WSR 24-17-002

PROPOSED RULES

DEPARTMENT OF HEALTH

(Pharmacy Quality Assurance Commission)

[Filed August 8, 2024, 8:06 a.m.]

Original Notice.

Preproposal statement of inquiry was filed as WSR 23-23-051.

Title of Rule and Other Identifying Information: Prescription transfers. The pharmacy quality assurance commission (commission) is proposing to amend WAC 246-945-345 and add new WAC 246-945-346 in chapter 246-945 WAC to establish the expectations of pharmacies related to noncontrolled and controlled substance prescription transfers upon patient request.

Hearing Location(s): On October 10, 2024, at 1:30 p.m., at the Department of Labor and Industries, Room S117/118, 7273 Linderson Way S.W., Tumwater, WA 98501; or virtually via Zoom https://us02web.zoom.us/webinar/tZwvcu-orjooGdL0ucE3WWkJLsRorLzko_bx/ics?icsToken=98tyKuGgrD4sGtSUshqBRpw-AI_4M_TziH5BjadxzArmJnNkVQjcGvFwPaBTCtPf. To access the meeting on August 22, 2024, at 9:00 a.m., go to https://zoom.us/join or https://us02web.zoom.us/j/87143495001 and use the Webinar ID 871 4349 5001. The access options include One-tap mobile: US +12532158782,,86114958466# or +16699009128,,86114958466#; or by telephone: Dial (for higher quality, dial a number based on your current location): US +1 253 215 8782 or +1 669 900 9128 or +1 346 248 7799 or +1 669 444 9171 or +1 386 347 5053 or +1 564 217 2000 or +1 646 558 8656 or +1 646 931 3860 or +1 301 715 8592 or +1 312 626 6799, Webinar ID 861 1495 8466. International numbers available at https://us02web.zoom.us/u/kdLNo6unOZ.

Date of Intended Adoption: October 10, 2024.

Submit Written Comments to: Julia Katz, P.O. Box 47852, Olympia, WA 98504-7852, email https://fortress.wa.gov/doh/policyreview/, fax 360-236-2901, beginning date and time of this filing, by September 25, 2024, at midnight.

Assistance for Persons with Disabilities: Contact Julia Katz, phone 360-502-5058, fax 360-236-2901, TTY 711, email PharmacyRules@doh.wa.gov, by October 3, 2024.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The purpose of the amended WAC 246-945-345 is to make the fulfillment of patient-requested noncontrolled prescription transfers enforceable by the commission and occur within a set time frame. Revising "may" to "shall" in WAC 246-945-345(1) will make prescription transfers upon patient request enforceable. Additionally, the time parameter added to WAC 246-945-345(2) will encourage prescription transfers to be conducted in a timely manner. The anticipated effect of the commission's rule is to increase the timeliness of patient access to medication therapy.

The proposed new WAC 246-945-346 applies the same enforceability and time parameters to patient-requested controlled substance prescription transfers. Its anticipated effect is also to increase the timeliness of patient access to medication therapy.

Reasons Supporting Proposal: The commission received feedback from interested parties about challenges obtaining requested prescription transfers permitted by WAC 246-945-345(2) in a timely manner and voted to address the concerns at the March 2, 2023, business meeting. The commission could not hold facilities accountable for the expressed challenges due to the permissive language in WAC 246-945-345. The proposed language will compel compliance among facilities, reducing the challenges faced by some patients requesting a prescription transfer.

Statutory Authority for Adoption: RCW 18.64.005, 69.41.075, and 69.50.301.

Statute Being Implemented: RCW 18.64.005, 69.41.075, and 69.50.301.

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

Name of Proponent: Pharmacy quality assurance commission, governmental.

Name of Agency Personnel Responsible for Drafting and Implementation: Julia Katz, 111 Israel Road S.E., Tumwater, WA 98501, 360-502-5058; and Enforcement: Marlee O'Neill, 111 Israel Road S.E., Tumwater, WA 98501, 360-502-5058.

A school district fiscal impact statement is not required under RCW 28A.305.135.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Julia Katz, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-502-5058, fax 360-236-2901, email PharmacyRules@doh.wa.gov.

Scope of exemption for rule proposal from Regulatory Fairness Act requirements:

Is not exempt.

The proposed rule does impose more-than-minor costs on businesses.

Small Business Economic Impact Statement (SBEIS)

SECTION 1:A brief description of the proposed rule including the current situation/rule, followed by the history of the issue and why the proposed rule is needed. A description of the probable compliance requirements and the kinds of professional services that a small business is likely to need in order to comply with the proposed rule: The commission is proposing this rule to regulate the fulfillment of patient-requested prescription transfers in a timely manner. Currently, WAC 246-945-345(2) states that upon patient request, prescriptions "may be transferred." The term "may" makes the provision difficult to enforce. The proposed rule aims to protect and promote public health and safety by ensuring patients' prescriptions are transferred upon request.

The proposed rule stems from feedback the commission received from interested parties about challenges obtaining requested prescription transfers permitted by WAC 246-945-345(2). On March 2, 2023, the commission voted to address the expressed concerns. The commission filed a CR-101 as WSR 23-23-051 on November 7, 2023. On May 2, 2024, the commission voted to approve the filing of the CR-102.

The proposed rules are needed to ensure patient-requested prescription transfers are transferred by pharmacies. Amending WAC 246-945-345(2) to state that prescriptions "shall be transferred" and applying the same language to the new section makes the provision enforceable. The addition of time frames to both chapter 246-945 WAC sections provides a guidance to determine compliance with the rules.

Pharmacies must transfer prescriptions, upon patient request, and must do so within three business days or a time frame that does not adversely impact the provision of medication therapy, whichever comes first.

SECTION 2: Identification and summary of which businesses are required to comply with the proposed rule using the North American Industry Classification System (NAICS).

*The employment security department (ESD) reported 267 businesses categorized as pharmacies and drug stores, but department of health staff reported the number of pharmacies as of April 2024, with 1,283 facilities being standalone pharmacies and 110 facilities being hospital pharmacies.

SECTION 3: Analysis of probable costs of businesses in the industry to comply to the proposed rule and includes the cost of equipment, supplies, labor, professional services, and administrative costs. The analysis considers if compliance with the proposed rule will cause businesses in the industry to lose sales or revenue:

WAC 246-945-345 Noncontrolled prescription transfers: Description: Currently, pharmacies are not required to fulfill noncontrolled prescription transfers requested by patients and while most do, approximately 15 percent of prescription transfers requested by patients are believed to be unfulfilled. The commission is proposing to amend WAC 246-945-345 to require pharmacies to transfer all noncontrolled prescriptions upon patient request and to do so within three business days of receiving the request or a time frame that does not adversely impact the provision of medication therapy, whichever comes first.

Pharmacy managers will need to apprise pertinent staff of the rule adoption. The content may be supplemental to an existing communication.

The commission assumes that all pharmacies dispensing noncontrolled prescriptions have a fax machine, but should they have to purchase one the cost could be $200 to $1,000.1

Pharmacies will need to fulfill all patient-requested noncontrolled prescription transfers within three business days of receiving the request or a time frame that does not adversely impact medication therapy.

Cost(s): Pharmacies will need to communicate with staff the requirement that they must transfer noncontrolled prescriptions upon request and that the transfer must happen within three days of receiving the request, or in a time frame that does not adversely impact the medication therapy. The following cost estimate applies to communications for both WAC 246-945-345 and WAC 246-945-346.

Estimate: The estimated average probable cost is $150.51 per pharmacy to communicate with its employees these new requirements.

Cost assumptions for estimate:

Calculations for estimate:

Estimate: $0 to $1,303.05 total estimated average probable annual cost per pharmacy to transfer currently unfulfilled noncontrolled prescription transfers requested by patients.

Cost assumptions for estimate:

Calculations for estimate:

Estimate: The commission estimates a negligible annual cost to pharmacies for fulfilling patient-requested noncontrolled prescription transfers within three business days of receiving the request or a time frame that does not adversely impact medication therapy.

Cost assumptions for estimate:

WAC 246-945-346 Controlled substance prescription transfers: Description: Pharmacies are not currently required to fulfill controlled prescription transfers requested by patients and while most do, approximately 15 percent of prescription transfers requested by patients are believed to be unfulfilled. The commission is proposing to add WAC 246-945-346 to require pharmacies to transfer all controlled substance prescriptions upon patient request and to do so within three business days of receiving the request or a time frame that does not adversely impact the provision of medication therapy, whichever comes first.

Pharmacy managers will need to apprise pertinent staff of the rule adoption. The content may be supplemental to an existing communication. See cost estimate above.

The commission assumes all pharmacies transferring controlled prescriptions have electronic medical record systems in accordance with 21 C.F.R. § 1306.08 and 21 C.F.R. § 1306.25.

Pharmacies will need to fulfill all patient-requested controlled prescription transfers within three business days of receiving the request or a time frame that does not adversely impact medication therapy.

Cost(s): Pharmacies will need to fulfill all controlled prescription transfers requested by patients.

Estimate: $0 to $11,141.52 total estimated average probable annual cost per pharmacy to transfer currently unfulfilled patient-requested controlled prescriptions in accordance with 21 C.F.R. § 1306.08 and 21 C.F.R. § 1306.25. Controlled prescription transfers must be communicated via electronic medical record system by licensed pharmacists.14

Cost assumptions for estimate:

Calculations for estimate:

Estimate: The commission estimates a negligible annual cost to pharmacies for fulfilling patient-requested controlled prescription transfers within three business days of receiving the request or a time frame that does not adversely impact medication therapy.

Cost assumptions for estimate: No additional staff time nor equipment are necessary to comply with the time frame of the proposed rule. However, the commission acknowledges that there may be unforeseen negligible administrative costs in this space.

Summary of all Cost(s):

SBEIS Table 2. Summary of Section 3 Probable Cost(s):

SECTION 4:Analysis on if the proposed rule may impose more-than-minor costs for businesses in the industry. Includes a summary of how the costs were calculated: While the commission has no reason to believe that the cost for business to comply with the proposed rule would exceed the minor cost threshold at the maximum probable cost, the commission was only able to calculate a scenario that produced the average cost of compliance per business. Because the estimate did not include a potential maximum cost of compliance per businesses, the commission decided it was most protective to determine that:

Yes, the costs of the proposed rule could be more than the minor cost threshold ($19,161.74).

Summary of how the costs were calculated: The average probable costs were calculated for pharmacies to comply with the proposed rule under what the commission believes to be a likely scenario for an average pharmacy to comply with the proposed rule. Probable costs affiliated with compliance primarily pertain to staff time and equipment. Average staff wages in Washington state were sourced from data produced by the United States Bureau of Labor and Statistics. Additional resources were used to estimate employee quantities and equipment costs. Commission staff, including a pharmacist consultant, determined the estimated time and equipment requirements.

SECTION 5: Determination on if the proposed rule may have a disproportionate impact on small businesses as compared to the 10 percent of businesses that are the largest businesses required to comply with the proposed rule: No, the commission believes the proposed rule does not have a disproportionate impact on small businesses as compared to the 10 percent of businesses that are the largest businesses required to comply with the proposed rule.

The commission believes that there is not a disproportionate impact because costs to comply with the rule are based on number of staff and volume of businesses. The commission anticipates that all businesses will have a scaled impact because the cost will vary depending on size of the business (number of employees) and volume of service.

A copy of the statement may be obtained by contacting Julia Katz, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-502-5058, fax 360-236-2901, email PharmacyRules@doh.wa.gov.

August 7, 2024

Hawkins DeFrance, PharmD, Chair

Pharmacy Quality Assurance Commission

OTS-5466.1