(A) Definitions; for purposes of this
rule and interpretation of the formulary set forth in paragraph (B) of this
rule, except as otherwise provided:
(1) "Acute
pain" means pain that normally fades with healing, is related to tissue
damage, significantly alters a patient's typical function, and is expected
to be time-limited and not more than six weeks in duration.
(2) "Chronic
pain" means pain that has persisted after reasonable medical efforts have
been made to relieve it and continues either episodically or continuously for
twelve or more weeks following initial onset of pain. It may be the result of
an underlying medical disease or condition, injury, medical treatment,
inflammation, or unknown cause. "Chronic pain" does not include pain
associated with a terminal condition or with a progressive disease that, in the
normal course of progression, may reasonably be expected to result in a
terminal condition.
(3) "Extended-release or long-acting
opioid analgesic" means an opioid analgesic that:
(a) Has United States food and drug administration approved
labeling indicating that it is an extended-release or controlled release
formulation;
(b) Is administered via a transdermal route; or
(c) Contains methadone.
(4) "Family member" means a
spouse, parent, child, sibling or other individual with respect to whom an
advanced practice registered nurse's personal or emotional involvement may
render the advanced practice registered nurse unable to exercise detached
professional judgment in reaching diagnostic or therapeutic
decisions.
(5) "Hospice care program" has
the same meaning as in section 3712.01 of the Revised Code.
(6) "ICD-10-CM medical diagnosis
code" means the disease code in the most current international
classification of diseases, clinical modifications published by the United
States department of health and human services.
(7) "Opioid analgesic" has the
same meaning as in section 3719.01 of the Revised Code, and means a controlled
substance that has analgesic pharmacological activity at the opioid receptors
of the central nervous system, including but not limited to the following drugs
and their varying salt forms or chemical congeners: buprenorphine, butorphanol,
codeine (including acetaminophen and other combination products),
dihydrocodeine, fentanyl, hydrocodone (including acetaminophen combination
products), hydromorphone, meperidine, methadone, morphine sulfate, oxycodone
(including acetaminophen, aspirin, and other combination products),
oxymorphone, tapentadol, and tramadol.
(8) "Medication
therapy management" has the same meaning as in rules adopted by agency
4729 of the Administrative Code.
(9) "Minor" has the same
meaning as in section 3719.061 of the Revised Code.
(10) "Morphine equivalent daily dose
(MED)" means a conversion of various opioid analgesics to a morphine
equivalent dose by the use of accepted conversion tables provided by the state
board of pharmacy at: https://www.ohiopmp.gov/MED_Calculator.aspx (effective
2017).
(11) "Palliative care" has the
same meaning as in section 3712.01 of the Revised Code.
(12) "Sub-acute
pain" means pain that has persisted after reasonable medical efforts have
been made to relieve it and continues either episodically or continuously for
more than six weeks but less than twelve weeks following initial onset of pain.
It may be the result of an underlying medical disease or condition, injury,
medical or surgical treatment, inflammation, or unknown cause.
(13) "Terminal condition" has
the same meaning as in section 2133.01 of the Revised Code.
(B) Exclusionary formulary. An advanced practice registered
nurse with a current valid license issued by the board and designated as a
certified nurse practitioner, clinical nurse specialist or certified nurse
midwife shall not prescribe or furnish any drug or device in violation of
federal or Ohio law, or rules adopted by the board, including this rule. The
prescriptive authority of an advanced practice registered nurse designated as a
certified nurse practitioner, clinical nurse specialist and certified nurse
midwife shall not exceed the prescriptive authority of the collaborating
physician or podiatrist.
(C) An advanced practice registered nurse with a current
valid license issued by the board and designated as a clinical nurse
specialist, certified nurse-midwife, or certified nurse practitioner may
prescribe any drug or therapeutic device in any form or route of administration
if:
(1) The ability to
prescribe the drug or therapeutic device is within the scope of practice in the
advanced practice registered nurse's license designation;
(2) The prescription is
consistent with the terms of a standard care arrangement entered into with a
collaborating physician;
(3) The prescription
would not exceed the prescriptive authority of the collaborating physician,
including restrictions imposed on the physician's practice by action of
the United States drug enforcement administration or the state medical board,
or by the state medical board rules, including but not limited to rule
4731-11-09 of the Administrative Code;
(4) The individual drug
or subtype or therapeutic device is not one excluded by the exclusionary
formulary set forth in paragraph (B ) of this rule;
(5) The prescription
meets the requirements of state and federal law, including but not limited to
this rule, and all prescription issuance rules adopted by agency 4729 of the
Administrative Code;
(6) A valid
prescriber-patient relationship exists. This relationship may include, but is
not limited to:
(a) Obtaining a relevant history of the patient;
(b) Conducting a physical or mental examination of the
patient;
(c) Rendering a diagnosis;
(d) Prescribing medication;
(e) Consulting with the collaborating physician when necessary;
and
(f) Documenting these steps in the patient's medical
records;
(7) Notwithstanding
paragraph (C)(6) of this rule, a clinical nurse specialist, certified
nurse-midwife, or certified nurse practitioner may prescribe or personally
furnish a drug according to section 4723.4810 of the Revised Code to not more
than a total of two individuals who are sexual partners of the advanced
practice registered nurse's patient.
(8) If the patient is a
family member, acceptable and prevailing standards of safe nursing care require
that the advanced practice registered nurse maintain detached professional
judgment. The advanced practice registered nurse shall not prescribe to a
family member unless:
(a) The advanced practice registered nurse is able to exercise
detached professional judgment in reaching diagnostic or therapeutic
decisions;
(b) The prescription is documented in the patient's
record.
(9) Controlled
substances. For drugs that are a controlled substance:
(a) The advanced practice registered nurse has obtained a United
States drug enforcement administration registration, except if not required to
do so as provided in rules adopted by agency 4729 of the Administrative Code,
and indicates the number on the prescription;
(b) The prescription indicates the ICD-10-CM medical diagnosis
code of the primary disease or condition that the controlled substance is being
used to treat. The code shall, at minimum, include the first four alphanumeric
characters of the ICD-10 CM medical diagnosis code, sometimes referred to as
the category and etiology (ex. M165);
(c) The prescription indicates the days' supply of the
controlled substance prescription.
(d) The patient is not a family member; and
(e) The advanced practice registered nurse shall not
self-prescribe a controlled substance.
(D) Schedule II controlled substances. Except as provided
in paragraph (E) of this rule, an advanced practice registered nurse with a
current valid license issued by the board and designated as a clinical nurse
specialist, certified nurse-midwife, or certified nurse practitioner may
prescribe a schedule II controlled substance only in situations where all of
the following apply:
(1) A patient has a
terminal condition;
(2) A physician initially
prescribed the substance for the patient; and
(3) The prescription is
for a quantity that does not exceed the amount necessary for the patient's
use in a single, seventy-two hour period.
(E) Subject to the requirements set forth in paragraphs (F)
and (J) of this rule, a clinical nurse specialist, certified nurse-midwife, or
certified nurse practitioner may prescribe a schedule II controlled substance,
if not excluded by the exclusionary formulary set forth in paragraph (B) of
this rule, if the advanced practice registered nurse issues the prescription to
the patient from any of the following locations:
(1) A hospital registered under section
3701.07 of the Revised Code;
(2) An entity owned or controlled, in
whole or in part, by a hospital or by an entity that owns or controls, in whole
or in part, one or more hospitals;
(3) A health care facility operated by
the department of mental health or the department of developmental
disabilities;
(4) A nursing home licensed under section
3721.02 of the Revised Code or by a political subdivision certified under
section 3721.09 of the Revised Code;
(5) A county home or district home
operated under Chapter 5155. of the Revised Code that is certified under the
medicare or medicaid program;
(6) A hospice care program;
(7) A community mental health agency, as
defined in section 5122.01 of the Revised Code;
(8) An ambulatory surgical facility, as
defined in section 3702.30 of the Revised Code;
(9) A freestanding birthing center, as
defined in section 3702.141 of the Revised Code;
(10) A federally qualified health center,
as defined in section 3701.047 of the Revised Code;
(11) A federally qualified health center
look-alike, as defined in section 3701.047 of the Revised Code;
(12) A health care office or facility
operated by the board of health of a city or general health district or the
authority having the duties of a board of health under section 3709.05 of the
Revised Code;
(13) A site where a medical practice is
operated, but only if the practice is comprised of one or more physicians who
also are owners of the practice; the practice is organized to provide direct
patient care; and the clinical nurse specialist, certified nurse-midwife, or
certified nurse practitioner providing services at the site has a standard care
arrangement and collaborates with at least one of the physician owners who
practices primarily at that site; or
(14) A residential care
facility, as defined in section 3721.01 of the Revised Code.
(F) An advanced practice registered nurse with a current
valid license issued by the board and designated as a clinical nurse
specialist, certified nurse-midwife, or certified nurse practitioner shall not
issue to a patient a prescription for a schedule II controlled substance from a
convenience care clinic even if the clinic is owned or operated by an entity
specified in paragraph (E) of this rule.
(G) Acute pain. For the treatment of acute pain, an
advanced practice registered nurse with a current valid license issued by the
board and designated as a clinical nurse specialist, certified nurse-midwife,
or certified nurse practitioner shall comply with the following:
(1) Extended-release or
long-acting opioid analgesics shall not be prescribed for the treatment of
acute pain;
(2) Before prescribing an
opioid analgesic, the advanced practice registered nurse shall first consider
non-opioid treatment options. If opioid analgesic medications are required as
determined by history and physical examination, the prescription should be for
the minimum quantity and potency needed to treat the expected duration of pain,
with a presumption that a three-day supply or less is frequently
sufficient;
(3) In all circumstances
where opioid analgesics are prescribed for acute pain:
(a) Except as provided in paragraph (G)(3)(a)(iii) of this rule,
the duration of the first opioid analgesic prescription for the treatment of an
episode of acute pain shall be:
(i) For adults, not more
than a seven-day supply with no refills;
(ii) For minors, not more
than a five-day supply with no refills. As set forth in section 4723.481 of the
Revised Code, the advanced practice registered nurse shall comply with section
3719.061 of the Revised Code, including but not limited to obtaining the parent
or guardian's written consent prior to prescribing an opioid analgesic to
a minor;
(iii) The seven-day limit
for adults and five-day limit for minors may be exceeded for pain that is
expected to persist for longer than seven days based on the pathology causing
the pain. In this circumstance, the reason that the limits are being exceeded
and the reason that a non-opioid analgesic medication was not appropriate to
treat the patient's condition shall be documented in the patient's
medical record; and
(iv) If a patient is
intolerant of or allergic to an opioid medication initially prescribed, a
prescription for a different opioid medication may be issued at any time during
the initial seven-day or five-day dosing period, and the new prescription shall
be subject to the requirements of this rule. The patient's intolerance or
allergy shall be documented in the patient's medical record, and the
patient advised to safely dispose of the unused medication;
(b) The patient, or a minor's parent or guardian, shall be
advised of the benefits and risks of the opioid analgesic, including the
potential for addiction, and the advice shall be documented in the
patient's medical record; and
(c) The total morphine equivalent dose (MED) of a prescription
for opioid analgesics for treatment of acute pain shall not exceed an average
of thirty MED per day, except when:
(i) The circumstances set
forth in paragraph (A)(3)(c) of rule 4731-11-13 of the Administrative Code
exist; and
(ii) The patient's
treating physician has entered a standard care arrangement with the advanced
practice registered nurse that states the understanding of the physician as to
when the advanced practice registered nurse may exceed the thirty MED average,
and when the advanced practice registered nurse must consult with the physician
prior to exceeding the thirty MED average. The standard care arrangement in
this circumstance must comply with rule 4731-11-13 of the Administrative Code,
and the advanced practice registered nurse must document in the patient's
record the reason for exceeding the thirty MED average and the reason it is the
lowest dose consistent with the patient's medical condition.
(H) The requirements of paragraph (G) of this rule apply to
treatment of acute pain, and do not apply when an opioid analgesic is
prescribed:
(1) To a patient in a
hospice care;
(2) To a patient who is
receiving palliative care;
(3) To a patient who has
been diagnosed with a terminal condition, as defined as follows:
(a) An irreversible, incurable, and untreatable condition caused
by disease, illness, or injury from which, to a reasonable degree of medical
certainty as determined in accordance with reasonable medical standards by a
physician who has examined the patient, both of the following
apply:
(i) There can be no
recovery; and
(ii) Death is likely to
occur within a relatively short time if life-sustaining treatment is not
administered; or
(4) To a patient who has
cancer or a condition associated with the individual's cancer or history
of cancer.
(I) The requirements of paragraph (G) of this rule do not
apply to:
(1) Prescriptions for
opioid analgesics for the treatment of opioid addiction utilizing a controlled
substance that is approved by the FDA for opioid detoxification or maintenance
treatment; or
(2) Inpatient
prescriptions as defined in rules adopted by agency 4729 of the Administrative
Code.
(J) Sub-acute and chronic pain. As specified in section
4723.481 of the Revised Code, for treatment of sub-acute and chronic pain, an
advanced practice registered nurse with a current valid license issued by the
board and designated as a clinical nurse specialist, certified nurse-midwife,
or certified nurse practitioner shall prescribe in a manner not exceeding the
prescriptive authority of the collaborating physician or podiatrist.
Prescribing parameters specifically include, but are not limited to, the
following requirements set forth in rule 4731-11-14 of the Administrative
Code:
(1) Prior to treating, or
continuing to treat sub-acute or chronic pain with an opioid analgesic, the
advanced practice registered nurse shall first consider and document
non-medication options. If opioid analgesic medications are required as
determined by a history and physical examination, the advanced practice
registered nurse shall prescribe the minimum quantity and potency needed to
treat the expected duration of pain and improve the patient's ability to
function;
(2) Before prescribing an
opioid analgesic for sub-acute or chronic pain, the advanced practice
registered nurse shall complete or update and document in the patient record
assessment activities to assure the appropriateness and safety of the
medication, as required by rule 4731-11-14 of the Administrative Code,
including but not limited to:
(a) Completing an OARRS check in compliance with rule 4723-9-12
of the Administrative Code;
(b) Offering the patient a prescription for naloxone if the
following circumstances exist:
(i) The patient has a
prior history of opioid overdose;
(ii) The patient is
co-prescribed a benzodiazepine, sedative hypnotic drug, carisprodal, tramadol,
or gabapentin;
(iii) The patient has a
concurrent substance use disorder; or
(iv) The dosage exceeds
eighty MED as discussed in paragraph (J)(5) of this rule;
(c) The advanced practice registered nurse shall consider
offering the patient a prescription for naloxone if the dosage exceeds fifty
MED as discussed in paragraph (J)(4) of this rule.
(3) During the course of
treatment with an opioid analgesic at doses below the average of fifty MED per
day, the advanced practice registered nurse shall provide periodic follow-up
assessment and documentation of the patient's functional status, the
patient's progress toward treatment objectives, indicators of possible
addiction, drug abuse or diversion, and any adverse drug effects.
(4) Fifty MED. Prior to
increasing the opioid dosage to a daily average of fifty MED or greater, the
advanced practice registered nurse shall complete and document in the patient
record the activities and information set forth in rule 4731-11-14 of the
Administrative Code, including but not limited to the following:
(a) Review and update the assessment completed in paragraph
(J)(2) of this rule if needed. The advanced practice registered nurse may rely
on an appropriate assessment completed within a reasonable time if the advanced
practice registered nurse is satisfied that he or she may rely on that
information for purposes of meeting the requirements of Chapter 4723-8 and
Chapter 4723-9 of the Administrative Code;
(b) Except when the patient was prescribed an average daily
dosage that exceeded fifty MED before the effective date of this rule, document
consideration of:
(i) Consultation with a
specialist in the area of the body affected by the pain;
(ii) Consultation with a
pain management specialist;
(iii) Obtaining a
medication therapy management review by a pharmacist;
(iv) Consultation with a
specialist in addiction medicine or addiction psychiatry, if aberrant behaviors
indicating medication misuse or substance use disorder are noted;
(c) The advanced practice registered nurse shall consider
offering the patient a prescription for naloxone if the dosage exceeds fifty
MED as discussed in paragraph (J)(4) of this rule;
(d) During the course of treatment with an opioid analgesic at
doses at or above the average of fifty MED per day, the advanced practice
registered nurse shall complete and document in the patient record all of the
information and activities required by rule 4731-11-14 of the Administrative
Code not less than every three months.
(5) Eighty MED. Prior to
increasing the opioid dosage to a daily average of eighty MED or greater, the
advanced practice registered nurse shall complete and document in the patient
record the activities and information set forth in rule 4731-11-14 of the
Administrative Code, including but not limited to the following:
(a) A written pain management agreement shall be entered with the
patient that outlines the advanced practice registered nurse's and
patient's responsibilities during treatment, which requires the patient or
patient guardian's agreement to all of the provisions set forth in rule
4731-11-14 of the Administrative Code;
(b) The advanced practice registered nurse shall offer the
patient a prescription for naloxone;
(c) Except when the patient was prescribed an average daily
dosage that exceeded eighty MED before the effective date of this rule, the
advanced practice registered nurse shall obtain at least one of the following
based upon the patient's clinical presentation:
(i) Consultation with a
specialist in the area of the body affected by the pain;
(ii) Consultation with a
pain management specialist;
(iii) A medication
therapy management review by a pharmacist; or
(iv) Consultation with a
specialist in addiction medicine or addiction psychiatry, if aberrant behaviors
indicating medication misuse or substance use disorder are noted.
(6) One hundred twenty
MED. The advanced practice registered nurse shall not prescribe a dosage that
exceeds an average of one hundred twenty MED per day. This prohibition shall
not apply under the following circumstances:
(a) The advanced practice registered nurse holds national
certification by a national certifying organization approved according to
section 4723.46 of the Revised Code in:
(i) Pain
management;
(ii) Hospice and
palliative care;
(iii) Oncology;
or
(iv) Hematology, or
coursework in hematology leading to certification in oncology;
(b) The advanced practice registered nurse of has received a
written recommendation for a dosage exceeding an average of one hundred twenty
MED per day from a board certified pain medicine physician, a board certified
hospice and palliative care physician, or a board certified oncology or
hematology physician, who based the recommendation on a face-to-face visit and
examination of the patient. The advanced practice registered nurse shall
maintain the written recommendation in the patient's record;
or
(c) The patient was receiving an average daily dose of one
hundred twenty MED or more prior to the effective date of this rule. However,
prior to escalating the patient's dose, the advanced practice registered
nurse shall receive a written recommendation as set forth in paragraph
(J)(6)(b) of this rule.
(7) The requirements of
paragraph (J) of this rule do not apply when an opioid analgesic is
prescribed:
(a) To a patient in hospice care;
(b) To an patient who has terminal cancer or another terminal
condition, as defined as follows:
An irreversible, incurable, and untreatable
condition caused by disease, illness, or injury from which, to a reasonable
degree of medical certainty as determined in accordance with reasonable medical
standards by a physician who has examined the patient, both of the following
apply:
(i) There can be no
recovery; and
(ii) Death is likely to
occur within a relatively short time if life-sustaining treatment is not
administered; or
(c) As an inpatient prescription as defined in rules adopted by
agency 4729 of the Administrative Code.
(K) As specified in section 4723.44 of the Revised Code, an
advanced practice registered nurse designated as a clinical nurse specialist,
certified nurse-midwife, or certified nurse practitioner shall not prescribe
any drug or device to perform or induce an abortion, as that term is defined in
section 2919.11 of the Revised Code.
(L) As specified in section 4723.488 of the Revised Code,
notwithstanding the requirements of this rule, an advanced practice registered
nurse with a current valid license issued by the board and designated as a
clinical nurse specialist, certified nurse-midwife, or certified nurse
practitioner may prescribe or personally furnish naloxone.
(M) The requirements of paragraph (C)(9)(c) of this rule
apply to prescriptions for products that contain gabapentin.
(N) The advanced practice registered nurse may enter
consult agreements with pharmacists in accordance with section 4729.39 of the
Revised Code and rules 4723-8-12 and 4723-8-13 of the Administrative Code.
