Rule 480-35-.04 - Requirements for a Protocol(1) A physician may delegate authority to a pharmacist certified under this chapter to modify drug therapy through a protocol for a patient under the physician's direct medical care and supervision. The protocol shall meet the applicable requirements for the issuance of prescriptions provided in O.C.G.A. Section 16-13-41 or 16-13-74, which ever is applicable.(2) A protocol shall be in writing and must contain the following: (a) The printed name and signature of the physician, along with the license number issued to the physician by the Georgia Composite Board of Medical Examiners;(b) The printed name and signature of the pharmacist, along with the license number issued to the pharmacist by the Board;(c) The date the protocol was established, and the date the protocol becomes effective;(d) The length of time the protocol shall be in effect;(e) The identity of each patient covered by the protocol, and a mechanism to inform the patient the physician has authorized the pharmacist to modify the patient's drug therapy pursuant to this protocol, including information as to how the patient may opt out of the protocol;(f) The physician's diagnosis of condition or disease state for each patient identified in the protocol, along with a listing of the initial drug therapy prescribed by the physician for each patient;(g) A description of the parameters and responsibilities for drug therapy modification;(h) Description of the monitoring required by the pharmacist and physician for each patient identified in the protocol;(i) The procedures the pharmacist must follow when modifying drug therapy including, but not limited to, the method and frequency of notification to the physician of any drug therapy modification;(j) For each patient's drug therapy modification, the identification of types and categories of medications allowed to be utilized, and the maximum/minimum dosage levels within each type and category of medication; and(k) Identification of the documentation required by the pharmacist when drug therapy has been modified, including, but not limited to, a record of any problems or complications encountered, a list of recommendations, and a list of all drug modifications.(3) No protocol can be longer than two (2) years. Protocols shall terminate immediately when the pharmacist's or physician's license and/or certificate has lapsed, been revoked, or has not been renewed.Ga. Comp. R. & Regs. R. 480-35-.04
O.C.G.A. Secs. 16-13-41, 16-13-74, 26-4-6, 26-4-27, 26-4-28, 26-4-50, 26-4-81, 43-1-7, 43-34-26.2.
Original Rule entitled "Requirements for a Protocol" adopted. F. Aug. 31, 2005; eff. Sept. 20, 2005.