Ohio Administrative Code
Title 4723 - Ohio Board of Nursing
Chapter 4723-9 - Prescriptive Authority
Section 4723-9-13 - Medication-assisted treatment
Universal Citation: OH Admin Code 4723-9-13
Current through all regulations passed and filed through September 16, 2024
(A) Definitions; for purposes of this rule and interpretation of the formulary set forth in rule 4723-9-10 of the Administrative Code:
(1) "Community addiction services
provider" has the same meaning as in section
5119.01 of the Revised
Code.
(2) "Community mental health
services provider" has the same meaning as in section
5119.01 of the Revised
Code.
(3) "Controlled substance,"
"schedule III," "schedule IV," and "schedule V" have the same meanings as in
section 3719.01 of the Revised
Code.
(4) "FDA" means the United
States food and drug administration.
(5) "Induction phase" means the phase of
opioid treatment during which maintenance medication dosage levels are adjusted
until a patient attains stabilization.
(6) "Medication-assisted treatment" means
alcohol or drug addiction services that are accompanied by medication that has
been approved by the United States food and drug administration for the
treatment of substance use disorder, prevention of relapse of substance use
disorder, or both.
(7)
"Office-based opioid treatment" or "OBOT" means medication-assisted treatment
of opioid dependence or addiction utilizing controlled substances, in a private
office or public sector clinic that is not otherwise regulated, by
practitioners who are authorized to prescribe outpatient supplies of
medications approved by the FDA for the treatment of opioid addiction or
prevention of relapse. OBOT includes treatment with all controlled substance
medications approved by the FDA for such treatment. OBOT does not include
treatment that occurs in the following settings:
(a) A state or local correctional facility,
as defined in section
5163.45 of the Revised
Code;
(b) A hospital, as defined in
section 3727.01 of the Revised
Code;
(c) A provider certified to
provide residential and inpatient substance use disorder services, including
withdrawal management, by the Ohio department of mental health and addiction
services;
(d) An opioid treatment
program certified by SAMHSA and accredited by an independent, SAMHSA-approved
accrediting body; or
(e) A youth
services facility, as defined in section
103.75 of the Revised
Code.
(8) "OARRS" means
the "Ohio Automated RX Reporting System" drug database established and
maintained pursuant to section
4729.75 of the Revised
Code.
(9) "Qualified behavioral
healthcare provider" means the following who is practicing within the scope of
professional licensure:
(a) A medical doctor
or doctor of osteopathic medicine and surgery who holds board certification in
addiction medicine or addiction psychiatry, or a psychiatrist, licensed under
Chapter 4731. of the Revised Code;
(b) A licensed independent chemical
dependency counselor-clinical supervisor, licensed independent chemical
dependency counselor, licensed chemical dependency counselor III, licensed
chemical dependency counselor II, or licensed chemical dependency counselor
assistant licensed under Chapter 4758. of the Revised Code;
(c) A professional clinical counselor,
licensed professional counselor, licensed independent social worker, licensed
social worker, or marriage and family therapist, licensed under Chapter 4757.
of the Revised Code;
(d) An
advanced practice registered nurse licensed as a clinical nurse specialist or
certified nurse practitioner licensed by the board, who holds national
certification in psychiatric mental health, or clinical nurse specialist who
was not required to obtain national certification according to section
4723.41 of the Revised Code, and
whose specialty is psychiatric mental health; or
(e) A psychologist, as defined in division
(A) of section 4732.01 of the Revised Code,
licensed under Chapter 4732. of the Revised Code; or
(f) An advanced practice registered nurse
licensed by the board who holds additional certification as a certified
addictions registered nurse-advanced practice issued by the addictions nursing
certification board.
Nothing in paragraph (A)(9) of this rule shall be construed to prohibit an advanced practice registered nurse who collaborates with a physician licensed under Chapter 4731. of the Revised Code and certified as an addiction psychiatrist, addictionologist, or psychiatrist, from providing services within the normal course of practice and expertise of the collaborating physician, including addiction services, other mental health services, and prescriptive services in compliance with Ohio and federal law and rules.
(10)
"SAMHSA" means the United States substance abuse and mental health services
administration.
(11) "Stabilization
phase" means the medical and psychosocial process of assisting the patient
through acute intoxication and withdrawal management to the attainment of a
medically stable, fully supported substance-free state, which may include the
use of medications.
(B) An advanced practice registered nurse with a current valid license issued by the board and designated as a clinical nurse specialist, certified nurse midwife or certified nurse practitioner may provide medication-assisted treatment, including prescribing controlled substances in schedule III, IV or V, if the advanced practice registered nurse:
(1) Complies with section
3719.064 of the Revised Code,
and all federal and state laws and regulations governing the prescribing of the
medication, including but not limited to incorporating into the advanced
practice registered nurse's practice knowledge of Chapter 4729. of the Revised
Code, and Chapter 4731. of the Revised Code and rules adopted under that
Chapter that govern the practice of the advanced practice registered nurse's
collaborating physician;
(2)
Completes at least eight hours of continuing nursing education in each renewal
period related to substance abuse and addiction. Courses completed in
compliance with this requirement shall be accepted toward meeting the
continuing education requirements for biennial renewal of the advanced practice
registered nurse license; and
(3)
Only provides medication-assisted treatment if the treatment is within the
collaborating physician's normal course of practice and expertise.
(C) In addition to the requirements for medication-assisted treatment set forth in paragraph (B) of this rule, an advanced practice registered nurse with a current valid license issued by the board and designated as a clinical nurse specialist or certified nurse practitioner may provide OBOT under the following circumstances:
(1) The standard
care arrangement statement of services offered includes OBOT;
(2) The advanced practice registered nurse
performs, or confirms the completion of, and documents a patient assessment
that includes all of the following:
(a) A
comprehensive medical and psychiatric history;
(b) A brief mental status history;
(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 patient's prescription
information in OARRS;
(i) Testing
for human immunodeficiency virus;
(j) Testing for hepatitis B;
(k) Testing for hepatitis C;
(l) Consideration of screening for
tuberculosis and sexually-transmitted diseases in patients with known risk
factors.
(m) For other than the
toxicology tests for drugs and alcohol, appropriate history, substance abuse
history, and pregnancy test, the advanced practice registered nurse 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.
(n) If any part of the assessment cannot be
completed prior to the initiation of OBOT, the advanced practice registered
nurse shall document the reasons in the medical record.
(3) The advanced practice registered nurse
establishes and documents a treatment plan that includes all of the following:
(a) The advanced practice registered nurse's
rationale for selection of the specific drug to be used in the
medication-assisted treatment;
(b)
Patient education;
(c) The
patient's written, informed consent;
(d) Random urine-drug screens or oral fluid
drug testing;
(e) A signed
treatment agreement with the patient that outlines the responsibilities of the
patient and the advanced practice registered nurse;
(f) A plan for psychosocial treatment as
discussed in paragraph (C)(5) of this rule;
(4) The advanced practice registered nurse
shall provide OBOT in accordance with an acceptable treatment protocol for
assessment, induction, stabilization, maintenance and tapering. Acceptable
protocols are any of the following:
(a) SAMSHA
treatment improvement protocol publications for medication-assisted treatment
available from the SAMSHA website at: https://store.samhsa.gov;
(b) "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, and available from the
website of the American society of addiction medicine at
https://www.asam.org/.
(5) Except if the advanced
practice registered nurse is a qualified behavior healthcare provider, the
advanced practice registered nurse shall refer and work jointly with a
qualified behavioral healthcare provider, community mental health services
provider, or community addiction services provider to determine the optimal
type and intensity of psychosocial treatment for the patient and document the
treatment plan in the patient record.
(a) The
treatment shall at minimum include a psychosocial needs assessment, supportive
counseling, links to existing family supports, and referral to community
services;
(b) The treatment shall
include at least one of the following interventions:
(i) Cognitive behavioral treatment;
(ii) Community reinforcement
approach;
(iii) Contingency
management/motivational incentives; or
(iv) Behavioral couples counseling;
(c) The treatment plan shall
include a structure for renegotiation of the treatment plan if the patient does
not adhere to the original plan.
(6) 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, the advanced practice registered nurse 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
advanced practice registered nurse shall require the patient to provide
documentation of on-going participation in the program.
(7) If the advanced practice registered nurse
refers the patient to a qualified behavioral health service provider, community
addiction services provider, or community mental health services provider, the
advanced practice registered nurse shall document the referral and the advanced
practice registered nurse's meaningful interactions with the provider in the
patient record.
(8) The advanced
practice registered nurse shall offer the patient a prescription for a naloxone
kit.
(a) The advanced practice registered
nurse 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 advanced practice registered nurse
shall offer the patient a new prescription for naloxone upon expiration or use
of the old kit.
(c) The advanced
practice registered nurse shall be exempt from this requirement if the patient
refuses the prescription. If the patient refuses the prescription the advanced
practice registered nurse shall provide the patient with information on where
to obtain a kit without a prescription.
(9) If the advanced practice registered nurse
provides OBOT using buprenorphine products, the following additional
requirements must be met:
(a) The provision
shall comply with the FDA approved "Risk Evaluation and Mitigation Strategy"
for buprenorphine products, which can be found on FDA website at the following
address:
https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm.
With the exception of those conditions listed in paragraph (C)(9)(b) of this
rule, the advanced practice registered nurse who treats an opioid use disorder
with a buprenorphine product shall only prescribe buprenorphine/naloxone
combination products for use in OBOT.
(b) The advanced practice registered nurse
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 patient's record:
(i) When the patient is pregnant or
breast-feeding;
(ii) When
converting the patient from buprenorphine mono-product to a
buprenorphine/naloxone combination product;
(iii) In formulations other than tablet or
film form for indications approved by the FDA;
(iv) For withdrawal management when a
buprenorphine/naloxone combination product is contraindicated, with the
contraindication documented in the patient record; or
(v) 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
documentation included in the patient record.
(c) Due to a higher risk of fatal overdose
when buprenorphine is prescribed with other opioids, benzodiazepines, sedative
hypnotics, carisoprodol, and tramadol, the advanced practice registered nurse
shall only co-prescribe these substances when it is medically necessary, and
only if:
(i) The advanced practice registered
nurse verifies the diagnosis for which the patient is receiving the other drug
and coordinates care with the prescriber for the other drug, including whether
it is possible to taper the drug to discontinuation. If the advanced practice
registered nurse prescribing buprenorphine is the prescriber of the other drug,
the advanced practice registered nurse shall taper the other drug to
discontinuation if it is safe to do so. The advanced practice registered nurse
shall educate the patient about the serious risks of the combined use;
and
(ii) The advanced practice
registered nurse documents progress in achieving the tapering plan in the
patient record.
(d)
During the induction phase, the advanced practice registered nurse shall not
prescribe a dosage that exceeds the recommendation in the FDA approved
labeling, except for medically indicated circumstances as documented in the
patient record. The advanced practice registered nurse shall see the patient at
least once per week during this phase.
(e) During the stabilization phase, when
using any oral formulation of buprenorphine, the advanced practice registered
nurse 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.
(i) During the first
ninety days of treatment, the advanced practice registered nurse shall
prescribe no more than a two-week supply of the buprenorphine product
containing naloxone.
(ii) Starting
with the ninety-first day of treatment and until the completion of twelve
months of treatment, the advanced practice registered nurse shall prescribe no
more than a thirty-day supply of the buprenorphine product containing
naloxone.
(f) The
advanced practice registered nurse 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 advanced
practice registered nurse shall also 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.
(g) When using any oral formulation of
buprenorphine, the advanced practice registered nurse shall document in the
patient record the rationale for prescribed doses exceeding sixteen milligrams
of buprenorphine per day. The advanced practice registered nurse shall not
prescribe a dose of buprenorphine exceeding twenty-four milligrams per
day.
(h) The advanced practice
registered nurse shall incorporate relapse prevention strategies into
counseling or assure that they are addressed by a qualified behavioral
healthcare provider who has the education and experience to provide substance
abuse counseling.
(i) The advanced
practice registered nurse may treat a patient using the administration of
extended-release, injectable, or implanted buprenorphine under the following
circumstances:
(i) The advanced practice
registered nurse strictly complies with any required risk evaluation and
mitigation strategy program for the drug;
(ii) The advanced practice registered nurse
shall prescribe an extended-release buprenorphine product strictly in
accordance with the FDA's approved labeling for the drug's use;
(iii) The advanced practice registered nurse
documents in the patient record the rationale for the use of the
extended-release product; and
(iv)
The advanced practice registered nurse who orders or prescribes
extended-release, injectable, or implanted buprenorphine product shall
administer the drug, or require it to be administered by another Ohio licensed
health care provider acting in accordance with the scope of their professional
license.
(10)
If the clinical nurse specialist or certified nurse practitioner is using
naltrexone to treat opioid use disorder, the advanced practice registered nurse
shall comply with the following additional requirements:
(a) Prior to treating a patient with
naltrexone, the advanced practice registered nurse shall inform the patient
about the risk of opioid overdose if the patient ceases naltrexone and then
uses opioids. The advanced practice registered nurse shall take measures to
ensure that the patient is adequately detoxified from opioids and is no longer
physically dependent prior to treatment with naltrexone;
(b) The advanced practice registered nurse
shall use oral naltrexone only for treatment of patients who can be closely
supervised and who are highly motivated;
(i)
The dosage regime shall strictly comply with the FDA approved labeling for
naltrexone hydrochloride tablets;
(ii) The patient shall be encouraged to have
a support person assist with the administration of the medication and supervise
the medication. Examples of a support person are a family member, close friend,
or employer;
(c) The
advanced practice registered nurse shall require urine drug screens, serum
medication levels or oral fluid testing at least every three months for the
first year of treatment and at least every six months thereafter;
(d) The advanced practice registered nurse
shall incorporate relapse prevention strategies into counseling or assure that
they are addressed by a qualified behavioral healthcare or mental health
services provider who has eduction and experience to provide substance abuse
counseling.
(e) The advanced
practice registered nurse may treat a patient with extended-release naltrexone
for opioid dependence or for co-occurring opioid and alcohol use disorders.
(i) The advanced practice registered nurse
should consider treatment with extended-release naltrexone for patients who
have issues with treatment adherence;
(ii) The injection dosage shall strictly
comply with FDA labeling for extended-release naltrexone; and
(iii) The advanced practice registered nurse
shall incorporate relapse prevention strategies into counseling or assure that
they are addressed by a qualified behavioral healthcare provider or mental
health services provider who has the education and experience to provide
substance abuse counseling.
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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