Compilation of Rules and Regulations of the State of Georgia
Department 360 - RULES OF GEORGIA COMPOSITE MEDICAL BOARD.
Chapter 360-12 - CONTROLLED SUBSTANCES THERAPEUTIC RESEARCH PROGRAM
Rule 360-12-.03 - Patients Certified to the Patient Qualification Review Board by a Physician

Universal Citation: GA Rules and Regs r 360-12-.03

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.

Ga. L. 1980, pp. 82-88 (Ga. Code Ann. 84-904a and 84-905a).

(Original Rule entitled "Patients Certified to the Patient Qualification Review Board by a Physician" adopted. F. Apr. 23, 1981; eff. May 13, 1981. Amended: F. May 20, 1988; eff. June 9, 1988.)
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