07 LC 36
0715S
The
Senate Health and Human Services Committee offered the following substitute to
HB 330:
A
BILL TO BE ENTITLED
AN ACT
AN ACT
To
amend Chapter 4 of Title 26 of the Official Code of Georgia Annotated, relating
to pharmacists and pharmacies, so as to provide for the registration of pharmacy
technicians; to require the Georgia State Board of Pharmacy to establish and
maintain a registry of pharmacy technicians; to authorize the board to require
background checks; to provide for rules and regulations; to revise certain
provisions relating to patient counseling; to require pharmacists in charge to
provide updated information for the registry; to provide for an effective date
contingent on funding; to provide for related matters; to repeal conflicting
laws; and for other purposes.
BE
IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:
SECTION
1.
Chapter
4 of Title 26 of the Official Code of Georgia Annotated, relating to pharmacists
and pharmacies, is amended by revising subsection (a) of Code Section 26-4-28,
relating to the powers, duties, and authority of the Georgia State Board of
Pharmacy, as follows:
"(a)
The board shall have the power, duty, and authority for the control and
regulation of the practice of pharmacy in the State of Georgia including, but
not limited to, the following:
(1)
The licensing by examination or by license transfer of applicants who are
qualified to engage in the practice of pharmacy under the provisions of this
chapter;
(2)
The renewal of licenses to engage in the practice of pharmacy;
(3)
The establishment and enforcement of compliance with professional standards and
rules of conduct of pharmacists engaged in the practice of
pharmacy;
(4)
The determination and issuance of standards for recognition and approval of
degree programs of schools and colleges of pharmacy whose graduates shall be
eligible for licensure in this state, and the specification and enforcement of
requirements for practical training including internship;
(5)
The enforcement of those provisions of this chapter relating to the conduct or
competence of pharmacists practicing in this state and the suspension,
revocation, or restriction of licenses to engage in the practice of
pharmacy;
(6)
The licensure and regulation of pharmacies and pharmacy interns;
(7)
The regulation of other employees in the prescription or pharmacy
department,
including but not limited to the registration and regulation of pharmacy
technicians. The board shall be required to establish the minimum
qualifications for the registration of pharmacy technicians and shall be
authorized to require the completion of a background check and criminal history
record check for each person applying for registration as a pharmacy technician
in this state. The certificate of registration, once issued, may be valid for
no more than two years and shall be renewable biennially upon payment of a
renewal fee and compliance with such other conditions as the board may establish
by rule or regulation. The board shall be authorized to deny registration, to
deny renewal, or to revoke or suspend the registration of a pharmacy technician
for any of the grounds set forth in Code Section 26-4-60 or Code Section
43-1-19. However, said denial of a technician application, denial of the
renewal of a certificate, or suspension or revocation of a technician
registration shall not be considered a contested case under Chapter 13 of Title
50, the 'Georgia Administrative Procedure Act,' but said applicant or registrant
shall be entitled to an appearance before the board. The board shall be
required to establish and maintain a registry of pharmacy technicians in this
state which contains the name and home address of each pharmacy technician and
his or her employer and location of employment. The board shall establish a
process by which the pharmacist in charge of each pharmacy shall provide updated
information on the pharmacy technicians in the pharmacy. The board may
establish and collect fees from pharmacy technicians, their employers, or both
for the registration of pharmacy technicians and maintenance of the
registry;
(8)
The collection of professional demographic data;
(9)
The right to seize any such drugs and devices found by the board to constitute
an imminent danger to the public health and welfare;
(10)
The establishment of minimum specifications for the physical facilities,
technical equipment, environment, supplies, personnel, and procedures for the
storage, compounding, and dispensing of such drugs or devices utilized within
the practice of pharmacy;
(11)
The establishment of minimum standards for the purity and quality of such drugs
utilized within the practice of pharmacy;
(12)
The establishment of minimum standards for the purity and quality of such
devices and other materials utilized within the practice of
pharmacy;
(13)
The issuance and renewal of licenses of all persons engaged in the manufacture
and distribution of drugs;
(14)
The issuance and renewal of licenses of all persons engaged in the manufacture
and distribution of devices utilized within the practice of
pharmacy;
(15)
The inspection of any licensed person at all reasonable hours for the purpose of
determining if any provisions of the laws governing the legal distribution of
drugs or devices or the practice of pharmacy are being violated. The board and
its officers, agents, and designees shall cooperate with all agencies charged
with the enforcement of the laws of the United States, of this state, and of all
other states relating to drugs, devices, and the practice of
pharmacy;
(16)
The investigation of alleged violations of this chapter or any other law in this
state pertaining to, or in connection with, persons or firms licensed by the
board or otherwise authorized by the laws of this state to manufacture, sell,
distribute, dispense, or possess drugs, medicines, poisons, cosmetics, or
devices, as related to misbranded or counterfeit drugs, or any rules and
regulations promulgated by the board under this chapter; the conducting of
investigative interviews or full board hearings, with or without the necessity
of utilizing the Office of State Administrative Hearings, in respect thereto
when in its discretion it appears to be necessary; and the bringing of such
violations to the notice of the Attorney General;
(17)
The listing at any time upon either a list under Article 3 of Chapter 13 of
Title 16, the 'Dangerous Drug Act,' or upon a schedule under Article 2 of
Chapter 13 of Title 16, the 'Georgia Controlled Substances Act,' of any drug
found to be potentially dangerous to public safety if dispensed without
prescription;
(18)
The expunging of the pharmacy related practice record of any pharmacist whose
record consists of a sole sanction resulting from alcohol impairment and whose
pharmacy related practice record during a five-year time period dating from the
time of the sanction has incurred no additional charges or
infractions;
(19)
Restricting the inspection or examination of records or access to any area
licensed and under the control of any registrant, which has been issued a permit
by the board, to members of the board, agents for the Georgia Drugs and
Narcotics Agency, the United States Drug Enforcement Administration, the Georgia
Department of Medical Assistance, or other federal agencies or agencies of this
state otherwise entitled to such inspections or examinations by law, subpoena,
or court order. This paragraph specifically prohibits inspections or
examinations of board registrants or any requirement which forces board
registrants to allow inspection or examination, or both, of their records by
representatives for any nongovernment affiliated, private organization for any
purpose since the access of patient prescription records is restricted by this
chapter and access by such private organizations is unnecessary in that this
access only duplicates existing record-keeping and inspection requirements
already addressed by the laws and regulations of the board and other government
organizations. This restriction shall also prohibit a private, nongovernment
affiliated organization from examining or copying continuing education
certificates maintained by individual registrants. Nothing in this paragraph
shall prohibit the pharmacist in charge from voluntarily allowing appropriate
agencies and organizations to inspect or examine the records and pharmacy area
under the control of the pharmacist in charge provided such inspections or
examinations are for the purposes of ensuring the quality of care provided to
patients;
and
(20)
The requiring of background checks, including, but not limited to, criminal
history record checks, on any persons or firms applying for licensure or
registration pursuant to this chapter; and
(20)(21)
Serving as the sole governmental or other authority which shall have the
authority to approve or recognize accreditation or certification programs for
specialty pharmacy practice or to determine the acceptability of entities which
may accredit pharmacies or certify pharmacists in a specialty of pharmacy
practice, and the board may require such accreditation or certification as a
prerequisite for specialty or advanced pharmacy practice. Such accreditation and
certification standards for specialties shall be set forth in rules promulgated
by the board with such rules to contain the required qualifications or
limitations. Any accreditation or certification for specialty pharmacy practice
approved or recognized by the board shall be deemed sufficient to meet any and
all standards, licensure, or requirements, or any combination thereof, otherwise
set forth by any private entity or other government agency to satisfy its stated
goals and standards for such accreditation or certification. Nothing in this
paragraph shall prohibit private entities, government agencies, professional
organizations, or educational institutions from submitting accreditation or
certification programs for the review and potential approval or recognition by
the board. Accreditation and certification for specialty pharmacy practice under
this paragraph shall be subject to the following conditions:
(A)
Applications shall be submitted as set forth in rules promulgated or approved by
the board for accreditation or certification;
(B)
Only a pharmacist registered by this state and maintaining an active license in
good standing is eligible for certification in a specialty pharmacy practice by
the board;
(C)
Only a pharmacy registered by this state and maintaining an active license in
good standing is eligible for accreditation for specialty pharmacy practice by
the board;
(D)
Any board approved or recognized accreditation for a specialty pharmacy practice
of a pharmacy is to be deemed sufficient and shall satisfy any standards or
qualifications required for payment of services rendered as set forth by any
insurance company, carrier, or similar third-party payor plan in any policy or
contract issued, issued for delivery, delivered, or renewed on or after July 1,
1999;
(E)
Any board approved or recognized specialty certification issued to a pharmacist
is deemed sufficient and shall satisfy any standards or qualifications required
for payment of services rendered as set forth by any insurance company, carrier,
or similar third-party payor plan in any policy or contract issued, issued for
delivery, delivered, or renewed on or after July 1, 1999; and
(F)
The board may deny, revoke, limit, suspend, probate, or fail to renew the
accreditation or specialty certification of a pharmacy, pharmacist, or both for
cause as set forth in Code Section 26-4-60 or for a violation of Chapter 13 of
Title 16 or if the board determines that a pharmacy, pharmacist, or both, no
longer meet the accreditation or certification requirements of the board.
Before such action, the board shall serve upon the pharmacist in charge of a
pharmacy or pharmacist an order to show cause why accreditation or certification
should not be denied, revoked, limited, suspended, or probated or why the
renewal should not be refused. The order to show cause shall contain a
statement for the basis therefor and shall call upon the pharmacist in charge of
a pharmacy, the pharmacist, or both, to appear before the board at a time and
place not more than 60 days after the date of the service of the
order."
SECTION
2.
Said
chapter is further amended by revising subsection (d) of Code Section 26-4-82,
relating to duties requiring professional judgment and responsibilities of a
licensed pharmacist, as follows:
"(d)
The board of pharmacy shall promulgate rules and regulations regarding the
activities and utilization of pharmacy technicians in
pharmacies,
including the establishment of a registry as required in paragraph (7) of
subsection (a) of Code Section 26-4-28;
provided, however, that the pharmacist to pharmacy technician ratio shall not
exceed one pharmacist providing direct supervision of three pharmacy
technicians. The board may consider and approve an application to increase the
ratio in a pharmacy located in a licensed hospital. Such application must be
made in writing and must be submitted to the board by the pharmacist in charge
of a specific hospital pharmacy in this state. One of the three technicians
must:
(1)
Have successfully passed a certification program approved by the board of
pharmacy;
(2)
Have successfully passed an employer´s training and assessment program
which has been approved by the board of pharmacy; or
(3)
Have been certified by either the Pharmacy Technician Certification Board or any
other nationally recognized certifying body approved by the board of
pharmacy."
SECTION
3.
Said
chapter is further amended by revising subsection (b) of Code Section 26-4-85,
relating to patient counseling, as follows:
"(b)
Upon receipt of a prescription drug order and following a review of the
patient´s record, the pharmacist or the pharmacy intern operating under the
direct supervision of the pharmacist shall
personally
offer, either
orally or in writing, to discuss matters
which will enhance or optimize drug therapy with each patient or caregiver of
such a patient. Such discussion shall be in person, whenever practicable, or by
telephone and shall include appropriate elements of patient counseling, based on
the professional judgment of the pharmacist. Such elements may include but are
not limited to the following:
(1)
The name and description of the drug;
(2)
The dosage form, dose, route of administration and duration of
therapy;
(3)
The intended use of the drug and expected action or result;
(4)
Any special directions or precautions for preparation, administration, or use by
the patient;
(5)
Common severe side effects or adverse effects or interactions and therapeutic
contraindications that may be encountered, including their avoidance, and the
action required if such side effect, adverse effect, interaction, or therapeutic
contraindication occurs;
(6)
Techniques for self-monitoring of drug therapy;
(7)
The proper storage of the drug;
(8)
Prescription refill information;
(9)
The action to be taken in the event of a missed dose; and
(10)
The comments of the pharmacist relevant to the patient´s drug therapy,
including any other information peculiar to the specific patient or
drug."
SECTION
4.
Said
chapter is further amended by revising subsection (d) of Code Section 26-4-110,
relating to pharmacy licenses, as follows:
"(d)
Each pharmacy shall have a pharmacist in charge. Whenever an applicable rule
requires or prohibits action by a pharmacy, responsibility shall be that of the
owner and the pharmacist in charge of the pharmacy, whether the owner is a sole
proprietor, partnership, association, corporation, or otherwise.
The pharmacist
in charge shall be responsible for notifying the board in accordance with its
rules and regulations of updated information regarding the registration of
pharmacy technicians."
SECTION
5.
This
Act shall become effective only if funds are specifically appropriated for
purposes of this Act in an appropriations Act making specific reference to this
Act and shall become effective when funds so appropriated become available for
expenditure.
SECTION
6.
All
laws and parts of laws in conflict with this Act are repealed.