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Subject 511-7-2 PRESCRIPTION DRUG MONITORING PROGRAM

Rule 511-7-2-.01 Definitions

(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;
(h) Patient's name;
(i) Patient's address;
(j) Patient's date of birth;
(k) Patient gender;
(l) Method of payment;
(m) Approved prescriber identification number or prescriber's DEA permit number; and
(n) Date the prescription was issued by the prescriber.

Rule 511-7-2-.02 Internet access to the Prescription Drug Monitoring Program database (PDMP)

(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.

Rule 511-7-2-.03 Obligation of dispensers to transmit prescription information to the PDMP

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.

Rule 511-7-2-.04 Delegates

(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.

Rule 511-7-2-.05 Dispenser claims for hardship waiver

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.

Rule 511-7-2-.06 Duty of prescribers and dispensers to safeguard information obtained from the PDMP

(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."

Rule 511-7-2-.07 Requests for prescription data held in the PDMP

(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).

Rule 511-7-2-.08 De-identification of prescription information held in the PDMP for more than two years

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.