Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO:
KRS
218A.171,
218A.172,
218A.202,
218A.205(3)(a),
(b),
314.011(7),
(8),
314.042,
314.091,
314.193(2),
314.195
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
218A.205(3)(a) and (b)
require the Board of Nursing, in consultation with the Kentucky Office of Drug
Control Policy, to establish by administrative regulation mandatory prescribing
and dispensing standards for licensees authorized to prescribe or dispense
controlled substances, and in accordance with the Centers for Disease Control
and Prevention (CDC) guidelines, to establish a prohibition on a practitioner
issuing a prescription for a Schedule II controlled substance for more than a
three (3) day supply if intended to treat pain as an acute medical condition,
unless an exception applies.
KRS
314.131(1) authorizes the
board to promulgate administrative regulations necessary to enable it to carry
into effect the provisions of KRS Chapter 314, and authorizes the board to
require by administrative regulation that licensees and applicants utilize a
specific method of submission of documents or information that is required to
be provided to the board, including electronic submission.
KRS
314.193(2) authorizes the
board to promulgate administrative regulations establishing standards for the
performance of advanced practice registered nursing to safeguard the public
health and welfare. This administrative regulation establishes the scope and
standards of practice for an advanced practice registered nurse.
Section 1. Definitions.
(1) "Collaboration" means the relationship
between the advanced practice registered nurse and a physician in the provision
of prescription medication, including both autonomous and cooperative
decision-making, with the advanced practice registered nurse and the physician
contributing their respective expertise.
(2) "Collaborative Agreement for the Advanced
Practice Registered Nurse's Prescriptive Authority for Controlled Substances"
or "CAPA-CS" means the written document pursuant to
KRS
314.042(10).
(3) "Collaborative Agreement for the Advanced
Practice Registered Nurse's Prescriptive Authority for Nonscheduled Legend
Drugs" or "CAPA-NS" means the written document pursuant to
KRS
314.042(8).
(4) "Immediate family" means a spouse,
parent, child, sibling, parent-in-law, son-in-law, daughter-in-law, brother
in-law, sister in-law, step-parent, step-child, step-sibling, or other relative
residing in the same residence as a prescribing practitioner.
(5) "KASPER" means the Kentucky All Schedule
Prescription Electronic Reporting System established in
KRS
218A.202.
Section 2.
(1) The practice of the advanced practice
registered nurse shall be in accordance with the standards and functions
established in scope and standards of practice statements adopted by the board
in subsection (2) of this section.
(2) The following scope and standards of
practice statements shall be adopted:
(a) AACN
Scope and Standards for Acute Care Nurse Practitioner Practice;
(b) AACN Scope and Standards for Acute Care
Clinical Nurse Specialist Practice;
(c) Neonatal Nursing: Scope and Standards of
Practice;
(d) Nursing: Scope and
Standards of Practice;
(e)
Pediatric Nursing: Scope and Standards of Practice;
(f) Psychiatric- Mental Health Nursing: Scope
and Standards of Practice;
(g)
Scope of Practice for Nurse Practitioners;
(h) Standards of Practice for Nurse
Practitioners;
(i) Scope of Nurse
Anesthesia Practice;
(j) Standards
for Nurse Anesthesia Practice;
(k)
Standards for Office Based Anesthesia Practice;
(l) Standards for the Practice of
Midwifery;
(m) Oncology Nursing
Scope and Standards of Practice;
(n) The Women's Health Nurse Practitioner:
Guidelines for Practice and Education;
(o) Definition of Midwifery and Scope of
Practice of Certified Nurse-Midwives and Certified Midwives; and
(p) Standards for Professional Nursing
Practice in the Care of Women and Newborns.
Section 3. In the performance of advanced
practice registered nursing, the advanced practice registered nurse shall seek
consultation or referral in those situations outside the advanced practice
registered nurse's scope of practice.
Section
4. Advanced practice registered nursing shall include prescribing
medications and ordering treatments, devices, diagnostic tests, and performing
certain procedures that shall be consistent with the scope and standards of
practice of the advanced practice registered nurse.
Section 6.
(1)
(a) A
CAPA-NS and a CAPA-CS shall include the:
1.
Name;
2. Practice
address;
3. Phone number;
4. License number of both the advanced
practice registered nurse and each physician who is a party to the agreement;
and
5. Population focus and area of
practice of the advanced practice registered nurse.
(b) An advanced practice registered nurse
shall use the Common CAPA-NS form.
(2)
(a) To
notify the board of the existence of a CAPA-NS pursuant to
KRS
314.042(8)(b), the APRN
shall file with the board the APRN Prescriptive Authority Notification
Form.
(b) To notify the board that
the requirements of
KRS
314.042(9) have been met and
that the APRN will be prescribing nonscheduled legend drugs without a CAPA-NS,
the APRN shall file the APRN Prescriptive Authority Notification
Form.
(c) To notify the board of
the existence of a CAPA-CS pursuant to
KRS
314.042(10)(b), the APRN
shall file with the board the APRN Prescriptive Authority Notification
Form.
(3) For purposes
of the CAPA-NS and the CAPA-CS, in determining whether the APRN and the
collaborating physician are qualified in the same or a similar specialty, the
board shall consider the facts of each particular situation and the scope of
the APRN's and the physician's actual practice.
(4)
(a) An
APRN with a CAPA-CS, shall obtain a United States Drug Enforcement Agency (DEA)
Controlled Substance Registration Certificate and shall report all DEA numbers,
including a DEA-X Controlled Substance Registration Certificate, and any change
in the status of a certificate by providing a copy of each registration
certificate to the board within thirty (30) days of issuance.
(b) An APRN shall register for a master
account with the Kentucky All Schedule Prescription Electronic Reporting System
(KASPER) within thirty (30) days of obtaining a DEA Controlled Substance
Registration Certificate, and prior to prescribing controlled substances. A
copy of the KASPER master account registration certificate shall be submitted
to the board via the online APRN Update portal within thirty (30) days of
receipt of confirmation of registration by KASPER.
(5) An APRN shall report any changes to a
CAPA-NS or a CAPA-CS to the board within thirty (30) days.
(6) If an APRN's CAPA-NS ends unexpectedly
for reasons outside the APRN's control such as being ended by the physician
without notice, the physician's license becoming no longer valid in Kentucky,
or the death of a physician, the APRN may continue to prescribe non-scheduled
legend drugs for thirty (30) days, after documenting in each patient's medical
record the applicant's professional determination that the continued
prescribing is justified based on the individual facts applicable to the
patient's diagnosis and treatment. This thirty (30) day grace period shall not
be extended or occur successively. The APRN with a CAPA-CS shall cease
prescribing controlled substances if the collaborative agreement unexpectedly
ends, until the CAPA-CS is resumed or the APRN enters into a new
CAPA-CS.
(7) An APRN with a CAPA-NS
or a CAPA-CS shall report a practice address to the board. A change to the
practice address shall be reported to the board within thirty (30)
days.
(8) All documents and
information required to be reported to the board by this section shall be
reported by uploading the document or information through the board's Web site,
kbn.ky.gov, utilizing the tab APRN Update. The board shall not accept documents
or information sent in any other format.
Section 7. Prescribing medications without a
CAPA-NS or a CAPA-CS shall constitute a violation of
KRS
314.091(1), except if a
CAPA-NS has been discontinued pursuant to
KRS
314.042(9) or if the
prescribing occurred within the grace period established in Section 6(6) of
this administrative regulation.
Section
8. The board may make an unannounced visit to an advanced practice
registered nurse to determine if the advanced practice registered nurse's
practice is consistent with the requirements established by KRS Chapter 314 and
201 KAR Chapter 20, and patient and prescribing records shall be made available
for immediate inspection.
Section
9. Prescribing Standards for Controlled Substances.
(1)
(a) This
section shall apply to APRN with a CAPA-CS, if prescribing a controlled
substance. It also applies to the utilization of KASPER.
(b) The APRN shall practice according to the
applicable scope and standards of practice for the APRN'S role and population
focus. This section does not alter the prescribing limits established in
KRS
314.011(8).
(2) Prior to the initial
prescribing of a controlled substance to a patient, the APRN shall:
(a) Obtain the patient's medical history,
including history of substance use, and conduct an examination of the patient
and document the information in the patient's medical record. An APRN certified
in psychiatric-mental health shall obtain a medical and psychiatric history,
perform a mental health assessment, and document the information in the
patient's medical record;
(b) Query
KASPER for the twelve (12) month period immediately preceding the request for
available data on the patient and maintain all KASPER report identification
numbers and the date of issuance of each KASPER report in the patient's
record;
(c) Develop a written
treatment plan stating the objectives of the treatment and further diagnostic
examinations required; and
(d)
Discuss with the patient, the patient's parent if the patient is an
unemancipated minor child, or the patient's legal guardian or health care
surrogate:
1. The risks and benefits of the
use of controlled substances, including the risk of tolerance and drug
dependence;
2. That the controlled
substance shall be discontinued once the condition requiring its use has
resolved; and
3. Document that the
discussion occurred and obtain written consent for the treatment.
(3) The treatment plan
shall include an exit strategy, if appropriate, including potential
discontinuation of the use of controlled substances.
(4) For subsequent or continuing long-term
prescriptions of a controlled substance for the same medical complaint, the
APRN shall:
(a) Update the patient's medical
history and document the information in the patient's medical record;
(b) Modify and document changes to the
treatment plan as clinically appropriate; and
(c) Discuss the risks and benefits of any new
controlled substances prescribed, including the risk of tolerance and drug
dependence with the patient, the patient's parent if the patient is an
unemancipated minor child, or the patient's legal guardian or health care
surrogate.
(5) During
the course of treatment, the APRN shall query KASPER no less than once every
three (3) months for the twelve (12) month period immediately preceding the
request for available data on the patient. The APRN shall maintain in the
patient's record all KASPER report identification numbers and the date of
issuance of each KASPER report or a copy or saved image of the KASPER report.
If neither an identification number nor an image can be saved to the patient's
record as a result of technical limitations of the APRN's electronic health
record system, the APRN shall make a concurrent note in the patient's record
documenting the date and time that the APRN reviewed the patient's KASPER
report.
(6) These requirements may
be satisfied by other licensed practitioners in a single group practice if:
(a) Each licensed practitioner involved has
lawful access to the patient's medical record;
(b) Each licensed practitioner performing an
action to meet these requirements is acting within the scope of practice of his
or her profession; and
(c) There is
adequate documentation in the patient's medical record reflecting the actions
of each practitioner.
(7) If prescribing a controlled substance for
the treatment of chronic, non-cancer pain, the APRN. In addition to the
requirements of this section, shall obtain a baseline drug screen and further
random drug screens if the APRN:
(a) Finds a
drug screen clinically appropriate; or
(b) Believes that it is appropriate to
determine whether or not the controlled substance is being taken by the
patient.
(8) If
prescribing a controlled substance for the treatment of a mental health
condition, the APRN shall meet the requirements of this section and
KRS 314.011(8)(a) and
(b).
(9) Prior to prescribing a controlled
substance for a patient in the emergency department of a hospital that is not
an emergency situation, the APRN shall:
(a)
Obtain the patient's medical history, conduct an examination of the patient,
and document the information in the patient's medical record. An APRN certified
in psychiatric - mental health shall obtain a medical and psychiatric history,
perform a mental health assessment, and document the information in the
patient's medical record;
(b) Query
KASPER for the twelve (12) month period immediately preceding the request for
available data on the patient and document the data in the patient's
record;
(c) Develop a written
treatment plan stating the objectives of the treatment and further diagnostic
examinations required; and
(d)
Discuss the risks and benefits of the use of controlled substances with the
patient, the patient's parent if the patient is an unemancipated minor child,
the patient's legal guardian, or health care surrogate, including the risks of
tolerance and drug dependence, and document that the discussion occurred and
that the patient consented to that treatment.
(10) For each patient for whom an APRN
prescribes a controlled substance, the APRN shall keep accurate, readily
accessible, and complete medical records, which include:
(a) Medical history and physical or mental
health examination;
(b) Diagnostic,
therapeutic, and laboratory results;
(c) Evaluations and consultations;
(d) Treatment objectives;
(e) Discussion of risk, benefits, and
limitations of treatments;
(f)
Treatments;
(g) Medications,
including date, type, dosage, and quantity prescribed;
(h) Instructions and agreements;
(i) Periodic reviews of the patient's file;
and
(j) All KASPER report
identification numbers and the date of issuance of each KASPER
report.
(11) The
requirement to query KASPER shall not apply to:
(a) An APRN prescribing or administering a
controlled substance immediately prior to, during, or within the fourteen (14)
days following an operative or invasive procedure or a delivery if the
prescribing or administering is medically related to the operative or invasive
procedure of the delivery and the medication usage does not extend beyond the
fourteen (14) days;
(b) An APRN
prescribing or administering a controlled substance necessary to treat a
patient in an emergency situation; or
(c) An APRN prescribing a controlled
substance:
1. For administration in a hospital
or long-term-care facility with an institutional account, or an APRN in a
hospital or facility without an institutional account, if the hospital,
long-term-care facility, or licensee queries KASPER for all available data on
the patient or resident for the twelve (12) month period immediately preceding
the query within twelve (12) hours of the patient's or resident's admission and
places a copy of the query in the patient's or resident's medical records
during the duration of the patient's stay at the facility;
2. As part of the patient's hospice or
end-of-life treatment;
3. For the
treatment of pain associated with cancer or with the treatment of
cancer;
4. To assist a patient with
submitting to a diagnostic test or procedure;
5. Within seven (7) days of an initial
prescription pursuant to subsection (1) of this section if the prescriber:
a. Substitutes a controlled substance for the
initial prescribing;
b. Cancels any
refills for the initial prescription; and
c. Requires the patient to dispose of any
remaining unconsumed medication;
6. Within ninety (90) days of an initial
prescription pursuant to subsection (1) of this section if the prescribing is
done by another licensee in the same practice or in an existing coverage
arrangement, if done for the same patient for the same condition;
7. To a research subject enrolled in a
research protocol approved by an institutional review board that has an active
federal-wide assurance number from the United States Department of Health and
Human Services, Office for Human Research Protections if the research involves
single, double, or triple blind drug administration or is additionally covered
by a certificate of confidentiality from the National Institutes of
Health;
8. During the effective
period of any disaster or situation with mass casualties that have a direct
impact on the APRN's practice;
9.
As part of the administering or ordering of controlled substances to prisoners
in a state, county, or municipal correctional facility;
10. That is a Schedule IV controlled
substance for no longer than three (3) days for an established patient to
assist the patient in responding to the anxiety of a nonrecurring event;
or
11. That is classified as a
Schedule V controlled substance.
(12) In accordance with
21
C.F.R. 1306.12(b)(1)(iv) -
(v), federal regulation
21
C.F.R. 1306.12(b) concerning
the issuance of multiple prescriptions for Schedule II controlled substances
shall not apply to APRNs in this state.
(13) No less than once every six (6) months,
an APRN who holds a DEA Controlled Substance Registration Certificate shall
review a reverse KASPER report for the preceding six (6) months to determine if
the information contained in KASPER is correct. If the information is
incorrect, the APRN shall comply with
902
KAR 55:110 and take the necessary steps to seek
correction of the information, by:
(a) First
contacting the reporting pharmacy;
(b) Contacting law enforcement if suspected
fraudulent activity; or
(c)
Contacting the Drug Enforcement Professional Practices Branch, Office of
Inspector General, Cabinet for Health and Family Services.
(14) An APRN shall not issue a prescription
for hydrocodone combination products for more than a three (3) day supply if
the prescription is intended to treat pain as an acute medical condition,
except if:
(a) The APRN, in his or her
professional judgment, believes that more than a three (3) day supply of
hydrocodone combination products is medically necessary to treat the patient's
pain as an acute medical condition and the APRN adequately documents the acute
medical condition and lack of alternative treatment options that justifies
deviation from the three (3) day supply limit on the patient's medical
records;
(b) The prescription for
hydrocodone combination products is prescribed to treat chronic pain;
(c) The prescription for hydrocodone
combination products is prescribed to treat pain associated with a valid cancer
diagnosis;
(d) The prescription for
hydrocodone combination products is prescribed to treat pain while the patient
is receiving hospice or end-of-life treatment;
(e) The prescription for hydrocodone
combination products is prescribed as part of a narcotic treatment program
licensed by the Cabinet for Health and Family Services;
(f) The prescription for hydrocodone
combination products is prescribed to treat pain following a major surgery,
which is any operative or invasive procedure or a delivery, or the treatment of
significant trauma; or
(g)
Hydrocodone combination products are administered directly to an ultimate user
in an inpatient setting.
(15) Prescriptions written for hydrocodone
combination products pursuant to subsection (14)(a) through (g) of this section
shall not exceed thirty (30) days without any refill.
(16) An APRN may prescribe electronically.
Electronic prescription shall be as established in
KRS
218A.171.
(17) For any prescription for a controlled
substance, the prescribing APRN shall discuss with the patient the effect the
patient's medical condition and medication may have on the patient's ability to
safely operate a vehicle in any mode of transportation.
Section 10. Immediate Family and
Self-prescribing or Administering Medications.
(1) An APRN shall not self-prescribe or
administer controlled substances.
(2) An APRN shall not prescribe or administer
controlled substances to his or her immediate family except as established in
subsections (3) and (4) of this section.
(3) An APRN may prescribe or administer
controlled substances to an immediate family member:
(a) In an emergency situation;
(b) For a single episode of an acute illness
through one (1) prescribed course of medication; or
(c) In an isolated setting, if no other
qualified practitioner is available.
(4)
(a) An
APRN who prescribes or administers controlled substances for an immediate
family member pursuant to subsections (3)(a) or (b) of this section shall
document all relevant information and notify the appropriate
provider.
(b) An APRN who
prescribes or administers controlled substances for an immediate family member
pursuant to subsection (3)(c) of this section shall maintain a
provider-practitioner relationship and appropriate patient records.
Section 11.
Incorporation by Reference.
(1) The following
material is incorporate by reference:
(a)"AACN
Scope and Standards for Acute Care Nurse Practitioner Practice", 2017 Edition,
American Association of Critical-Care Nurses;
(b) "ACCN Scope and Standards for Acute Care
Clinical Nurse Specialist Practice", 2014 Edition, American Association of
Critical-Care Nurses;
(c) "Neonatal
Nursing: Scope and Standards of Practice", 2013 Edition, American Nurses
Association/ National Association of Neonatal Nurses;
(d) "Nursing: Scope and Standards of
Practice", 2015 Edition, American Nurses Association;
(e) "Pediatric Nursing: Scope and Standards
of Practice", 2015 Edition, American Nurses Association/ Society of Pediatric
Nursing/ National Association of Pediatric Nurse Practitioners;
(f) "Psychiatric-Mental Health Nursing: Scope
and Standards of Practice", 2014, American Nurses Association/ American
Psychiatric Nursing Association;
(g) "Scope of Practice for Nurse
Practitioners", 2019 Edition, American Association of Nurse
Practitioners;
(h) "Standards of
Practice for Nurse Practitioners", 2019 Edition, American Association of Nurse
Practitioners;
(i) "Scope of Nurse
Anesthesia Practice", 2013 Edition, American Association of Nurse
Anesthetists;
(j) "Standards for
Nurse Anesthesia Practice", 2019 Edition, American Association of Nurse
Anesthetists;
(k) "Standards for
Office Based Anesthesia Practice", 2019 Edition, American Association of Nurse
Anesthetists;
(l) "Standards for
the Practice of Midwifery", 2011 Edition, American College of Nurse
Mid-wives;
(m) "Oncology Nursing
Scope and Standards of Practice", 2019 Edition, Oncology Nursing
Society;
(n) "The Women's Health
Nurse Practitioner: Guidelines for Practice and Education", 2014 Edition,
Association of Women's Health, Obstetric and Neonatal Nurses/Nurse
Practitioners in Women's Health;
(o) "Definition of Midwifery and Scope of
Practice of Certified Nurse-Midwives and Certified Midwives", 2012 Edition,
American College of Nurse Midwives;
(p) "Standards for Professional Nursing
Practice in the Care of Women and Newborns", 2019 Edition, Association of
Women's Health, Obstetric and Neonatal Nurses;
(q) "APRN Prescriptive Authority Notification
Form", 6/2018, Kentucky Board of Nursing; and
(r) "Common CAPA-NS Form", 6/2015, Kentucky
Board of Nursing.
(2)
This material may be inspected, copied, or obtained, subject to applicable
copyright law, at the Kentucky Board of Nursing, 312 Whittington Parkway, Suite
300, Louisville, Kentucky 40222, Monday through Friday, 8 a.m. to 4:30 p.m.
This material is also available on the board's Web site at
https://kbn.ky.gov/legalopinions/Pages/laws.aspx.
STATUTORY AUTHORITY:
KRS
218A.205(3)(a), (b),
314.131(1),
314.193(2)