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(123rd General Assembly)(Amended Substitute Senate Bill Number 248)
AN ACT
To amend section 4729.01 and to enact section 4729.41 of the
Revised Code to establish standards for the administration of certain adult
immunizations by pharmacists.
Be it enacted by the General Assembly of the State of Ohio:
SECTION 1 . That section 4729.01 be amended and section 4729.41 of
the Revised Code be enacted 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) Compounding or dispensing drugs and dispensing drug therapy
related devices; (3) 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; (4) Performing drug regimen reviews with individuals
by discussing all of the drugs that the individual is taking and
explaining the interactions of the drugs; (5) 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; (6) Advising an individual and the health care
professionals treating an individual with regard to the
individual's drug therapy; (7) Acting pursuant to a consult agreement with a
physician 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; (8) Administering by injection the adult immunizations specified in
section 4729.41 of the Revised Code, if the pharmacist has met the requirements of that
section. (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 prescription drug orders based
on routine, regularly observed dispensing patterns. (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. (E) "Drug" means: (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 (C)(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) Until three years and eight months after the effective date
of this amendment JANUARY 17, 2000, an advanced
practice nurse
approved
under section
4723.56 of the Revised Code to prescribe drugs and therapeutic
devices; (3) 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; (4) An optometrist licensed under
Chapter 4725. of the Revised
Code to practice optometry
under a therapeutic pharmaceutical agents certificate; (5) A physician authorized under
Chapter 4731. of the Revised Code to practice medicine and surgery,
osteopathic medicine and surgery, or podiatry; (6) 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. (4) The dosage form; (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. Sec. 4729.41. (A) A pharmacist licensed under this chapter who
meets the requirements of division (B) of this section may
administer, by injection, adult immunizations for any of the
following: (1) Influenza; (2) Pneumonia; (3) Tetanus; (4) Hepatitis A; (5) Hepatitis B. (B) To be authorized to administer the adult immunizations
specified in division (A) of this section, a pharmacist shall do all
of the following: (1) Successfully complete a course in the administration of
adult immunizations that has been approved by the state board of pharmacy
as meeting the standards established for such courses by the centers for
disease control and prevention in the public health service of the
United States department of health and human services; (2) Receive and maintain certification to perform basic
life-support procedures by successfully completing a basic life-support
training course certified by the American red cross or
American heart association; (3) Practice in accordance with a definitive set of treatment
guidelines specified in a protocol established by a physician and approved by
the state board of
pharmacy. The protocol shall include provisions requiring that the
pharmacist
do both of the following: (a) Observe an individual who has been immunized by the
pharmacist to determine whether the individual has an adverse reaction to the
immunization. The length of time and
location of the observation shall be specified in rules adopted by
the state board of pharmacy under division (D) of this section. (b) Not later than thirty days after administering an
adult immunization to an individual, notify the individual's family
physician or, if the individual has no family physician, the board
of health of the health district in which the individual resides. (C) No pharmacist shall do either of the following: (1) Engage in the administration of adult immunizations by injection
unless the requirements of division (B) of this section have been
met; (2) Delegate to any person the
pharmacist's authority to administer adult immunizations. (D) The state board of pharmacy shall adopt rules
to implement this section, including rules for approval of courses in
administration of adult immunizations and approval of protocols to
be followed by pharmacists in administering adult immunizations. Prior to
adopting the rules regarding approval of protocols, the state board of
pharmacy shall consult with the state medical board and the board of nursing.
The rules shall be adopted in accordance with Chapter 119. of the
Revised Code. SECTION 2 . That existing section 4729.01 of the Revised Code is
hereby repealed.
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