Executive Director, Pharmacy Quality Assurance Commission

July __, 2016

Steven Saxe, R.Ph, FACHE

Executive Director, Pharmacy Quality Assurance Commission

Washington State Department of Health

PO Box 47852

Olympia, WA 98501

Dear Mr. Saxe,

As you know, ESSB 6203, the Long Term Care Pharmacy bill, was signed into law this year on April 1, 2016, and took effect on June 9. That bill gives the Pharmacy Quality Assurance Commission the authority, and in some instances the obligation, to adopt regulations to effectuate and to clarify the law’s requirements. It is in the interest of pharmacies, long term care providers, and patients to ensure that those new regulations are adopted in an efficient and straightforward manner. Accordingly, we write to you to highlight some areas in which rule-making is required or desirable; as well as some issues for which the Commission’s early attention and interim guidance would be most helpful.

We specifically call the Commission’s attention to the following sections of ESSB 6203:

Section 1(29): The law provides a definition for closed-door LTC pharmacies for the purpose of technician ratios. The Commission should consider whether this would best be implemented through providing a specific, formal license designation for such pharmacies. We also urge the Commission to adopt rules addressing the situation in which a retail pharmacy and a closed-door LTC pharmacy exist under the same roof, to clarify the circumstances if any in which separate licenses will be permitted to allow a closed-door LTC pharmacy to share space (or to use separate space in the same building) with a retail pharmacy.

Section 1(31): The definition of institutional facilities in which chart orders are appropriate includes “any organization whose primary purpose is to provide a physical environment for patients to obtain health care services,” and provides a non-exclusive list of examples. The Commission may wish to consider whether additional health care environments (e.g., soliders’ homes) should be added to that list by rule; or whether that determination would be more appropriately made by the state agencies that regulate those facility types.

Section 1(33): The definition of shared pharmacy services includes a non-exclusive list of activities that may be provided through shared pharmacy services. The Commission may wish to specifically define additional activities that may be part of shared pharmacy services, or further define the activities themselves.

Section 2(1)(e)(ii): In the context of the new electronic signature elements, the Commission should consider providing guidance regarding the use of new technology. For instance, medication orders signed via a mobile device such as an iPad are increasingly in use by physicians who conduct business from the road. Physician use of such technology is particularly important for residents of assisted living communities, where there may be no nurse present to take a verbal prescription and create a chart order.

Section 3: The Commission should consider updating its emergency kit and supplemental dose kit regulations in WAC chapter 246-865 in light of the new law. Those changes could be coordinated with the pending changes to the ADDD regulations explicitly carving out e-kit and supplemental dose kit devices from the definition of automatic drug dispensing devices. The regulations should also be coordinated with WAC 246-869-100(f) which allows emergency refills up to a 72-hour supply.

Section 3(2):Under the supplemental dose kit rule WAC 246-865-040, from which this new statutory language was borrowed, a “unit dose drug distribution system” is generally understood to include salad kits, bingo cards, and other single-unit dosing systems. The Commission should consider revising the rule to make that understanding explicit.

Section 3(4): The use of nursing staff to restock an e-kit or supplemental dose kit, authorized by this section of the law, is clearly not exclusive. In addition to nurses, the supplying pharmacy (pharmacists and pharmacy staff members operating under appropriate pharmacist oversight) may restock a kit. The Commission should consider providing guidance to clarify that pharmacy assistants and specialized technicians, who currently are used for restocking ADDDs, may similarly restock e-kits and supplemental dose kits.

Section 4(2): ESSB 6203 authorizes outsourced or shared pharmacy services based on transmission of a “copy” of the prescription or order. The method of creating or transmitting that “copy” is not specified. In the context of prescription transfers, a prescription copy may be communicated verbally between pharmacists if appropriately documented by both the transferring and receiving pharmacist. The Commission should consider adopting similar elements for communicating a prescription in the context of shared or outsourced pharmacy services as those described in the prescription transfer rule, WAC 246-869-090.

Section 4(4): The Commission is required to adopt rules around safe return and reuse, taking into consideration some of the same factors that govern drug donation program safety. Pending the adoption of permanent rules, the Commission should consider providing preliminary guidance to the industry, either in the form of a newsletter article or temporary emergency rules, to allow unused drugs from long term care facilities and hospice programs to be returned and reused. In particular, guidance clarifying the acceptability of punching out and re-packaging "bingo" cards or similar unit doses, with proper procedures and in a manner that allows for tracking lots and expiration dates, would allow facilities and pharmacies to continue using safe and efficient reuse practices pending the final rules.

Section 5: The Commission is required to adopt a LTC pharmacy-specific pharmacist-to-technician ratio. We understand that pending the adoption of those new rules the general 1:3 technician ratio will continue to apply to LTC pharmacies. However, it is our understanding that the carve out for technician-licensed individuals performing administrative tasks became effective June 9. The Commission should provide interim guidance to that effect to avoid confusion and to ensure a level playing field among LTC pharmacies pending the outcome of the rule-making process.

Section 15(2): In approving electronic prescription systems for use in Washington, the Commission has previously required vendors to disable elements of their systems that would allow nurse e-signature. ESSB 6203 allows for nurses to act as physician agents in this context; presumably e-prescription vendors will now update their systems to enable nurse signature as allowed by the new law. Ordinarily, we understand that the Commission would review and approve system changes of that sort. Given the limited nature of this particular system change, and in the interest of facilitating the full and efficient implementation of the new law, the Commission should consider providing guidance that e-prescription vendors may enable nurse signature without requiring individual application and re-approval of that software update by the Commission.

Section 17: The law allows pharmacies to electronically store faxed prescriptions. The Commission should consider whether any specific guidance is required as to requirements or best practices regarding such storage.

Note that several elements of ESSB 6203 are based on concepts and language suggested in the National Association of Boards of Pharmacy model rules on LTC pharmacy practice. We urge the Commission to refer to those model rules, as well as the related guidance issued in the July 2007 joint report of NABP and the American Society of Consultant Pharmacists, as resources in implementing Washington’s LTC pharmacy law.

Finally, the Commission has previously provided certain guidance impacting LTC pharmacy practice through the Washington State Board of Pharmacy News. That guidance may no longer be accurate given the statutory changes effected by ESSB 6203. In particular, Article No. 997 (Vol. 30 No. 4, April 2009) and Article No. 1064 (Vol. 32 No. 4, April 2011) may at some point need to be revisited. In the meantime, the Commission should consider including a newsletter item alerting pharmacies of ESSB 6203, and noting that changes to the underlying laws may have rendered some previous guidance, including Articles No. 997 and 1064, obsolete effective June 3.

Sincerely,

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