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S. B. No. 240 As IntroducedAs Introduced
130th General Assembly | Regular Session | 2013-2014 |
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Cosponsors:
Senators Manning, Patton
A BILL
To amend sections 4729.01 and 4729.39 of the Revised
Code to revise the laws governing pharmacist
consult agreements and to authorize a pharmacist
to prescribe and administer drugs under a consult
agreement.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:
Section 1. That sections 4729.01 and 4729.39 of the Revised
Code be amended to read as follows:
Sec. 4729.01. As used in this chapter:
(A) "Pharmacy," except when used in a context that refers to
the practice of pharmacy, means any area, room, rooms, place of
business, department, or portion of any of the foregoing where the
practice of pharmacy is conducted.
(B) "Practice of pharmacy" means providing pharmacist care
requiring specialized knowledge, judgment, and skill derived from
the principles of biological, chemical, behavioral, social,
pharmaceutical, and clinical sciences. As used in this division,
"pharmacist care" includes the following:
(1) Interpreting prescriptions;
(2) Dispensing drugs and drug therapy related devices;
(4) Counseling individuals with regard to their drug therapy,
recommending drug therapy related devices, and assisting in the
selection of drugs and appliances for treatment of common diseases
and injuries and providing instruction in the proper use of the
drugs and appliances;
(5) Performing drug regimen reviews with individuals by
discussing all of the drugs that the individual is taking and
explaining the interactions of the drugs;
(6) Performing drug utilization reviews with licensed health
professionals authorized to prescribe drugs when the pharmacist
determines that an individual with a prescription has a drug
regimen that warrants additional discussion with the prescriber;
(7) Advising an individual and the health care professionals
treating an individual with regard to the individual's drug
therapy;
(8) Acting pursuant to a consult agreement with a physician
one or more physicians authorized under Chapter 4731. of the
Revised Code to practice medicine and surgery or osteopathic
medicine and surgery, if an agreement has been established with
the physician;
(9) Engaging in the administration of immunizations to the
extent authorized by section 4729.41 of the Revised Code.
(C) "Compounding" means the preparation, mixing, assembling,
packaging, and labeling of one or more drugs in any of the
following circumstances:
(1) Pursuant to a prescription issued by a licensed health
professional authorized to prescribe drugs;
(2) Pursuant to the modification of a prescription made in
accordance with a consult agreement;
(3) As an incident to research, teaching activities, or
chemical analysis;
(4) In anticipation of orders for drugs pursuant to
prescriptions, based on routine, regularly observed dispensing
patterns;
(5) Pursuant to a request made by a licensed health
professional authorized to prescribe drugs for a drug that is to
be used by the professional for the purpose of direct
administration to patients in the course of the professional's
practice, if all of the following apply:
(a) At the time the request is made, the drug is not
commercially available regardless of the reason that the drug is
not available, including the absence of a manufacturer for the
drug or the lack of a readily available supply of the drug from a
manufacturer.
(b) A limited quantity of the drug is compounded and provided
to the professional.
(c) The drug is compounded and provided to the professional
as an occasional exception to the normal practice of dispensing
drugs pursuant to patient-specific prescriptions.
(D) "Consult agreement" means an agreement to manage an
individual's drug therapy that has been entered into by a
pharmacist and a physician authorized under Chapter 4731. of the
Revised Code to practice medicine and surgery or osteopathic
medicine and surgery under section 4729.39 of the Revised Code.
(1) Any article recognized in the United States pharmacopoeia
and national formulary, or any supplement to them, intended for
use in the diagnosis, cure, mitigation, treatment, or prevention
of disease in humans or animals;
(2) Any other article intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease in humans or
animals;
(3) Any article, other than food, intended to affect the
structure or any function of the body of humans or animals;
(4) Any article intended for use as a component of any
article specified in division (E)(1), (2), or (3) of this section;
but does not include devices or their components, parts, or
accessories.
(F) "Dangerous drug" means any of the following:
(1) Any drug to which either of the following applies:
(a) Under the "Federal Food, Drug, and Cosmetic Act," 52
Stat. 1040 (1938), 21 U.S.C.A. 301, as amended, the drug is
required to bear a label containing the legend "Caution: Federal
law prohibits dispensing without prescription" or "Caution:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian" or any similar restrictive statement, or
the drug may be dispensed only upon a prescription;
(b) Under Chapter 3715. or 3719. of the Revised Code, the
drug may be dispensed only upon a prescription.
(2) Any drug that contains a schedule V controlled substance
and that is exempt from Chapter 3719. of the Revised Code or to
which that chapter does not apply;
(3) Any drug intended for administration by injection into
the human body other than through a natural orifice of the human
body.
(G) "Federal drug abuse control laws" has the same meaning as
in section 3719.01 of the Revised Code.
(H) "Prescription" means a written, electronic, or oral order
for drugs or combinations or mixtures of drugs to be used by a
particular individual or for treating a particular animal, issued
by a licensed health professional authorized to prescribe drugs.
(I) "Licensed health professional authorized to prescribe
drugs" or "prescriber" means an individual who is authorized by
law to prescribe drugs or dangerous drugs or drug therapy related
devices in the course of the individual's professional practice,
including only the following:
(1) A dentist licensed under Chapter 4715. of the Revised
Code;
(2) A clinical nurse specialist, certified nurse-midwife, or
certified nurse practitioner who holds a certificate to prescribe
issued under section 4723.48 of the Revised Code;
(3) An optometrist licensed under Chapter 4725. of the
Revised Code to practice optometry under a therapeutic
pharmaceutical agents certificate;
(4) A pharmacist licensed under this chapter acting under a
consult agreement;
(5) A physician authorized under Chapter 4731. of the Revised
Code to practice medicine and surgery, osteopathic medicine and
surgery, or podiatric medicine and surgery;
(5)(6) A physician assistant who holds a certificate to
prescribe issued under Chapter 4730. of the Revised Code;
(6)(7) A veterinarian licensed under Chapter 4741. of the
Revised Code.
(J) "Sale" and "sell" include delivery, transfer, barter,
exchange, or gift, or offer therefor, and each such transaction
made by any person, whether as principal proprietor, agent, or
employee.
(K) "Wholesale sale" and "sale at wholesale" mean any sale in
which the purpose of the purchaser is to resell the article
purchased or received by the purchaser.
(L) "Retail sale" and "sale at retail" mean any sale other
than a wholesale sale or sale at wholesale.
(M) "Retail seller" means any person that sells any dangerous
drug to consumers without assuming control over and responsibility
for its administration. Mere advice or instructions regarding
administration do not constitute control or establish
responsibility.
(N) "Price information" means the price charged for a
prescription for a particular drug product and, in an easily
understandable manner, all of the following:
(1) The proprietary name of the drug product;
(2) The established (generic) name of the drug product;
(3) The strength of the drug product if the product contains
a single active ingredient or if the drug product contains more
than one active ingredient and a relevant strength can be
associated with the product without indicating each active
ingredient. The established name and quantity of each active
ingredient are required if such a relevant strength cannot be so
associated with a drug product containing more than one
ingredient.
(5) The price charged for a specific quantity of the drug
product. The stated price shall include all charges to the
consumer, including, but not limited to, the cost of the drug
product, professional fees, handling fees, if any, and a statement
identifying professional services routinely furnished by the
pharmacy. Any mailing fees and delivery fees may be stated
separately without repetition. The information shall not be false
or misleading.
(O) "Wholesale distributor of dangerous drugs" means a person
engaged in the sale of dangerous drugs at wholesale and includes
any agent or employee of such a person authorized by the person to
engage in the sale of dangerous drugs at wholesale.
(P) "Manufacturer of dangerous drugs" means a person, other
than a pharmacist, who manufactures dangerous drugs and who is
engaged in the sale of those dangerous drugs within this state.
(Q) "Terminal distributor of dangerous drugs" means a person
who is engaged in the sale of dangerous drugs at retail, or any
person, other than a wholesale distributor or a pharmacist, who
has possession, custody, or control of dangerous drugs for any
purpose other than for that person's own use and consumption, and
includes pharmacies, hospitals, nursing homes, and laboratories
and all other persons who procure dangerous drugs for sale or
other distribution by or under the supervision of a pharmacist or
licensed health professional authorized to prescribe drugs.
(R) "Promote to the public" means disseminating a
representation to the public in any manner or by any means, other
than by labeling, for the purpose of inducing, or that is likely
to induce, directly or indirectly, the purchase of a dangerous
drug at retail.
(S) "Person" includes any individual, partnership,
association, limited liability company, or corporation, the state,
any political subdivision of the state, and any district,
department, or agency of the state or its political subdivisions.
(T) "Finished dosage form" has the same meaning as in section
3715.01 of the Revised Code.
(U) "Generically equivalent drug" has the same meaning as in
section 3715.01 of the Revised Code.
(V) "Animal shelter" means a facility operated by a humane
society or any society organized under Chapter 1717. of the
Revised Code or a dog pound operated pursuant to Chapter 955. of
the Revised Code.
(W) "Food" has the same meaning as in section 3715.01 of the
Revised Code.
(X) "Pain management clinic" has the same meaning as in
section 4731.054 of the Revised Code.
Sec. 4729.39. (A) A pharmacist One or more pharmacists may
enter into a consult agreement with a physician one or more
physicians authorized under Chapter 4731. of the Revised Code to
practice medicine and surgery or osteopathic medicine and surgery.
Under With respect to consult agreements, all of the following
apply:
(1) Under a consult agreement, a pharmacist is authorized to
manage an individual's drug therapy do both of the following, but
only to the extent specified in the agreement, this section, and
the rules adopted under this section:
(a) Manage an individual's drug therapy;
(B) All of the following apply to a consult agreement that
authorizes a pharmacist to manage the drug therapy of an
individual who is not a patient of a hospital, as defined in
section 3727.01 of the Revised Code, or a resident in a long-term
care facility, as defined in section 3729.01 of the Revised Code:
(1) A separate consult agreement must be entered into for
each individual whose drug therapy is to be managed by a
pharmacist. A consult agreement applies only to the particular
diagnosis for which a physician prescribed an individual's drug
therapy. If a different diagnosis is made for the individual, the
pharmacist and physician must enter into a new or additional
consult agreement.
(2) Management of an individual's drug therapy by a
pharmacist under a consult agreement may include monitoring and
modifying a prescription that has been issued for the individual.
Except as provided in section 4729.38 of the Revised Code for the
selection of generically equivalent drugs, management of an
individual's drug therapy by a pharmacist under a consult
agreement shall not include dispensing a drug that has not been
prescribed by the physician.
(3) Each consult agreement shall be in writing, except that a
consult agreement may be entered into verbally if it is
immediately reduced to writing.
(4) A physician entering into a consult agreement shall
specify in the agreement the extent to which the pharmacist is
authorized to manage the drug therapy of the individual specified
in the agreement.
(5) A physician entering into a consult agreement may specify
one other physician who has agreed to serve as an alternate
physician in the event that the primary physician is unavailable
to consult directly with the pharmacist. The pharmacist may
specify one other pharmacist who has agreed to serve as an
alternate pharmacist in the event that the primary pharmacist is
unavailable to consult directly with the physician.
(6) A consult agreement may not be implemented until it has
been signed by the primary pharmacist, the primary physician, and
the individual whose drug therapy will be managed or another
person who has the authority to provide consent to treatment on
behalf of the individual. Once the agreement is signed by all
required parties, the physician shall include in the individual's
medical record the fact that a consult agreement has been entered
into with a pharmacist.
(7) Prior to commencing any action to manage an individual's
drug therapy under a consult agreement, the pharmacist shall make
reasonable attempts to contact and confer with the physician who
entered into the consult agreement with the pharmacist. A
pharmacist may commence an action to manage an individual's drug
therapy prior to conferring with the physician or the physician's
alternate, but shall immediately cease the action that was
commenced if the pharmacist has not conferred with either
physician within forty-eight hours.
A pharmacist acting under a consult agreement shall maintain
a record of each action taken to manage an individual's drug
therapy. The pharmacist shall send to the individual's physician a
written report of all actions taken to manage the individual's
drug therapy at intervals the physician shall specify when
entering into the agreement. The physician shall include the
pharmacist's report in the medical records the physician maintains
for the individual.
(8)(2) A consult agreement may be terminated by either the
pharmacist or physician who entered into the agreement. By
withdrawing consent, the individual whose drug therapy is being
managed or the individual who consented to the treatment on behalf
of the individual may terminate a consult agreement. The
pharmacist or physician who receives the individual's withdrawal
of consent shall provide written notice to the opposite party. A
pharmacist or physician who terminates a consult agreement shall
provide written notice to the opposite party and to the individual
who consented to treatment under the agreement. The termination of
a consult agreement shall be recorded by the pharmacist and
physician in the records they maintain on the individual being
treated.
(9) Except as described in division (B)(5) of this section,
the authority of a pharmacist to manage an individual's drug
therapy under a consult agreement does not permit the pharmacist
to manage drug therapy prescribed by any other physician.
(C) All of the following apply to a consult agreement that
authorizes a pharmacist to manage the drug therapy of an
individual who is a patient of a hospital, as defined in section
3727.01 of the Revised Code, or a resident in a long-term care
facility, as defined in section 3729.01 of the Revised Code:
(1) Before a consult agreement may be entered into and
implemented, a hospital or long-term care facility shall adopt a
policy for consult agreements. For any period of time during which
a pharmacist or physician acting under a consult agreement is not
physically present and available at the hospital or facility, the
policy shall require that another pharmacist and physician be
available at the hospital or facility.
(2) The (3) A consult agreement shall be made in writing and
shall comply with the hospital's or facility's policy on consult
agreements.
(3)(4) The content of the a consult agreement shall be
communicated to the each individual whose drug therapy will be is
managed
in a manner consistent with the hospital's or facility's
policy on consult agreements under the agreement.
(4)(5) A pharmacist acting under a consult agreement shall
maintain in the individual's medical record a record of each
action taken for each individual whose drug therapy is managed
under the agreement.
(5)(6) Communication between a pharmacist and physician
acting under the a consult agreement shall take place at regular
intervals specified by the primary physician acting under the
agreement. The agreement may include a requirement that a
pharmacist send a consult report to each consulting physician.
(6)(7) A consult agreement may be terminated by the
individual, a person authorized to act on behalf of the
individual, the primary physician acting under the agreement, or
the primary pharmacist acting under the agreement. When a consult
agreement is terminated, all parties to the agreement shall be
notified and the termination shall be recorded in the individual's
medical record.
(7) The authority of a pharmacist acting under a (8) A
consult agreement does not permit the a pharmacist to act under
the agreement in a hospital long-term care facility at which the
pharmacist is not authorized to practice manage drug therapy
prescribed by a physician who has not entered into the agreement.
(D)(9) A pharmacist may prescribe or administer dangerous
drugs under a consult agreement, subject to the terms of the
agreement and in accordance with rules adopted under this section.
A physician who has entered into a consult agreement may limit the
categories of drugs a pharmacist may prescribe or administer under
the agreement.
(B) The state board of pharmacy, in consultation with the
state medical board, shall adopt rules to be followed by
pharmacists, and the state medical board, in consultation with the
state board of pharmacy, shall adopt rules to be followed by
physicians, that establish standards and procedures for entering
into a consult agreement and managing an individual's drug therapy
under a consult agreement. The boards shall specify in the rules
any categories of drugs or types of diseases for which a consult
agreement may not be established. Either board may adopt any other
rules it considers necessary for the implementation and
administration of this section. All rules adopted under this
division shall be adopted in accordance with Chapter 119. of the
Revised Code.
Section 2. That existing sections 4729.01 and 4729.39 of the
Revised Code are hereby repealed.
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