Ohio Administrative Code
Title 4731 - State Medical Board
Chapter 4731-35 - Consult Agreements Between Physicians and Pharmacists
Section 4731-35-01 - Consult agreements
Universal Citation: OH Admin Code 4731-35-01
Current through all regulations passed and filed through December 16, 2024
(A) For purposes of this chapter, practitioner includes the following:
(1)
Physician
authorized to practice medicine and surgery or osteopathic medicine and surgery
under chapter 4731 of the revised code.
(2)
Physician
assistant who is licensed to practice as a physician assistant under Chapter
4730. of the Revised Code, holds a valid prescriber number issued by the state
medical board, and has been granted physician-delegated prescriptive
authority.
(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
into the agreement. They may include:
(i)
Individual names of practitioners and pharmacists;
(ii)
Practitioner or pharmacist practice
groups; or
(iii) Identification
based on institutional credentialing or privileging.
(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 as set forth in
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 of 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 agency 4729 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
practitioners and pharmacists shall meet minimal and
prevailing 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 agreement shall be signed by the
primary practitioner, which may include a medical director or
designee if the designee is licensed pursuant to Chapter 4731. of the Revised
Code, 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, which may include a medical director or
designee if the designee is licensed pursuant to Chapter 4731. of the Revised
Code, 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 withing the agreement
(5) A consult agreement shall be valid for a
period not to exceed two years.
(6)
Only the following Ohio licensed
practitioners practicing in Ohio and Ohio licensed
pharmacists may participate in a consult agreement pursuant to section
4729.39 of the Revised Code.
(a)
Physicians
(b)
Physician
assistants if entering into a consult agreement is authorized by one or more
supervising physicians under a supervision agreement under section
4730.19 of the Revised Code;
and
(c)
Clinical nurse specialists, certified nurse-midwives,
or certified nurse practitioners, if entering into a consult agreement is
authorized by one or more collaborating physician.
(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, and all amendments made thereafter, and a record of actions made in consultation with the managing pharmacist regarding each patient's drug therapy. These 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. Such consult agreements shall be considered confidential patient records.
(D) Managing drug therapy.
(1) For the purpose 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; and
(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 Chapter 4729:5-5 of the
Administrative Code for outpatient and Chapter
4729:5-9 of the Administrative Code for
inpatient; 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, and
(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 state medical board, the primary practitioner shall immediately provide a copy of the consult agreement, amendments, and any relating policies or documentation pursuant to this rule and section 4729.39 of the Revised Code. The state medical 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
this division of the administrative code; or
(2) The consult agreement, if executed, would
present a danger to patient safety.
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