Ga. Comp. R. & Regs. R. 480-33-.04 - Absence of Pharmacist

The following regulations shall be followed in the absence of a pharmacist:

(a) General. When a licensed pharmacist is not physically present in the clinic pharmacy, written policies and procedures shall be prepared in advance by the pharmacist-in-charge for the provision of drugs to the medical staff and other authorized licensed personnel of the clinic by use of after hours cabinets or containers and/or by access to the pharmacy.

(b) After hours cabinets or containers. Access to drugs, in the absence of a licensed pharmacist, shall be by locked cabinet(s) or other enclosure(s) or container(s) constructed and located outside of the pharmacy area to which only specifically authorized licensed clinic personnel as indicated by written policies and procedures may obtain access by key or combination, and which is sufficiently secure to deny access to unauthorized persons. The pharmacist-in-charge shall, in conjunction with the appropriate committee of the outpatient clinic facility, develop inventory listings of those drugs to be included in such cabinet(s), enclosure(s) or container(s) and shall insure that:

1. Such drugs available are properly labeled, with drug name, strength, lot number and expiration date;

2. Only pre-packaged drugs are available therein, in amounts sufficient for immediate therapeutic requirements;

3. Whenever access to such cabinet(s), enclosure(s) or container(s) shall have been gained, written practitioner's orders and proof of use for controlled substances are provided;

4. All drugs therein are inventoried no less than once per week. A system of accountability must exist for all drugs contained therein; and

5. Written policies and procedures are established to implement the requirements of this subsection.

(c) Access to pharmacy. Whenever any drug is not available from standard ward inventories or after hours cabinet(s), container(s) or enclosure(s) and such drug is required to treat the immediate needs of a patient whose health would otherwise be jeopardized, such drug may be obtained from the pharmacy pursuant to the practitioner's order and the requirements of this subsection. One licensed health care professional as designated in the policies and procedures may have access to the pharmacy and may remove drugs therefrom. Such licensed health care professional shall be designated in writing by the pharmacist-in-charge of the outpatient clinic pharmacy and shall, prior to being permitted to obtain access to the pharmacy, receive thorough education and training in the proper methods of access, removal of drugs, and records and procedures required. Such education and training shall be given by the pharmacist-in-charge who shall require, at a minimum, the following records and procedures:

1. Removal of any drug from the pharmacy by an authorized licensed health care professional must be recorded on a suitable form showing name of drug, strength, amount, date, time and signature of the designated licensed health care professional;

2. The container from which the drug is removed shall be placed conspicuously in the pharmacy to be promptly reviewed and inspected by a pharmacist.

(d) Emergency kits. Drugs may be provided for use by authorized health care personnel by emergency kits, provided such kits meet the following requirements:

1. Emergency kit drugs defined. Emergency kit drugs are those drugs which may be required to meet the immediate therapeutic needs of patients and which are not available from any other authorized source within the clinic in sufficient time to prevent risk of harm to patients;

2. Drugs included. The pharmacist-in-charge and the medical staff of the clinic shall jointly determine the drugs, by identity and quantity, to be included in emergency kits;

3. Storage. Emergency kits shall be locked and stored in limited access areas to prevent unauthorized access, and to insure a proper environment for preservation of the drugs within them;

4. 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 the contents 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, the GDNA or one of their agents;

5. 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;

6. Removal of drugs. Drugs shall be removed from emergency kits only pursuant to a valid prescription drug order of an authorized prescribing practitioner, by authorized clinic personnel, or by a pharmacist of the clinic facility;

7. Notification. Whenever an emergency kit is opened, the pharmacy shall be notified; and the pharmacy shall replace or re-stock and re-seal 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;

8. 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 resealed.

9. Procedures. The pharmacist-in-charge shall, in conjunction with the medical staff of the clinic, develop and implement written policies and procedures to insure compliance with the provisions of this subsection.

(e) Authoritative, current antidote information as well as the telephone number of the regional poison control information center shall be posted or readily available in areas outside the pharmacy where these drugs are stored or patients are being cared for.

Notes

Ga. Comp. R. & Regs. R. 480-33-.04

O.C.G.A. Secs. 26-3-16, 26-4-27, 26-4-28, 26-4-37, 26-4-100, 26-4-110.

Original Rule entitled "Absence of Pharmacist" adopted. F. June 7, 1995; eff. June 27, 1995. Repealed: New Rule of same title adopted. F. July 24, 2002; eff. August 13, 2002.