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Rules and Regulations of the State of Georgia
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Chapter 360-12 CONTROLLED SUBSTANCES THERAPEUTIC RESEARCH PROGRAM

Rule 360-12-.01 Organization of the Patient Qualification Review Board

(1) The Composite State Board of Medical Examiners shall appoint the Patient Qualification Review Board. Each member of the Review board shall be approved for such membership by a majority vote of the Composite Board. The Review board shall consist of:
(a) a Board certified physician of Ophthalmology;
(b) a Board certified physician in Surgery;
(c) a Board certified physician in Internal Medicine and Medical Oncology;
(d) a Board certified physician in Psychiatry;
(e) a Board certified physician in Radiology;
(f) a Pharmacist licensed under Code Title 79A, relating to pharmacists, pharmacy, and drugs, as now or hereafter amended.
(2) Board members shall serve terms as specified by the Composite board. They are as follows:
(a) two (2) three year appointments;
(b) two (2) four year appointments;
(c) two (2) five year appointments.
(3) The Review board shall elect from its members a chairman and vice-chairman.
(a) The Review board shall hold regular meetings at least once every 60 days and shall meet at such additional times as shall be called by the chairman of the Review board or the president of the Composite board. Meetings of the Review board to certify patients, physicians or pharmacies shall not be open to the public, as otherwise required by an Act providing for open meetings.
(b) Each member of the Review board shall receive for services for each day's attendance upon meetings of such board the same amount authorized by law for members of the General Assembly for attendance upon meetings of the General Assembly.

Rule 360-12-.02 Definitions

As used in these rules, the following shall mean:

(a) "Composite Board" means the Composite State Board of Medical Examiners established pursuant to Code Chapter 84-9, as now or hereafter amended;
(b) "marijuana" means marijuana or tetrahydrocannabinol, as defined or listed in the "Georgia Controlled Substances Act," as now or hereafter amended:
(c) "physician" means person licensed to practice medicine pursuant to Code Chapter 84-9, as now or hereafter amended;
(d) "program" means the Controlled Substances Therapeutic Research Program established pursuant to Code Section 84-904A;
(e) "Review Board" means the Patient Qualification Review Board established pursuant to Code Section 84-905A.

Rule 360-12-.03 Patients Certified to the Patient Qualification Review Board by a Physician

(1) Such patients are defined as:
(a) Cancer patients involved in a life-threatening situation in which treatment by chemotherapy or radiology has produced severe side effects; or
(b) glaucoma patients who are not responding to conventional controlled substances;
(2) No patient may be admitted to the program without full disclosure by the physician of the experimental nature of the program and of the possible risks and side effects of the proposed treatment.
(3) The patient shall pay the cost of any blood test required by the Federal Food and Drug Administration prior to entrance into the program.
(4) The Review board shall review all patient applicants for the program and their physicians and shall certify those qualified for their participation in the program.
(5) No patient's name shall be disclosed to the public and patient applications and records shall be reviewed by the Board in closed session.
(6) Patients Eligible to Participate in Research Program:
(a) Males and non-pregnant females, willing to sign an informed consent, who reside in Georgia and who are patients of duly licensed Georgia physicians may be impanelled. Patients under the age of 18 will require parental consent;
(b) all eligible patients must have histologically documented evidence of malignancy and must be under treatment with chemotherapeutic agents and/or radiotherapy known to cause nausea and/or vomiting. There must be evidence that conventional anti-emetic therapy has been tried and failed.
(c) patient must live with or have available another person over the age of 18 to monitor side effects and provide transportation. Patient must agree not to operate dangerous machinery such as an automobile within 24 hours after the last dose of THC/Marijuana;
(d) patient must not be under treatment for any significant mental disorder known to contraindicate the use of THC/Marijuana. Exceptions may be made upon written recommendations of a psychiatrist;
(e) patients with a history of allergy to ragweed and other plant antigens may be at greater than average risk of allergic reaction. These patients will be required to be in an inpatient facility during the first five doses (24 hours) of THC or marijuana and then have available an emergency epinephrine injection kit for self administration if needed;
(f) patients with a history of angina and/or other cardiovascular problems known to contraindicate the use of THC/Marijuana will be ineligible. Also ineligible will be patients with symptoms of uncontrolled nausea and/or vomiting due to organic disease such as brain metastases or intestinal obstruction.
(7) Patients accepted into this study will require the following parameters before therapy begins:
(a) Physical exam, including height and current weight;
(b) Forms A and B;
(c) CBC, platelet count, SMA-12 panel, BUN, creatinine;
(d) EKG, chest x-ray.

Rule 360-12-.04 Pharmacies Certified by the Patient Qualification Review Board

The Review Board shall additionally certify pharmacies which are licensed by the State and which are otherwise qualified, and physicians regarding the distribution of marijuana pursuant to the provisions of Code Section 84-906A.

Rule 360-12-.05 Patient Application

(1) Procedures and methods shall be as follows:
(a) A physician requesting that his patient be included in this study must submit an application and notify the Patient Qualification Review Board that there is in the medical record a copy of the biopsy report and a consultation request for evaluation of THC/Marijuana antiemetic protocol. A copy of the biopsy report shall then be sent to the Board.
(2) Control of this drug will be based on assignment of patients to protocol.
(a) A copy of the Medical Registration Form shall be forwarded to the pharmacist before any drug is dispensed. The drug shall then be issued in accordance with written physician orders after matching these orders with the Medical Registration Form copy. The pharmacist shall maintain a ledger sheet on each patient. Monthly, the pharmacist shall review all ledgers, take a physical inventory of all THC/Marijuana on hand, and prepare a written report to the PQR Board.
(3) If a patient is to receive THC/Marijuana on subsequent cycles, an order shall be sent to the pharmacy with a copy of the evaluation form. The patient will then receive the drug for another cycle.
(4) If the patient is taken off the study for any reason, physician shall notify the PQR Board and send narrative off study form. A copy of this form will then be sent to the pharmacy.
(5) If patient has cancer chemotherapy changed to other drugs that produce nausea and vomiting, physician shall send notice to the Board of his intent to keep patient on protocol. A copy will then be sent to the pharmacy.
(6) In addition to the above audits, pharmacists shall handle THC/Marijuana exactly as Schedule II control drugs are handled.
(7) Unused drug will be returned to the pharmacist and will be retained separately.