(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, including holding a "DATA 2000" waiver to prescribe
buprenorphine if buprenorphine is to be prescribed for withdrawal management in
a medical office, public sector clinic, or urgent care
facility.
(B)
Prior to providing ambulatory detoxification, as that
term is defined in rule
4731-33-01 of the
Administrative Code, for any substance use disorder the physician shall inform
the patient that ambulatory detoxification alone is not substance abuse
treatment. If the patient prefers substance abuse treatment, the physician
shall comply with the requirements of section
3719.064 of the Revised Code, by
completing all of the following actions:
(1)
Both orally and
in writing, give the patient information about all drugs approved by the U.S.
food and drug administration for use in medication-assisted treatment,
including withdrawal management. That information was given shall be documented
in the patient's medical record.
(2)
If the patient
agrees to enter opioid treatment and the physician determines that such
treatment is clinically appropriate, the physician shall refer the patient to
an opioid treatment program licensed or certified by the Ohio department of
mental health and addiction services to provide such treatment or to a
physician, physician assistant, or advanced practice registered nurse who
provides treatment using Naltrexone or who holds the DATA 2000 waiver to
provide office-based treatment for opioid use disorder. The name of the
program, physician, physician assistant, or advanced practice registered nurse
to whom the patient was referred, and the date of the referral shall be
documented in the patient record.
(C)
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.
(D)
Ambulatory
detoxification for opioid addiction.
(1)
The physician shall provide ambulatory detoxification
only when all of the following conditions are met:
(a)
A positive and
helpful support network is available to the patient.
(b)
The patient has a
high likelihood of treatment adherence and retention in
treatment.
(c)
There is little risk of medication
diversion.
(2)
The physician shall provide ambulatory detoxification
under a defined set of policies and procedures or medical protocols consistent
with American Society of Addiction Medicine's Level I-D or II-D level of care,
under which services are designed to treat the patient's level of clinical
severity, to achieve safe and comfortable withdrawal from a mood-altering drug,
and to effectively facilitate the patient's transition into treatment and
recovery. The ASAM Criteria, Third Edition, 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 detoxification, the
physician shall perform an assessment of the patient. The assessment shall
include a thorough medical history and physical examination. The assessment
must focus on signs and symptoms associated with opioid addiction 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)
Prior to
providing ambulatory detoxification, the physician shall conduct a biomedical
and psychosocial evaluation of the patient, to include the following:
(a)
A comprehensive
medical and psychiatric history;
(b)
A brief mental
status exam;
(c)
Substance abuse history;
(d)
Family history
and psychosocial supports;
(e)
Appropriate
physical examination;
(f)
Urine drug screen or oral fluid drug
testing;
(g)
Pregnancy test for women of childbearing age and
ability;
(h)
Review of the patient's prescription information in
OARRS;
(i)
Testing for human immunodeficiency
virus;
(j)
Testing for hepatitis B;
(k)
Testing for
hepatitis C; and
(l)
Consideration of screening for tuberculosis and
sexually-transmitted diseases in patients with known risk
factors.
(m)
For other than toxicology tests for drugs and alcohol,
appropriate history, substance abuse history, and pregnancy test, the physician
may satisfy the assessment requirements by reviewing records from a physical
examination and laboratory testing of the patient that was conducted within a
reasonable period of time prior to the visit. If any part of the assessment
cannot be completed prior to the initiation of treatment, the physician shall
document the reason in the medical record.
(5)
The physician
shall request and document review of an OARRS report on the
patient.
(6)
The physician shall inform the patient about the
following before the patient is undergoing withdrawal from opioids:
(a)
The
detoxification process and potential subsequent treatment for substance use
disorder, including information about all drugs approved by the United States
food and drug administration for use in medication-assisted
treatment;
(b)
The risk of relapse following detoxification without
entry into medication-assisted treatment;
(c)
The high risk of
overdose and death when there is a relapse following
detoxification;
(d)
The safe storage and disposal of the
medications.
(7)
The physician shall not establish standardized routines
or schedules of increases or decreases of medications but shall formulate a
treatment plan based on the needs of the specific patient.
(8)
For persons
projected to be involved in withdrawal management for six months or less, the
physician shall offer the patient counseling as described in paragraphs (F) and
(G) of rule
4731-33-03
of the Administrative Code.
(9)
The physician
shall require the patient to undergo urine and/or other toxicological
screenings during withdrawal management in order to demonstrate the absence of
use of alternative licit and/or illicit drugs. The physician shall consider
referring a patient who has a positive urine/and or toxicological screening to
a higher level of care, with such consideration documented in the patient's
medical record.
(10)
The physician shall comply with the following
requirements for the use of medication:
(a)
The physician may
treat the patient's withdrawal symptoms by use of any of the following drugs as
determined to be most appropriate for the patient.
(i)
A drug, excluding
methadone, that is specifically FDA approved for the alleviation of withdrawal
symptoms.
(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). However, buprenorphine without
naloxone (buprenorphine mono-product) may be used if a buprenorphine/naloxone
combination product is contraindicated, with the contraindication documented in
the patient record.
(b)
The physician
shall not use any of the following drugs to treat the patient's withdrawal
symptoms:
(i)
Methadone;
(ii)
Anesthetic
agents
(c)
The physician shall comply with the following:
(i)
The physician
shall not initiate treatment with buprenorphine to manage withdrawal symptoms
until between twelve and eighteen hours after the last dose of short-acting
agonist such as heroin or oxycodone, and twenty-four to forty-eight hours after
the last dose of long-acting agonist such as methadone. 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 well tolerated
by the patient.
(b)
The dosage level shall be consistent with the minimal
standards of care.
(iii)
In withdrawal
management programs of thirty days or less duration, the physician shall not
allow more than one week of unsupervised or take-home medications for the
patient.
(11)
The physician
shall offer the patient a prescription for a naloxone kit.
(a)
The physician
shall ensure that the patient receives instruction on the kit's use including,
but not limited to, recognizing the signs and symptoms of overdose and calling
911 in an overdose situation.
(b)
The physician
shall offer the patient a new prescription for naloxone upon expiration or use
of the old kit.
(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 a
kit without a prescription.
(12)
The physician
shall take steps to reduce the chances of medication diversion by using the
appropriate frequency of office visits, pill counts, and weekly checks of
OARRS.
(E)
The physician who provides ambulatory detoxification
with medication management for withdrawal from 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 detoxification
with medication management only when a positive and helpful support network is
available to the patient whose use of benzodiazepines was mainly in therapeutic
ranges and who does 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 past history of
withdrawal seizures or withdrawal delirium.
(2)
Prior to
providing ambulatory detoxification, the physician shall perform and document
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 detoxification, the physician shall conduct and document a
biomedical and psychosocial evaluation of the patient meeting the requirements
of paragraph (B)(4) of this rule.
(4)
The physician
shall instruct the patient not to drive or operate dangerous machinery during
treatment.
(5)
During the ambulatory detoxification, the physician
shall regularly assess the patient during the course of treatment so that
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 demonstrate the absence of use of alternative licit and/or illicit
drugs.
(b)
The physician shall document consideration of referring
the patient who has a positive urine and/or toxicology screening to a higher
level of care.
(c)
The physician shall take steps to reduce the chances of
diversion by using the appropriate frequency of office visits, pill counts, and
weekly checks of OARRS.
(F)
The physician who
provides ambulatory detoxification with medication management of withdrawal
from alcohol addiction 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 detoxification
from alcohol with medication management only when a positive and helpful
support network is available to the patient who does not have a polysubstance
dependence. The patient should exhibit no more than mild to moderate withdrawal
symptoms, have no comorbid medical conditions or severe psychiatric disorders,
and no past history of withdrawal seizures or withdrawal
delirium.
(2)
Prior to providing ambulatory detoxification, the
physician shall perform and document 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 detoxification, the
physician shall perform and document a biomedical and psychosocial evaluation
meeting the requirements of paragraph (D)(4) of this rule.
(4)
During the course
of ambulatory detoxification, the physician shall assess the patient
regularly:
(a)
The physician shall adjust the dosage as medically
appropriate;
(b)
The physician shall require the patient to undergo
urine and/or other toxicological screenings in order to demonstrate the absence
of illicit drugs;
(c)
The physician shall document the consideration of
referring a patient who has a positive urine and/or toxicological screening to
a higher level of care;
(5)
If the patient
agrees to enter alcohol treatment and the physician determines that such
treatment is clinically appropriate, the physician shall refer the patient to
an alcohol treatment program licensed or certified by the Ohio department of
mental health and addiction services to provide such treatment or to a
physician, physician assistant, or advanced practice registered nurse who
provides treatment using any FDA approved forms of medication assisted
treatment for alcohol use disorder. The name of the program, physician,
physician assistant, or advanced practice registered nurse to whom the patient
was referred, and the date of the referral shall be documented in the patient
record.
(6)
The physician shall instruct the patient not to drive
or operate dangerous machinery during treatment.