La. Admin. Code tit. 46 § LIII-1713

Current through Register Vol. 50, No. 11, November 20, 2024

Section LIII-1713 - Emergency Drug Kit Requirements

A. Emergency Use. An EDK is solely intended for the immediate therapeutic emergency needs of a resident or patient.

B. Security. The EDK shall be tamper-evident and shall be maintained in a secure enclosure located within the institutional facility and shall be available for emergency use by authorized personnel only.

C. Exterior Identification and Labeling. The EDK shall be clearly labeled to indicate that it is an emergency drug kit. In addition, the attached exterior label shall have an inventory of contents and contact information of the provider pharmacy.

D. Labeling. Medications stored in an EDK shall bear a label with the following minimum information:

1. drug name;

2. dosage form;

3. strength;

4. name of manufacturer and/or distributor;

5. manufacturer's lot or batch number; and

6. expiration date, according to United States Pharmacopeia guidelines.

E. Storage. All drugs in an EDK shall be stored to ensure a proper environment for the preservation of the drugs. If federal or state laws or regulations require adequate storage outside the EDK, documentation shall be kept with the EDK properly identifying this special storage requirement and drug(s) involved.

F. Policies and Procedures. Policies and procedures shall be maintained by the provider pharmacy and the applicant facility to implement the EDK requirements.

G. Accountability. Documented medical practitioner's orders and proof of use shall be provided when an EDK inventory is utilized. Medication administered to patients from the EDK shall be documented with the following information, in accordance with the institutional facility policy manual, that shall be immediately reduced to writing and a copy delivered to the provider pharmacy:

1. name of the resident patient;

2. drug name, strength, and quantity;

3. nature of the emergency;

4. time and date of administration;

5. name of person administering the medication; and

6. name of prescriber authorizing the medication.

H. Records. Records shall be readily retrievable and comply with applicable federal and state laws and regulations.

I. Inspection

1. The provider pharmacy shall inspect the EDK every 30 days, plus or minus five days. Proper documentation of these inspections, EDK inventory, and all records of use shall be maintained and made available to the board upon request.

2. The EDK shall be available for inspection by the board.

J. The placement of controlled dangerous substances in an EDK in non-federally registered long-term care facilities shall be deemed in compliance with the Comprehensive Drug Abuse Prevention and Control Act of 1970 provided that:

1. controlled dangerous substances shall be stored in the EDK as deemed necessary and jointly approved by the pharmacist, medical director and the director of nursing services;

2. the source from which the controlled dangerous substances for EDKs are obtained shall be a pharmacy licensed by the board in possession of a valid DEA registration and Louisiana CDS license;

3. the number of different controlled dangerous substances in a single EDK shall be limited to a maximum of eight separate drug entities with not more than eight single-use containers of each drug entity;

4. the EDK containing controlled dangerous substances shall be closed with a tamper proof seal and kept in a locked medication room, cart or closet;

5. access to controlled dangerous substances stored in an EDK shall be limited to the pharmacist, a practitioner, the director of nursing services, or the registered nurse or licensed practical nurse on duty;

6. controlled dangerous substances stored in an EDK shall be administered to a patient only by authorized personnel and only as expressly authorized by an individual practitioner and in compliance with the provisions of 21 CFR 1306.11 and 21 CFR 1306.21 or their successors;

7. a usage record shall be retained in the EDK for each separate drug included which shall be completed by the nursing staff when retrieving any controlled dangerous substance(s) from the EDK;

8. the pharmacist at the provider pharmacy shall receive and retain all completed usage records for a minimum of two years;

9. when the EDK is opened:

a. the pharmacist shall be notified by the facility within 24 hours; and

b. shift counts shall be performed by the nursing staff on all controlled dangerous substances until the kit is resealed by the pharmacist;

10. shift counts of the controlled dangerous substances contained in the EDK shall not be required when the EDK is sealed;

11. the pharmacist shall check the controlled dangerous substances in the EDK at least monthly and so document that check inside the kit.

La. Admin. Code tit. 46, § LIII-1713

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2096 (October 2003), effective January 1, 2004, amended LR 39:312 (February 2013), Amended by Department of Health, Board of Pharmacy, LR 46584 (4/1/2020).

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.