3 Colo. Code Regs. § 719-1-10.00.00
Current through Register Vol. 48, No. 1, January 10, 2025
Section 3 CCR 719-1-10.00.00 - EMERGENCY KITS10.00.05 Definitions. a. "Emergency kit" or "kit" means a tamper-evident sealed and secured container or secured electronic system containing drugs which are used for either immediate administration to patients of facilities delineated in 10.00.10 or in an emergency situation or as a starter dose.b. "Starter dose" means a dose of medication contained in an emergency kit for the purpose of starting the initial therapy for a patient residing in a facility delineated in Rule 10.00.10.10.00.10 A prescription drug outlet or a hospital other outlet may provide an emergency kit to any of the following facilities that are licensed or certified by the Colorado Department of Public Health and Environment: Long-Term Care Facilities, Hospices, Acute Treatment Units and Home Health Agencies. Such kit is to provide an emergency supply of drugs, both controlled and non-controlled as provided below. The drugs maintained in the emergency drug supply shall remain the property of the prescription drug outlet or the hospital other outlet who supplied the drugs. a. Only one prescription drug outlet or hospital other outlet may provide a kit to any of the above facilities. Multiple pharmacies or hospital other outlets may not supply emergency kits to the same facility.b. The pharmacist manager of the prescription drug outlet supplying the kit or the consultant pharmacist of the hospital other outlet supplying the kit shall be responsible for the accurate stocking or restocking of the kit. He/she may delegate this function to non-pharmacist personnel, but the pharmacist manager or other outlet consultant pharmacist assumes responsibility for the accuracy of the contents of the kit.10.00.20 Categories and Limits a. For Long-Term Care Facilities, Acute Treatment Units, and Inpatient Hospices, the medical director of the facility, or equivalent, and the consulting pharmacist shall determine the specific drugs to be kept in the kit. The number of drugs allowed in the kit shall be limited to sixty. Of the sixty, twelve may be controlled substances. The kit may contain no more than thirty doses of any separate drug dosage form or strength for each drug. The container size for each drug shall be limited to unit dose or unit of issue packaging.b. In the case of a Certified Home Health Agency or an Outpatient Hospice, the director of nursing of the Certified Home Health Agency or of the Licensed Hospice, and a pharmacist employed and designated by the prescription drug outlet or hospital other outlet providing the kit shall determine the specific drugs to be kept in the kit. A Certified Home Health Agency or Outpatient Hospice may not have oral dosage forms or controlled substances in the kit. The container size for each injectable drug shall be limited to unit dose or unit of issue packaging. The number of drugs allowed in the kit shall be limited to sixty. The kit may contain only thirty doses of any separate drug dosage form or strength for each drug.10.00.30 The kit shall be sealed with a tamper-evident seal or an electronic system which notifies the pharmacy when the kit has been accessed. Paper or tape seals are unacceptable. If an electronic system is utilized, the pharmacy and facility must maintain a written procedure for how the kit can be accessed in the event of downtime.10.00.40 The following information shall be readily retrievable and up-dated as required: a. Name, address and telephone number of the prescription drug outlet or hospital other outlet providing the contents of the kit;b. The date of sealing of the kit;c. A suitable expiration date which shall be the earliest expiration date of any drug in the kit, but in no event shall it be more than one year from the date of sealing; andd. In the case of a Long-Term Care Facility, Acute Treatment Unit or Inpatient Hospice, the name of the consulting pharmacist, or, in the case of a Certified Home Health Agency or an Outpatient Hospice, the name of the designated pharmacist.10.00.41 A copy of the kit contents shall also be attached to the kit.10.00.50 Access. Access to the contents of the kit shall be limited as follows:a. In the case of a Long-Term Care Facility, Acute Treatment Unit, or Inpatient Hospice, only a pharmacist employed by the prescription drug outlet or hospital other outlet which provides the kit or his/her designee, the consulting pharmacist, and any nurse employed at the facility shall have access.b. In the case of a Certified Home Health Agency or an Outpatient Hospice, only a pharmacist employed by the prescription drug outlet or hospital other outlet which provides the kit or a nurse employed by the Certified Home Health Agency or an Outpatient Hospice shall have access.10.00.60 Inspection. A pharmacist employed by the prescription drug outlet or hospital other outlet providing the kit or that pharmacist's designee shall inspect and inventory the contents of the kit at least annually and within seventy-two hours after being notified that the kit has been accessed. An off-site review is acceptable, if the kit is an electronic system and meets the following requirements:a. chain of custody report which includes the nurses name, patient name, medication, and quantity removed;b. has the ability to show discrepancy in count; andc. has secured access to medications, unable to access medications without approved request, and only able to access the medication that is requested. Inspection shall be documented by that pharmacist, and such documentation shall be maintained and available for inspection at the prescription drug outlet or hospital other outlet for a period of two years.
10.00.70 A separate record of use for each drug placed in the kit, and for each kit provided, which shall state the following Records. The prescription drug outlet or hospital other outlet providing the kit shall maintain: a. The name and address of the Acute Treatment Unit, Long-Term Care Facility, Certified Home Health Agency, or Hospice;b. The name and strength of the drug; andc. The container size and the quantity initially placed in the kit.10.00.71 When a drug is removed for administration the prescription drug outlet or hospital other outlet shall obtain a prescription order or LTCF chart order for the drug within seventy-two hours after being notified that the kit was opened and the drug was used. The order shall indicate the total number of doses administered. The order shall be assigned a serial number and the order shall be retained as required by Rule 11.04.10 . Additionally, the separate record required for each drug in the kit shall reflect the following information: a. Date and quantity administered;b. Names of both the patient and practitioner;c. Date the drug was replaced in the kit;d. The quantity of the drug replaced, which shall not exceed the quantity administered or removed for administration; ande. The prescription order number assigned.10.00.80 Use. The drugs shall only be administered to patients of the Acute Treatment Unit, Long-Term Care Facility, Certified Home Health Care Agency, or Hospice pursuant to the order of a practitioner.37 CR 18, September 25, 2014, effective 10/15/201438 CR 16, August 25, 2015, effective 9/14/201539 CR 04, February 25, 2016, effective 3/16/201639 CR 19, October 10, 2016, effective 11/14/201640 CR 04, February 25, 2017, effective 3/17/201740 CR 20, October 25, 2017, effective 11/14/201741 CR 16, August 25, 2018, effective 9/17/201842 CR 21, November 10, 2019, effective 11/30/201943 CR 10, May 25, 2020, effective 5/1/202043 CR 08, April 25, 2020, effective 5/15/202043 CR 15, August 10, 2020, effective 8/30/202043 CR 20, October 25, 2020, effective 11/14/202044 CR 04, February 25, 2021, effective 3/17/202144 CR 08, April 25, 2021, effective 5/15/202144 CR 21, November 10, 2021, effective 11/30/202145 CR 20, October 25, 2022, effective 9/29/202245 CR 21, November 10, 2022, effective 11/30/2022