Chapter DHS 75

DHS 75.60(10)(b) (b) The OBOT service shall ensure that all prescriptions for buprenorphine products shall comply with all of the following requirements:

DHS 75.60(10)(b)1. 1. The provision shall be in compliance with the FDA-approved risk evaluation and mitigation strategy” for buprenorphine products.

DHS 75.60 Note Note: The FDA-approved risk evaluation and mitigation strategy for buprenorphine products can be found at https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm.

DHS 75.60(10)(b)2. 2. With the exception of those conditions listed in subd. 3. a. to e., a prescriber who treats opioid use disorder with a buprenorphine product shall only prescribe buprenorphine and naloxone combination products for use in the OBOT service.

DHS 75.60(10)(b)3. 3. The prescriber shall prescribe buprenorphine without naloxone (buprenorphine mono-product) at the OBOT service only in the following situations, and shall fully document the evidence for the decision to use buprenorphine mono-product in the patient’s record when any of the following apply:

DHS 75.60(10)(b)3.a. a. A patient is pregnant or breast-feeding.

DHS 75.60(10)(b)3.b. b. Converting a patient from buprenorphine mono-product to buprenorphine and naloxone combination product.

DHS 75.60(10)(b)3.c. c. Formulations other than tablet or film form approved by the FDA are administered.

DHS 75.60(10)(b)3.d. d. A buprenorphine and naloxone combination product is contraindicated for withdrawal management and the contraindication documented in the patient record.

DHS 75.60(10)(b)3.e. e. The patient, after an explanation by the service of the difference between an allergic reaction and symptoms of opioid withdrawal precipitated by buprenorphine or naloxone, has an allergy to or intolerance of a buprenorphine and naloxone combination product. This information shall be included in the patient’s record.

DHS 75.60(10)(b)4. 4. Due to a higher risk of fatal overdose when buprenorphine is prescribed with other opioids, benzodiazepines, sedative hypnotics, carisoprodol, or tramadol, the prescriber shall only co-prescribe these substances when it is medically necessary and the following requirements are met:

DHS 75.60(10)(b)4.a. a. The prescriber shall verify the diagnosis for which the patient is receiving the other drug and coordinate care with the prescriber for the other drug, including whether it is possible to taper the drug to discontinuation. If the prescriber prescribing buprenorphine is the prescriber of the other drug, the prescriber shall taper the other drug to discontinuation, if it is safe to do so. The prescriber shall educate the patient about the serious risks of the combined use.

DHS 75.60(10)(b)4.b. b. The prescriber shall document progress with achieving the tapering plan.

DHS 75.60(10)(b)5. 5. During the induction phase the prescriber shall not prescribe a dosage that exceeds the recommendation in the United States FDA-approved labeling, except for medically indicated circumstances as documented in the patient record. The prescriber shall see the patient at least once per week during this phase.

DHS 75.60(10)(b)6. 6. During the stabilization phase, when using any oral formulation of buprenorphine, the prescriber shall increase the daily dosage of buprenorphine in safe and effective increments to achieve the lowest dose that avoids intoxication, withdrawal, or significant drug craving.

DHS 75.60(10)(b)7. 7. During the first 90 days of treatment, no more than a 2-week supply of the buprenorphine and naloxone combination product may be prescribed.

DHS 75.60(10)(b)8. 8. Starting with the 91st day of treatment and until the completion of 12 months of treatment, no more than a 30-day supply of the buprenorphine and naloxone combination product may be prescribed.

DHS 75.60(10)(b)8m. 8m. The prescriber shall take steps to reduce the chances of buprenorphine diversion by using the lowest effective dose, appropriate frequency of office visits, pill or film counts, and checks of the PDMP. The prescriber shall require urine drug screens, serum medication levels, or oral fluid testing at least twice per quarter for the first year of treatment and at least once per quarter thereafter.

DHS 75.60(10)(b)9. 9. When using any oral formulation of buprenorphine, the prescriber shall document in the medical record the rationale for prescribed doses exceeding 16 milligrams of buprenorphine per day.

DHS 75.60(10)(b)10. 10. Relapse prevention strategies shall be incorporated into counseling or assure that they are addressed by a qualified behavioral healthcare provider who has the education and experience to provide substance abuse counseling.

DHS 75.60(10)(b)11. 11. Extended-release, injectable, or implanted buprenorphine product may be used. In using these formulations, the prescriber shall:

DHS 75.60(10)(b)11.a. a. Strictly comply with any required risk evaluation and mitigation strategy program for the drug.

DHS 75.60(10)(b)11.b. b. Prescribe an extended-release buprenorphine product strictly in accordance with the FDA’s approved labeling for the drug’s use.

DHS 75.60(10)(b)11.c. c. Document in the patient record the rationale for the use of the extended-release buprenorphine product.

DHS 75.60(10)(b)11.d. d. Require the extended-release, injectable, or implanted buprenorphine product to be administered by a licensed health care professional acting in accordance with the scope of the professional license.

DHS 75.60(10)(c) (c) The OBOT service that utilizes naltrexone to treat opioid use disorder shall comply with all of the following requirements:

DHS 75.60(10)(c)1. 1. Prior to treating a patient with naltrexone, the patient shall be informed about the risk of opioid overdose if the patient ceases naltrexone and then uses opioids.

DHS 75.60(10)(c)2. 2. The prescriber shall take measures to ensure that the patient is adequately detoxified from opioids prior to treatment with naltrexone.

DHS 75.60(10)(c)3. 3. The prescriber shall use oral naltrexone only for treatment of patients who can be closely supervised and who are highly motivated and:

DHS 75.60(10)(c)3.a. a. The dosage regime shall strictly comply with FDA-approved labeling for naltrexone hydrochloride tablets.

DHS 75.60(10)(c)3.b. b. The patient shall be encouraged to have a support person administer and supervise the medication. Examples of a support person are a family member, close friend, or employer.

DHS 75.60(10)(c)3.c. c. The OBOT service shall require urine drug screens, serum medication levels, or oral fluid drug testing at least every 3 months for the first year of treatment and at least every 6 months thereafter.

DHS 75.60(10)(c)3.d. d. The OBOT service shall incorporate relapse prevention strategies into counseling or assure that they are addressed by a qualified behavioral healthcare provider who has the education and experience to provide substance abuse counseling.

DHS 75.60(10)(c)4. 4. The OBOT service may treat a patient with extended-release naltrexone for opioid dependence or for co-occurring opioid and alcohol use disorders.

DHS 75.60(10)(c)4.a. a. Treatment with extended-release naltrexone for patients who have issues with treatment adherence should be considered.

DHS 75.60(10)(c)4.b. b. The injections dosage shall strictly comply with FDA-approved labeling for extended-release naltrexone.

DHS 75.60(10)(c)4.c. c. Relapse prevention strategies shall be incorporated into counseling or assure that they are addressed by a qualified behavioral healthcare provider who has the education and experience to provide substance abuse counseling.

DHS 75.60 History History: CR 20-047: cr. Register October 2021 No. 790, eff. 10-1-22; correction in (1) (c), (2), (6) (a) 3. b., (d) made under s. 35.17, Stats., correction in numbering of (4) (c) 1. to 6., (10) (b) 8m. made under s. 13.92 (4) (b) 1., Stats., and correction in (10) (b) 2. made under s. 13.92 (4) (b) 7., Stats., Register October 2021 No. 790; correction in (11) (b) made under s. 35.17, Stats., Register November 2021 No. 791.