Ohio Administrative Code
Title 4731 - State Medical Board
Chapter 4731-33 - Opioid Treatment
Section 4731-33-03 - Office-based treatment for opioid addiction
Universal Citation: OH Admin Code 4731-33-03
Current through all regulations passed and filed through September 16, 2024
(A) A physician who provides OBOT shall comply with all of the following requirements:
(1)
Before initiating
OBOT, the physician shall comply with section
3719.064 of the Revised
Code.
(2)
Comply with all federal and state laws and regulations
governing the prescribing of the medication; and
(3)
Complete at least
eight hours of "Category 1" continuing medical education relating to substance
abuse and addiction every two years. Courses completed in compliance with this
requirement shall be accepted toward meeting the physician's "Category 1"
continuing medical education requirement for biennial renewal of the
physician's license.
(B) The physician who provides OBOT shall perform and document an assessment of the patient.
(1)
The assessment
shall include all of 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.
(2)
For other than the 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.
(3)
If any part of
the assessment cannot be completed prior to the initiation of OBOT, the
physician shall document the reasons in the medical record.
(C) The physician who provides OBOT shall establish and document a treatment plan that includes all of the following:
(1)
The physician's rationale for selection of the specific
drug to be used in the medication-assisted treatment;
(2)
Patient
education;
(3)
The patient's written, informed
consent;
(4)
Random urine-drug screens;
(5)
A signed
treatment agreement that outlines the responsibilities of the patient and the
physician; and
(6)
A plan for psychosocial treatment, pursuant to
paragraph (E) of this rule.
(D) The physician shall provide OBOT in accordance with an acceptable treatment protocol for assessment, induction, stabilization, maintenance, and tapering. Acceptable protocols are any of the following:
(1)
SAMHSA treatment improvement protocol publications for
medication assisted treatment available from the SAMHSA website at:
https://store.samhsa.gov.
(2)
"National Practice Guideline for the Use of Medications
in the Treatment of Addiction Involving Opioid Use," approved by the American
society of addiction medicine in 2015, available from the website of the
American society of addiction medicine at https://www.asam.org/.
(E) Except if the physician providing OBOT is a board certified addictionologist, board certified addiction psychiatrist, or psychiatrist, the physician shall refer and work jointly with a qualified behavioral healthcare provider, community mental health services provider, or community addiction services provider, as those terms are defined in rule 4731-33-01 of the Administrative Code, to determine the optimal type and intensity of psychosocial treatment for the patient and document the treatment plan in the patient record.
(1)
The treatment shall, at a minimum, include a
psychosocial needs assessment, supportive counseling, links to existing family
supports, and referral to community services.
(2)
The treatment
shall include at least one of the following interventions, unless reasons for
exception are documented in the patient record:
(a)
Cognitive
behavioral treatment;
(b)
Community reinforcement approach;
(c)
Contingency
management/motivational incentives;
(d)
Motivational
interviewing; or
(e)
Behavioral couples counseling.
(3)
The
treatment plan shall include a structure for revision of the treatment plan if
the patient does not adhere to the original plan.
(4)
When clinically
appropriate and if the patient refuses treatment from a qualified behavioral
healthcare provider, community mental health services provider, or community
addiction services provider, as defined in rule
4731-33-01 of the
Administrative Code, the physician shall ensure that the OBOT treatment plan
requires the patient to participate in a twelve step program or appropriate
self-help recovery program. If the patient is required to participate in a
twelve step program or self-help recovery program, the physician shall require
the patient to provide documentation of on-going participation in the
program.
(5)
Additional requirements related to the provider of
behavioral health services:
(a)
If the physician providing OBOT is a board certified
addictionologist, psychiatrist, or board certified psychiatrist, the physician
may personally provide behavioral health services for
addiction.
(b)
If the physician refers the patient to a qualified
behavioral healthcare provider, community addiction services provider, or
community mental health services provider, the physician shall document the
referral and the physician's maintenance of meaningful interactions with the
provider in the patient record.
(F) The physician who provides OBOT shall offer the patient a prescription for a naloxone kit.
(1)
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.
(2)
The physician
shall offer the patient a new prescription for naloxone upon expiration or use
of the old kit.
(3)
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.
(G) In addition to paragraphs (A) to (F) of this rule, the physician who provides OBOT using buprenorphine products shall comply with all of the following requirements:
(1)
The provision shall 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. With the exception of those conditions listed in paragraph
(G)(2) of this rule, a physician who treats the opioid use disorder with a
buprenorphine product shall only prescribe buprenorphine/naloxone combination
products for use in OBOT.
(2)
The physician shall prescribe buprenorphine without
naloxone (buprenorphine mono-product) only in the following situations, and
shall fully document the evidence for the decision to use buprenorphine
mono-product in the medical record:
(a)
When a patient is pregnant or
breast-feeding;
(b)
When converting a patient from buprenorphine
mono-product to buprenorphine/naloxone combination product;
(c)
In formulations
other than tablet or film form for indications approved by the United States
food and drug administration;
(d)
For withdrawal
management when a buprenorphine/naloxone combination product is
contraindicated, with the contraindication documented in the patient record;
or
(e)
When the patient has an allergy to or intolerance of a
buprenorphine/ naloxone combination product, after explaining to the patient
the difference between an allergic reaction and symptoms of opioid withdrawal
precipitated by buprenorphine or naloxone, and with documenation included in
the patient record.
(3)
Due to a higher
risk of fatal overdose when buprenorphine is prescribed with other opioids,
benzodiazepines, sedative hypnotics, carisoprodol, or tramadol, the physician
shall only co-prescribe these substances when it is medically necessary.
(a)
The physician
shall verify the diagnosis for which the patient is receiving the other drug
and coordinate care with the prescriber for the other drug, including whether
it is possible to taper the drug to discontinuation. If the physician
prescribing buprenorphine is the prescriber of the other drug, the physician
shall taper the other drug to discontinuation, if it is safe to do so. The
physician shall educate the patient about the serious risks of the combined
use.
(b)
The physician shall document progress with achieving
the tapering plan.
(4)
During the
induction phase the physician shall not prescribe a dosage that exceeds the
recommendaton in the United States food and drug administration approved
labeling, except for medically indicated circumstances as documented in the
patient record. The physician shall see the patient at least once a week during
this phase.
(5)
During the stabilization phase, when using any oral
formulation of buprenorphine, the physician shall increase the daily dosage of
buprenorphine in safe and effective increments to achieve the lowest dose that
avoids intoxication, withdrawal, or significant drug craving.
(a)
During the first
ninety days of treatment, the physician shall prescribe no more than a two-week
supply of the buprenorphine product containing naloxone.
(b)
Starting with the
ninety-first day of treatment and until the completion of twelve months of
treatment, the physician shall prescribe no more than a thirty-day supply of
the buprenorphine product containing naloxone.
(6)
The physician
shall take steps to reduce the chances of buprenorphine diversion by using the
lowest effective dose, appropriate frequency of office visits, pill counts, and
checks of OARRS. The physician shall require urine drug screens, serum
medication levels, or oral fluid testing at least twice per quarter for the
first year of treatment and at least once per quarter
thereafter.
(7)
When using any oral formulation of buprenorphine, the
physician shall document in the medical record the rationale for prescribed
doses exceeding sixteen milligrams of buprenorphine per day. The physician
shall not prescribe a dosage exceeding twenty-four milligrams of buprenorphine
per day.
(8)
The physician shall incorporate relapse prevention
strategies into counseling or assure that they are addressed by a qualified
behavioral healthcare provider, as defined in rule
4731-33-01 of the
Administrative Code, who has the education and experience to provide substance
abuse counseling.
(9)
The physician may treat a patient using the
administration of an extended-release, injectable, or implanted buprenorphine
product.
(a)
The
physician shall strictly comply with any required risk evaluation and
mitigation strategy program for the drug.
(b)
The physician
shall prescribe an extended-release buprenorphine product strictly in
accordance with the United States food and drug administration's approved
labeling for the drug's use.
(c)
The physician
shall document in the patient record the rationale for the use of the
extended-release buprenorphine product.
(d)
The physician who
orders or prescribes an extended-release, injectable, or implanted
buprenorphine product shall require it to be administered by an Ohio licensed
health care professional acting in accordance with the scope of the
professional license.
Replaces: 4731-11-12
Disclaimer: These regulations may not be the most recent version. Ohio may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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