Ohio Admin. Code 4731-33-02 - Standards and procedures for withdrawal management for substance use disorder
(A)
A physician who provides withdrawal management, as that
term is defined in rule
4731-33-01 of the Administrative
Code, shall comply with all federal and state laws and rules applicable to
prescribing.
(B)
Prior to providing ambulatory withdrawal management for
any substance use disorder the physician shall inform the patient that
ambulatory withdrawal management alone is not complete treatment for a
substance use disorder. If the patient prefers continuing treatment for a
substance use disorder, the physician shall comply with the requirements of
section 3719.064 of the Revised
Code.
(C)
The physician shall provide accurate, objective and
complete documentation of all patient encounters, including referrals, test
results, and significant changes to the treatment plan.
(D)
When providing
withdrawal management for opioid use disorder the physician may use a medical
device that is approved by the United States food and drug administration as an
aid in the reduction of opioid withdrawal symptoms.
(E)
Ambulatory
withdrawal management for opioid use disorder.
(1)
The physician
shall provide ambulatory withdrawal management only when the following
conditions are met:
(a)
The patient has adequate social, medical, and
psychiatric stability to engage in and safely complete ambulatory withdrawal
management; and
(b)
There is little risk of medication
diversion.
(2)
The physician shall provide ambulatory withdrawal
management under a defined set of policies and procedures or medical protocols,
with patient placement in outpatient or residential settings consistent with
American society of addiction medicine's level of care criteria. Such services
are designed to treat the patient's level of clinical severity, to achieve safe
and comfortable withdrawal from a drug, and to effectively facilitate the
patient's transition into treatment and recovery. In the event that ambulatory
withdrawal management is unsafe or inappropriate for a patient, referral to a
higher level of care, such as inpatient hospitalization shall be completed. The
ASAM criteria can be obtained from the website of the American society of
addiction medicine at
https://www.asam.org/
. A copy of the ASAM criteria may be reviewed at the medical
board office, 30 East Broad street, third floor, Columbus, Ohio, during normal
business hours.
(3)
Prior to providing ambulatory withdrawal management,
the physician shall perform an assessment of the patient to gather sufficient
information and data to justify the use of this treatment intervention. The
assessment shall include a thorough medical history and physical examination
sufficient to assure safety in commencing ambulatory withdrawal management and
shall include a review of the patient's prescription history in OARRS. The
assessment must focus on signs and symptoms associated with opioid use disorder
and include assessment with a nationally recognized scale, such as one of the
following:
(a)
"Objective Opioid Withdrawal Scale" (OOWS);
(b)
"Clinical Opioid
Withdrawal Scale" (COWS); or
(c)
"Subjective
Opioid Withdrawal Scale" (SOWS).
(4)
If any part of
the assessment cannot be completed prior to the initiation of treatment, the
physician shall complete as soon as possible following initiation of
treatment.
(5)
The physician shall inform the patient about the
following before treatment for opioid withdrawal is initiated:
(a)
The withdrawal
management process and importance of subsequent treatment for substance use
disorder, including information about all medications approved by the United
States food and drug administration for use in MOUD treatment;
(b)
The risk of
relapse and lethal overdose following completion of withdrawal without entry
into continuation of MOUD treatment;
(c)
The safe storage
and disposal of prescribed medications.
(6)
The physician
shall not establish standardized regimens of medications for management of
substance withdrawal symptomatology but shall formulate an individualized
treatment plan based on the needs of the specific patient.
(7)
For persons
projected to be involved in withdrawal management for six months or less, the
physician shall offer the patient counseling as described in paragraph (D) of
rule 4731-33-03 of the Administrative
Code.
(8)
The physician shall require the patient to undergo
urine and/or other toxicological screenings during withdrawal management in
order to assess for use of licit and/or illicit drugs. The physician shall
consider revising the treatment plan or referring a patient who has a positive
toxicological screening result to a higher level of care.
(9)
The physician
shall comply with the following requirements for the use of medication:
(a)
The physician may
treat the patient's withdrawal symptoms with any of the following medications
as determined to be most appropriate for the patient.
(i)
A medication that
is specifically FDA approved for the alleviation of withdrawal symptoms.
Methadone may only be utilized with strict adherence to the stipulations of
21 C.F.R.
1306.07(b).
(ii)
An alpha-2
adrenergic agent along with other non-narcotic medications as recommended in
the American society of addiction medicine's "National Practice Guideline"
(https://www.asam.org/
), which is available on the medical board's website
at:
https://www.med.ohio.gov
;
(iii)
A combination of buprenorphine and low dose naloxone
(buprenorphine/naloxone combination product), unless contraindicated, in which
case buprenorphine mono-product may be utilized.
(b)
The physician
shall not use anesthetic agents to treat the patient's withdrawal
symptoms.
(c)
The physician shall comply with the following:
(i)
Treatment with a
buprenorphine product must be in compliance with the United States food and
drug administration approved "Risk Evaluation and Mitigation Strategy" for
buprenorphine products, which can be found on the United States food and drug
administration website at the following address:
https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm
.
(ii)
The physician shall determine on an individualized
basis the appropriate dosage of medication to ensure stabilization during
withdrawal management.
(a)
The dosage level shall be that which is effective in
suppressing withdrawal symptoms and is well tolerated by the
patient.
(b)
The dosage level shall be consistent with the currently
accepted standards of care.
(iii)
In withdrawal
management programs of thirty days or less duration, the physician shall not
prescribe nor dispense more than one week of unsupervised or take-home
medications for the patient.
(10)
The physician
shall offer the patient a prescription for an overdose reversal drug, directly
provide them with the overdose reversal drug, or direct the patient to an
easily accessible source to obtain the overdose reversal drug, such as
http://www.naloxone.ohio.gov
, a local health department, or other agency or facility
that provides overdose reversal drugs.
(a)
The physician
shall ensure that the patient and, if possible, those residing with the patient
receive instruction on the drug's use including, but not limited to,
recognizing the signs and symptoms of opioid overdose and calling 911 in an
overdose situation.
(b)
The physician shall offer the patient a new
prescription for an overdose reversal drug upon expiration or
use.
(c)
The physician shall be exempt from this requirement if
the patient refuses the prescription. If the patient refuses the prescription
the physician shall provide the patient with information on where to obtain the
overdose reversal drug without a prescription.
(11)
The physician
shall take steps to reduce the risk of medication diversion by doing one or
more of the following: frequent office visits, pill counts, urine drug
screening, and frequent checks of OARRS.
(F)
The physician who
provides ambulatory withdrawal management for benzodiazepines or other
sedatives shall comply with paragraphs (A), (B), and (C) of this rule and "TIP
45, A Treatment Improvement Protocol for Detoxification and Substance Abuse
Treatment" by the substance abuse and mental health services administration
available from the substance abuse and mental health services administration
website at the following link:
https://store.samhsa.gov/
(search for "TIP 45") and available on the medical
board's website at:
https://med.ohio.gov
.
(1)
The physician shall provide ambulatory withdrawal
management for benzodiazepines with medication only when a patient has
sufficient social, medical, and psychiatric stability when their use of
benzodiazepines was primarily in therapeutic dose ranges and when they do not
have polysubstance dependence. The patient should exhibit no more than mild to
moderate withdrawal symptoms, have no comorbid medical condition or severe
psychiatric disorder, and no history of withdrawal seizures or withdrawal
delirium.
(2)
Prior to providing ambulatory withdrawal management,
the physician shall perform an assessment of the patient that focuses on signs
and symptoms associated with benzodiazepine or other sedative use disorder and
include assessment with a nationally recognized scale, such as the "Clinical
Institute Withdrawal Assessment for Benzodiazepines"
("CIWA-B").
(3)
Prior to providing ambulatory withdrawal management,
the physician shall conduct a biomedical and psychosocial evaluation of the
patient to gather sufficient information and data to justify the use of this
treatment intervention.
(4)
The physician shall instruct the patient about the
following before treatment for benzodiazepine withdrawal management is
initiated:
(a)
Not to drive or operate dangerous machinery during
treatment;
(b)
The withdrawal management process and importance of
subsequent treatment for substance use disorder, including information about
all medications approved by the United States food and drug administration for
use in substance use disorder treatment;
(c)
The risk of
relapse and lethal overdose following completion of withdrawal without entry
into continuation of treatment for substance use disorder; and
(d)
The safe storage
and disposal of prescribed medications.
(5)
During the
ambulatory withdrawal management, the physician shall regularly assess the
patient so that medication dosage can be adjusted if needed.
(a)
The physician
shall require the patient to undergo urine and/or other toxicological
screenings during withdrawal management in order to assess for the use of licit
and/or illicit drugs.
(b)
The physician shall consider revising the treatment
plan or referring the patient who has a positive toxicology screening to a
higher level of care.
(c)
The physician shall take steps to reduce the risk of
diversion by doing one or more of the following: frequent office visits, pill
counts, urine drug screening and frequent checks of OARRS.
(G)
The physician who provides ambulatory withdrawal
management for withdrawal from alcohol shall comply with paragraphs (A), (B),
and (C) of this rule and "Clinical Practice Guideline on Alcohol Withdrawal
Management" by the American society of addiction medicine available from the
American society of addiction medicine website at the following link:
https://www.asam.org/quality-care/clinical-guidelines/alcohol-withdrawal-management-guideline.
(1)
The physician
shall provide ambulatory withdrawal from alcohol only when:
(a)
The patient has
sufficient social, medical, and psychiatric stability to adhere to prescribed
treatments and successfully complete withdrawal with minimal risk of
complications;
(b)
The patient is not at risk for serious withdrawal from
substances other than alcohol; and
(c)
The patient has
no history of withdrawal seizures or withdrawal delirium.
(2)
Prior
to providing ambulatory withdrawal management, the physician shall perform an
assessment of the patient. The assessment must focus on signs and symptoms
associated with alcohol use disorder and include assessment with a nationally
recognized scale, such as the "Clinical Institute Withdrawal Assessment for
Alcohol-revised" ("CIWA-AR").
(3)
Prior to
providing ambulatory withdrawal management, the physician shall perform a
biomedical and psychosocial evaluation to gather sufficient information and
data to justify the use of this treatment intervention.
(4)
During the
ambulatory withdrawal management, the physician shall regularly assess the
patient so that the dosage can be adjusted if needed.
(a)
The physician
shall require the patient to undergo toxicological screenings in order to
assess for the presence of alcohol metabolites, licit or illicit
drugs;
(b)
The physician shall consider revising the treatment
plan or referring a patient who has a positive toxicological screening test to
a higher level of care; and
(c)
The physician
shall take steps to reduce the risk of diversion by doing one or more of the
following: frequent office visits, pill counts, urine drug screening and
frequent checks of OARRS.
Replaces: 4731-33-02
Notes
Promulgated Under: 119.03
Statutory Authority: 4731.05, 4731.056
Rule Amplifies: 4731.056, 4731.83
Prior Effective Dates: 10/31/2020
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