WSR 06-10-082

PROPOSED RULES

DEPARTMENT OF HEALTH


(Board of Pharmacy)

[ Filed May 3, 2006, 10:00 a.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 03-18-117.

Title of Rule and Other Identifying Information: Chapter 246-872 WAC, Automated drug distribution devices, the proposed rule will create a new chapter in Title 246 WAC and will adopt uniform standards for the use of automated drug distribution devices for those facilities that choose to use them. In addition, the proposed rules will include current board of pharmacy requirements for drug storage, security, and accountability in WAC 246-873-070 and 246-873-080. It will recognize the automated drug distribution device as an appropriate storage site for controlled substances.

Hearing Location(s): Department of Health, 310 Israel Road, Room 152-153 PPE, Tumwater, WA 98501, on July 20, 2006, at 10:00 a.m.

Date of Intended Adoption: July 20, 2006.

Submit Written Comments to: Tim Fuller, P.O. Box 47863, Olympia, WA 98502-7863, www.doh.wa.gov/policyreview/, fax (360) 586-4359, by July 19, 2006.

Assistance for Persons with Disabilities: Contact Doreen Beebe by July 5, 2006, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rule will create new chapter 246-872 WAC, regarding automated drug distribution devices. It will set standards for the use of these devices for hospitals and healthcare facilities, which the current rules do not. In addition, they will provide standards that will improve medication safety, appropriate access to medications, and accountability, particularly for controlled substances. The current rule WAC 246-869-120 Mechanical devices in hospitals, applies to devices that are not available. For the few devices in use, the mechanical device rule will remain in place.

Reasons Supporting Proposal: Hospitals and other healthcare facilities have purchased automated drug distribution devices to store and distribute medications. For public health and safety, the board of pharmacy establishes the minimum standards automated devices meet the standards for drug storage, security, distribution, and accountability.

Statutory Authority for Adoption: RCW 18.64.005.

Statute Being Implemented: RCW 18.64.005.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Department of health, board of pharmacy, governmental.

Name of Agency Personnel Responsible for Drafting: Tim S. Fuller, P.O. Box 47863, (360) 236-4825; Implementation and Enforcement: Steven M. Saxe, P.O. Box 47863, (360) 236-4825.

A small business economic impact statement has been prepared under chapter 19.85 RCW.

Small Business Economic Impact Statement

1. Briefly describe the proposed rule: Hospitals and other healthcare facilities have purchased automated drug distribution devices to store and distribute medications in a secure manner outside a pharmacy and to improve access to medications for administration to a patient. The devices also ensure that each patient is charge[d] appropriately and provides accountability for each unit of medication.

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

The current rule applies to mechanical devices that are no longer available. For the few devices in use, the mechanical device rule will remain in place.

2. Is a small business economic impact statement (SBEIS) required for this rule? Yes, the costs of compliance by hospitals and other health care facilities exceed minor costs on small businesses. The automated devices are purchased voluntarily by hospitals and other healthcare facilities. However, the proposed rule ensures that the board of pharmacy requirements for drug storage are met by generating reports that the pharmacist must review. The cost of generating the required reports is an additional cost, if a provider decides to purchase automated drug distribution devices. The additional cost exceeds minor costs.

The costs to comply with the mechanical devices are greater than for automated drug distribution devices, since they no longer record medications removed and require a separate paper record system to meet board of pharmacy requirements.

3. Which industries are affected by this rule?


II. What industries are affected?
8051 Skilled Nursing Care
8062 General Medical & Surgical Hospital
Average Employment
Number of Firms Total Employment Small Business Large Business
8051 Skilled nursing care facilities 281 26,407 14.7 144.2
8062 General medical & surgical hospital 146 78,593 11.1 2027.7

4. What are the costs of complying with this rule for small businesses (those with fifty or fewer employees) and for the largest 10% of businesses affected? It was estimated that costs of generating reports for small facilities would be $600.00 per year. The estimated cost for large facilities is $9,600.00 per year. The higher cost for large facilities is due to the difference in the number of automated devices used by small and large businesses.

5. Does the rule impose a disproportionate impact on small businesses? Yes, when the costs for small and large facilities are averaged, there is a disproportionate impact on small businesses.

Average Employment Average Employment Compliance Costs Compliance Costs Average Costs Average Costs
Small Business Large Business Small Business Large Business Small Business Large Business
8051 Skilled nursing care facilities 14.7 144.2 $600 $9,600 $40.82 $66.57
8062 General medical and surgical hospital 11.1 2027.7 $600 $9,600 $54.05 $4.73

As the table indicates, only SIC 8062 employers would be disproportionately affected by the costs of the proposed rule. Average per employee costs for small businesses in this industry $54.04 is much higher than $4.73 which is the average per employee costs of compliance for large businesses.

6. If the rule imposes a disproportionate impact on small businesses, what efforts were taken to reduce that impact (or why is it not "legal and feasible" to do so) by:

a) Reducing, modifying, or eliminating substantive regulatory requirements? The board of pharmacy standards for drug storage apply to all facilities and incorporate several Federal standards. No exemptions are allowed.

b) Simplifying, reducing, or eliminating record-keeping and reporting requirements? The proposed rule language allows the facility flexibility in how they comply with drug storage standards.

c) Reducing the frequency of inspections? [Answer here.]

d) Delaying compliance timetables? [Answer here.]

e) Reducing or modifying fine schedules for noncompliance? Fines are not levied against firms for noncompliance of standards for drug storage.

f) Any other mitigation techniques? Pharmacist investigator would provide technical assistance to the facility to simplify record-keeping and reporting requirements.

7. How are small businesses involved in the development of this rule? Stakeholders included employees from small as well as large healthcare facilities. Representatives from small facilities attended the stakeholders meeting, reviewed and commented on the proposed rule, sent e-mails, and made phone calls to express concerns. A listserv notice was used to confirm the proposed rule language.

A copy of the statement may be obtained by contacting Tim Fuller, P.O. Box 27863, Olympia, WA 98502-7863, phone (360) 236-4827, fax (360) 586-4359, e-mail timothy.fuller@doh.wa.gov.

A cost-benefit analysis is not required under RCW 34.05.328. Tim Fuller, P.O. Box 27863, Olympia, WA 98502-7863, phone (360) 236-4827, fax (360) 586-4359, e-mail timothy.fuller@doh.wa.gov.

May 2, 2006

Steven M. Saxe

Executive Director

OTS-8659.3

Chapter 246-872 WAC

AUTOMATED DRUG DISTRIBUTION DEVICES


NEW SECTION
WAC 246-872-010   Purpose.   The purpose of this chapter is to better ensure that licensed pharmacies and health care facilities that choose to use automated drug distribution devices to distribute medications both in a secure manner to protect public health and safety and in a manner that provides access to medications for quality care. The chapter defines appropriate medication security, accountability, and device performance as well as patient confidentially. It specifies standards of care and provides guidance on how to meet those standards and required approval by the board of pharmacy.

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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, including those removed 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) Supervision of medication preparation and distribution of medications used in automated drug distribution devices.

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

(a) Pharmacy technicians checking automated drug distribution devices must have completed competency-based training 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.

(6) 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) Controlling user access to prevent unauthorized access to the devices;

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

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

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

(8) 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 or return including date and time, identity of user, patient name, complete description of medication, quantity, and cosignatures, 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; and

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

(3) Medication refilling and removal.

(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;

(c) The process for securing and accounting for returned or wasted medication is defined; and

(d) Verification that a patient's information in automated drug distribution devices match facility records.

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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