COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, January 17, 2008

Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		Rule 10.00.00 is being repealed and readopted to allow for automated emergency kits and to modify outdated terminology.  An emergency kit is a kit containing emergency drugs which, by statute, a prescription drug outlet may provide to an approved facility, licensed Hospice or Certified Home Health Agency.

Statement of Authority:	The Board is granted authority to promulgate rules pursuant to CRS sections 12-22-108 and 110 and 24-4-103.

10.00.00  Emergency Kits.

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, 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 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 (60).  Of the 60, twelve (12) may be controlled substances.  The kit may contain no more than thirty (30) 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 (60).  The kit may contain only thirty (30) 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; and

d.	In the case of a Long-Term Care Facility 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 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.

10.00.51	Notification.  A prescription drug outlet or hospital other outlet which supplies an emergency drug kit to a Long-Term Care Facility, Hospice, or home health agency shall notify the board in writing within seven days that it has done so, specifying the name and address of the facility.

Notification must be repeated, within 30 days:

a.	If there is any change of ownership of the kit,

or 

b.	If there is a change of the consulting pharmacist, in the case of a Long-Term Care Facility or Inpatient Hospice, or of the designated pharmacist in the case of a Certified Home Health Agency or a Outpatient Hospice.

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 72 hours after being notified that the kit has been accessed. 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	Records.  The prescription drug outlet or hospital other outlet providing the kit shall maintain a separate record of use for each drug placed in the kit, and for each kit provided, which shall state the following:

a.	The name and address of the Long-Term Care Facility, Certified Home Health Agency, or Hospice;

b.	The name and strength of the drug; and

c.  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 72 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 regulation 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; and 

e.	The prescription order number assigned.

10.00.80	Use.  The drugs shall only be administered to patients of the long term care facility, certified home health care agency, or Hospice pursuant to the order of a practitioner.