Ohio Administrative Code
Title 4723 - Ohio Board of Nursing
Chapter 4723-9 - Prescriptive Authority
Section 4723-9-14 - Standards and procedures for withdrawal management for drug or alcohol addiction
Universal Citation: OH Admin Code 4723-9-14
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)
The
definitions set forth in rule
4723-9-13 of the Administrative
Code apply in addition to those definitions set forth in this
paragraph;
(2)
"Ambulatory detoxification" means withdrawal management
delivered in a medical office, public sector clinic, or urgent care facility by
trained practitioners authorized to prescribe outpatient supplies of drugs
approved by the FDA for the treatment of addiction, prevention of relapse of
drug addiction, or both. Ambulatory detoxification is the provision of
medically supervised evaluation, withdrawal management, and referral services
without extended onsite monitoring. For purposes of this rule, ambulatory
detoxification does not include withdrawal management that occurs in the
following settings:
(a)
A state or local correctional facility, as defined in
section 5163.45 of the Revised
Code;
(b)
In-patient treatment in a hospital, as defined in
section 3727.01 of the Revised
Code;
(c)
An opioid treatment program certified by SAMHSA and
accredited by an independent SAMHSA-approved accrediting body;
or
(d)
A youth services facility, as defined in section
103.75 of the Revised
Code.
(3)
"ASAM" means the American society of addiction
medicine;
(4)
"Withdrawal management" or "detoxification" is a set of
medical interventions aimed at managing the acute physical symptoms of
intoxication and withdrawal. Detoxification denotes a clearing of toxins from
the body of the patient who is acutely intoxicated and/or dependent on a
substance of abuse. Withdrawal management seeks to minimize the physical harm
caused by the intoxication and withdrawal of a substance of abuse. Withdrawal
management occurs when the patient has a substance use disorder and either
evidence of the characteristic withdrawal syndrome produced by withdrawal from
that substance, or evidence that supports the expectation that such syndrome
would develop without the provision of detoxification services. Withdrawal
management alone does not constitute substance abuse treatment or
rehabilitation.
(B) A clinical nurse specialist, certified nurse midwife or certified nurse practitioner who holds a current valid advanced practice registered nurse license may provide ambulatory detoxification consistent with this rule if the advanced practice registered nurse:
(1)
Only
provides withdrawal management in collaboration with a physician who provides
withdrawal management as part of the physician's normal course of practice and
with whom the advanced practice registered nurse has a current standard care
arrangement;
(2)
Complies with the medication withdrawal policies of the
healthcare facilities in which the advanced practice registered nurse engages
in withdrawal management practice; and
(3)
Complies with all
state and federal 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.
(C) Prior to providing ambulatory detoxification for any substance use disorder the advanced practice registered nurse shall inform the patient that ambulatory detoxification alone is not substance abuse treatment. If the patient prefers substance abuse treatment, the advanced practice registered nurse shall comply with the requirements of section 3719.064 of the Revised Code, by completing the following actions:
(1)
Both verbally and in writing give the patient
information about all drugs approved by the FDA for use in medication-assisted
treatment including withdrawal management. The information given shall be
documented in the patient's record.
(2)
If the patient
agrees to enter opioid treatment and the advanced practice registered nurse
determines that such treatment is clinically appropriate, the advanced practice
registered nurse 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 or provider to whom the patient was referred
and the date of the referral shall be documented in the patient
record.
(D) When providing withdrawal management for opioid use disorder an advanced practice registered nurse may be authorized to use a medical device that is approved by the FDA as an aid in the reduction of opioid withdrawal symptoms.
(E) Ambulatory detoxification for opioid addiction.
(1)
An advanced
practice registered nurse 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; and
(c)
There is little
risk of medication diversion.
(2)
The advanced
practice registered nurse shall provide ambulatory detoxification under a
defined set of policies and procedures or medical protocols consistent with
level of care I-D or II-D as set forth in "The ASAM Criteria, Third Edition,"
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 effectively facilitate the patient's transition into treatment and
recovery. "The ASAM Criteria, Third Edition," can be obtained from the website
of ASAM at https://www.asam.org/, and may be reviewed at the board office, located at 17 S.
High street, suite 660, Columbus, Ohio, 43215 during normal business
hours.
(3)
Prior to providing ambulatory detoxification, the
advanced practice registered nurse 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");
(c)
Subjective opioid withdrawal scale
("SOWS"),
(4)
Prior to providing ambulatory detoxification, the
advanced practice registered nurse 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)
A 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 factor.
(m)
For other than 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. If any
part of the assessment cannot be completed prior to the initiation of
treatment, the advanced practice registered nurse shall document the reasons in
the medical record.
(5)
The advanced
practice registered nurse shall request and document review of an OARRS report
on the patient.
(6)
The advanced practice registered nurse 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 FDA 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; and
(d)
The safe storage
and disposal of the medications.
(7)
The advanced
practice registered nurse 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
advanced practice registered nurse shall offer the patient counseling and
follow the procedures described in paragraphs (C)(8) and (C)(9) of rule
4723-9-13 of the Administrative
Code.
(9)
The advanced practice registered nurse 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 advanced practice registered nurse 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, and confer with the collaborating physician prior to
prescribing a buprenorphine/naloxone combination product to the
patient.
(10)
The advanced practice registered nurse shall comply
with the following requirements for the use of medication:
(a)
The advanced
practice registered nurse may treat the patient's withdrawal symptoms by use of
any of the following drugs as determined to be the 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 ASAM National Practice Guideline For the Use of Medications in the
Treatment of Addiction Involving Opioid Use," available at:
https://www.asam.org, and available on the board's website at https://nursing.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 advanced
practice registered nurse shall not use any of the following drugs to treat the
patient's withdrawal symptoms:
(i)
Methadone;
(ii)
Anesthetic
agents.
(c)
The advanced practice registered nurse shall:
(i)
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 hours after the last does of long-acting agonist
such as methadone. Treatment with buprenorphine product must be in compliance
with the FDA approved "Risk Evaluation and Mitigation Strategy" for
buprenorphine products, which can be found on the FDA website at:
https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm.
(ii)
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.
(11)
The advanced
practice registered nurse shall offer the patient a prescription for a naloxone
kit and shall:
(a)
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)
Offer the patient
a new prescription for naloxone upon expiration or use of the old
kit;
(c)
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.
(12)
The advanced
practice registered nurse shall take steps to reduce the chances of medication
diversion by using an appropriate frequency of office visits, pill counts, and
weekly checks of OARRS.
(F)
The advanced
practice registered nurse who provides ambulatory detoxification with
medication management for withdrawal from benzodiazepines or other sedatives
shall comply with paragraphs (B), (C), and (D) of this rule and "TIP 45, A
Treatment Improvement Protocol for Detoxification and Substance Abuse
Treatment" by SAMHSA, available from the SAMHSA website at:
https://store.samhsa.gov/ (search for "TIP 45") and available on the board's website
at:
(1)
A positive and
helpful support network is available to the patient;
(2)
The patient's use
of benzodiazepines was mainly in therapeutic ranges;
(3)
The patient does
not have polysubstance dependence;
(4)
The patient
exhibits no more than mild to moderate withdrawal symptoms;
(5)
The patient has
no comorbid medical condition or severe psychiatric disorder;
(6)
The patient has
no history of withdrawal seizures or withdrawal delirium;
(7)
Prior to
providing ambulatory detoxification, the advanced practice registered nurse
performs and documents an assessment of the patient that focuses on signs and
symptoms associated with benzodiazepine or other sedative use disorder,
including assessment with a nationally recognized scale, such as the "Clinical
Institute Withdrawal Assessment for Benzodiazepines"
("CIWA-B");
(8)
Prior to providing ambulatory detoxification, the
advanced practice registered nurse conducts and documents a biomedical and
psychosocial evaluation of the patient meeting the requirements of paragraph
(E)(4) of this rule.
(9)
The advanced practice registered nurse instructs the
patient not to drive or operate dangerous machinery during
treatment;
(10)
The advanced practice registered nurse regularly
assesses the patient during the course of ambulatory detoxification so that
dosage can be adjusted if needed;
(a)
The patient shall be required to undergo urine and/or
other toxicological screening during withdrawal management in order to
demonstrate the absence of use of alternative licit and/or illicit
drugs;
(b)
The advanced practice registered nurse shall document
consideration of referral of the patient who has a positive urine and/or
toxicological screen to a higher level of care;
(c)
The advanced
practice registered nurse shall take steps to reduce the chances of diversion
by using an appropriate frequency of office visits, pill counts, and weekly
checks of OARRS.
(G)
An advanced
practice registered nurse who provides ambulatory detoxification with
medication management of withdrawal from alcohol addiction shall comply with
paragraphs (B), (C), and (D) of this rule and "TIP 45, A Treatment Improvement
Protocol for Detoxification and Substance Abuse Treatment" by SAMHSA, available
from the SAMHSA website at:
https://store.samhsa.gov/
(search for "TIP 45") and available on the board's
website at:
(1)
A positive and
helpful support network is available to the patient;
(2)
The patient does
not have polysubstance dependence;
(3)
The patient
exhibits no more than mild to moderate withdrawal symptoms;
(4)
The patient has
no comorbid medical condition or severe psychiatric disorder;
(5)
The patient has
no history of withdrawal seizures or withdrawal delirium;
(6)
Prior to
providing ambulatory detoxification, the advanced practice registered nurse
performs and documents an assessment of the patient that focuses on signs and
symptoms associated with alcohol use disorder, including assessment with a
nationally recognized scale, such as the "Clinical Institute Withdrawal
Assessment for Alcohol-revised" ("CIWA-Ar");
(7)
Prior to
providing ambulatory detoxification, the advanced practice registered nurse
conducts and documents a biomedical and psychosocial evaluation of the patient
meeting the requirements of paragraph (E)(4) of this rule;
(8)
The advanced
practice registered nurse regularly assesses the patient during the course of
ambulatory detoxification. The advanced practice registered nurse shall:
(a)
Adjust the dosage
of medication as medically appropriate;
(b)
Require the
patient to undergo urine and/or other toxicological screening in order to
demonstrate the absence of illicit drugs;
(c)
Document the
consideration of referral of the patient who has a positive urine and/or
toxicological screen to a higher level of care.
(9)
If the patient
agrees to enter alcohol treatment and the advanced practice registered nurse
determines that such treatment is clinically appropriate, the advanced practice
registered nurse 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.
(10)
The advanced
practice registered nurse shall instruct the patient not to drive or operate
dangerous machinery during treatment.
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