09 LC 33
2910S
The House Committee on Health and Human Services offers the following substitute
to HB 217:
A
BILL TO BE ENTITLED
AN ACT
AN ACT
To
amend Article 2 of Chapter 34 of Title 43 of the Official Code of Georgia
Annotated, relating to physicians, so as to authorize the use of influenza
vaccine orders for a group of patients; to provide for influenza vaccine
protocol agreements between physicians and pharmacists or nurses; to provide for
definitions; to provide requirements for the content of influenza vaccine
protocol agreements; to provide that a party to an influenza vaccine protocol
agreement shall not delegate his or her authority; to provide for statutory
construction; to provide for policies for handling used equipment; to limit the
number of influenza vaccine protocol agreements in which a physician may enter
at any one time; to prohibit certain entities from entering into influenza
vaccine protocol agreements; to provide for rules and regulations; to provide
for limited liability; to provide for applicability; to provide for related
matters; to provide for an effective date; to repeal conflicting laws; and for
other purposes.
BE
IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:
SECTION
1.
Article
2 of Chapter 34 of Title 43 of the Official Code of Georgia Annotated, relating
to physicians, is amended by adding a new Code section to read as
follows:
"43-34-26.4.
(a)
As used in this Code section, the term:
(1)
'Administer' means the provision of a unit dose of influenza vaccine by a
pharmacist or nurse pursuant to an influenza vaccine order contained in an
influenza vaccine protocol agreement with a physician.
(2)
'Adverse event' means an event that is a negative consequence of the
administration of influenza vaccine by a pharmacist or nurse that results in an
unintended reaction, injury, or illness, which may or may not have been
preventable.
(3)
'Board' means the Composite State Board of Medical Examiners.
(4)
'Influenza vaccine' means a vaccine administered by injection that contains
inactivated influenza viruses that is prepared for the applicable season and
that is administered to produce or increase immunity to the influenza
virus.
(5)
'Influenza vaccine order' means a prescription drug order, contained in an
influenza vaccine protocol agreement, for influenza vaccine issued by a
physician for a group of patients that meet a certain criteria and to be
administered by a pharmacist or a nurse. An influenza vaccine order shall also
mean a prescription drug order, contained in an influenza vaccine protocol
agreement, for epinephrine issued by a physician for a group of patients that
meet a certain criteria and to be administered by a pharmacist or a nurse only
upon the occurrence of an actual or perceived anaphylactic adverse reaction to
the administered influenza vaccine provided that the influenza vaccine protocol
agreement sets forth the signs and symptoms that warrant the administration of
epinephrine.
(6)
'Influenza vaccine protocol agreement' means a written document mutually agreed
upon and signed by a physician and a pharmacist or by a physician and a nurse,
by which document the physician prescribes influenza vaccine and epinephrine, if
determined appropriate by the physician, by means of an influenza vaccine order
for administration by a pharmacist or a nurse.
(7)
'Nurse' means a registered professional nurse as defined in paragraph (9) of
Code Section 43-26-3.
(8)
'Pharmacist' means an individual licensed under Chapter 4 of Title 26 to engage
in the practice of pharmacy in the State of Georgia.
(9)
'Pharmacy intern' means a pharmacy intern as defined in paragraph (19) of Code
Section 26-4-5.
(10)
'Physician' means an individual licensed to practice medicine and surgery
pursuant to this article and whose principal place of practice is located in
this state.
(b)
A physician engaged in the active practice of medicine may prescribe influenza
vaccine for a group of patients via an influenza vaccine order contained in an
influenza vaccine protocol agreement to be administered by a pharmacist,
provided the physician is registered with the vaccination registry established
by the Department of Human Resources pursuant to Code Section 31-12-3.1,
commonly known as the Georgia Registry of Immunization Transactions and
Services, the pharmacist is located within the county of the physician's place
of registration with the vaccination registry or a county contiguous thereto,
and the pharmacist holds current certification in Basic Cardiac Life Support and
has completed a course of training accredited by the Accreditation Council for
Pharmacy Education or similar health authority or professional body approved by
the Georgia State Board of Pharmacy. A physician who is a party to an influenza
vaccine protocol agreement may also prescribe epinephrine via an influenza
vaccine order contained in an influenza vaccine protocol agreement for
administration by a pharmacist upon the occurrence of an actual or perceived
anaphylactic adverse reaction to the administered influenza vaccine provided
that the influenza vaccine protocol agreement sets forth the signs and symptoms
that warrant the administration of epinephrine.
(c)
A physician engaged in the active practice of medicine may prescribe influenza
vaccine for a group of patients via an influenza vaccine order contained in an
influenza vaccine protocol agreement to be administered by a nurse, provided the
physician is registered the vaccination registry established by the Department
of Human Resources pursuant to Code Section 31-12-3.1, commonly known as the
Georgia Registry of Immunization Transactions and Services, the nurse is located
within the county of the physician's place of registration with the vaccination
registry or a county contiguous thereto, and the nurse holds current
certification in Basic Cardiac Life Support. A physician who is a party to an
influenza vaccine protocol agreement may also prescribe epinephrine via an
influenza vaccine order contained in an influenza vaccine protocol agreement for
administration by a nurse upon the occurrence of an actual or perceived
anaphylactic adverse reaction to the administered influenza vaccine provided
that the influenza vaccine protocol agreement sets forth the signs and symptoms
that warrant the administration of epinephrine.
(d)
An influenza vaccine protocol agreement between a physician and a pharmacist or
a physician and a nurse pursuant to this Code section shall, without
limitation:
(1)
Contain the current names, addresses, telephone numbers, and professional
license numbers of the physician and the pharmacist or nurse;
(2)
Contain a provision for immediate consultation between the pharmacist or nurse
and the physician. If the physician is not available, the physician for purposes
of consultation may designate another physician who concurs with the terms of
the influenza vaccine protocol agreement;
(3)
Require the pharmacist or nurse to provide the influenza vaccine recipient with
the appropriate and current Vaccine Information Statement (VIS) as provided by
the federal Centers for Disease Control and Prevention;
(4)
Require the pharmacist or nurse or his or her employer to retain documentation
of each dose of influenza vaccine administered. Such documentation shall
include, but not be limited to:
(A)
The administering pharmacist's or nurse's name, address, telephone number, and
professional license number;
(B)
The name, dose, manufacturer, and lot number of the influenza
vaccine;
(C)
The vaccine recipient's name, address, date of birth, and telephone
number;
(D)
The date of administration and injection site;
(E)
A signed and dated consent form by which the vaccine recipient acknowledges
receipt of the VIS and consents to the administration of the influenza vaccine;
and
(F)
Any adverse events or complications that occur;
(5)
Require the pharmacist or nurse to enter the patient's influenza vaccine
information in the Georgia Registry of Immunization Transactions and Services
within the registry's designated time frame, or as designated by the Department
of Human Resources;
(6)
Require, as a condition of administration of the influenza vaccine, the
influenza vaccine recipient to remain under the observation of the administering
pharmacist or nurse for a period of not less than 15 minutes immediately
subsequent to the administration of the influenza vaccine;
(7)
Contain procedures to follow up on the occurrence of an adverse event or
complication including, if prescribed via an influenza vaccine order contained
in an influenza vaccine protocol agreement, the administration of
epinephrine;
(8)
Provide for prioritization of influenza vaccine recipients in the event the
supply of influenza vaccine is limited; and
(9)
Be renewed and, if necessary, revised or updated biennially by the physician and
the pharmacist or nurse. An influenza vaccine protocol agreement that is not
renewed biennially shall expire.
(e)
A pharmacist that is a party to an influenza vaccine protocol agreement pursuant
to this Code section shall not delegate the administration of influenza vaccine
to any individual other than a pharmacy intern under the direct supervision of
the pharmacist whether or not any such other individual is under the
supervision, direct or otherwise, of the pharmacist.
(f)
A nurse that is a party to an influenza vaccine protocol agreement pursuant to
this Code section shall not delegate the administration of influenza vaccine to
any individual, whether or not any such individual is under the supervision,
direct or otherwise, of the nurse; provided, however, that a nurse that is a
party to an influenza protocol agreement pursuant to this Code section may
delegate the administration of influenza vaccine to a licensed practical nurse
under the direct on-site supervision of the nurse.
(g)
Notwithstanding any law to the contrary, a nurse acting pursuant to an influenza
vaccine protocol agreement as provided in this Code section may possess and
transport influenza vaccine and epinephrine.
(h)
A pharmacist or nurse administering influenza vaccines pursuant to an influenza
vaccine protocol agreement authorized by this Code section shall maintain
policies and procedures for the handling and disposal of used or contaminated
equipment and supplies.
(i)
Nothing in this Code section shall be construed to authorize a physician to
prescribe any vaccines or other drugs pursuant to an influenza vaccine protocol
agreement or influenza vaccine order contained in an influenza vaccine protocol
agreement other than influenza vaccines and epinephrine.
(j)
A delegating physician may not enter into an influenza vaccine protocol
agreement with more than ten pharmacists or nurses, or any combination thereof,
at any one time; provided, however, and notwithstanding subsections (b) and (c)
of this Code section, a delegating physician may enter into an influenza vaccine
protocol agreement with more than ten pharmacists or nurses, or any combination
thereof, at any one time so long as the pharmacists or nurses are in the same
public health district as established pursuant to Code Section 31-3-15, and are
employees or agents of the same corporate entity.
(k)
It shall be unlawful for a physician who is employed by a pharmacist or nurse to
enter into an influenza vaccine protocol agreement or otherwise delegate medical
acts to such pharmacist or nurse. It shall be unlawful for a physician who is
employed by a pharmacy to enter into an influenza vaccine protocol agreement or
otherwise delegate medical acts to a pharmacist or nurse who is also employed by
such pharmacy.
(l)
The board shall have the authority to promulgate rules and regulations governing
a physician who is a party to an influenza vaccine protocol agreement in order
to carry out the intent and purposes of this Code section. Further, the board
shall:
(1)
Require that the influenza vaccine protocol agreement be filed by the physician
with the board and be made available by the board for public inspection;
and
(2)
Promulgate by rule an approved standard protocol template that may be utilized
as an influenza vaccine protocol agreement and make such template available on
the board's website.
(m)
Nothing in this Code section shall be construed to require a physician to enter
into an influenza vaccine protocol agreement. A public or private managed care
system, health plan, hospital, insurance company, or similar entity shall not
require a physician, pharmacist, or nurse to enter into an influenza vaccine
protocol agreement as a condition for participation in or reimbursement from
such entity.
(n)
No physician who complies with the provisions of this Code section shall be
subject to criminal or civil liability or discipline for unprofessional conduct
for:
(1)
Entering into an influenza vaccine protocol agreement with a pharmacist or
nurse;
(2)
Issuing an influenza vaccine order contained in an influenza vaccine protocol
agreement with a pharmacist or nurse; or
(3)
The acts or omissions of a pharmacist or nurse pursuant to an influenza vaccine
protocol agreement including the administration of influenza vaccine or
epinephrine.
Nothing
in this subsection shall be interpreted as altering liability of an employer for
acts of his or her employees.
(o)
This Code section shall not apply to any activities conducted within a hospital
or within any other facility or entity owned, operated, or leased by a
hospital.
(p)
This Code section shall not be interpreted as limiting the authority of any
authorized person to dispense or administer influenza vaccine or other
medications."
SECTION
2.
This
Act shall become effective upon its approval by the Governor or upon its
becoming law without such approval.
SECTION
3.
All
laws and parts of laws in conflict with this Act are repealed.