N.H. Admin. Code § Ph 2506.02

Current through Register No. 45, November 7, 2024

Section Ph 2506.02 - Automated Pharmacy Systems Emergency Kit Use Requirements

(a) Automated electronic emergency drug kits located in remote sites shall:

(1) Provide real time electronic communication to the provider pharmacy;

(2) Have a method to ensure security of the system to prevent unauthorized access. Such method shall include the use of electronic passwords, biometric identification or other coded identification;

(3) Be supervised by a New Hampshire licensed pharmacist or licensed advanced pharmacy technician employed by the provider pharmacy;

(4) Have all the drug inventory stored in the automated dispensing system shall be owned by the provider pharmacy;

(5) When placed in non-federally registered long term care facilities and other health care institutions be deemed to be in compliance with the Comprehensive Drug Abuse Prevention and Control Act of 1970 provided that:

a. Controlled substances selected and stored in the automated electronic emergency drug kits is in quantities deemed necessary and jointly approved by the pharmacist in charge and the consultant pharmacist, medical director, and director of nursing services;

b. Controlled substances in emergency drug kits are limited to a maximum of 250 total dosage units per kit;

c. Only the director of nursing services, registered nurse on duty, licensed practical nurse on duty, pharmacist, registered pharmacy technician, or New Hampshire licensed health care professionals authorized under regulations associated with their scope of practice shall have access to controlled substances stored in an automated electronic emergency drug kit; and

d. Controlled substances are only released from the automated electronic emergency drug kit to authorized personnel by a supervising pharmacist in compliance with provisions in 21 CFR 1306.11 and 21 CFR 1306.21;

(6) Be able to automatically generate notice to the provider pharmacy whenever the kit is accessed and provide at least the following information:

a. Name of individual accessing the kit;

b. Date and time the kit was accessed;

c. Name, strength, and quantity of the drug removed; and

d. Name of the patient for whom the drug was administered;

(7) Be restocked by a licensed pharmacist, licensed pharmacist assistant, physician, physician assistant, advanced practice nurse, registered nurse, certified pharmacy technician, or an advanced practice technician;

(8) Have a system to allow for records to be retrievable and in a readily available manner; and

(9) Allow for the storage of records of all transactions with the automated pharmacy system for at least 4 years.

(b) In the instance where an automated system is unavailable the following criteria shall be met:

(1) Controlled substances shall be stored in the emergency drug kit as deemed necessary and jointly approved by the pharmacist in charge and the consultant pharmacist, medical director, and the director of nursing services;

(2) The source from which controlled substances for emergency drug kits are obtained shall be a DEA registered hospital, clinic, pharmacy, or practitioner;

(3) Controlled substances in emergency drug kits shall be limited to a maximum of 250 dosage units per kit;

(4) The emergency drug kit containing controlled substances shall be closed with a tamper proof seal and kept in a locked medication room, cart, or closet;

(5) Only a NH licensed healthcare professional authorized under regulations associated by their scope of practice shall have access to the drug kit;

(6) Controlled substances in emergency drug kits shall be administered to patients 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 1306.21;

(7) A usage record shall be contained in the emergency drug kit for each separate drug included and shall be completed by the nursing staff when using any controlled substance or substances from the kit;

(8) The pharmacist shall receive a copy of all completed usage records and keep those records on file for a period not less than 2 years;

(9) When the emergency drug kit is opened a shift count shall be completed by the a member of the nursing staff on all controlled substances until the emergency drug kit is resealed by the consultant pharmacist;

(10) Shift counts of the controlled substances contained in the emergency kit shall not be required when the kit is sealed; and

(11) The pharmacist shall check the controlled substances in the emergency drug kit at least once a month and so document inside the kit.

N.H. Admin. Code § Ph 2506.02

Derived from Volume XLII Number 45, Filed November 10, 2022, Proposed by #13465, Effective 12/19/2022, Expires 12/19/2032