GENERAL GOVERNMENT CABINET

Kentucky Board of Nursing

(New Administrative Regulation)

 

††††† 201 KAR 20:065. Professional standards for prescribing Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone by APRNs for medication assisted treatment for opioid use disorder.

 

††††† RELATES TO: KRS 314.011, 314.042; Public Law 114-198

††††† STATUTORY AUTHORITY: KRS 314.131

††††† NECESSITY, FUNCTION, AND CONFORMITY: KRS 314.131 authorizes the board to promulgate administrative regulations to regulate the conduct of its licensees. This administrative regulation establishes the professional standards for APRNs practicing in Kentucky who prescribe Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone.

 

††††† Section 1. Definitions. (1) "Advanced Practice Registered Nurse" is defined in KRS 314.011(7).

††††† (2) "Buprenorphine" means the controlled substances Buprenorphine-Mono-Product and Buprenorphine-Combined-with-Naloxone.

 

††††† Section 2. Minimum Qualifications for Prescribing Buprenorphine. An advanced practice registered nurse (APRN) shall not prescribe Buprenorphine unless that APRN possesses the minimum qualifications established in this section.

††††† (1) The APRN shall obtain and maintain in good standing a waiver and registration as issued by the Drug Enforcement Administration (DEA) to prescribe Buprenorphine for the treatment of Opioid Use Disorder.

††††† (2) The APRN shall be a DEA-registered prescriber of Buprenorphine and shall have obtained medication assisted treatment education through completion of a Substance Abuse and Mental Health Services Administration (SAMHSA) approved course.

††††† (3) Only an APRN designated nurse practitioner may prescribe Buprenorphine.

††††† (4) The APRN shall provide to the board a copy of the DEA waiver registration as required by 201 KAR 20:057, Section 6(4).

††††† (5) The APRN shall comply with all federal statutes and regulations pertaining to the prescribing of Buprenorphine. This shall include the maximum number of patients, which may be seen by the APRN each year and the inclusion of the special DEA identification number in addition to the regular DEA registration number on all prescriptions for opioid dependency treatment.

 

††††† Section 3. Professional Standards for Prescribing Buprenorphine for Supervised Withdrawal or the Treatment of Opioid Use Disorder. (1) Buprenorphine may be prescribed for supervised withdrawal or as a maintenance treatment for a patient diagnosed with Opioid Use Disorder in accordance with the standards established by this administrative regulation.

††††† (2) Buprenorphine-Mono-Product shall not be prescribed for supervised withdrawal or as a maintenance treatment for a patient diagnosed with Opioid Use Disorder, except:

††††† (a) To a pregnant patient, as set out in subsection (4)(b) of this section;

††††† (b) To a patient with demonstrated hypersensitivity to naloxone; or

††††† (c) As an implant-delivered or injectable treatment administered in an APRNís office or other healthcare facility.

††††† (3)(a) Except as provided in paragraph (b) of this subsection, Buprenorphine shall not be prescribed to a patient who is also being prescribed benzodiazepines, other sedative hypnotics, stimulants or other opioids, without consultation of a physician or an APRN who is certified in addiction therapy.

††††† (b) An APRN may prescribe Buprenorphine to a patient who is also being prescribed benzodiazepines, other sedative hypnotics, stimulants, or other opioids, without consultation in order to address an extraordinary and acute medical need not to exceed a combined period of thirty (30) days.

††††† (4) Each APRN who prescribes Buprenorphine for supervised withdrawal or for the treatment of Opioid Use Disorder shall fully comply with the professional standards established in this subsection.

††††† (a) Prior to initiating treatment, the APRN shall:

††††† 1. Obtain, review, and record a complete and appropriate evaluation of the patient, which shall at a minimum include:

††††† a. The patientís history of present illness;

††††† b. The patientís history of drug use;

††††† c. The patientís social and family history;

††††† d. The patientís medical and psychiatric histories;

††††† e. A physical examination of the patient;

††††† f. Appropriate laboratory tests, which may include a complete blood count (CBC), a drug screen, liver function tests, a complete metabolic panel (CMP), HIV screening, and hepatitis serology; and

††††† g. An evaluation by a mental health provider with expertise in addiction and compliance with the recommendations of the evaluator.

††††† 2. Obtain the patientís consent and authorizations in order to obtain and discuss the patientís prior medical records.

††††† a. Upon receipt of the medical records, the APRN shall review and incorporate the information from the records into the evaluation and treatment of the patient.

††††† b. If the APRN is unable, despite best efforts, to obtain the patientís prior medical records, the APRN shall document those efforts in the patientís chart.

††††† 3. Obtain and review a KASPER or other prescription drug monitoring program (PDMP) report for that patient for the twelve (12) month period immediately preceding the initial patient encounter and appropriately utilize that information in the evaluation and treatment of the patient;

††††† 4. Explain treatment alternatives, the risks, and the benefits of treatment with Buprenorphine to the patient.

††††† 5. Obtain written informed consent from the patient for treatment.

††††† 6. Discuss and document the patientís treatment with the patientís other providers; and

††††† 7. If the patient is a female of childbearing potential and age, meet the requirements of paragraph (b) of this subsection.

††††† (b) 1. Prior to initiating treatment, the APRN shall require that the patient first submit to a pregnancy test and the APRN shall provide counseling as to the risk of neonatal abstinence syndrome which shall be consistent with patient education material on neonatal abstinence syndrome from the American Congress of Obstetricians and Gynecologists, American Academy of Pediatrics, American Society of Addiction Medicine (ASAM) and the Kentucky Department for Public Health, and offer means to prevent pregnancy.

††††† 2. An APRN shall not prescribe Buprenorphine to a patient who is pregnant or breastfeeding unless the APRN first obtains and documents consultation for an opinion as to whether the potential benefit of Buprenorphine use outweighs the potential risk of use.

††††† 3. The consultation shall be obtained from a physician or an APRN who is certified in addiction therapy.

††††† (c) Except as provided by paragraph (d) of this subsection, while initiating treatment with Buprenorphine, the APRN shall comply with the following requirement:

††††† 1. The APRN shall recommend to the patient an in-office observed induction protocol.

††††† a. Except as provided in clause b. of this subparagraph, the APRN shall conduct the in-office observed induction protocol.

††††† b. If an in-office observed induction does not occur, the APRN shall appropriately document the circumstances in the patient record and shall implement a SAMHSA-recognized or ASAM-recognized home-based induction protocol.

††††† 2. The APRN shall document the presence of any opioid withdrawal symptoms before the first dose is given by using a standardized instrument, such as the clinic opioid withdrawal scale (COWS) or other similarly recognized instrument.

††††† 3. The APRN shall initiate treatment with a dose not to exceed the dose equivalency of four (4) milligrams buprenorphine generic tablet, which:

††††† a. May be followed by subsequent doses if withdrawal persists and is not improving; and

††††† b. Shall not exceed the dose equivalency of sixteen (16) milligrams buprenorphine generic tablet on the first day of treatment.

††††† (d) If the patient is transferred from another treatment provider and has previously experienced withdrawal without a relapse, the APRN shall:

††††† 1. Document the previous history of withdrawal.

††††† 2. Educate the patient about the potential for precipitated withdrawal; and

††††† 3. Continue maintenance treatment of the patient on the same dosage as established by the previous treatment provider and then as provided in paragraph (e) of this subsection.

††††† (e) After initial induction of Buprenorphine, the APRN shall prescribe to the patient an amount of Buprenorphine that:

††††† 1. Is necessary to minimize craving and opiate withdrawal.

††††† 2. Does not produce opiate sedation

††††† 3. Is able only to supply the patient until the next visit, which shall be scheduled as required by this section; and

††††† 4. Does not exceed the FDA-approved dosage limit of twenty-four (24) milligrams per day.

††††† (f) The patientís visits shall be scheduled as follows:

††††† 1. The APRN shall see the patient at least weekly for the first two (2) months.

††††† 2. If the patient demonstrates objective signs of positive treatment progress after the first two (2) months, the APRN shall see the patient at least once monthly thereafter for up to two (2) years.

††††† 3. If after two (2) years after initiation of treatment, the patient has demonstrated objective signs of positive treatment progress, including documented evidence that the patient has been compliant with the treatment plan and all treatment directives, then the APRN may require that the patient be seen only by the APRN at least once every three (3) months. The APRN shall evaluate the patient to determine whether the patientís dosage should be continued or modified and shall appropriately document that evaluation and clinical judgment in the patientís chart.

††††† 4. The APRN shall see the patient in shorter intervals if the patient demonstrates any noncompliance with the treatment plan.

††††† 5. If extenuating circumstances arise that require a patient to unexpectedly reschedule a visit, the APRN shall make best efforts to see the patient as soon as possible and document the circumstances in the patient chart.

††††† (g) The APRN shall review compliance with the recommendations of the treatment plan, including review of KASPER or other PDMP reports and drug screens to help guide the treatment plan at each visit.

††††† 1. The APRN shall incorporate those findings into the treatment plan to support the continuation or modification of treatment and shall accurately document the same in the patient record.

††††† 2. Appropriate evaluation may include adjustment of dose strength or frequency of visits, increased screening, a consultation with or referral to a specialist, or an alternative treatment, including consideration of weaning.

††††† 3. The APRN shall obtain a minimum of eight (8) drug screens from the patient within each twelve (12) month period of treatment in order to help guide the treatment plan.

††††† a. At least two (2) of the drug screens shall be random and shall be coupled with a pill count. At least one (1) of those two (2) shall be confirmed by gas chromatography/mass spectrometry (GC/MS) or liquid chromatography/mass spectrometry (LC/MS).

††††† b. Each drug screen shall, at a minimum, screen for buprenorphine, methadone, oxycodone, other opioids, THC, benzodiazepines, amphetamines, alcohol, and cocaine.

††††† c. If a drug screen indicates the presence of any of the drugs screened, the APRN shall incorporate those findings into appropriate clinical evaluation to support the continuation or modification of treatment and shall document in the patient record.

††††† d. Appropriate evaluation may include adjustment of dose strength or frequency of visits, increased screening, a consultation with or referral to a specialist, or an alternative treatment.

††††† (h) Every twelve (12) months following initiation of treatment, if a patientís prescribed daily therapeutic dosage exceeds the dose equivalency of sixteen (16) milligrams Buprenorphine generic tablet per day, then the APRN shall refer the patient for evaluation by a physician or an APRN who is certified in addiction therapy for an opinion as to whether continued treatment and dosage is appropriate and shall document the results of that evaluation in the patient chart.

††††† (i) For patients who have demonstrated objective signs of positive treatment progress for at least two (2) years from the date of initiation of treatment, including documented evidence that the patient has been compliant with the treatment plan and all treatment directives, the APRN shall evaluate for and document every twelve (12) months the medical necessity for continued treatment at the established dose.

††††† (j) The APRN shall document a plan for dealing with any lost or stolen medication, which:

††††† 1. Shall not provide for the automatic replacement of medication prior to the specified interval date; and

††††† 2. If the APRN determines that it is necessary to minimize improper or illegal diversion of medications under the circumstances, the APRN shall require the patient to first report the lost or stolen medications to police or other law enforcement agencies and require the patient to provide evidence to the APRN of having so reported.

 

††††† Section 4. Continuing Education. An APRN who has obtained a waiver and registration as issued by the Drug Enforcement Administration (DEA) to prescribe Buprenorphine for the treatment of Opioid Use Disorder shall complete the one and one-half (1 1/2) contact hours of continuing education required annually by 201 KAR 20:215, Section 5(1)(b) in addiction disorders

 

LEWIS PERKINS, President

††††† APPROVED BY AGENCY: September 12, 2017

††††† FILED WITH LRC: September 12, 2017 at 4 p.m.

††††† PUBLIC HEARING AND PUBLIC COMMENT PERIOD: A public hearing on this administrative regulation shall be held on October 23, 2017 at 10:00 a.m. (EST) in the office of the Kentucky Board of Nursing, 312 Whittington Parkway, Suite 300, Louisville, Kentucky. Individuals interested in being heard at this hearing shall notify this agency in writing five workdays prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who wishes to be heard will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on the proposed administrative regulation. Written comments shall be accepted until end of day (11:59 p.m.) October 31, 2017. Send written notification of intent to be heard at the public hearing or written comments on the proposed administrative regulation to the contact person.

††††† CONTACT PERSON: Nathan Goldman, General Counsel, Kentucky Board of Nursing, 312 Whittington Parkway, Suite 300, Louisville, Kentucky 40222, phone (502) 429-3309, fax (502) 564-4251, email nathan.goldman@ky.gov.

 

REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT

 

Contact Person: Nathan Goldman

††††† (1) Provide a brief summary of:

††††† (a) What this administrative regulation does: This administrative regulation establishes standards for APRNs who are authorized to prescribe Buprenorphine (also known as Suboxone) for the treatment of addiction.

††††† (b) The necessity of this administrative regulation: This administrative regulation is necessary because the federal government has authorized APRNs who meet federal requirements to prescribe this medication.

††††† (c) How this administrative regulation conforms to the content of the authorizing statutes: This administrative regulation conforms to the content of the federal law by setting standards.

††††† (d) How this administrative regulation currently assists or will assist in the effective administration of the statutes: This administrative regulation assists in the effective administration of the statutes by setting standards.

††††† (2) If this is an amendment to an existing administrative regulation, provide a brief summary of:

††††† (a) How the amendment will change this existing administrative regulation:

††††† (b) The necessity of the amendment to this administrative regulation:

††††† (c) How the amendment conforms to the content of the authorizing statutes:

††††† (d) How the amendment will assist in the effective administration of the statutes:

††††† (3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation: APRNs who have been authorized by the federal government to prescribe this medication, approximately 24.

††††† (4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:

††††† (a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment: The APRNs will have to comply with these standards.

††††† (b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3): There is no additional cost imposed by the amendment.

††††† (c) As a result of compliance, what benefits will accrue to the entities identified in question (3): They will be in compliance with the regulation.

††††† (5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:

††††† (a) Initially: There is no additional cost.

††††† (b) On a continuing basis: There is no additional cost.

††††† (6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation: Agency funds.

††††† (7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment: No increase is needed.

††††† (8) State whether or not this administrative regulation established any fees or directly or indirectly increased any fees: It does not.

††††† (9) TIERING: Is tiering applied? Tiering was not applied as the changes apply to all equally.

 

FISCAL NOTE ON STATE OR LOCAL GOVERNMENT

 

††††† (1) What units, parts, or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation? The Kentucky Board of Nursing.

††††† (2) Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation. KRS 314.131

††††† (3) Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect.

††††† (a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year? None.

††††† (b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years? None.

††††† (c) How much will it cost to administer this program for the first year? No additional cost.

††††† (d) How much will it cost to administer this program for subsequent years? No additional cost.

††††† Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.

††††† Revenues (+/-):

††††† Expenditures (+/-):

††††† Other Explanation: