Subject 511-7-2 PRESCRIPTION DRUG MONITORING PROGRAM
| (1) |
"Delegate"
means an individual designated by a prescriber or dispenser, and meeting all
the requirements of DPH Rule
511-7-2-.04, who is authorized to
access the PDMP for the purpose of reviewing a patient's prescription
information. |
| (2) |
"Department" means
the Georgia Department of Public Health. |
| (3) |
"Dispenser" means a person licensed under
the laws of this state, or any other state or territory of the United States,
to dispense or deliver a Schedule II, III, IV, or V controlled substance to an
ultimate user in this state, but does not include (a) a pharmacy licensed as a
hospital pharmacy by the State Board of Pharmacy pursuant to Code Section
26-4-110;
(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 patient care and which
pharmacy dispenses such substances to be administered and used by a patient on
the premises of the facility; (c) a licensed health care practitioner or other
authorized person who administers such a substance; or (d) a pharmacy operated
by, or 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, including correctional institutions
operated by private entities in this state which house inmates under authority
of the Department of Corrections. |
| (4) |
"PDMP" means the Prescription Drug
Monitoring Program database authorized by Code Section
16-13-57
and maintained by the department. |
| (5) |
"Prescriber" means a physician, dentist,
scientific investigator, or other person licensed, registered, or otherwise
authorized under the laws of this state, or any other state or territory of the
United States, to prescribe a controlled substance in the course of
professional practice or research in this state, and who has been assigned a
DEA number. "Prescriber" shall not include a veterinarian. |
| (6) |
"Prescription information" means all of
the following:
| (a) |
DEA permit number or
approved dispenser facility controlled substance identification
number; |
| (b) |
Date the prescription
was dispensed; |
| (c) |
Prescription
serial number; |
| (d) |
If the
prescription is new or a refill; |
| (e) |
National Drug Code (NDC) for drug
dispensed; |
| (f) |
Quantity and
strength dispensed; |
| (g) |
Number of
days' supply of the drug; |
| (j) |
Patient's date of
birth; |
| (m) |
Approved prescriber
identification number or prescriber's DEA permit number; and |
| (n) |
Date the prescription was issued by the
prescriber. |
|
| (1) |
Prescribers and dispensers are eligible
to request approval for internet access to the PDMP. |
| (2) |
Prescribers and dispensers approved for
internet access to the PDMP database may delegate their authority to use that
access only as permitted in DPH Rule
511-7-2-.04. |
| (3) |
Prescribers and dispensers shall use
information obtained from the PDMP database solely to make treatment decisions
about their patients, to communicate concerns about a patient's potential
usage, misuse, abuse or underutilization of a controlled substance to
prescribers or dispensers involved in the patient's care, or to report
potential violations of Title 16, Chapter 13, Article 2 to the Georgia Drugs
and Narcotics Agency. |
A dispenser shall transmit prescription information
electronically to the PDMP database for each prescription dispensed in Georgia
for a Schedule II, III, IV, or V controlled substance. Prescription information
shall be transmitted no more than 24 hours after the prescription is dispensed.
If no prescriptions are dispensed within a 24 hour period, then a report shall
be made indicating that fact.
| (1) |
Subject to the
requirements of this Rule, a prescriber or dispenser approved for internet
access to the PDMP may designate up to two individuals per shift or rotation to
access the PDMP on their behalf as delegates, provided that such individuals
are:
| (a) |
Members of the prescriber's or
dispenser's staff; |
| (b) |
Employed by
the health care facility in which the prescriber practices, and approved by the
medical director of such health care facility; or |
| (c) |
Employed by the emergency department of
the hospital in which the prescriber practices, and approved by the medical
director of such hospital. |
|
| (2) |
To be eligible to serve as a delegate, an
individual must:
| (a) |
Hold a current license as
a dentist, dental hygienist, optometrist, physician, physician assistant, or
podiatrist under Title 43 of the Official Code of Georgia; |
| (b) |
Hold a current license as a pharmacist or
pharmacist intern or registered as a pharmacist technician under Title 26 of
the Official Code of Georgia; or |
| (c) |
Comply with the requirements of
subsection (4) of this Rule. |
|
| (3) |
An individual shall be ineligible to
become a delegate if that person has been convicted of a felony, or of any
criminal offense involving illegal drug use, possession, trafficking, or sale.
"Convicted" as used in this subsection includes a plea of guilty or
nolo contendere, but does not include a conviction that has
been exonerated and discharged pursuant to Title 42, Chapter 8, Article 3 of
the Official Code of Georgia or pardoned. |
| (4) |
Before an individual may act as a
delegate, the delegating person or entity must:
| (a) |
Ensure that the proposed delegate has
taken the department's online training course entitled "The Georgia
Prescription Drug Monitoring Database: Understanding Your Responsibilities" and
passed the online test with a score of at least 70: |
| (b) |
Instructed in the prescriber or
dispenser's security policies pertaining to the PDMP; and |
| (c) |
Obtain a signed Responsibility Statement
from the proposed delegate and place it in the delegate's personnel
file. |
|
| (5) |
A delegating
person or entity shall maintain records documenting the delegate's completion
of the online PDMP training, the execution of the Responsibility Statement, the
date on which each delegate was granted access to the PDMP, and the date on
which the delegate's access was terminated. Those records shall be made
available for inspection by the department. |
| (6) |
A delegate may access the PDMP only for
the purpose of providing medical or pharmaceutical care to a specific patient
of the delegating prescriber or dispenser, or to inform the delegating person
or entity of a patient's potential use, misuse, abuse, or underutilization of
prescribed medication. |
A dispenser may submit a written request for a hardship
waiver from the requirement that it transmit prescription information within 24
hours by electronic means as required by paragraphs (a) and (b) of Code Section
16-13-59.
The request must explain in detail the nature of the hardship, and propose an
alternative method whereby the dispenser will report all prescription
information within 24 hours. No request for a waiver will be approved without
sufficient proof that compliance would impose an undue hardship upon the
dispenser, meaning that it lacks sufficient financial resources to arrange for
electronic transmission on its own or by arrangement with a third
party.
| (1) |
All prescribers and dispensers authorized
to have internet access to the PDMP shall protect prescription information
obtained from the PDMP in accordance with the federal regulations implementing
the Health Insurance Portability and Accountability Act (HIPAA) and the Health
Information Technology for Economic and Clinical Health (HITECH Act) as they
may be amended from time to time. Prescription information obtained from the
PDMP may be included in the patient's chart. |
| (2) |
All prescribers and dispensers authorized
to have internet access to the PDMP shall follow written policies governing
access to the PDMP, the recording and use of prescription information obtained
from the PDMP, and the protection of any written or electronic records in which
prescription information is recorded. |
| (3) |
All prescribers and dispensers authorized
to have internet access to the PDMP shall review DPH Form 7207 "Guide To The
Georgia Prescription Drug Monitoring Database" and sign DPH Form 7207-A
"Responsibility Statement." |
| (1) |
This regulation is intended to govern all
requests for prescription data from the PDMP other than queries for particular
patients made by prescribers, dispensers, or their delegates. Except as
provided in this Chapter or by law, prescription information held in the PDMP
database is confidential and will not be disclosed by the department. |
| (2) |
The following persons may request
information contained in the PDMP, for the purposes identified below, and in
the manner set forth below:
| (a) |
Local or
state law enforcement or prosecutorial officials, pursuant to a search warrant
issued by an appropriate court or official for the jurisdiction in which the
office of such law enforcement or prosecutorial officials is located; |
| (b) |
Federal law enforcement or prosecutorial
officials, pursuant to a search warrant issued pursuant to Title 21 of the
United States Code, a grand jury subpoena issued pursuant to Title 18 of the
United States Code, an administrative subpoena, or a civil investigative
demand; |
| (c) |
The Georgia Drugs and
Narcotics Agency, for health oversight purposes, or upon presentation of a
subpoena issued by or on behalf of that agency, or as part of an investigation
into suspected or reported abuses or regarding illegal access to the PDMP
database; |
| (d) |
The Georgia Composite
Medical Board, for health oversight purposes, or upon presentation of a
subpoena issued by or on behalf of such board; |
| (e) |
The Georgia Board of Pharmacy, for health
oversight purposes, or upon presentation of a subpoena issued by or on behalf
of such board; |
| (f) |
The Georgia
Department of Community Health, for oversight of the state Medicaid program, or
upon presentation of a subpoena issued by or on behalf of that
agency; |
| (g) |
The Georgia Board of
Nursing, for health oversight purposes, or upon presentation of a subpoena
issued by or on behalf of such board; |
| (h) |
The federal Centers for Medicare and
Medicaid Services, upon presentation of a subpoena issued by or on behalf of
that agency; |
| (i) |
An individual
whose prescription history appears in the PDMP is entitled to a copy of that
history, upon written request made by that person or their attorney; |
| (j) |
A prescriber is entitled to a copy of
prescription information in the PDMP which pertains to prescriptions written by
that person, upon written request made by that prescriber or their
attorney; |
| (k) |
A dispenser is
entitled to a copy of prescription information in the PDMP which pertains to
prescriptions dispensed by that person, upon written request made by that
dispenser or their attorney; |
| (l) |
A
prescription drug monitoring program operated by a government entity in another
state, or an electronic medical records system operated by a prescriber or
health care facility, provided that the program or system has been determined
by DPH to contain legal, administrative, technical, and physical safeguards
that meet or exceed the security measures employed by DPH in the operation of
the PDMP. |
| (m) |
Persons or entities
may request prescription information for purposes of statistics, education,
instruction, drug abuse prevention, or scientific research; provided, however,
that such data will first be de-identified according to the standards set forth
in
45
C.F.R. 164.514 as it may be amended from time
to time. |
|
| (3) |
Requests
for data made pursuant to subsections (a) through (l) of this Rule shall be
submitted to the Director of the DPH Office of Drug Misuse Evaluation in
writing or through a dedicated email address set up by the department for that
purpose. Requests for data made pursuant to subsection (l) of this Rule shall
be made through the department's Public Health Information Portal
(PHIP). |
Prescription information entered into the PDMP shall be
de-identified two years from the date such information was transmitted to the
database by the dispenser. De-identification shall be conducted according to
the standards set forth in
45
C.F.R. 164.514 as it may be amended from time
to time.
