(A) For purposes of this rule and rule
4723-8-13 of the Administrative Code, practitioner means an advanced practice
registered nurse licensed under Chapter 4723. of the Revised Code and
practicing in Ohio as a certified nurse-midwife, certified nurse practitioner,
or clinical nurse specialist.
(B) Requirements of a consult agreement
(1) A consult agreement shall include all
of the following:
(a) Identification of the practitioner(s) and pharmacist(s)
authorized to enter the agreement. They may include:
(i) Individual names of the practitioner(s) and
pharmacists;
(ii) Practitioner or pharmacist practice
groups;
(iii) Identification based on institutional credentialing or
privileging; or
(iv) If multiple
practitioners are entering the consult agreement, identification of the primary
practitioner for the patient.
(b) A description of the patient's consent to drug
therapy management pursuant to the consult agreement in compliance with
paragraph (E) of rule 4729:1-06-01 of the Administrative Code.
(c) The specific diagnoses and diseases being managed under
the agreement, including whether each disease is primary or
comorbid.
(d) A description of the drugs or drug categories managed
as part of the agreement.
(e) A description of the procedures, decision criteria, and
plan the managing pharmacist is to follow in acting under a consult agreement.
Such a description should provide a reasonable set of parameters for the
activities a managing pharmacist is allowed to perform under a consult
agreement.
(f) A description of the types of tests permitted pursuant
to section 4729.39 of the Revised Code that may be ordered and evaluated by the
managing pharmacist as long as the tests relate directly to the management of
drug therapy. This may include specific tests or categories of testing that may
be ordered and evaluated.
(g) A description of how the managing pharmacist shall
maintain a record of each action taken for each patient whose drug therapy is
managed under the agreement. All prescribing, administering, and dispensing of
drugs shall be documented using positive identification pursuant to paragraph
(N) of rule 4729-5-01 of the Administrative Code.
(h) A description of how communication between a managing
pharmacist and practitioner acting under a consult agreement shall take place
at regular intervals specified by the practitioner who authorized the
agreement. The agreement may include a requirement that the managing pharmacist
send a consult report to each consulting practitioner.
(i) A provision that allows a practitioner to override a
decision made by the managing pharmacist when appropriate.
(j) An appropriate quality assurance mechanism to ensure
that managing pharmacists only act within the scope authorized by the consult
agreement.
(k) A description of a continuous quality improvement (CQI)
program used to evaluate effectiveness of patient care and ensure positive
patient outcomes. The CQI program shall be implemented pursuant to the
agreement.
(l) The training and experience criteria for managing
pharmacists. The criteria may include privileging or credentialing, board
certification, continuing education or any other training requirements. The
agreement shall include a process to verify that the managing pharmacists meet
the specified criteria.
(m) A statement that the practitioner(s) and pharmacists
shall meet minimal standards of care at all times.
(n) An effective date and expiration date.
(o) Any other requirements contained in rules 4729:1-6-01,
4729:1-6-02 and 4729:1-6-03 of the Administrative Code.
(2) Institutional or ambulatory
outpatient facilities may implement a consult agreement and meet the
requirements of paragraphs (A)(1)(c) to (A)(1)(f) of this rule through
institutional credentialing standards or policies. Such standards or policies
shall be referenced as part of the consult agreement and available to an agent
of the board upon request.
(3) The consult agreement shall be signed
by the primary practitioner and one of the following:
(a) The terminal distributor's responsible person,
which may include the responsible person's designee if the designee meets
the qualifications of the responsible person pursuant to Chapter 4729. of the
Revised Code; or
(b) A managing pharmacist licensed pursuant to Chapter
4729. of the Revised Code.
(4) All amendments to a
consult agreement shall be signed and dated by the primary practitioner and one
of the following:
(a) The terminal distributor's responsible person,
which may include the responsible person's designee if the designee meets
the qualifications of the responsible person pursuant to Chapter 4729. of the
Revised Code; or
(b) A managing pharmacist licensed pursuant to Chapter
4729. of the Revised Code.
(c) Amendments to the consult agreement are required when
the scope of the managing pharmacist's permitted procedures expands past
what was contemplated in the original agreement.
(5) A consult agreement
shall be valid for a period not to exceed two years.
(6) A practitioner may
enter a consult agreement with an Ohio licensed pharmacist if the physician or
podiatrist with whom the practitioner collaborates, with respect to patient(s)
that are the proposed subjects of consult agreements, has authorized in the
standard care agreement that the practitioner may enter consult agreements for
those patient(s).
(C) Recordkeeping. The primary practitioner, practitioner
group or institution as defined in agency 4729 of the Administrative Code shall
maintain a copy of the original consult agreement, all amendments made to the
agreement, and a record of actions made in consultation with the managing
pharmacist regarding each patient's drug therapy. The records shall be
maintained in such a manner that they are readily retrievable for at least
three years from the date of the last action taken under the agreement. Consult
agreements shall be considered confidential patient records.
(D) Managing drug therapy.
(1) For purposes of
implementing the management of a patient's drug therapy by an authorized
managing pharmacist acting pursuant to a consult agreement, the primary
practitioner must:
(a) Provide the managing pharmacist with access to the
patient's medical record;
(b) Establish the managing pharmacist's prescriptive
authority as one or both of the following:
(i) A prescriber
authorized to issue a drug order in writing, orally, by a manually signed drug
order sent via facsimile or by an electronic prescribing system for drugs or
combinations or mixtures of drugs to be used by a particular patient as
authorized by the consult agreement. For all prescriptions issued by a
pharmacist pursuant to this paragraph, the pharmacist shall comply with rules
4729-5-30 and 4729-5-13 of the Administrative Code; and or
(ii) With respect to
non-controlled dangerous drugs only, an agent of the consulting
practitioner(s). As an agent of the consulting practitioner(s), a pharmacist is
authorized to issue a drug order, on behalf of the consulting practitioner(s),
in writing, orally, by a manually signed drug order sent via facsimile or by an
electronic prescribing system for drugs or combinations or mixtures of drugs to
be used by a particular patient as authorized by the consult
agreement;
(c) Specifically authorize the managing pharmacist's
ability to:
(i) Change the duration
of treatment for the current drug therapy; adjust a drug's strength, dose,
dosage form, frequency of administration, route of administration, discontinue
a drug, or to prescribe new drugs; and or
(ii) Order tests related
to the drug therapy being managed and to evaluate those results;
and
(d) Identify the extent to which, and to whom, the managing
pharmacist may delegate drug therapy management to other authorized pharmacists
under the agreement.
(E) Review of consult agreements. Upon the request of the
board, the practitioner shall immediately provide a copy of the consult
agreement, amendments, and any related policies or documentation pursuant to
this rule and section 4729.39 of the Revised Code. The board may prohibit the
execution of a consult agreement, or subsequently void a consult agreement, if
the board finds any of the following:
(1) The agreement does
not meet the requirements set forth in section 4729.39 of the Revised Code or
Chapter 4723. of the Administrative Code; or
(2) The consult
agreement, if executed, would present a danger to patient safety.