WSR 06-23-078

PERMANENT RULES

DEPARTMENT OF HEALTH


(Board of Pharmacy)

[ Filed November 13, 2006, 2:14 p.m. , effective December 14, 2006 ]


Effective Date of Rule: Thirty-one days after filing.

Purpose: This rule will create a new chapter in Title 246 WAC and will adopt uniform standards for the use of automated drug distribution devices for facilities that choose to use them. In addition, the rules include current board of pharmacy requirements for drug storage, security, and accountability. It also recognizes the automated device as an appropriate storage site for controlled substances.

Statutory Authority for Adoption: RCW 18.64.005.

Adopted under notice filed as WSR 06-10-082 [06-11-163] on May 3, 2006 [May 24, 2006].

Changes Other than Editing from Proposed to Adopted Version: Changes were made to proposed rule to include all health care facilities in the definition, to expand the record-keeping requirements to account for drugs leaving and returning to the device, and to allow other DEA-approved methods of drug accountability to reduce staff time and errors.

A final cost-benefit analysis is available by contacting Tim S. Fuller, Department of Health, Board of Pharmacy, P.O. Box 47863, Olympia, WA 98504-7863, phone (360) 236-4827, fax (360) 586-4359, e-mail tim.fuller@doh.wa.gov.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 5, Amended 0, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 5, Amended 0, Repealed 0.

Date Adopted: August 31, 2006.

Lisa Salmi

for Asaad Awan, Chair

Board of Pharmacy

OTS-8659.4

Chapter 246-872 WAC

AUTOMATED DRUG DISTRIBUTION DEVICES


NEW SECTION
WAC 246-872-010   Purpose.   The purpose of this chapter is to define the requirements for automated drug distribution devices in licensed pharmacies and healthcare facilities as defined in RCW 70.38.025(6) and medical facilities as defined in RCW 70.40.020(7) that choose to use them. The requirements for automated drug distribution devices provide drug security to protect public health and safety and provides access to medications for quality care. The chapter defines appropriate medication security, accountability, device performance, and patient confidentiality. Facilities with automated drug distribution devices must obtain board of pharmacy approval for the use of the devices.

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NEW SECTION
WAC 246-872-020   What definitions do I need to know to understand these rules?   (1) "Automated drug distribution devices" means automated equipment used for remote storage and distribution of medication for use in patient care. The system is supported by an electronic data base.

(2) "Information access" means entry into a recordkeeping component of the automated drug distribution device, by electronic or other means, to add, update, or retrieve any patient record, medication record, or other data.

(3) "Medication access" means the physical entry into any component of the automated drug distribution devices to stock, inventory, remove medications, or repair the device.

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NEW SECTION
WAC 246-872-030   What are the pharmacy's responsibilities?   Each facility using drug distribution devices must designate a registered pharmacist responsible for the oversight of the use of these devices. The responsibilities of this pharmacist are to ensure:

(1) Policies and procedures are in place for the safe use of patient medications that are removed from the devices, prior to pharmacist review of the prescriber's order.

(2) Conduct of quarterly audits of compliance with policies and procedures.

(3) Approval of the medication inventory to be stocked in the automated drug distribution devices.

(4) The checking and stocking of medications in the automated drug distribution devices is reserved to a pharmacist, pharmacy intern, or a pharmacy technician.

(a) A pharmacy technician checking the accuracy of medications to be refilled into automated drug distribution devices must have met the criteria for specialized functions in WAC 246-901-035 and have documentation of the training on file in the pharmacy.

(b) The board may approve electronic bar code checking, or other approved technology, in place of manual double-checking of the medications stocked in the automated drug distribution devices.

(5) Ensure the security of medications in automated drug distribution devices by:

(a) Limiting access to licensed health personnel consistent with the patient care services identified within their scope of practice;

(b) Using safeguards to prevent unauthorized access to the devices, including termination of access at the end of employment;

(c) Monitoring controlled substance usage and taking appropriate action as warranted; and

(d) Working in cooperation with nursing administration to maintain an ongoing medication discrepancy resolution and monitoring process.

(6) A process is in place for all staff using the automated drug distribution devices to receive adequate training.

(7) Pharmacist participation in the facility automated drug distribution devices system quality assurance and performance improvement program.

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NEW SECTION
WAC 246-872-040   What are the responsibilities of the facility in the use of automated drug distribution devices?   The licensed health care facility must maintain readily available policies and procedures for the use of automated drug distribution devices that address:

(1) Type of equipment, components, and locations.

(2) Medication and information access.

(a) The automated drug distribution devices must have a system in place to record all medication removal, waste, and returns including date and time, identity of user, patient name, complete description of medication, quantity, and witness signature or verification, if required;

(b) The record of medications filled, inventoried, or stocked including identification of the person accessing the automated drug distribution devices shall be readily retrievable and maintained by authorized personnel;

(c) Verification that a patient's information in the automated drug distribution device matches the information in facility records; and

(d) The records for patients discharged from the facility must be removed from the automated drug distribution devices data base within twelve hours.

(3) Medication management.

(a) All medications in the automated drug distribution devices must be packaged and labeled in compliance with state and federal laws;

(b) All controlled substances activities must comply with requirements of state and federal laws. The responsible pharmacist must have a system in place to verify the accuracy of controlled substance counts. Once in place, the counting system no longer requires compliance with WAC 246-873-080 (7)(h). The process for securing and accounting for returned or wasted medication is defined.

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NEW SECTION
WAC 246-872-050   What are quality assurance and performance improvement requirements for the use of automated drug distribution devices?   Each facility shall establish and maintain a quality assurance and performance program that includes but is not limited to:

(1) Accuracy of medication filling and removal;

(2) Regular review of controlled substances discrepancies;

(3) Use of the data collected to take action to insure quality of care and make improvements to the automated drug distribution device system;

(4) Documentation of the outcomes of the quality assurance activities.

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Washington State Code Reviser's Office