Ariz. Admin. Code § 4-23-701.04

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

Section R4-23-701.04 - Long-term Care Facilities Pharmacy Services: Automated Dispensing Systems

A.Before using an automated dispensing system as defined in R4-23-110, a pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall:

1. Notify the Board or its staff in writing of the intent to use an automated dispensing system, including the name and type of system;

2. Obtain a separate controlled substances registration at the location of each long-term care facility at which an automated dispensing system containing controlled substances will be located as required by federal law; and

3. Maintain copies of the registrations required under subsection (A)(2) at the provider pharmacy for inspection by the Board or its staff.

B.A pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall ensure:

1. Drugs contained in an automated dispensing system remain the property of the provider pharmacy,

2. Controlled substance drugs contained in an automated dispensing system are included in all inventories required under A.R.S. §36-2523(B) and R4-23-1003(A),

3. Schedule II drugs are not stocked in an automated dispensing system, and

4. A separate emergency drug supply unit is available in the long-term care facility to meet the requirements of R4-23-701.02.

C.A pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall:

1. Ensure that policies and procedures as required in subsection (D) for the use of an automated dispensing system in a long-term care facility are prepared, implemented, and complied with;

2. Review biennially and, if necessary, revise the policies and procedures required under subsection (D);

3. Document the review required under subsection (C)(2);

4. Assemble the policies and procedures as a written or electronic manual; and

5. Make the policies and procedures available for employee reference and inspection by the Board or its staff within the pharmacy and at any location outside of the pharmacy where the automated dispensing system is used.

D.A pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall ensure the written policies and procedures include:

1. Drug removal procedures that include the following:

a. A drug is provided only by a valid prescription order for an individual long-term care facility resident;

b. A drug is dispensed from an automated dispensing system only after a pharmacist has:

i. Reviewed and verified the resident's prescription order as required by R4-23-402(A), and

ii. Electronically authorized the access for that drug for that particular resident, and

c. The automated dispensing system labels each individual drug packet with a resident specific label that complies with R4-23-701.01(2) and contains the resident's room number or facility identification number; and

2. Security procedures that include the following:

a. The pharmacy permittee or pharmacist-in-charge of the provider pharmacy is responsible for authorizing user access, including adding and removing users and modifying user access;

b. Each authorized user is a licensee of the Board or authorized licensed personnel of the long-term care facility; and

c. The automated dispensing system is secured at the long-term care facility by electronic or mechanical means or a combination thereof designed to prevent unauthorized access;

3. Drug stocking procedures that include the following:

a. Automated dispensing systems that use non-removable containers that do not allow prepackaging of the container as set out in subsection (D)(3)(b):

i. Are stocked at the long-term care facility 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

ii. Utilize bar code or other technologies to ensure the correct drug is placed in the correct canister or container; and

b. Automated dispensing systems that use removable containers may be stocked at the long-term care facility by an authorized user provided:

i. The prepackaging of the container occurs at the provider pharmacy;

ii. A pharmacist verifies the container has been properly filled and labeled, and the container is secured with a tamper-evident seal;

iii. The individual containers are transported to the long-term care facility in a secure, tamperevident shipping container; and

iv. The automated dispensing system uses microchip, bar-coding, or other technologies to ensure the containers are accurately loaded in the automated dispensing system; and

4. Recordkeeping and report procedures that include the following:

a. All events involving the access of the automated dispensing system are recorded electronically and maintained for not less than two years;

b. The provider pharmacy is capable of producing a report of all transactions of the automated dispensing system including:

i. A single drug usage report that complies with R4-23-408(B)(5); and

ii. An authorized user history including date and time of access and type of transaction; and

c. The provider pharmacy has procedures to safeguard the storage, packaging, and distribution of drugs by monitoring:

i. Current inventory;

ii. Expiration dates;

iii. Controlled substance dispensing;

iv. Re-dispense requests; and

v. Wastage.

E.A pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall:

1. Ensure that an electronic log is kept for each container fill that includes:

a. An identification of the container by drug name and strength, and container number;

b. The drug's manufacturer or National Drug Code (NDC) number;

c. The expiration date and lot number from the manufacturer's stock bottle that is used to fill the container. If multiple lot numbers of the same drug are added to a container, each lot number and expiration date shall be documented;

d. The date the container is filled;

e. Documentation of the identity of the licensee who placed the drug into the container; and

f. If the licensee who filled the container is not a pharmacist, documentation of the identity of the pharmacist who supervised the non-pharmacist licensee; and

2. Maintain the electronic log for inspection by the Board or its staff for not less than two years.

F.A pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall:

1. Implement an ongoing quality assurance program that monitors performance of the automated dispensing system and compliance with the established policies and procedures that includes:

a. Training in the use of the automated dispensing system for all authorized users,

b. Maintenance and calibration of the automated dispensing system as recommended by the device manufacturer,

c. Routine accuracy validation testing no less than every three months, and

d. Downtime and malfunction procedures to ensure the timely provision of medication to the long-term care facility resident, and

2. Maintain documentation of the requirements of subsections (F)(1)(b) and (F)(1)(c) for inspection by the Board or its staff for not less than two years.

G.The Board may prohibit a pharmacy permittee or pharmacist-in-charge from using an automated dispensing system in a long-term care facility if the pharmacy permittee or the pharmacy permittee's employees do not comply with the requirements of subsections (A) through (F).

Ariz. Admin. Code § R4-23-701.04

New Section made by final rulemaking at 19 A.A.R. 2894, effective November 10, 2013.