Bill Text: GA HB184 | 2011-2012 | Regular Session | Introduced
Bill Title: Controlled substances; Electronic Database Review Advisory Committee; establish provisions
Spectrum: Moderate Partisan Bill (Republican 5-1)
Status: (Introduced - Dead) 2011-02-09 - House Second Readers [HB184 Detail]
Download: Georgia-2011-HB184-Introduced.html
11 LC
33 3887
House
Bill 184
By:
Representatives Weldon of the
3rd,
Harden of the
147th,
Lane of the
167th,
Neal of the
1st,
Dollar of the
45th,
and others
A
BILL TO BE ENTITLED
AN ACT
AN ACT
To
amend Chapter 13 of Title 16 of the Official Code of Georgia Annotated, relating
to controlled substances, so as to provide for the establishment of a program to
monitor the prescribing and dispensing of Schedule II, III, IV, and V controlled
substances; to provide for definitions; to require dispensers to submit certain
information regarding the dispensing of such controlled substances; to provide
for the confidentiality of submitted information except under certain
circumstances; to provide for the establishment of an Electronic Database Review
Advisory Committee; to provide for its membership, duties, and organization; to
provide for the establishment of rules and regulations; to provide for limited
liability; to provide for penalties; 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.
Chapter
13 of Title 16 of the Official Code of Georgia Annotated, relating to controlled
substances, is amended by revising Code Section 16-13-21, relating to
definitions relative to regulation of controlled substances, as
follows:
"16-13-21.
As
used in this article, the term:
(0.5)
'Addiction' means a primary, chronic, neurobiologic disease with genetic,
psychosocial, and environmental factors influencing its development and
manifestations. It is characterized by behaviors that include the following:
impaired control drug use, craving, compulsive use, and continued use despite
harm. Physical dependence and tolerance are normal physiological consequences
of extended opioid therapy for pain and are not the same as
addiction.
(1)
'Administer' means the direct application of a controlled substance, whether by
injection, inhalation, ingestion, or by any other means, to the body of a
patient or research subject by:
(A)
A practitioner or, in his
or
her presence, by his
or
her authorized agent; or
(B)
The patient or research subject at the direction and in the presence of the
practitioner.
(2)
'Agent' of a manufacturer, distributor, or dispenser means an authorized person
who acts on behalf of or at the direction of a manufacturer, distributor, or
dispenser. It does not include a common or contract carrier, public
warehouseman, or employee of the carrier or warehouseman.
(2.1)
'Board' means the State Board of Pharmacy or its designee, so long as such
designee is another state entity.
(3)
'Bureau' means the
Drug
Enforcement Administration, United States Department of Justice, or its
successor agency
Georgia Bureau
of Investigation.
(4)
'Controlled substance' means a drug, substance, or immediate precursor in
Schedules I through V of Code Sections 16-13-25 through 16-13-29 and Schedules I
through V of 21 C.F.R. Part 1308.
(5)
'Conveyance' means any object, including aircraft, vehicle, or vessel, but not
including a person, which may be used to carry or transport a substance or
object.
(6)
'Counterfeit substance' means:
(A)
A controlled substance which, or the container or labeling of which, without
authorization, bears the trademark, trade name, or other identifying mark,
imprint, number, or device, or any likeness thereof, of a manufacturer,
distributor, or dispenser other than the person who in fact manufactured,
distributed, or dispensed the controlled substance;
(B)
A controlled substance or noncontrolled substance, which is held out to be a
controlled substance or marijuana, whether in a container or not which does not
bear a label which accurately or truthfully identifies the substance contained
therein; or
(C)
Any substance, whether in a container or not, which bears a label falsely
identifying the contents as a controlled substance.
(6.1)
'Dangerous drug' means any drug, other than a controlled substance, which cannot
be dispensed except upon the issuance of a prescription drug order by a
practitioner authorized under this chapter.
(6.2)
'DEA' means the United States Drug Enforcement Administration.
(7)
'Deliver' or 'delivery' means the actual, constructive, or attempted transfer
from one person to another of a controlled substance, whether or not there is an
agency relationship.
(8)
'Dependent,' 'dependency,' 'physical dependency,' 'psychological dependency,' or
'psychic dependency' means and includes the state of
dependence
by an individual toward or upon a substance, arising from the use of that
substance, being characterized by behavioral and other responses which include
the loss of self-control with respect to that substance, or a strong compulsion
to use that substance on a continuous basis in order to experience some psychic
effect resulting from the use of that substance by that individual, or to avoid
any discomfort occurring when the individual does not use that
substance
adaptation
that is manifested by drug class specific signs and symptoms that can be
produced by abrupt cessation, rapid dose reduction, decreasing blood level of
the drug, and administration of an antagonist. Physical dependence, by itself,
does not equate with
addiction.
(9)
'Dispense' means to deliver a controlled substance to an ultimate user or
research subject by or pursuant to the lawful order of a practitioner, including
the prescribing, administering, packaging, labeling, or compounding necessary to
prepare the substance for that delivery, or the delivery of a controlled
substance by a practitioner, acting in the normal course of his
or
her professional practice and in
accordance with this article, or to a relative or representative of the person
for whom the controlled substance is prescribed.
(10)
'Dispenser' means
a
practitioner who dispenses
a person that
delivers a Schedule II, III, IV, or V controlled substance to the ultimate user
but shall not include:
(A)
A licensed pharmacy of a hospital that dispenses such substances for the purpose
of inpatient hospital care;
(B)
An institutional pharmacy that serves only a health care facility, including,
but not limited to, a nursing home, an intermediate care home, a personal care
home, or a hospice program, which provides inpatient care and which pharmacy
dispenses such substances to be administered and used by a patient on the
premises of the facility;
(C)
A practitioner or other authorized person who administers such a substance;
or
(D)
A pharmacy operated by, on behalf of, or under contract with the Department of
Corrections for the sole and exclusive purpose of providing services in a secure
environment to prisoners within a penal institution, penitentiary, prison,
detention center, or other secure correctional institution. This shall include
correctional institutions operated by private entities in this state which house
inmates under the Department of
Corrections.
(11)
'Distribute' means to deliver a controlled substance, other than by
administering or dispensing it.
(12)
'Distributor' means a person who distributes.
(12.05)
'FDA' means the United States Food and Drug Administration.
(12.1)
'Imitation controlled substance' means:
(A)
A product specifically designed or manufactured to resemble the physical
appearance of a controlled
substance,
such that a reasonable person of ordinary knowledge would not be able to
distinguish the imitation from the controlled substance by outward appearances;
or
(B)
A product, not a controlled substance, which, by representations made and by
dosage unit appearance, including color, shape, size, or markings, would lead a
reasonable person to believe that, if ingested, the product would have a
stimulant or depressant effect similar to or the same as that of one or more of
the controlled substances included in Schedules I through V of Code Sections
16-13-25 through 16-13-29.
(13)
'Immediate precursor' means a substance which the State Board of Pharmacy has
found to be and by rule identifies as being the principal compound commonly used
or produced primarily for use, and which is an immediate chemical intermediary
used or likely to be
used,
in the manufacture of a controlled substance, the control of which is necessary
to prevent, curtail, or limit manufacture.
(14)
'Isomers' means stereoisomers (optical isomers), geometrical isomers, and
structural isomers (chain and positional
isomers,)
but shall not include functional
isomers).
(15)
'Manufacture' means the production, preparation, propagation, compounding,
conversion, or processing of a controlled substance, either directly or
indirectly by extraction from substances of natural origin, or independently by
means of chemical synthesis, and includes any packaging or repackaging of the
substance or labeling or relabeling of its container, except that this term does
not include the preparation, compounding, packaging, or labeling of a controlled
substance:
(A)
By a practitioner as an incident to his
or
her administering or dispensing of a
controlled substance in the course of his
or
her professional practice; or
(B)
By a practitioner or by his
or
her authorized agent under his
or
her supervision for the purpose of, or as
an incident to, research, teaching, or chemical analysis and not for
sale.
(16)
'Marijuana' means all parts of the plant of the genus Cannabis, whether growing
or not, the seeds thereof, the resin extracted from any part of such plant, and
every compound, manufacture, salt, derivative, mixture, or preparation of such
plant, its seeds, or resin; but shall not include samples as described in
subparagraph (P) of paragraph (3) of Code Section 16-13-25 and shall not include
the completely defoliated mature stalks of such plant, fiber produced from such
stalks, oil, or cake, or the completely sterilized samples of seeds of the plant
which are incapable of germination.
(17)
'Narcotic drug' means any of the following, whether produced directly or
indirectly by extraction from substances of vegetable origin, or independently
by means of chemical synthesis, or by a combination of extraction and chemical
synthesis:
(A)
Opium and opiate, and any salt, compound, derivative, or preparation of opium or
opiate;
(B)
Any salt, compound, isomer, derivative, or preparation thereof which is
chemically equivalent or identical
with
to
any of the substances referred to in subparagraph (A) of this paragraph, but not
including the isoquinoline alkaloids of opium;
(C)
Opium poppy and poppy straw;
or
(D)
Coca leaves and any salt, compound, derivative, stereoisomers of cocaine, or
preparation of coca leaves, and any salt, compound, stereoisomers of cocaine,
derivative, or preparation thereof which is chemically equivalent or identical
with
to
any of these substances, but not including decocainized coca leaves or
extractions of coca leaves which do not contain cocaine or
ecgonine.
(18)
'Opiate' means any substance having an addiction-forming or addiction-sustaining
liability similar to morphine or being capable of conversion into a drug having
addiction-forming or addiction-sustaining liability. It does not include,
unless specifically designated as controlled under Code Section 16-13-22, the
dextrorotatory isomer of 3-methoxy-n-methylmorphinan and its salts
(dextromethorphan). It does include its racemic and levorotatory
forms.
(19)
'Opium poppy' means the plant of the species Papaver somniferum L., except its
seeds.
(19.1)
'Patient' means the person who is the ultimate user of a drug for whom a
prescription is issued or for whom a drug is dispensed.
(20)
'Person' means an individual, corporation, government, or governmental
subdivision or agency, business trust, estate, trust, partnership, or
association, or any other legal entity.
(21)
'Poppy straw' means all parts, except the seeds, of the opium poppy after
mowing.
(22)
'Potential for abuse' means and includes a substantial potential for a substance
to be used by an individual to the extent of creating hazards to the health of
the user or the safety of the public, or the substantial potential of a
substance to cause an individual using that substance to become dependent upon
that substance.
(23)
'Practitioner' means:
(A)
A physician, dentist, pharmacist, podiatrist,
veterinarian,
scientific investigator, or other person licensed, registered, or otherwise
authorized under the laws of this state to distribute, dispense, conduct
research with respect to, or to administer a controlled substance in the course
of professional practice or research in this state;
(B)
A pharmacy, hospital, or other institution licensed, registered, or otherwise
authorized by law to distribute, dispense, conduct research with respect to, or
to administer a controlled substance in the course of professional practice or
research in this state;
(C)
An advanced practice registered nurse acting pursuant to the authority of Code
Section 43-34-25. For purposes of this chapter and Code Section 43-34-25, an
advanced practice registered nurse is authorized to register with the federal
Drug Enforcement Administration and appropriate state authorities;
or
(D)
A physician assistant acting pursuant to the authority of subsection (e.1) of
Code Section 43-34-103. For purposes of this chapter and subsection (e.1) of
Code Section 43-34-103, a physician assistant is authorized to register with the
federal Drug Enforcement Administration and appropriate state
authorities.
(23.1)
'Prescriber' means a physician, dentist, scientific investigator, or other
person licensed, registered, or otherwise authorized under the laws of this
state to prescribe, distribute, dispense, conduct research with respect to, or
administer a controlled substance in the course of professional practice or
research in this state.
(24)
'Production' includes the manufacture, planting, cultivation, growing, or
harvesting of a controlled substance.
(25)
'Registered' or 'register' means registration as required by this
article.
(26)
'Registrant' means a person who is registered under this article.
(26.1)
'Schedule II, III, IV, or V controlled substance' means a controlled substance
that is classified as a Schedule II, III, IV, or V controlled substance under
Code Section 16-13-26, 16-13-27, 16-13-28, or 16-13-29, respectively, or under
the Federal Controlled Substances Act, 21 U.S.C. Section 812.
(27)
'State,' when applied to a part of the United States, includes any state,
district, commonwealth, territory, insular possession thereof, or any area
subject to the legal authority of the United States.
(27.1)
'Tolerance' means a physiologic state resulting from regular use of a drug in
which an increased dosage is needed to produce a specific effect or a reduced
effect is observed with a constant dose over time. Tolerance may or may not be
evident during opioid treatment and does not equate with addiction.
(28)
'Ultimate user' means a person who lawfully possesses a controlled substance for
his or
her own use, for the use of a member of
his or
her household, or for administering to an
animal owned by him
or
her or by a member of his
or
her household or an agent or
representative of the person.
(29)
'Noncontrolled substance' means any drug or other substance other than a
controlled substance as defined by paragraph (4) of this Code
section."
SECTION
2.
Said
chapter is further amended by designating Article 2 as Part 1 of Article 2 and
by adding a new part to Article 2 to read as follows:
"Part
2
16-13-57.
(a)
Subject to funds as may be appropriated by the General Assembly or otherwise
available for such purpose, the board shall, in consultation with members of the
Georgia Composite Medical Board, establish and maintain a program to
electronically record into an electronic data base prescription information
resulting from the dispensing of Schedule II, III, IV, or V controlled
substances and to electronically review such prescription information that has
been entered into such data base. The purpose of such program shall be to
assist in the reduction of the abuse of controlled substances, to improve,
enhance, and encourage a better quality of health care by promoting the proper
use of medications to treat pain and terminal illness, and to reduce duplicative
prescribing and overprescribing of controlled substance practices.
(b)
Such program shall be administered by the board at the direction and oversight
of the board.
16-13-58.
(a)
The board shall be authorized to apply for available grants and may accept any
gifts, grants, donations, and other funds, including funds from the disposition
of forfeited property, to assist in developing and maintaining the program
established pursuant to Code Section 16-13-57.
(b)
The board shall be authorized to grant funds to dispensers for the purpose of
covering costs for dedicated equipment and software for dispensers to use in
complying with the reporting requirements of Code Section 16-13-59. Such grants
to dispensers shall be funded by gifts, grants, donations, or other funds,
including funds from the disposition of forfeited property, received by the
board for the operation of the program established pursuant to Code Section
16-13-57. The board shall be authorized to establish standards and
specifications for any equipment and software purchased pursuant to a grant
received by a dispenser pursuant to this Code section. Nothing in this part
shall be construed to require a dispenser to incur costs to purchase equipment
or software to comply with this part.
(c)
Nothing in this part shall be construed to require any appropriation of state
funds.
16-13-59.
(a)
For purposes of the program established pursuant to Code Section 16-13-57, each
dispenser shall submit to the board by electronic means information regarding
each prescription dispensed for a Schedule II, III, IV, or V controlled
substance. The information submitted for each prescription shall include at a
minimum, but shall not be limited to:
(1)
DEA permit number or approved dispenser facility controlled substance
identification number;
(2)
Date the prescription was dispensed;
(3)
Prescription serial number;
(4)
If the prescription is new or a refill;
(5)
National Drug Code (NDC) for drug dispensed;
(6)
Quantity and strength dispensed;
(7)
Number of days supply of the drug;
(8)
Patient's name;
(9)
Patient's address;
(10)
Patient's date of birth;
(11)
Approved prescriber identification number or prescriber's DEA permit
number;
(12)
Date the prescription was issued by the prescriber; and
(13)
Other data elements consistent with standards established by the American
Society for Automation in Pharmacy, if designated by regulations of the
board.
(b)
Each dispenser shall submit the prescription information required in subsection
(a) of this Code section in accordance with transmission methods and frequency
requirements established by the board on at least a weekly basis and shall
report, at a minimum, such prescription information no later than ten days after
the prescription is dispensed. If a dispenser is temporarily unable to comply
with this subsection due to an equipment failure or other circumstances, such
dispenser shall notify the board.
(c)
The board may issue a waiver to a dispenser that is unable to submit
prescription information by electronic means acceptable to the board. Such
waiver may permit the dispenser to submit prescription information to the board
by paper form or other means, provided all information required in subsection
(a) of this Code section is submitted in this alternative format and in
accordance with the frequency requirements established pursuant to subsection
(b) of this Code section. Requests for waivers shall be submitted in writing to
the board.
(d)
The board shall not revise the information required to be submitted by
dispensers pursuant to subsection (a) of this Code section more frequently than
annually. Any such change to the required information shall neither be effective
nor applicable to dispensers until six months after the adoption of such
changes.
(e)
The board shall not access or allow others to access any identifying
prescription information from the electronic data base after two years after the
date such information was originally received. The board may retain aggregated
prescription information that is two years old or great but shall ensure that
any identifying information that is two years old or greater is deleted or
destroyed on an ongoing basis in a timely and secure manner.
(f)
A dispenser may apply to the board for an exemption to be excluded from
compliance with this Code section if compliance would impose an undue hardship
on such dispenser. The board shall provide guidelines and criteria for what
constitutes an undue hardship.
16-13-60.
(a)
Except as otherwise provided in subsections (c) and (d) of this Code section,
prescription information submitted pursuant to Code Section 16-13-59 shall be
confidential and shall not be subject to open records requirements, as contained
in Article 4 of Chapter 18 of Title 50.
(b)
The board shall establish and maintain strict procedures to ensure that the
privacy and confidentiality of patients, prescribers, and patient and prescriber
information collected, recorded, transmitted, and maintained pursuant to this
part are protected. Such information shall not be disclosed to persons except as
otherwise provided in this part and only in a manner which in no way would
conflict with the requirements of the federal Health Insurance Portability and
Accountability Act (HIPAA) of 1996, P.L. 104-191.
(c)
The board shall be authorized to provide requested prescription information
collected pursuant to this part:
(1)
To persons authorized to prescribe or dispense controlled substances for the
sole purpose of providing medical or pharmaceutical care for their
patients;
(2)
Upon the request of a patient, prescriber, or dispenser about whom the
prescription information requested concerns or upon the request on his or her
behalf of his or her attorney;
(3)
To the Georgia Composite Medical Board or any licensing board whose
practitioners have the authority to prescribe or dispense controlled substances
in this state;
(4)
To any local, state, or federal law enforcement, regulatory, or prosecutorial
officials upon receipt of a subpoena issued by a court of record, located within
or outside of this state;
(5)
To a state agency, board, or entity with administrative subpoena powers upon
receipt of an administrative subpoena issued by such state agency, board, or
entity which is authorized to receive such prescription
information;
(6)
Upon the lawful order of a court of competent jurisdiction; and
(7)
To personnel of the board for purposes of administration and enforcement of this
part or any other applicable state law.
(d)
The board may provide data to government entities for statistical, research,
educational, or grant application purposes after removing information that could
be used to identify prescribers or individual patients or persons who received
prescriptions from dispensers.
(e)
The board may prepare a plan to provide electronic data base prescription
information to a prescription monitoring program in another state if the
confidentiality, security, privacy, and utilization standards of the requesting
state are determined to be equivalent to those of the board.
(f)
Any person who receives electronic data base prescription information or related
reports relating to this part from the board shall not provide such information
or reports to any other person except by order of a court of competent
jurisdiction or as otherwise permitted pursuant to this part.
(g)
Any permissible user identified in this part who directly accesses electronic
base prescription information shall implement and maintain a comprehensive
information security program that contains administrative, technical, and
physical safeguards that are appropriate to the user's size and complexity and
to the sensitivity of the personal information obtained. The permissible user
shall identify reasonably foreseeable internal and external risks to the
security, confidentiality, and integrity of personal information that could
result in the unauthorized disclosure, misuse, or other compromise of the
information and shall assess the sufficiency of any safeguards in place to
control the risks.
16-13-61.
(a)
There is established an Electronic Database Review Advisory Committee for the
purposes of consulting with and advising the board on matters related to the
establishment, maintenance, and operation of how prescriptions are
electronically reviewed pursuant to this part. This shall include, but shall
not be limited to, data collection, regulation of access to data, evaluation of
data to identify benefits and outcomes of the reviews, communication to
prescribers and dispensers as to the intent of the reviews and how to use the
data base, and security of data collected.
(b)
The advisory committee shall consist of nine members as follows:
(1)
A representative from the board;
(2)
A representative from the Georgia Composite Medical Board;
(3)
A representative from the Georgia Board of Dentistry;
(4)
A consumer representative, appointed by the board;
(5)
A representative from a specialty profession that deals in addictive medicine,
appointed by the Georgia Composite Medical Board;
(6)
A pain management specialist, appointed by the Georgia Composite Medical
Board;
(7)
An oncologist, appointed by the Georgia Composite Medical Board;
(8)
A representative from a hospice or hospice organization, appointed by the
Georgia Composite Medical Board; and
(9)
A representative from the State Board of Optometry.
(c)
Each member of the advisory committee shall serve a three-year term or until the
appointment and qualification of such member's successor.
(d)
The advisory committee shall elect a chairperson and vice chairperson from among
its membership to serve a term of one year. The vice chairperson shall serve as
the chairperson at times when the chairperson is absent.
(e)
The advisory committee shall meet at the call of the chairperson or upon request
by at least three of the members and shall meet at least one time per year.
Five members of the committee shall constitute a quorum.
(f)
The members shall receive no compensation or reimbursement of expenses from the
state for their services as members of the advisory committee.
16-13-62.
The
board shall establish rules and regulations to implement the requirements of
this part. Nothing in this part shall be construed to authorize the board to
establish policies, rules, or regulations which limit, revise, or expand or
purport to limit, revise, or expand any prescription or dispensing authority of
any prescriber or dispenser subject to this part.
16-13-63.
Nothing
in this part shall require a dispenser or prescriber to obtain information about
a patient from the program established pursuant to this part. A dispenser or
prescriber shall not have a duty and shall not be held liable for damages to any
person in any civil, criminal, or administrative action for injury, death, or
loss to person or property on the basis that the dispenser or prescriber did or
did not seek or obtain information from the electronic data base established
pursuant to Code Section 16-13-57.
16-13-64.
(a)
A dispenser who knowingly and intentionally fails to submit prescription
information to the board as required by this part or knowingly and intentionally
submits incorrect prescription information shall be guilty of a misdemeanor and,
upon conviction thereof, shall be punished for each such offense by imprisonment
for a period not to exceed 12 months, a fine not to exceed $1,000.00, or both,
and such actions shall be reported to the licensing board responsible for
issuing such dispenser's dispensing license for action to be taken against such
dispenser's license.
(b)
An individual authorized to access electronic data base prescription information
pursuant to this part who negligently uses, releases, or discloses such
information in a manner or for a purpose in violation of this part shall be
guilty of a misdemeanor. Any person who is convicted of negligently using,
releasing, or disclosing such information in violation of this part shall, upon
the second or subsequent conviction, be guilty of a felony and shall be punished
by imprisonment for not less than one nor more than three years, by a fine not
to exceed $5,000.00, or by both.
(c)(1)
An individual authorized to access electronic data base prescription information
pursuant to this part who knowingly obtains or discloses such information in a
manner or for a purpose in violation of this part shall be guilty of a felony
and, upon conviction thereof, shall be punished by a fine not to exceed
$50,000.00, imprisonment for not more than one year, or by both.
(2)
Any person who knowingly obtains, attempts to obtain, or discloses electronic
data base prescription information pursuant to this part under false pretenses
shall be guilty of a felony and, upon conviction thereof, shall be punished by a
fine not to exceed $100,000.00, by imprisonment for not more than five years, or
by both.
(3)
Any person who obtains or discloses electronic data base prescription
information pursuant to this part with the intent to sell, transfer, or use such
information for commercial advantage, personal gain, or malicious harm shall be
guilty of a felony and, upon conviction thereof, shall be punished by a fine not
to exceed $250,000.00, by imprisonment for not more than ten years, or by
both.
(d)
Any person who is injured by reason of any violation of this part shall have a
cause of action for the actual damages sustained and, where appropriate,
punitive damages. Such person may also recover attorney's fees in the trial and
appellate courts and the costs of investigation and litigation reasonably
incurred.
(e)
The penalties provided by this Code section are intended to be cumulative of
other penalties which may be applicable and are not intended to repeal such
other penalties."
SECTION
3.
This
Act shall become effective on July 1, 2011.
SECTION
4.
All
laws and parts of laws in conflict with this Act are repealed.