201 KAR 9:270 - Professional standards for prescribing or dispensing Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone
RELATES TO: KRS 218A.205, 311.530-311.620, 311.840-311.862, 311.990
NECESSITY, FUNCTION, AND CONFORMITY: KRS 311.565(1)(a) authorizes the board to promulgate administrative regulations to regulate the conduct of its licensees. KRS 218A.205(3)(a) and (b) require the board to establish mandatory prescribing and dispensing standards related to controlled substances. KRS 311.842(1)(b) requires that the board promulgate administrative regulations establishing professional standards for prescribing and administering controlled substances by physician assistants. This administrative regulation establishes the professional standards for any board licensee who prescribes, dispenses, or administers Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone in the Commonwealth of Kentucky. Nothing within this administrative regulation shall be interpreted to grant physician assistants authority to dispense Buprenorphine-Mono-Product or Buprenorphine-Combined-With-Naloxone, unless otherwise authorized by KRS 311.842.
Section
1. Minimum Qualifications for Prescribing, Dispensing, or
Administering Buprenorphine-Mono-Product or
Buprenorphine-Combined-with-Naloxone. Except as provided in Section 3 of this
administrative regulation, a licensee shall not prescribe, dispense, or
administer Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone
unless that licensee possesses the minimum qualifications established in this
section.
(1) The licensee shall obtain and
maintain in good standing a waiver and license as issued by the Drug
Enforcement Administration (DEA) to prescribe Buprenorphine-Mono-Product or
Buprenorphine-Combined-with-Naloxone for the treatment of opioid use disorder
in the Commonwealth of Kentucky.
(2) The licensee shall successfully complete
the approved educational programs required by this subsection.
(a) The prescribing licensee shall be a
DEA-licensed prescriber of Buprenorphine-Mono-Product or
Buprenorphine-Combined-with-Naloxone and shall have obtained Buprenorphine
certification through completion of a Substance Abuse and Mental Health
Services Administration ("SAMHSA") certified course.
(b) For each three (3) year continuing
education cycle, each DEA-licensed prescriber of Buprenorphine-Mono-Product or
Buprenorphine-Combined-with-Naloxone shall complete at least twelve (12) hours
of continuing medical education certified in Category I specific to addiction
medicine as part of the required continuing medical education hours set forth
in
201 KAR
9:310 and
201
KAR 9:360.
(3) The licensee shall enroll in the Kentucky
Health Information Exchange to the extent necessary to query and pull
information from the Kentucky Health Information Exchange. The licensee shall
not report the prescribing, dispensing, or administering
Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone for
medically-supervised withdrawal or as maintenance treatment for a patient
diagnosed with opioid use disorder into the Kentucky Health Information
Exchange unless otherwise required by law.
Section 2. Professional Standards for
Prescribing, Dispensing, or Administering Buprenorphine-Mono-Product or
Buprenorphine-Combined-with-Naloxone for Medically-Supervised Withdrawal or the
Treatment of Opioid Use Disorder.
(1)
(a) Except as provided in paragraph (b) of
this subsection, transmucosal Buprenorphine-Mono-Product or
Buprenorphine-Combined-with-Naloxone shall only be prescribed, dispensed, or
administered for medically-supervised withdrawal or as a maintenance treatment
for a patient diagnosed with opioid use disorder.
(b) Buprenorphine-Mono-Product or
Buprenorphine-Combined-with-Naloxone shall not be used for the treatment of
pain or any other condition, unless delivered in a Federal Drug Administration
(FDA) approved form and for an FDA approved purpose.
(2) Buprenorphine-Mono-Product shall not be
prescribed, dispensed, or administered for medically-supervised withdrawal or
as a maintenance treatment for a patient diagnosed with opioid use disorder,
except:
(a) To a pregnant patient;
(b) To a patient with demonstrated
hypersensitivity to naloxone;
(c)
As administered under supervision in a physician's office or other healthcare
facility, including hospitals, urgent care settings, surgical care centers,
residential treatment facilities, and correctional facilities; or
(d) To a patient transitioning from methadone
to buprenorphine, limited to a period of no longer than one week.
(3)
(a) Except as provided in paragraph (b) of
this section, Buprenorphine-Mono-Product or
Buprenorphine-Combined-with-Naloxone shall not be prescribed, dispensed, or
administered to a patient who is also being prescribed benzodiazepines, other
sedative hypnotics, stimulants or other opioids, without consultation of a
physician who is certified by the American Board of Addiction Medicine, the
American Board of Preventive Medicine, the American Board of Medical
Specialties (ABMS) in psychiatry, or an American Osteopathic Association (AOA)
certifying board in addiction medicine or psychiatry.
(b) A licensee may prescribe, dispense, or
administer Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone
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)
Except as provided in Section 3 of this administrative regulation, each
licensee who prescribes, dispenses, or administers Buprenorphine-Mono-Product
or Buprenorphine-Combined-with-Naloxone for medically-supervised withdrawal or
for the treatment of opioid use disorder shall fully comply with the
professional standards established in this subsection.
(a) Prior to or at least within two (2) weeks
of initiating treatment, the prescribing, dispensing, or administering licensee
shall:
1. Obtain and record a complete and
appropriate evaluation of the patient which shall at a minimum include:
a. The patient's history of present
illness;
b. The patient's history
of substance use;
c. The patient's
social and family history;
d. The
patient's past medical and psychiatric histories;
e. A focused physical examination of the
patient;
f. Screening for HIV and
hepatitis serology; and
g. Arranging
appropriate laboratory tests, which shall include a CBC, a drug screen, and a
CMP;
2. Obtain the
patient's consent and authorizations in order to obtain the patient's prior
medical records.
a. Upon receipt of the
medical records, the prescribing, dispensing, or administering licensee shall
review and incorporate the information from the records into the evaluation and
treatment of the patient.
b. If the
prescribing, dispensing, or administering licensee is unable, despite best
efforts, to obtain the patient's prior medical records, the licensee shall
document those efforts in the patient's chart;
3. Obtain and review a KASPER 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 and the risks and the benefits of treatment with
Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone to the
patient;
5. Obtain written informed
consent from the patient in a manner that meets professional standards;
and
6. If the patient is a female
of child-bearing age and ability, meet the requirements of paragraph (b) of
this subsection.
(b)
Except as provided in Section 3 of this administrative regulation, the
requirements of this paragraph shall apply to the treatment of a female of
child-bearing age and ability.
1. Prior to
initiating treatment, the licensee shall require that the patient submit to a
pregnancy test and, if pregnant, the licensee shall provide counseling as to
the risk of neonatal abstinence syndrome which shall be consistent with current
SAMHSA guidance.
2.
a. Unless the licensee is certified by the
American Board of Addiction Medicine, the American Board of Preventive
Medicine, the American Board of Medical Specialties (ABMS) in psychiatry, or an
American Osteopathic Association (AOA) certifying board in addiction medicine
or psychiatry or an obstetrician or maternal-fetal medicine specialist, a
licensee who prescribes, dispenses, or administers Buprenorphine-Mono-Product
or Buprenorphine-Combined-with-Naloxone to a patient who is pregnant or
breastfeeding shall first obtain and document consultation with another
independent physician that the potential benefit of Buprenorphine-Mono-Product
or Buprenorphine-Combined-with-Naloxone use outweighs the potential risk of
use.
b. The consultation shall be
obtained from a physician who is certified by the American Board of Addiction
Medicine, the American Board of Preventive Medicine, the American Board of
Medical Specialties (ABMS) in psychiatry, or an American Osteopathic
Association (AOA) certifying board in addiction medicine or psychiatry or from
an obstetrician or maternal-fetal medicine
specialist.
(c)
Except as provided by paragraph (d) of this subsection, while initiating
treatment with Buprenorphine-Mono-Product or
Buprenorphine-Combined-with-Naloxone, the licensee shall comply with the
requirements of this paragraph.
1. The
licensee shall recommend to the patient an in-office observed induction
protocol.
a. Except as provided in clause b.
of this subparagraph, the licensee shall supervise the in-office observed
induction protocol.
b. If an
in-office observed induction does not occur, the licensee shall appropriately
record the circumstances in the patient chart.
2. The licensee shall document the presence
of opioid withdrawal 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 licensee 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
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 and has not had a lapse in treatment, the licensee shall:
1. Document that fact;
2. Educate the patient about the potential
for precipitated withdrawal; and
3.
Continue maintenance treatment of the patient on the same or less dosage as
established by the previous treatment provider and then as provided in
paragraph (e) of this subsection.
(e) After initial induction of
Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone, the
licensee shall meet the requirements established in this paragraph.
1. If the licensee prescribes, dispenses, or
administers Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone
medication, the licensee shall implement a treatment plan that requires
objective behavioral modification by the patient. The behavioral modification
shall include the patient's participation in a behavioral modification program
that may include counseling or a twelve (12) step facilitation.
2. The licensee shall prescribe, dispense, or
administer to the patient an amount of Buprenorphine-Mono-Product or
Buprenorphine-Combined-with-Naloxone that:
a.
Is necessary to minimize craving and opiate withdrawal;
b. Does not produce opiate
sedation;
c. Except as provided in
subclauses (i) through (iv) of this clause, is to be taken no more frequently
than once daily;
(i) If the patient is
pregnant, is to be taken no more than twice daily;
(ii) If the patient is receiving a daily
dosage of less than 16mg, is to be taken no more than twice daily;
(iii) If the patient is simultaneously
engaged in cancer treatment, hospice or palliative care, is to be taken bid or
tid; or
(iv) If the patient is
undergoing a major surgery, being any operative or invasive procedure or
delivery, or has suffered a significant physical trauma, being any acute,
blunt, blast or penetrating bodily injury that has a risk of death, physical
disability or impairment, is to be taken bid or tid for up to fourteen (14)
days; and
d. Is able only
to supply the patient until the next licensee visit, which shall be scheduled
as required by subparagraph 3. of this paragraph.
3.
a. The
licensee shall ensure that the patient is seen:
(i) No later than ten (10) days after
induction and then at intervals of no more than ten (10) days for the first
month after induction; and
(ii) At
intervals of no more than fourteen (14) days for the second month after
induction.
b.
(i) If the patient demonstrates objective
signs of positive treatment progress, the licensee shall ensure that the
patient is seen at least once monthly thereafter.
(ii) If two (2) years after initiation of
treatment, the patient is being prescribed Buprenorphine-Mono-Product or
Buprenorphine-Combined-with-Naloxone for opioid use disorder and 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 for at least two (2) years, then the licensee may
require that the patient be seen only by the licensee at least once every three
(3) months.
(iii) The licensee
shall see the patient in shorter intervals if the patient demonstrates any
noncompliance with the treatment plan.
c. If extenuating circumstances arise that
require a patient to unexpectedly reschedule a physician visit, the licensee
shall make best efforts to see the patient as soon as possible and document the
circumstances in the patient chart.
4. At least every three (3) months after
initiation of treatment, the licensee shall evaluate the patient to determine
whether the patient's dosage should be continued or modified and shall
appropriately document that evaluation and clinical reasoning in the patient's
chart.
5. At least once every three
(3) months, the licensee shall obtain KASPER reports to help guide the
treatment plan.
a. If the KASPER indicates any
abnormal findings, the licensee shall incorporate those findings into
appropriate clinical reasoning to support the continuation or modification of
treatment and shall accurately document the same in the patient
record.
b. Appropriate clinical
reasoning may include adjustment of dose strength, adjustment of frequency of
visits, increased drug screening, a consultation with a specialist, or an
alternative treatment.
c. Every
twelve (12) months following initiation of treatment, if a patient's prescribed
daily therapeutic dosage exceeds the dose equivalency of sixteen (16)
milligrams buprenorphine generic tablet per day and the licensee is not
certified by the American Board of Addiction Medicine, the American Board of
Preventive Medicine, the American Board of Medical Specialties (ABMS) in
psychiatry, or an American Osteopathic Association (AOA) certifying board in
addiction medicine or psychiatry, then the licensee shall obtain a consultation
from a physician who is certified by the American Board of Addiction Medicine,
the American Board of Medical Specialties (ABMS) in psychiatry, or an American
Osteopathic Association (AOA) certifying board in addiction medicine or
psychiatry for an opinion as to whether continued treatment and dosage is
appropriate and shall accurately document the results of that consultation in
the patient chart.
d. The licensee
shall adjust dosages according to the individual patient's condition and within
acceptable and prevailing medical standards, with the goal of improving the
patient's quality of life and ability to function in the community.
e. Every twelve (12) months following
initiation of treatment, the licensee shall evaluate for and document the
medical necessity for continued treatment at the established dose.
f. The licensee shall ensure that the patient
is drug tested. A patient in early stages of treatment shall be tested at least
once weekly and as the patient becomes more stable in treatment, the frequency
of drug testing may be decreased, but shall be performed at least on a monthly
basis. Individual consideration may be given for less frequent testing if a
patient is in sustained remission. If the patient returns to substance use
after a period of abstinence, the licensee shall resume the early treatment
testing schedule, in conjunction with an adapted or intensified treatment plan.
(i) Each drug screen shall at a minimum
screen for buprenorphine, methadone, opioids, THC, benzodiazepines,
amphetamines, and cocaine.
(ii) If
a drug screen indicates any abnormal findings, the licensee shall incorporate
those findings into appropriate clinical reasoning to support the continuation
or modification of treatment and shall accurately document the same in the
patient record.
(iii) Appropriate
clinical reasoning may include adjustment of dose strength, adjustment of
frequency of visits, increased drug screening, a consultation with a
specialist, or an alternative treatment.
6. The licensee shall document a plan for
handling any lost or stolen medication, which shall not provide for the
automatic replacement of medication prior to the specified interval
date.
Section
3. Use of transmucosal buprenorphine-mono-product or
buprenorphine-combined-with-naloxone for treatment of opioid use disorder in an
emergency situation or inpatient setting.
(1)
In an emergency, including in a hospital emergency department or similar
outpatient urgent care setting, or in an inpatient setting, licensees may offer
and initiate buprenorphine treatment to patients who present with opioid use
disorder, without meeting the requirements established in Sections 1 and 2 of
this administrative regulation and to the extent permitted by federal law, if:
(a) The licensee has determined that the use
of buprenorphine-mono-product or buprenorphine-combined-with-naloxone will not
result in a harmful interaction with other medications or substances in the
patient's system, including benzodiazepines, sedative hypnotics, carisoprodol,
or tramadol;
(b) The licensee
obtains and documents written informed consent from the patient specific to
risks and benefits of buprenorphine treatment; and
(c) The licensee provides the patient with
written instructions and contact information for appropriate follow up care,
including bridge-provider services, residential treatment providers, and
outpatient treatment providers.
(2) The licensee shall initiate buprenorphine
treatment under an observed induction protocol with an initial dose not to
exceed the dose equivalency of four (4) milligrams buprenorphine generic
tablet, which may be followed by subsequent doses, up to a maximum of
twenty-four (24) milligrams buprenorphine generic tablet, if withdrawal
persists and is not improving.
Section 4. Professional Standards for
Documentation of Patient Assessment, Education, Treatment Agreement and
Informed Consent, Action Plans, Outcomes, and Monitoring.
(1) Each licensee prescribing, dispensing, or
administering Buprenorphine-Mono-Product or
Buprenorphine-Combined-With-Naloxone shall obtain and document all relevant
information in a patient's medical record in a legible manner and in sufficient
detail to enable the board to determine whether the licensee is conforming to
professional standards for prescribing, dispensing, or administering
Buprenorphine-Mono-Product or Buprenorphine-Combined-With-Naloxone and other
relevant professional standards.
(2) If a licensee is unable to conform to
professional standards for prescribing, dispensing, or administering
Buprenorphine-Mono-Product or Buprenorphine-Combined-With-Naloxone as set forth
in this administrative regulation due to circumstances beyond the licensee's
control, or the licensee makes a professional determination that it is not
appropriate to comply with a specific standard, based upon the individual facts
applicable to a specific patient's diagnosis and treatment, the licensee shall
document those circumstances in the patient's record and only prescribe,
dispense, or administer Buprenorphine-Mono-Product or
Buprenorphine-Combined-With-Naloxone to the patient if the patient record
appropriately justifies the prescribing, dispensing, or administering of
Buprenorphine-Mono-Product or Buprenorphine-Combined-With-Naloxone under the
circumstances and in accordance with SAMHSA guidelines as set forth in:
Substance Abuse and Mental Health Services Administration, Medications for
Opioid Use Disorder, Treatment Improvement Protocol (TIP) Series 63,
Publication No. PEP20-02-01-006, Rockville, MD: Substance Abuse and Mental
Health Services Administration, 2020.
Section 5. Violations. Failure to comply with
or a violation of the professional standards established in Sections 2, 3 and 4
of this administrative regulation shall constitute a "departure from, or
failure to conform to the standards of acceptable and prevailing medical
practice within the Commonwealth of Kentucky," in violation of
KRS
311.850(1)(p) and (s),
KRS
311.595(12) and (9), as
illustrated by
KRS
311.597(4), and may
constitute a violation of
KRS
311.595(9), as illustrated
by
KRS
311.597(3), subjecting the
licensee to sanctions authorized by
KRS
311.595 and
311.850.
Section 6. Incorporation by Reference.
(1) Substance Abuse and Mental Health
Services Administration, "Medications for Opioid Use Disorder, Treatment
Improvement Protocol (TIP) Series 63, Publication No. PEP20-02-01-006",
2020.
(2) This material may be
inspected, copied, or obtained, subject to applicable copyright law, at the
Kentucky Board of Medical Licensure, 310 Whittington Parkway, Suite 1B,
Louisville, Kentucky 40222, Monday through Friday, 8:00 a.m. to 4:30
p.m.
(3) This material may also be
obtained on the board's Web site at kbml.ky.gov.
Notes
STATUTORY AUTHORITY: KRS 311.565(1)(a)
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