Ohio Administrative Code|Rule 4731-33-02 | Standards and procedures for withdrawal management for drug or alcohol addiction.

                                                
(A) A physician who provides withdrawal
		  management, as that term is defined in rule 4731-33-01 of the Administrative
		  Code, shall comply with all federal and state 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.
(B) Prior to providing ambulatory
		  detoxification, as that term is defined in rule 4731-33-01 of the
		  Administrative Code, for any substance use disorder the physician shall inform
		  the patient that ambulatory detoxification alone is not substance abuse
		  treatment. If the patient prefers substance abuse treatment, the physician
		  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 determines that such treatment is
			 clinically appropriate, the physician 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 the physician may 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 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 shall
			 provide ambulatory detoxification under a defined set of policies and
			 procedures or medical protocols consistent with American society of addiction
			 medicines level I-D or II-D level of care, under which services are
			 designed to treat the patients level of clinical severity, to achieve
			 safe and comfortable withdrawal from a mood-altering drug, and to effectively
			 facilitate the patients 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 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 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
				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 shall
				document the reason in the medical record. 
(5) The physician shall
			 request and document review of an OARRS report on the patient.
(6) The physician 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 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
			 shall offer the patient counseling as described in paragraphs (F) and (G) of
			 rule 4731-33-03 of the Administrative Code.
(9) The physician 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 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.
(10) The physician shall
			 comply with the following requirements for the use of medication: 
(a) The physician 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 Medicines National Practice Guideline
				  (https://www.asam.org/), which is available on the Medical Boards
				  website at: https://www.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 shall not use any of the following drugs
				to treat the patients withdrawal symptoms:
(i) Methadone;
				  
(ii) Anesthetic
				  agents
(c) The physician shall comply with the
				following:
(i) The physician 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 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 shall not
				  allow more than one week of unsupervised or take-home medications for the
				  patient. 
(11) The physician shall
			 offer the patient a prescription for a naloxone kit.
(a) 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.
				
(b) The physician shall offer the patient a new
				prescription for naloxone upon expiration or use of the old kit.
(c) 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. 
(12) The physician 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 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 boards website at: https://med.ohio.gov.
(1) The physician 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 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 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 shall
			 instruct the patient not to drive or operate dangerous machinery during
			 treatment. 
(5) During the ambulatory
			 detoxification, the physician shall regularly assess the patient during the
			 course of treatment so that dosage can be adjusted if needed.
(a) The physician 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 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 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 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 on the medical board's website at:
		  https://med.ohio.gov.
(1) The physician 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 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 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 shall assess the patient
			 regularly:
(a) The physician shall adjust the dosage as medically
				appropriate;
(b) The physician shall require the patient to undergo
				urine and/or other toxicological screenings in order to demonstrate the absence
				of illicit drugs;
(c) The physician 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 determines that such treatment is
			 clinically appropriate, the physician 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 shall instruct the patient not to drive
			 or operate dangerous machinery during treatment.