Practice Of Pharmacy Under Collaborative Drug Therapy Agreements

PHARMACY QUALITY ASSURANCE COMMISSION—MEDICINE—PROFESSIONAL SERVICES—Practice Of Pharmacy Under Collaborative Drug Therapy Agreements

1.         A pharmacist’s application of guidelines or protocols previously established in a collaborative drug therapy agreement is statutorily authorized, even if it amounts to diagnosis of a patient’s condition.

2.         Under limited circumstances, a physician or physician assistant may enter into a collaborative drug treatment agreement that permits the diagnosis by a pharmacist of a patient’s condition.

3.         There is no statutory or administrative requirement that a collaborative drug treatment agreement call for direct contact between a physician or physician assistant and a patient.

4.         A pharmacist who diagnoses patients pursuant to a collaborative drug treatment agreement with a physician or a physician assistant does not commit an act of unlicensed practice of medicine under RCW 18.130.190 if the pharmacist acts within the scope of guidelines previously established under a collaborative drug treatment agreement.

December 14, 2020

Dear Mr. Maldon:

            By letter previously acknowledged, your predecessor requested our opinion on the following questions, which we have rephrased slightly:

1. Does the statutory definition of “practice of pharmacy” in
   RCW 18.64.011(28), which includes “the initiating or modifying of drug therapy in accordance with written guidelines or protocols previously established and approved for his or her practice by a practitioner authorized to prescribe drugs[,]” incorporate diagnosis of a patient’s condition?

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Brief Answer: It depends. A pharmacist’s application of the procedures, decision-making criteria, and plans established in their collaborative drug therapy agreements (CDTAs) is statutorily authorized, even if it amounts to diagnosis of a patient’s condition.

2. May a physician licensed under RCW 18.71 or a physician assistant licensed under RCW 18.71A enter into a CDTA that permits the diagnosis of a patient by a pharmacist licensed under RCW 18.64?[1]

Brief Answer: In limited circumstances, yes. Insofar as “the initiating or modifying of drug therapy” involves some aspect of “diagnosis,” such “diagnosis” is permissible if it is “in accordance with written guidelines or protocols” and complies with other applicable statutes and regulations. For physician assistants, the ability to enter into a CDTA must be considered on a case-by-case basis in light of the individual physician assistant’s delegation agreement approved by the Washington Medical Commission.

3. If so, is there a statutory or administrative requirement for direct contact between the non-pharmacist practitioner and the patient?

Brief Answer: No.

4. Does a pharmacist who diagnoses patients pursuant to a CDTA with a physician or a physician assistant commit an act of unlicensed practice of medicine under RCW 18.130.190?

Brief Answer: It depends. If pharmacists act within their statutory authority under RCW 18.64.011(28) to “initiat[e] or modify[] . . . drug therapy in accordance with written guidelines or protocols previously established and approved for his or her practice by a practitioner authorized to prescribe drugs[,]” then they are not engaged in the unlicensed practice of medicine.

FACTUAL BACKGROUND

            The legislature has defined the practice of pharmacy to include: “Interpreting prescription orders; the compounding, dispensing, labeling, administering, and distributing of drugs and devices; the monitoring of drug therapy and use; [and] the initiating or modifying of drug therapy in accordance with written guidelines or protocols previously established and approved for his or her practice by a practitioner authorized to prescribe drugs . . . .” RCW 18.64.011(28). The “initiating or modifying of drug therapy” has been expressly included in this definition since 1979. Laws of 1979, ch. 90, § 5. At least one purpose of allowing pharmacists to initiate or modify drug therapy is to increase availability of some health care services by eliminating the need for patients

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to see a physician or other health care provider before initiating some drug therapies. See, e.g., H.B. Rep. on Second Substitute H.B. 2681, 64th Leg., Reg. Sess. (Wash. 2016); Letter from Tim Lynch, Chair, Pharmacy Quality Assurance Commission, to Jeff Even, Deputy Solicitor General, State of Washington (July 26, 2018), at 6 (on file with author, 180807Saxe).

            In addition to the statute, there is a rule related to pharmacists’ initiating or modifying drug therapy. WAC 246-945-350. That rule dictates the content of “a written guideline or protocol . . . that enables a pharmacist to exercise prescriptive authority.” WAC 246-945-001(11), -350. Originally, the rule required that guidelines or protocols be approved by the Board of Pharmacy. Wash. St. Reg. 80-08-035. In 1981, the Board of Pharmacy adopted the rule substantially in its current form. Wash. St. Reg. 81-19-086. In 1991, the rule was recodified as WAC 246-863-100, but it was not substantively amended. Wash. St. Reg. 91-18-057. On July 1, 2020, the Pharmacy Quality Assurance Commission adopted WAC 246-945-350 to supersede WAC 246-863-100. Wash. St. Reg. 20-12-072.[2] With minor exceptions, the new rule is substantively identical to WAC 246-863-100.

Under the current version of the rule, a CDTA must include:

            (a)       A statement identifying the practitioner authorized to prescribe and the name of each pharmacist who is party to the agreement;

            . . . .

            (b)       A statement of the type of prescriptive authority decisions which the pharmacist is authorized to make, which includes:

            (i)        A statement of the types of diseases, drugs, or drug categories involved, and the type of prescriptive authority activity (e.g., modification or initiation of drug therapy) authorized in each case.

            (ii)       A general statement of the training required, procedures, decision criteria, or plan the pharmacist is to follow when making therapeutic decisions, particularly when modification or initiation of drug therapy is involved.

            (c)       A statement of the activities the pharmacist is to follow in the course of exercising prescriptive authority, including:

            (i)        Documentation of decisions made; and

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            (ii)       A plan for communication or feedback to the authorizing practitioner concerning specific decisions made.

WAC 246-945-350(2). In addition, the rule requires that the practitioner “be in active practice” and that “[t]he authority granted must be within the scope of the practitioners’ current practice.” WAC 246-945-350(2)(a)(i), (ii). CDTAs are “only valid for two years from the date of signing.” WAC 246-945-350(3). Any modification is treated as a new CDTA. WAC 246-945-350(4).

            In practice, many pharmacists initiate and modify drug therapy, including exercising prescriptive authority, under CDTAs with practicing physicians or other authorized prescribers, including physician assistants. As of 2018, there were more than 33,000 CDTAs on file with the Pharmacy Quality Assurance Commission in Washington. Commenters have explained that in Washington CDTAs are used to authorize pharmacists to provide, among other things, vaccinations, certain birth control, access to naloxone for emergency treatment of opioid overdose, and antibiotics for urinary tract infections. The requester has also explained that certain pharmacy chains have agreements that allow pharmacists to provide drug therapies to treat insect stings in order to reduce patient need for urgent care and emergency room visits. Letter from Warren Howe, Chair, Washington Medical Commission, to Bob Ferguson, Attorney General, State of Washington (June 6, 2018), at 3-5 (on file with the author).

            In sum, pharmacists in Washington routinely initiate and manage drug therapy under CDTAs. These agreements must provide procedures, decision-making criteria, or a plan that pharmacists must follow. The sample agreements we have reviewed restrict pharmacist discretion through detailed flow charts and patient assessment guides.

ANALYSIS

            You ask whether a pharmacist may diagnose a patient’s condition pursuant to a CDTA and whether a physician or physician assistant may enter into a CDTA that permits a pharmacist to diagnose a patient’s condition. The answer to both questions is a qualified yes. Under RCW 18.64.011(28), the legislature has granted pharmacists specific authority to “initiat[e] or modify[] . . . drug therapy in accordance with written guidelines or protocols previously established and approved for his or her practice by a practitioner authorized to prescribe drugs . . . .” RCW 18.64.011(28). This also creates implicit authority for practitioners, including physicians and physician assistants, to create such written guidelines and protocols. This authority is limited, however. The practitioner must be “authorized to prescribe drugs,” RCW 18.64.011, and in “active practice,” WAC 246-945-350(2)(a)(i). In entering into a CDTA and creating written guidelines and protocols, practitioners must act within the scope of their current practice, exercise an appropriate degree of competence, and act within the accepted standard of care. See, e.g., RCW 7.70.040; RCW 18.130.180(4); WAC 246-945-350(2)(a)(ii). Additionally, a CDTA must include “procedures, decision criteria, or plan[s]” for pharmacists “to follow when making therapeutic decisions[.]” WAC 246-945-350(2)(b)(ii).

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            A pharmacist may engage in some degree of diagnosis pursuant to the guidelines and protocols of a CDTA. We recognize that diagnosis is part of the practice of medicine and that, in general, no person may practice medicine without a valid license to do so. RCW 18.71.011, .021; see also State v. Wilson, 11 Wn. App. 916, 917-18, 528 P.2d 279 (1974). There is, however, an exception for practitioners of other “healing arts,” including pharmacists licensed under RCW 18.64, to engage in the practice of their professions. RCW 18.71.030(4); see also RCW 70.124.020(3) (defining “practitioner of the healing arts” to include a person licensed to practice pharmacy). The inquiry, then, is whether the definition of the practice of pharmacy in RCW 18.64.011(28) permits diagnosis pursuant to a CDTA.

            For purposes of the definition of the practice of medicine, “to diagnose” means “to determine,” State v. Pac. Health Ctr., Inc., 135 Wn. App. 149, 166, 143 P.3d 618 (2006), and “to identify (as a disease or condition) by symptoms or distinguishing characteristics,” Yow v. Dep’t of Health Unlicensed Practice Program, 147 Wn. App. 807, 819, 199 P.3d 417 (2008) (quoting Webster’s Third New International Dictionary 622 (1993)).

            Determining or identifying a condition in limited circumstances seems to fit within the authority the legislature granted via CDTAs in RCW 18.64.011(28). That provision gives pharmacists authority to “initiat[e] or modify[] . . . drug therapy in accordance with written guidelines or protocols previously established and approved for his or her practice by a practitioner authorized to prescribe drugs.” RCW 18.64.011(28). The word “initiate” means, as relevant here, “to begin or set going : make a beginning of : perform or facilitate the first actions, steps, or stages of . . . .” Webster’s Third New International Dictionary 1164 (2002). In the limited circumstances where a CDTA authorizes a pharmacist to identify a disease or condition, doing so would of course be a necessary predicate to initiating drug therapy. For example, one CDTA allows pharmacists to initiate drug therapy to treat insect stings. Request Letter, Ex. C. The written guidelines include criteria for diagnosing an insect sting that is appropriate for pharmacist-initiated drug therapy and conditions that require further evaluation by another healthcare provider. Request Letter, Ex. C.

            The requirement that the written guidelines or protocols must be created by individuals licensed to engage in diagnosis of conditions supports the conclusion that the guidelines or protocols may themselves involve some degree of diagnosis. This opinion does not address whether—and should not be read to suggest that—pharmacists may engage in diagnosis outside the context of a CDTA.

            The corresponding regulation, which has existed substantially in its current form since 1981, clarifies the authority of pharmacists. This longstanding regulation interprets RCW 18.64.011(28) to provide pharmacists with “prescriptive authority,” which includes the ability to “mak[e] therapeutic decisions” by applying “procedures, decision criteria, or plan[s]” set forth in the CDTA. WAC 246-945-350. The language was first adopted just two years after the legislature adopted what is now RCW 18.64.011(28). This contemporaneous interpretation of the statute is entitled to great weight, especially since the legislature has silently acquiesced by amending RCW 18.64.011 eleven times since 1982 without disturbing that interpretation. See First Student, Inc. v. Dep’t of Revenue, 194 Wn.2d 707, 718-19, 451 P.3d 1094 (2019).

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            In sum, pharmacists have authority to apply the protocols, guidelines, procedures, decision-making criteria, or plans established in a valid CDTA to assess and evaluate patients as dictated in the agreement, and pharmacists may initiate or modify drug therapy according to the criteria in the agreement. Even if the initiation or modification of drug therapy undertaken in compliance with RCW 18.64.011(28) and WAC 246-945-350 constitutes “diagnosis” to some limited degree, such action is authorized if authorized in the CDTA. Because such activity is expressly authorized in RCW 18.64.011(28), it is within the scope of a pharmacist’s license and is not the unauthorized practice of medicine. See RCW 18.71.030(4).

            You have also asked whether a physician licensed under RCW 18.71 or a physician assistant licensed under RCW 18.71A may enter into a CDTA that permits a pharmacist licensed under RCW 18.64 to diagnose a patient. For the reasons set forth above, we conclude that, in some circumstances, this is permissible.

            There are, however, important limitations on the ability of physicians and physician assistants to enter into CDTAs. The practitioner must be “authorized to prescribe drugs,” RCW 18.64.011(28), the practitioner “must be in active practice,” WAC 246-945-350(2)(a)(i), and “[t]he authority granted must be within the scope of the practitioner[’s] current practice,” WAC 246-945-350(2)(a)(ii). Importantly, the practitioner must provide written guidelines or protocols that contain the “procedures, decision criteria, or plan the pharmacist is to follow when making therapeutic decisions[.]” WAC 246-945-350(2)(b)(ii); see also RCW 18.64.011(28). If the physician or physician assistant’s written guidelines or protocols are insufficient to allow a pharmacist licensed under RCW 18.64 to make an accurate diagnosis, then the physician or physician assistant may be engaging in unprofessional conduct and/or malpractice. See RCW 7.70.040; RCW 18.130.180(4).

            The limitations on the ability to enter into CDTAs raise unique questions in the context of physician assistants. Physician assistants may practice medicine only pursuant to a delegation agreement and “only to the extent permitted by the” Washington Medical Commission. RCW 18.71A.030(1).[3] A physician assistant is not necessarily authorized to prescribe drugs. See WAC 246-918-035. Additionally, a physician assistant’s scope of practice is necessarily limited by a delegation agreement. RCW 18.71A.030; see also WAC 246-918-055. While physician assistants may, in appropriate circumstances, enter into CDTAs with pharmacists, a physician assistant’s authority will have to be determined on a case-by-case basis.

            You have asked whether there is a statutory or administrative requirement for direct contact between the non-pharmacist practitioner and the patient before drug therapy can be initiated or modified under a CDTA. We are not aware of a statutory or regulatory provision that requires physician or other provider contact in every case before drug therapy can begin under an agreement. While a practitioner may include a requirement for such contact in the written

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guidelines or protocols, neither RCW 18.64.011(28) nor WAC 246-945-350 require it. There may, however, be instances where the failure of the written guidelines or protocols to require direct contact would amount to unprofessional conduct and/or malpractice. See RCW 7.70.040; RCW 18.130.180(4).

            The legislature has provided authority for pharmacists and other practitioners to enter into CDTAs under which pharmacists may “initiat[e] and modify[]” drug therapy pursuant to “written guidelines and protocols” established by practitioners. RCW 18.64.011(28). The Washington Medical Commission and the Pharmacy Quality Assurance Commission retain important roles in regulating the adequacy of their respective members’ performance of their functions under CDTAs. Additionally, the legislature may revisit, at any time, the statutory authority permitting CDTAs, and this is certainly an area that would benefit from greater statutory clarity.

            We trust that the foregoing will be useful to you.

ROBERT W. FERGUSON
Attorney General

s/ Karl D. Smith

KARL D. SMITH
Deputy Solicitor General
360-664-2510

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