Ariz. Admin. Code § 4-23-701.02

Current through Register Vol. 30, No. 25, June 21, 2024

Section R4-23-701.02 - Long-term Care Facilities Pharmacy Services: Emergency Drugs

A.The limited-service pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall ensure that:

1. An emergency drug supply unit is available within the long-term care facility,

2. Drugs contained in an emergency drug supply unit remain the property of the provider pharmacy, and

3. Controlled substance drugs contained in an emergency drug supply unit are included in all inventories required under A.R.S. §36-2523(B) and R4-23-1003(A).

B.An emergency drug supply unit shall meet the following criteria:

1. The drugs are necessary to meet the immediate and emergency therapeutic needs of long-term care facility residents as determined by the provider pharmacy's pharmacist-in-charge in consultation with the long-term care facility's medical director and nursing director;

2. The purpose of the emergency drug supply unit in a long-term care facility is not to relieve a provider pharmacy of the responsibility for timely provision of the resident's routine drug needs, but to ensure that an emergency drug supply unit is available for facility residents in need of immediate and emergency therapeutic drugs; and

3. The drugs are provided in a manufacturer's unit of use package or are prepackaged and labeled to include the drug name, strength, dosage form, manufacturer, lot number, and expiration date and provider pharmacy's name, address, telephone number, and pharmacist's initials.

C. The limited-service pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall ensure that an emergency drug supply unit:

1. Is stored in an area that:

a. Is temperature controlled; and

b. Prevents unauthorized access;

2. Contains on the exterior of the emergency drug supply unit a label to indicate that the contents are for emergency use only;

3. Contains on the exterior of the emergency drug supply unit a complete list of the contents of the unit by drug name, strength, dosage form, , and quantity and the provider pharmacy's name, address, and telephone number;

4. Contains on the exterior of the emergency drug supply unit a label that indicates the date of the earliest drug expiration date; and

5. Contains on the exterior of the emergency drug supply unit a label that indicates the date of and pharmacist responsible for the last inspection of the emergency drug supply unit; and

6. Is secured with a tamper-evident seal, or is locked and sealed in a manner that obviously reveals when the unit has been opened or tampered with.

D. The limited-service pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall:

1. Prepare, implement, review, and revise in the same manner described in R4-23-671(E) and comply with written policies and procedures for the storage and use of an emergency drug supply unit in a long-term care facility;

2. Make the policies and procedures available in the provider pharmacy and long-term care facility for employee reference and inspection by the Board or its staff;

3. Ensure that the written policies and procedures include the following:

a. Drug removal procedures that require:

i. The long-term care facility's personnel receive a valid prescription order for each drug removed from the emergency drug supply unit,

ii. The long-term care facility's personnel notify the provider pharmacy when a drug is removed from the emergency drug supply unit,

b. Outdated drug replacement procedures, and seven days

seven days

c. Security and inspection procedures;

4. Exchange or restock the emergency drug supply unit weekly, or more often as necessary, to ensure the availability of an adequate supply of emergency drugs within the long-term care facility. Restocking of the emergency drug supply unit at the facility shall be completed by an Arizona licensed pharmacist employed by the provider pharmacy, or by an Arizona licensed intern, graduate intern, technician or technician trainee under the direct onsite supervision of an Arizona licensed pharmacist; and

5. Educate pharmacy and long-term care facility personnel in the storage and use of an emergency drug supply unit.

E.In addition to the requirements of subsections (A) through (D), an automated emergency drug supply unit may be used provided:

1. The pharmacy permittee or pharmacist-in-charge of the provider pharmacy notifies the Board or its staff in writing of the intent to use an automated emergency drug supply unit, including the name and type of unit;

2. The provider pharmacy is notified electronically when the automated emergency drug supply unit has been accessed;

3. All events involving the access of the automated emergency drug supply unit are recorded electronically and maintained for not less than two years;

4. The provider pharmacy is capable of producing a report of all transactions of the automated emergency drug supply unit including a single drug usage report as required in R4-23-408(B)(5) on inspection by the Board or its staff;

5. The provider pharmacy develops written policies and procedures for:

a. Accessing the automated emergency drug supply unit in the event of a system malfunction or downtime,

b. Authorizing and modifying user access,

c. An ongoing quality assurance program that includes:

i. Training in the use of the automated emergency drug supply unit for all authorized users,

ii. Maintenance and calibration of the automated emergency drug supply unit as recommended by the device manufacturer; and

6. Documentation of the requirements of subsection (E)(5)(c)(ii) is maintained for inspection by the Board or its staff for not less than two years.

F.The Board may prohibit a pharmacy permittee or pharmacist-in-charge of a provider pharmacy from using an automated emergency drug supply unit if the pharmacy permittee or pharmacy permittee's employees do not comply with the requirements of subsections (A) through (E).

Ariz. Admin. Code § R4-23-701.02

Adopted effective December 18, 1992 (Supp. 92-4). Amended by final rulemaking at 9 A.A.R. 1064, effective May 4, 2003 (Supp. 03-1). Amended by final rulemaking at 12 A.A.R. 3032, effective October 1, 2006 (Supp. 06-3). Amended by final rulemaking at 19 A.A.R. 2894, effective November 10, 2013.