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.
Supplemental Information