Ohio Administrative Code
Title 4730 - Physician Assistants
Chapter 4730-4 - Opioid Addiction Treatment
Section 4730-4-02 - Standards and procedures for withdrawal management for drug or alcohol addiction
Universal Citation: OH Admin Code 4730-4-02
Current through all regulations passed and filed through September 16, 2024
(A) In order to provide ambulatory detoxification, as that term is defined in rule 4730-4-01 of the Administrative Code, a physician assistant shall comply with all of the following requirements:
(1)
The physician assistant shall hold a valid prescriber
number.
(2)
The physician assistant shall provide withdrawal
management under the supervision of a physician who provides withdrawal
management as part of the physician's normal course of practice and with whom
the physician assistant has a supervision agreement.
(3)
The physician
assistant shall comply 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.
(4)
The physician
assistant who practices in a healthcare facility shall comply with all policies
of the healthcare facility concerning the provision of withdrawal
management.
(B) Prior to providing ambulatory detoxification, as that term is defined in rule 4730-4-01 of the Administrative Code, for any substance use disorder the physician assistant shall inform the patient that ambulatory detoxification alone is not substance abuse treatment. If the patient prefers substance abuse treatment, the physician assistant 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 assistant determines that
such treatment is clinically appropriate, the physician assistant 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 a physician assistant may be authorized to 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
assistant 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
assistant 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 assistant 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 assistant 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
assistant 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 assistant shall document the reason in the medical
record.
(5)
The physician assistant shall request and document
review of an OARRS report on the patient.
(6)
The physician
assistant 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
assistant 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 assistant shall offer the patient counseling as described in
paragraphs (F) and (G) of rule
4730-4-03
of the Administrative Code.
(9)
The physician
assistant 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 assistant 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 shall confer with the supervising physician prior
to prescribing the buprenorphine/naloxone combination product to the
patient.
(10)
The physician assistant shall comply with the following
requirements for the use of medication:
(a)
The physician
assistant 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 from the Medical Board's website at
https://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
assistant shall not use any of the following drugs to treat the patient's
withdrawal symptoms:
(i)
Methadone;
(ii)
Anesthetic
agents
(c)
The physician assistant shall comply with the
following:
(i)
The physician assistant 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 assistant 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
assistant shall not allow more than one week of unsupervised or take-home
medications for the patient.
(11)
The physician
assistant shall offer the patient a prescription for a naloxone kit.
(a)
The physician
assistant 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
assistant shall offer the patient a new prescription for naloxone upon
expiration or use of the old kit.
(c)
The physician
assistant shall be exempt from this requirement if the patient refuses the
prescription. If the patient refuses the prescription the physician assistant
shall provide the patient with information on where to obtain a kit without a
prescription.
(12)
The physician assistant 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
assistant 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:
(1)
The physician assistant 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 assistant 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 assistant 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
assistant shall instruct the patient not to drive or operate dangerous
machinery during treatment.
(5)
During the
ambulatory detoxification, the physician assistant shall regularly assess the
patient during the course of treatment so that dosage can be adjusted if
needed.
(a)
The
physician assistant 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
assistant 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 assistant 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
assistant 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:
(1)
The physician assistant 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 assistant 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 assistant 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 assistant shall assess the patient regularly:
(a)
The physician
assistant shall adjust the dosage as medically appropriate;
(b)
The physician
assistant shall require the patient to undergo urine and/or other toxicological
screenings in order to demonstrate the absence of illicit
drugs;
(c)
The physician assistant 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 assistant determines that
such treatment is clinically appropriate, the physician assistant 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 assistant shall instruct the patient not
to drive or operate dangerous machinery during treatment.
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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