Sec. 10.34.29.02. Content of Protocol

A. A protocol shall:

(1) Be:

(a) Written; and

(b) Condition or disease-state specific; and

(2) Contain the following:

(a) The condition that the protocol is designed to manage;

(b) A list of medications that may be used under the auspices of the protocol;

(c) Monitoring parameters including laboratory tests for the:

(i) Condition; and

(ii) Medication employed;

(d) A list of circumstances requiring contact with the authorized prescriber or authorized prescribers who are a party to the prescriber-pharmacist agreement;

(e) A statement prohibiting substitution of a chemically dissimilar drug product by the pharmacist for the product prescribed by the authorized prescriber unless permitted in the therapy management contract;

(f) A list of circumstances under which the pharmacist may alter doses, modify the treatment regimen, or switch the agent under the terms of the therapy management contract;

(g) Information to be documented;

(h) A listing of provisions within the protocol that may be customized within a therapy management contract; and

(i) An action plan for situations when the pharmacist encounters a situation that is not addressed in the protocol.

B. A protocol may authorize:

(1) The modification, continuation, and discontinuation of drug therapy;

(2) The ordering of laboratory tests;

(3) Other patient care management measures related to monitoring or improving the outcomes of drug or device therapy; and

(4) For protocols by a licensed physician and licensed pharmacist, the initiation of drug therapy under written, disease-state specific protocols.

C. A protocol may not authorize acts that exceed the scope of practice of the parties to the prescriber-pharmacist agreement.

D. Technical modifications to the protocol shall be registered with the Board of Pharmacy within 30 days of the technical modification.