Rule 480-18-.04 - Absence of a PharmacistThe following regulations shall be followed in the absence of a pharmacist:
(1) General. Access to drugs in the absence of a licensed pharmacist shall be limited to specifically authorized licensed medical personnel consistent with policies and procedures of the Director. Such areas shall be sufficiently secure to deny access by unauthorized persons. The Director shall, in conjunction with the appropriate committee of the narcotic treatment program clinic, develop a list of the drugs to be accessible and shall ensure that:(a) Such drugs available therein, are properly labeled, with drug name, strength, lot number and expiration date;(b) Only prepackaged drugs are available therein, in amounts sufficient for immediate therapeutic requirements;(c) Whenever access to such area shall have been gained, written physician's orders and proof of use for controlled substances are provided;(d) All drugs therein are inventoried no less than once per week. A system of accountability must exist for all drugs contained therein; and(2) Written policies and procedures are established to implement the requirements of this subsection.(3) Emergency Kits. Drugs may be provided for use by authorized licensed health care personnel by emergency kits, provided such kits meet the following requirements: (a) Drugs included. The Director and the medical staff of the clinic shall jointly determine the drugs, by identity and quantity, to be included in the emergency kits. Such drugs shall also be approved by the Board or its authorized agent;(b) Storage. Emergency kits shall be stored in limited access areas and sealed to prevent unauthorized access, and to insure a proper environment for preservation of the drugs within them;(c) Labeling-exterior. The exterior of emergency kits shall be labeled so as to clearly and unmistakably indicate that it is an emergency drug kit and is for use in emergencies only. In addition, a listing of the drugs contained therein, including name, strength, quantity, and expiration date of each drug shall be attached. Nothing in this section shall prohibit another method of accomplishing the intent of this section, provided such method is approved by the Board upon a recommendation of the GDNA.(d) Labeling-interior. All drugs contained in emergency kits shall be labeled in accordance with such state and federal laws and regulations which pertain thereto; and shall also be labeled with such other and further information as may be required by the medical staff of the clinic to prevent misunderstanding or risk of harm to the patients;(e) Removal of drugs. Drugs shall be removed from emergency kits only pursuant to a valid physician's order, by authorized licensed clinic personnel, or by a pharmacist for the clinic pharmacy;(f) Notification. Whenever an emergency kit is opened, the pharmacy shall be notified; and the pharmacy shall replace or re-stock and reseal the kit within a reasonable time so as to prevent risk of harm to patients. In the event the kit is opened in an unauthorized manner, the pharmacy and other appropriate personnel of the facility shall be notified;(g) Inspections. Each emergency kit shall be opened and its contents inspected by the pharmacy at least once every ninety (90) days. Upon completion of inspection, the emergency kit shall be re-sealed.(4) Access to pharmacy. Whenever any drugs are not available from an after hours safe or emergency kit(s), and such drugs are required to treat the immediate needs of a patient whose health would otherwise be jeopardized, such drugs may be obtained from the pharmacy pursuant to the physician's order and the requirements of this subsection. (a) At any given time, there may be only one licensed health care professional who is designated in the policies and procedures, to have access to the pharmacy and to remove drugs therefrom.(b) Such licensed health care professional shall be designated in writing by the Director of the OTP clinic pharmacy and shall, prior to being permitted to obtain access to the pharmacy, receive thorough education and training by the Director or his or her designee in the proper methods of access, removal of drugs, and records and procedures required.(c) Such licensed healthcare professional shall at a minimum record on a suitable form the name of any drug, the strength, amount, date and time removed from the pharmacy and his or her signature and title.(d) Such licensed healthcare professional shall place the container from which the drug is removed in a conspicuous place in the pharmacy to be promptly reviewed and inspected by a pharmacist.(e) Procedures. The Director, in conjunction with the medical staff of the clinic, shall develop and implement written policies and procedures to insure compliance with the provisions of this subsection.Ga. Comp. R. & Regs. R. 480-18-.04
O.C.G.A. Secs. 16-13-34, 26-4-27, 26-4-28, 26-4-87, 26-4-110, 26-4-111.
Original Rule entitled "Absence of a Pharmacist" adopted. F. Feb. 25, 2002; eff. Mar. 17, 2002.