Date of Adoption: October 12, 2000.

Purpose: To amend rules pertaining to patient counseling by pharmacists to promote appropriate use of medications by patients.

Citation of Existing Rules Affected by this Order: Amending WAC 246-869-220.

Statutory Authority for Adoption: RCW 18.64.005(7).

Adopted under notice filed as WSR 00-16-108 on August 2, 2000.

Changes Other than Editing from Proposed to Adopted Version: Rule was amended to clarify that the pharmacist is not responsible for determining "the optimal therapeutic outcome" for any patient. The pharmacist is responsible for determining the amount of counseling necessary to promote the safe and effective administration of a medication to facilitate an appropriate therapeutic outcome.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 1, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 1, Repealed 0.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 1, Repealed 0. Effective Date of Rule: Thirty-one days after filing.

November 15, 2000

C. A. Leon Alzola

Chair

OTS-4023.2

AMENDATORY SECTION(Amending Order 277B, filed 5/28/92, effective 6/28/92)

WAC 246-869-220   Patient ((information)) counseling required.   ((Except in those cases when the prescriber has advised that the patient is not to receive specified information regarding the medication:

     (1) In order to assure the proper utilization of the medication or device prescribed, with each new prescription dispensed by the pharmacist, in addition to labeling the prescription in accordance with the requirements of RCW 18.64.245 and WAC 246-869-210, the pharmacist must:

     (a) Orally explain to the patient or the patient's agent the directions for use and any additional information, in writing if necessary, for those prescriptions delivered inside the confines of the pharmacy; or

     (b) Explain by telephone or in writing for those prescriptions delivered outside the confines of the pharmacy.

     (2) In those instances where it is appropriate, when dispensing refill prescriptions, the pharmacist shall communicate with the patient or the patient's agent, by the procedure outlined in subsection (1)(a) or (b) of this section or the patient's physician regarding adverse effects, over or under utilization, or drug interaction with respect to the use of medications.

     (3) Subsections (1) and (2) of this section shall not apply to those prescriptions for inpatients in hospitals or institutions where the medication is to be administered by a nurse or other individual authorized to administer medications.

     (4) In the place of written statements regarding medications, the pharmacist may use abstracts of the Patient USP DI 1988 edition, or comparable information.)) The purpose of this counseling requirement is to educate the public in the use of drugs and devices dispensed upon a prescription.

     (1) The pharmacist shall directly counsel the patient or patient's agent on the use of drugs or devices.

     (2) For prescriptions delivered outside of the pharmacy, the pharmacist shall offer in writing, to provide direct counseling and information about the drug, including information on how to contact the pharmacist.

     (3) For each patient, the pharmacist shall determine the amount of counseling that is reasonable and necessary under the circumstance to promote safe and effective administration of the medication and to facilitate an appropriate therapeutic outcome for that patient from the prescription.

     (4) This rule applies to all prescriptions except where a medication is to be administered by a licensed health professional authorized to administer medications.

[Statutory Authority: RCW 18.64.005. 92-12-035 (Order 277B), § 246-869-220, filed 5/28/92, effective 6/28/92. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. 91-18-057 (Order 191B), recodified as § 246-869-220, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005. 89-04-016 (Order 223), § 360-16-265, filed 1/23/89.]

© Washington State Code Reviser's Office