(1) A pharmacist planning to exercise prescriptive authority in his or her practice (see RCW 18.64.011(11)) by initiating or modifying 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 must have on file at his/her place of practice a properly prepared written guideline or protocol indicating approval has been granted by a practitioner authorized to prescribe. A copy of the written guideline or protocol must also be on file with the board of pharmacy.

(2) For purposes of pharmacist prescriptive authority under RCW 18.64.011(11), a written guideline or protocol is defined as an agreement in which any practitioner authorized to prescribe legend drugs delegates to a pharmacist or group of pharmacists authority to conduct specified prescribing functions. Any modification of the written guideline or protocol shall be treated as a new protocol. It shall include:

(a) A statement identifying the practitioner authorized to prescribe and the pharmacist(s) who are party to the agreement. The practitioner authorized to prescribe must be in active practice, and the authority granted must be within the scope of the practitioners' current practice.

(b) A time period not to exceed 2 years during which the written guideline or protocol will be in effect.

(c) A statement of the type of prescriptive authority decisions which the pharmacist(s) is (are) 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 procedures, decision criteria, or plan the pharmacist(s) is (are) to follow when making therapeutic decisions, particularly when modification or initiation of drug therapy is involved.

(d) A statement of the activities pharmacist(s) is (are) to follow in the course of exercising prescriptive authority, including documentation of decisions made, and a plan for communication or feedback to the authorizing practitioner concerning specific decisions made. Documentation may occur on the prescription record, patient drug profile, patient medical chart, or in a separate log book.