Ohio Admin. Code 4723-9-14

Current through all regulations passed and filed through October 28, 2024

Section 4723-9-14 - Standards and procedures for withdrawal management for drug or alcohol addiction

(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: https://nursing.ohio.gov. In addition, ambulatory detoxification with medication management shall only be provided if:

(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: https://nursing.ohio.gov. In addition, ambulatory detoxification with medication management shall only be provided if:

(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.

Ohio Admin. Code 4723-9-14

Effective: 2/1/2021
Five Year Review (FYR) Dates: 10/15/2025
Promulgated Under: 119.03
Statutory Authority: 4723.50, 4723.51, 4723.07
Rule Amplifies: 4723.50, 4723.51