES & CONTRAINDICATIONS
Patients who have previously undergone supervised, in-office
ketamine treatments and have been observed without any
complications may be potential candidates for at-home oral ketamine
therapy. However, many factors need to be considered before a
provider can make such a determination. Substance use disorders or
excessive alcohol use, psychosis, history of mania, uncontrolled
hypertension, and history of any intracranial hemorrhage or
aneurysm are relative contraindications for at-home ketamine. It is
imperative to review concomitant medications, both prescribed and
over-the-counter, and counsel patients not to combine ketamine with
alcohol or non-authorized medications or substances.
The goals of an at-home oral ketamine protocol should be clearly
defined with the patient and determined to be appropriate and
medically necessary. For example, a protocol might be initiated to
extend the benefits of in-office ketamine treatment. However,
prescribers should first explore other methods to extend the
effects of in-office ketamine treatment before at-home ketamine is
prescribed.
DELIVERY
Oral ketamine in the form of sublingual (SL) lozenges and rapid
disintegrating tablets are currently a common route of
administration (ROA) prescribed for at-home use. Oral dosing can
also be a viable ROA, especially in pain conditions where frequent
doses are often needed. SL is the most common ROA being prescribed
by telehealth companies providing ketamine prescriptions without
in-office assessment of patients and ketamine safety and efficacy.
Compared to parenteral (i.e., intravenous, intramuscular and
subcutaneous) routes of administration, oral preparations are
likely the safest and most viable option for at-home ketamine when
prescribers are seeking to balance dosing, safety and efficacy.
Even within this relatively safe ROA for treatment, however,
outlying protocols that are dangerous to patients and facilitate
drug diversion do exist. Some patients are being prescribed very
high dose SL formulations – reported in the community to be in
excess of 1200 mg/dose – with instructions to spit out the drug
after a set time period. Accidentally swallowing a full dose would
be very dangerous, even deadly, due to the extreme strengths
prescribed. In addition, easy subversion of the "hold and spit"
protocol to "hold and swallow" is an obvious way to get a more
pronounced effect from each dose, which can directly enable misuse,
abuse and diversion to the community. As such, ASKP3 believes this
is a highly risky protocol that puts both patients and the
community at risk.
PHARMACOKINETICS
Regardless of safety and efficacy, off-label, compounded forms
of oral ketamine are less researched than intravenous (IV)
ketamine, and are generally accepted as less precise and perhaps
less effective for a number of key reasons:
1. Bioavailability: Oral and sublingual ketamine has lower
bioavailability compared to IV administration. When taken by these
routes of administration, ketamine undergoes significant breakdown
in the liver, called first-pass metabolism. This reduces the amount
of active drug reaching systemic circulation.
2. Onset and Duration: Oral and sublingual ketamine are more
variable in both onset and duration compared to IV ketamine, which
is 100% bioavailable, acts quickly and is highly predictable.
3. Dosing: Because of low bioavailability and inter-person
variation in liver metabolism, high and varying doses of oral
ketamine are often required to achieve similar effects to IV
ketamine, which can increase the risk of side effects due to long
acting metabolites.
While oral and sublingual ketamine can be effective for some
conditions, particularly chronic pain and certain psychiatric
disorders, its effects are generally less potent, less durable and
less predictable than IV, IM, or intranasal ketamine and
esketamine.
ENVIRONMENT
The patients prescribed at-home ketamine should be given clear
instructions about the appropriate at-home environment and need for
secondary support. Essential considerations include not being
alone, not being responsible for the care of others (e.g. children,
elderly, the disabled), and not needing to drive for the remainder
of the day. The environment should be safe, familiar, and
comfortable, with minimal distractions and obligations. An
emergency plan should be discussed with a responsible adult who
should be present at the time of treatment.
MITIGATING ADDICTION RISK
Patients with a recent history of substance abuse should not be
prescribed an at-home ketamine protocol without a serious
risk-benefit analysis. To further mitigate risk of abuse,
physicians should start with a low dose and increase slowly only as
indicated to achieve a balance of safety and efficacy.
Prescriptions should authorize only what is needed between points
of contact or other appropriate clinical intervals. Patients should
strictly follow the dosing instructions provided by the prescriber
and not adjust dosing and frequency without discussing changes with
their treatment team.
PATIENT-PHYSICIAN COMMUNICATION
An initial consultation and risk assessment should be performed
in person. The patient should be sent home with clear instructions
regarding dose and frequency, safety considerations and guidance
regarding when treatment is appropriate. Patients should be given
instructions on safe storage to minimize diversion and to keep the
medication away from children or pets. Clinical follow-up through
various means, and the frequency of in-person follow-up
assessments, should occur in the context of an established
provider-patient relationship and meet community standards-of-care
and state guidelines for prescribing controlled substances.
A PLEA FOR INSURANCE COVERAGE
ASKP3 postulates that many patients seek treatment through
online companies, which often cost less and provide less medical
supervision and patient-physician communication than in-person
office settings, due to lack of insurance coverage for IV ketamine
infusions. This cost burden on patients creates a notable lack of
affordability and restricted access to medically supervised
ketamine infusions. Given the body of evidence supporting IV
ketamine for appropriate pain and mental health disorders, ASKP3
requests medical insurance companies examine and revise benefit
plans and initiate prior authorization processes for this important
evidence-based treatment for patients who: a) are in need of
effective treatment; b) have an appropriate psychiatric or pain
diagnosis, and; c) will be monitored during treatment by clinicians
with reasonable training and education to safely administer and
monitor treatment.
"Home use can increase access and act as an adjunct to in-office
treatments, but it does not increase equitable access to some of
our most vulnerable populations without necessary funds. Even
telehealth services are often substantially out of reach for
society's least privileged. Equitable access can only improve with
insurance coverage. ASKP3 believes that this is an appropriate next
step in the evolution of this essential treatment, which is
supported by Phase II clinical evidence confirming a high efficacy
and safety profile when used at appropriate intervals in supervised
settings," says Sandhya Prashad, MD,
Founding Member & President, ASKP3.
About ASKP3
The American Society of Ketamine Physicians, Psychotherapists,
and Practitioners (ASKP3) is a non-profit group of professionals
dedicated to the safe clinical use of ketamine for mental health
disorders and pain conditions. Formed in 2016, ASKP3 represents a
growing membership of over 500 multidisciplinary professionals with
a faculty of 35 of the world's top doctors and therapists
administering ketamine as a mental health treatment. ASKP3 stands
as the sole entity to publish practical and ethical standards for
ketamine therapy during its nascent stages.
Media Contact
Teresa Bigelow, ASKP3, 1
6462230402, teresa@spiral5.com
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SOURCE ASKP3