HEALTH CARE AUTHORITY

RCW 41.05.021 (1)(((a))) (b)(iii) and 70.14.050 authorize the ((administrator)) director to establish an independent Washington state pharmacy and therapeutics committee within the health care authority to evaluate available evidence of the relative safety, efficacy and the effectiveness of prescription drugs within a class of prescription drugs, in the development of an evidence-based prescription drug program for participating state purchased health care programs. This section requires the ((administrator)) director to adopt rules governing practitioner endorsement and use of ((any)) the Washington preferred drug list developed as part of the prescription drug program.

When used in this chapter:

(1) "Appointing authority" ((shall)) means the following ((persons)) people acting jointly: The ((administrator)) director of the health care authority((, the secretary of the department of social and health services,)) and the director of the department of labor and industries.

(2) "Committee" means the independent Washington state pharmacy and therapeutics committee created by RCW 41.05.021 (1)(((a)))(b)(iii) and 70.14.050. At the election of the ((department of social and health services)) health care authority, the committee may serve as the drug use review board provided for in WAC ((388-530-1850)) 182-530-4000.

(3) "Drug" means the term as it is defined in RCW 69.41.010 (((9) and (12))).

(4) "Endorsing practitioner" means a practitioner who ((has reviewed the preferred drug list and)) has notified the health care authority that he or she ((has agreed)) agrees to allow therapeutic interchange ((of a preferred drug for any nonpreferred drug in a given therapeutic class)).

(5) "Practitioner" means a health care provider, except a veterinarian, as defined at RCW 18.64.011(((9))).

(6) "Preferred drug" means a drug selected by the appointing authority for inclusion in the Washington preferred drug list used by applicable state agencies for state purchased health care programs.

(7) (("Preferred drug list" or "PDL" means the list of drugs selected by the appointing authority to be used by applicable state agencies as the basis for the purchase of drugs in state purchased health care programs.

(8))) "Prescription" has the meaning set forth in RCW 18.64.011(((8))).

(((9))) (8) "Refill" means the continuation of therapy with the same drug, ((())including the renewal of a previous prescription or adjustments in dosage(() when a prescription is for an antipsychotic, antidepressant, chemotherapy, antiretroviral, or immunosuppressive drug, or for the refill of a immunomodulator/antiviral treatment for hepatitis C for which an established, fixed duration of therapy is prescribed for at least twenty-four weeks but no more than forty-eight weeks)).

(((10))) (9) "State purchased health care" has the meaning set forth in RCW 41.05.011(((2))).

(12))) (10) "Therapeutic interchange" means to dispense((, with the endorsing practitioner's authorization, a therapeutic alternative to the)) a preferred drug in place of a prescribed nonpreferred drug within the same therapeutic class listed on the Washington preferred drug list.

(11) "Washington preferred drug list" or "WPDL" means the list of drugs selected by the appointing authority to be used by applicable state agencies as the basis for the purchase of drugs in state purchased health care programs.

The purpose of the committee is to evaluate the available evidence of the relative safety, efficacy, and effectiveness of prescription drugs within a class of prescription drugs and make recommendations to the appointing authority for its deliberation in the development of the Washington preferred drug list established in RCW 70.14.050.

(1) Meetings of the pharmacy and therapeutics committee ((shall in all respects)) comply with the provisions of the Open Public Meetings Act, chapter 42.30 RCW, and ((shall be)) are subject to the provisions of the Administrative Procedure Act, chapter 34.05 RCW, as applicable.

(2) The pharmacy and therapeutics committee ((shall)) constitutes a technical review committee created to facilitate the development, acquisition, or implementation of ((a)) the Washington preferred drug list, for the purposes of state purchased health care under RCW 41.05.026, and ((as such)) may hold an executive session in accordance with chapter 42.30 RCW during any regular or special meeting to discuss information submitted in accordance with RCW 41.05.026 (((1) through (5))).

(1) The committee ((shall)) consists of no fewer than ten members appointed by the appointing authority.

(2) The appointing authority has the sole right to appoint committee members and may terminate appointment of any member at any time during the term.

(3) The appointing authority ((will)) makes appointments to the committee from a pool of interested applicants. Interested ((persons will be)) people are provided an opportunity to submit applications to the appointing authority.

(4) Members ((shall)) enter into an agreement with the health care authority at the time of their appointment to the committee and ((shall)) act in accordance with all of its terms and conditions. Failure to do so may result in termination of the appointment.

(5) The membership composition at all times ((shall be)) is consistent with applicable federal requirements ((under the federal Social Security Act, Title 19 § 1927 and the requirements of the department of social and health services medical assistance administration)) for its drug utilization review board((. Therefore,)) under the federal Social Security Act, Title 19 Sec. 1927 and the requirements of the health care authority. Pharmacists and physicians each ((shall)) represent at least thirty-one percent, but no more than fifty-one percent of committee membership respectively.

(6) Members must be actively practicing in their clinical area of expertise throughout the entire term of their appointments.

(7) Members must have knowledge and expertise in one or more of the following:

(a) Clinically appropriate prescribing of covered outpatient drugs;

(b) Clinically appropriate dispensing and monitoring of covered outpatient drugs;

(c) Drug use review;

(d) Medical quality assurance;

(e) Disease state management; or

(f) Evidence-based medicine.

(8) Members of the committee ((shall)) must not be employed by a pharmaceutical manufacturer, a pharmacy benefits management company, or by any state agency administering state purchased health care programs during their terms ((shall)) and must not have been so employed ((and)) for eighteen months prior to their appointment.

(9) A member ((shall)) must not have a substantial financial conflict of interest including any interest in any pharmaceutical company, including the holding of stock options or the receipt of honoraria or consultant moneys. The appointing authority in its sole discretion may disqualify any potential member if it determines that a substantial conflict of interest exists.

(10) As part of the application process, prospective committee members ((shall)) must complete a conflict of interest disclosure form, provided by the appointing authority, and after appointment, annually by July 1st of each year. Members must keep their disclosure statements current and provide updated information whenever circumstances change.

(11) Committee members must agree to keep all proprietary information confidential.

(1) Members ((shall be)) are appointed to a term of three years and ((shall)) serve until a successor is ((duly)) appointed. A member may be reappointed to one additional three-year term for a total of six years. One year after the end of a six-year term, a person is eligible for appointment to one additional three-year term.

(2) Committee members serve staggered three-year terms. Of the initial appointees, in order to provide for staggered terms, some members may be appointed initially for less than three years. If the initial appointment is for less than twenty-four months, that period of time ((shall not be)) is not counted toward the limitation of years of appointment described in subsection (1) of this section.

(3) Vacancies on the committee will be filled for the balance of the unexpired term from nominee lists for the appropriate committee category as provided under WAC 182-50-025.

(4) Members of the committee ((will be)) are compensated for participation in the work of the committee in accordance with a personal services contract executed after appointment and prior to commencement of activities related to the work of the committee.

Committee members ((shall)):

(1) Select a chair and a vice-chair from among the committee membership.

(2) Meet at least quarterly and may meet at other times at the discretion of the chair.

(3) Adopt a plan of operation that sets forth the policies and procedures established by the committee to develop an evidence-based prescription drug program as authorized by state law for approval by the appointing authority.

(4) Operate according to the plan of operation as approved by the appointing authority.

(1) When filling prescriptions for participating state purchased health care programs, pharmacists ((shall dispense a preferred drug in place of a drug not included in the preferred drug list in a given therapeutic class whenever pharmacists receive a prescription from)) must make a therapeutic interchange if the prescription is prescribed by an endorsing practitioner except:

(a) If the endorsing practitioner ((determines the nonpreferred drug is medically necessary by indicating)) indicates "dispense as written" on the nonpreferred prescription; ((or))

(b) If the prescription is a refill of an antipsychotic, antidepressant, antiepileptic, chemotherapy, antiretroviral, ((or)) immunosuppressive drug, or ((for the refill of a)) an immunomodulator/antiviral treatment for hepatitis C ((for which an established, fixed duration of therapy is prescribed for at least twenty-four weeks but no more than forty-eight weeks)); or

(c) If the pharmacy and therapeutics committee has determined that therapeutic interchange is not clinically appropriate for a specific drug or drug class on the Washington preferred drug list.

(2) When a therapeutic interchange is made, the pharmacist ((shall)) must notify the endorsing practitioner of the specific drug and dose dispensed.