(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: https://med.ohio.gov.
(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: https://store.samhsa.gov/ (search
for "TIP 45") and available from the medical board's website at:
https://med.ohio.gov.
(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.