Ga. Comp. R. & Regs. R. 480-17-.03 - Issuance of Sterile Drug IV Maintenance Kits by an Issuing Pharmacy

As set forth by this rule, pharmacies, hereafter known as Issuing Pharmacies, may issue sealed Sterile Drug IV Maintenance Kits (SDM Kits) to RNs who are employed or contracted by a HHA. The contents of such kits are strictly limited to the following IV maintenance drugs: sterile water, sterile saline, and diluted heparin. The manner of issuance of such SDM Kits is limited to procedures specified in written guidelines set forth by the Issuing Pharmacy and based on this rule. Pursuant to these guidelines, Home Health Agencies may authorize Registered Nurses employed or contracted by the Home Health Agency to carry and utilize such contingency kits for the purpose of IV maintenance for Home Health Agency patients. Nothing in this rule is to be interpreted to allow Home Health Agencies or registered professional nurses to independently possess dangerous drugs. Such SDM Kits and drugs contained therein, as described in this rule, will at all times be considered under the control of the Issuing Pharmacy described as follows:

(a) A written agreement, which has been signed by a pharmacist on behalf of the Issuing Pharmacy and by the medical director of the licensed Home Health Agency, will serve as a protocol, which establishes at a minimum, but not limited to: the contents of the kits and the manner in which sealed SDM kits will be issued, stored, handled, and restocked. Prior to any such agreement becoming effective, it must first be signed and dated by the medical director of the Home Health Agency and returned to the Issuing Pharmacy. This protocol will include at a minimum:
1. The manner in which a pharmacy initially labels and issues a SDM Kit;
2. The manner in which a pharmacy will restock or issue a replacement SDM Kit;
3. The manner in which sealed, SDM Kits are stored and kept secure at a licensed Home Health Agency (HHA);
4. The record keeping required of and the manner in which a HHA may issue on a daily basis the maximum number of SDM Kits necessary to authorized RNs. These issued kits may be carried by an R.N only during the nurse's daily, patient care duties, and such kits will be returned to the HHA after the completion of those duties;
5. The record keeping required of and the manner in which an authorized HHA RN may break the seal of and open a SDM Kit to utilize its' contents as necessary to perform necessary patient IV maintenance care duties. Such use requires the issuance of a prescriber's order prior to any drug being utilized;
6. The manner in which an Issuing Pharmacy will be notified within 72 hours of when such drug utilization occurs, with such notification to include a copy of the physician's order bearing the name of the prescriber, the name of the nurse administering the drug(s), the patient name, the name of the drug, the dosage form and directions for use, along with other pertinent information;
7. Once the seal on a SDM Kit has been broken and the SDM Kit has been opened, the kit shall be returned to the HHA. Upon being returned to the HHA, it cannot be reused or reissued until it has been restocked and resealed by a pharmacist from the Issuing Pharmacy.
(b) An Issuing Pharmacy will develop written guidelines in which, at a minimum, it establishes procedures for:
1. Maintaining a record of serial numbers on breakable seals utilized on individual.SD.M. Kits;
2. The record keeping of and manner of issuing or replacing the contents of SDM Kit;
3. The monthly inspection to include how SDM Kits are stored by a Home Health Agency, accountability for each issued kit, the condition of the drugs contained therein (including expiration date), and a method to handle the kits after their contents have expired;
4. How the authorized RN will possess kits in a manner which meets all Federal, State, and USP guidelines for the proper storage of the sterile dangerous drugs contained therein.
(c) Any retail pharmacy may enter into a SDM kit agreement with one or more Home Health Agencies. The pharmacist in charge of such pharmacy will be directly responsible for drafting a protocol which meets the requirements of this rule, and for the manner in which these SDM Kits are utilized by a Home Health Agency and their authorized registered RNs.
1. Any and all records relating to a pharmacy issuing SDM Kits will be made available for inspection and copying by a representative of the Georgia Drugs and Narcotics Agency (GDNA).
2. The issuing pharmacy shall maintain a list with the name, address and the responsible person of each H. H. A. where SDM Kits are stored. Agents of the GDNA shall have unrestricted access to inspect Home Health Agencies in relation to SDM Kits and corresponding storage and distribution records, as set forth under O.G.C.A Title 26, Chapter 3.
3. The Issuing Pharmacy will maintain a list of any and all nurses authorized to possess such SDM kits.
4. During the inspection, the GDNA Agent may make recommendations as to any problems or discrepancies.
5. When any Issuing Pharmacy experiences discrepancies in the record keeping of a H. H. A., or any SDM Kits previously issued to a H. H. A. cannot be accounted for, the pharmacist in charge shall notify the GDNA.

Notes

Ga. Comp. R. & Regs. R. 480-17-.03
O.C.G.A. Secs. 16-13-72(4.2), 26-4-27.
Original Rule entitled "Issuance of Sterile Drug IV Maintenance Kits by an Issuing Pharmacy" adopted. F. Feb. 20, 2002; eff. Mar. 12, 2002.

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