Current through Register Vol. 50, No. 9, September 20, 2024
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.
AUTHORITY NOTE:
Promulgated in accordance with
R.S.
37:1182.
